ISPOR 19th Annual European Congress - biznes.edu.pl · Invited Speaker and Award Recipient...

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ISPOR 19th Annual European Congress29 October - 2 November 2016

Austria Center Vienna Vienna, Austria

Program and SCHEdULE oF EVEnTS

Managing Access to Medical Innovation: Strengthening the Methodology-Policy Nexus

#ISPORVienna

ISPOR CONFERENCE APP: SEE PAgE 8

NEtwORk: ISPOR2016 / PASSwORd: vienna16

www.ispor.org

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The International Society for Pharmacoeconomics and Outcomes Research (ISPOR) is the leading global scientific and educational organization for health economics and outcomes research (HEOR). ISPOR’s mission is to promote HEOR excellence to improve decision making for health globally.

ISPOR Strategic Pillars

ISPOR MembershipISPOR has a 20+ year legacy as an unbiased organization of more than 20,000 individual and chapter members. ISPOR promotes HEOR excellence through its:

• Scientific meetings and conferences • Online tools

• Peer-reviewed journals • Scientific and health policy groups

• Educational programs • Regional consortia, networks, and chapters

• Roundtables, councils, and collaborative alliances • Dialog with payers and health care decision makers

About ISPOR

© 2016 International Society for Pharmacoeconomics and Outcomes Research (ISPOR)

Additional information on ISPOR and membership benefits can found at www.ispor.org.

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Dear Colleagues,

Welcome to Vienna and ISPOR’s 19th Annual European Congress, the largest international gathering of health economists and outcomes researchers with more than 5,000 attendees from over 100 countries.

Over the next week you will engage and exchange ideas with global leaders, policy makers, regulators, researchers, academicians, payers, decision makers, patients, and patient groups. This multi-stakeholder group represents ISPOR’s 20,000 members and regional chapter members invested in using science and research to make better health care decisions.

ISPOR’s global reach is critically important and positions us to have a positive impact on health globally—and not just by sheer numbers but by the quality of our science. The medical product and decision processes that we study are based on information—about how a molecule affects the body or about how well an HTA process works—and the knowledge created is a global public good, potentially benefitting the over 7 billion people on the planet.

This year’s engaging and stimulating program is focused on the important theme, Managing Access to Medical Innovation: Strengthening the Methodology-Policy Nexus. With health care systems in Europe and elsewhere under increasing cost and performance pressures, the issues that we will address here are very timely. Please join me in thanking our dedicated colleagues—including the Program Committee Co-Chairs, Hans-Georg Eichler, MD, MSc, European Medicines Agency, London, UK and Tomasz Hermanowski, PhD, Medical University of Warsaw, Warsaw, Poland, and the Research, Issue Panel and Workshop Review Committee Co-Chairs—responsible for guiding the vetting and selection of the high quality and relevant content presented at this meeting. As a member-driven organization, the contributions of hundreds of ISPOR members result in our outstanding meetings with rich plenary sessions, compelling issue panels and forums, practical workshops, podium and poster presentations, and pre-Congress short courses, taught by world-class faculty.

In terms of future ISPOR meetings, please plan to join us at our upcoming meetings. ISPOR’s 22nd International Meeting will be held in Boston, MA, USA, May 20-24, 2017, the 6th Latin America Conference is planned for São Paulo, Brazil, September 15-17, 2017, and next year’s Annual European Congress will be held in Glasgow, Scotland from November 4-8, 2017.

Thank you for participating in the 19th Annual European Congress. In addition to the networking and learning, I hope that you will make time to experience the art, music, architecture, and culinary offerings in the beautiful city of Vienna. Have a great conference!

Sincerely,

Lou Garrison, PhD 2016-2017 ISPOR President

Translating Outcomes Research to Health Care Decisions

International Society for Pharmacoeconomics and Outcomes Research

Garrison

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Translating Outcomes Research to Health Care Decisions

International Society for Pharmacoeconomics and Outcomes Research

We are pleased to welcome you to Vienna for the ISPOR 19th Annual European Congress. The theme of the Congress, “Managing Access to Medical Innovation: Strengthening

the Methodology-Policy Nexus,” will be centered on more extensive use of health technology assessment in country-level decision making. Given the many learnings and improved methods from at least three decades of health economics and outcomes research, how can this science be coordinated with regulatory decision-making, be leveraged for more creative technology financing, and help satisfy patient preferences for new technology?

Formal interactions and collaboration between regulators and the HTA bodies that inform payers have only started in recent years in the European Union (EU) and are mostly in a pilot stage. In the First Plenary Session, “What Synergies Could Be Created between Regulatory and Health Technology Assessments?” speakers will explore unrealised synergies in the work and processes of regulators and HTA bodies and also address the roadblocks in the EU health sector ecosystem that need to be removed in order to realise the synergies while respecting their different roles.

Differential pricing is another timely topic across Europe. Currently, law in the European Union supporting the free movement of goods makes it difficult to maintain different prices in different countries. Countries have resorted to referencing prices in other countries to support their local pricing policies and negotiations, and have developed schemes that allow them to obtain confidential discounts. In our Second Plenary Session, “Differential Pricing of Medicines in Europe: Implications for Access, Innovation, and Affordability?”, speakers will explore options for a defined and systematic approach to promoting efficient differential pricing in Europe. Operational and political feasibility are key considerations which will be discussed.

Our Third Plenary Session, “How to Control Costs and Improve Access to Medicines: Lessons from the InterQuality Project”, will describe a number of important themes emerging from the InterQuality Project including equity of access to health services and medicines and integrating patient preferences into health technology assessment.

Along with these plenaries, we hope you will be an active participant during the two-day short-course program and main meeting program consisting of issue panel, workshop, podium, poster, forum, and symposia presentations.

The European Congress is also a great opportunity for networking, featuring this year’s ISPOR Social Event at Grand Festival Hall (Festsaal) in Vienna’s City Hall (Wiener Rathaus). We hope you join your colleagues for an evening of dinner and dancing at this historic Vienna landmark.

Vienna is a vibrant city and we urge you to make time to do some sightseeing. With over 100 museums, the capital of Austria is both an old and new city. From exploring “Imperial Vienna” to taking in views from The Giant Ferris wheel or Danube Tower, there is something for everyone.

We hope that you enjoy the Congress and your travels to Vienna!

Sincerely,

Hans-Georg Eichler, MD, MSc and Tomasz Hermanowski, PhD ISPOR 19th Annual European Congress Program Committee Co-Chairs

Eichler Hermanowski

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ISPOR 19th Annual European Congress29 October - 2 November 2016, Vienna, Austria

CONGRESS PROGRAM COMMITTEE

PROGRAM COMMITTEE CO-CHAIRS

Hans-Georg Eichler, MD, MSc Senior Medical Officer, European Medicines Agency (EMA), London, Uk

Tomasz Hermanowski, PhD InterQuality Project Leader and Professor & Head, department of Pharmacoeconomics, Medical University of warsaw, warsaw, Poland

RESEARCH REVIEW COMMITTEE CO-CHAIRS

Paolo A. Cortesi, PhDResearcher, Research Centre on Public Health, University of Milano - Bicocca, Milan, Italy

Anthony J. Hatswell, MSc Principal Consultant (HtA Methodology), BresMed, department of Statistical Science, University College London, Uk, Sheffield, Uk

Rok Hren, PhD Assistant Professor, University of Ljubljana, Ljubljana, Slovenia

Ursula Rochau, MSc Assistant Professor, Institute of Public Health, Medical decision Making and Health technology Assessment, department of Public Health, Health Services Research and Health technology Assessment, UMIt, Hall i.t, tirol, Austria

ISSUE PANEL REVIEW COMMITTEE CO-CHAIRS

Simona de Portu, MSc Health Economic Manager, diabetes, EMEA, Medtronic International trading Sàrl, tolochenaz, Switzerland

Gottfried Endel, MD Head, HtA department, Main Association of Austrian Social Security Institutions, Vienna, Austria

Jan Geissler Chair & Co-Founder, CML Advocates Network, Founder & CEO, Patvocates, and director, European Patients’ Academy on therapeutic Innovation, Munich, germany

WORKSHOP REVIEW COMMITTEE CO-CHAIRS

Tara Symonds, PhD COA Strategic Lead & Partner, Clinical Outcomes Solutions Ltd., Folkestone, kent, Uk

Allan Wailoo, PhD Professor of Health Economics, University of Sheffield and director, NICE decision Support Unit, Sheffield, Uk

Anna Zawada, MSc director of the Office of transparency and tariff Councils, Agency for Health technology Assessment and tariff System (AOtMit), warsaw, Poland

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Letter from the ISPOR President 3

Letter from the ISPOR 19th Annual European Congress Program Committee Co-Chairs 4

Congress Program Committee 5

Table of Contents 6

Event Sponsors 7

Program & Schedule of Events

Saturday, 29 October 11

Sunday, 30 October 17

Monday, 31 October 27

Tuesday, 1 November 45

Wednesday, 2 November 63

Invitational Group Meetings 75-76

Research Poster Presentations Overview 78

Exhibit Program Overview 79

Exhibiting Organizations and Locations 80

Research Poster Presentations and Exhibit Program Floor Plan 81

Invited Speaker and Award Recipient Biographical Information 85

ISPOR 19th Annual European Congress Review Committee Members 93

ISPOR Leadership Directory 105

Key Information 109

Congress Rooms Floor Plan 114


TABLE OF CONTENTS

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EVENT SPONSORS

PLATINUM LEVEL SPONSORS

GOLD LEVEL SPONSORS

SILVER LEVEL SPONSORS

BRONzE LEVEL SPONSORS

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ISPOR Congress Mobile AppWi-Fi Network: ISPOR2016 / Password: vienna16

APP FEATURES• Update your “electronic business card” (personal profile)

• Create a personalized congress schedule

• Search the congress program by scientific topic, keyword, or speaker

• Connect with other attendees by sending messages (while keeping your email address private)

• Find exhibitors and sponsors to connect with by viewing their virtual booths

DOWNLOAD INFORMATIONDownload the mobile app on your smartphone or tablet

SeArch:

ISPOR 2016 Meetings

LOGIN INFORMATIONUse the same details used for the myISPORVienna web pages.

NEEd HELP?

Select “Need help logging in?” on the login screen.

No smartphone or tablet?

Use your laptop:

https://myisporvienna.zerista.com/

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SATURDAY, 29 OCTOBER page 11

SUNDAY, 30 OCTOBER page 17

MONDAY, 31 OCTOBER page 27

TUESDAY, 1 NOVEMBER page 45

WEDNESDAY, 2 NOVEMBER page 63

PROGRAM & SCHEDULE OF EVENTS

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ISPOR Vienna features nearly 2,500 presentations!

- Pre-Congress Short Courses are training courses offered in 7 key HEOR topic areas and range in skill level from introductory to advanced. Continuing education credits are available. Separate registration is required.

- Plenary Sessions feature thought-provoking presentations on controversial or challenging topics relating to HEOR methodology issues, application of HEOR in health care decision making, and health policy.

- Educational Symposia are sponsored presentations that relate to ISPOR’s mission. The sponsor organization chooses a subject of interest to delegates and arranges suitable speakers.

- Poster Presentations sessions contain 475+ research posters per session that are arranged by disease, topic, or health care intervention and include an author discussion hour.

- Breakout Sessions

Issue Panels (n IP) show real debate and stimulate discussion on a new or controversial issue in HEOR.

Workshops (n W) discuss new and innovative applications in the conduct and use of HEOR, the latest on real-world data, health care policy, and clinical, economic, or patient-reported outcomes and patient-preference outcomes.

ISPOR Forums (n F) are presented by ISPOR Groups on country/regional health policy, scientific research/initiatives, good practice for outcomes research, research tools, publications, and initiatives.

Podium Presentations (n P) sessions consist of four 15-minute research presentations related to outcomes research on health care interventions, diseases, or health disorders.

Scientific Topics Tags

ISPOR has tagged sessions with particular scientific topics in the ISPOR Vienna mobile app and web platform to help identify presentations to attend based on interest.

Use the app to filter presentations by these topics and add sessions you’d like to attend to your personal schedule!

Health Economics

Health technology Assessment

Medical devices & diagnostics

Methods

Modeling

Patient Preference & Adherence

Policy

Pricing & Access

PROs & Patient Engagement

Real world data

Regional or Country

Research Studies*

Specific disease or drug Areas

*Podium Presentations Only

Search “ISPOR 2016 Meetings” in the App Store or google Play and log in with the email address used to register for the ISPOR 19th Annual European Congress.

Alternatively, the myISPORVienna.zerista.com website is mobile friendly and offers the same functionalities!

Program – New Format!You asked. We listened. New Scheduling Format for ISPOR Sessions!

In response to feedback from meeting attendees, ISPOR is implementing a new scheduling format. Specific

topics of interest (e.g., modeling, PROs, HTA, etc.) will now be available at multiple session times and in a variety of

presentation formats (e.g., Issue Panels, Workshops, and Podium Presentations). The objective is to give attendees

the opportunity to concentrate on their preferred areas of interest by offering a greater diversity of topics and

presentation types in each session time frame. We hope this new scheduling format better meets your needs so that

you get the most out of your ISPOR meeting experience.


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SCHEDULE AT-A-GLANCE 9:00-18:00 SHORT COURSE FULL dAY (Separate Registration Required)

Introduction to Health Economic / Pharmacoeconomic Evaluations Hall E1 (L0)

9:00-13:00 SHORT COURSE MORNING SESSION (Separate Registration Required)

Introduction to the Design & Analysis of Observational Studies of Treatment Effects Using Retrospective Data Sources Hall E2 (L0)

Introduction to Patient-Reported Outcomes Assessment: Instrument Development & Evaluation Hall K1 (L-2)

Introduction to Modeling Hall K2 (L-2)

Statistical Methods for Pharmacoeconomics & Outcomes Research Hall G1 (L-2)

Development of Conceptual Models Hall G2 (L-2)

Elements of Pharmaceutical / Biotech Pricing Hall F1 (L0)

11:00-11:15 COFFEE BREAK

13:00-14:00 LUNCH (Attendees on their own)

Café Motto (L0) available for grab-and-go lunch purchases.

14:00-18:00 SHORT COURSE AFTERNOON SESSION (Separate Registration Required)

Introduction to Health Technology Assessment Hall F1 (L0)

Meta-Analysis & Systematic Literature Review Hall G2 (L-2)

Cost-Effectiveness Analysis alongside Clinical Trials Hall G1 (L-2)

Use of Propensity Scores in Observational Studies of Treatment Effects Hall E2 (L0)

Collecting Health-State Utility Estimates for Economic Models in Clinical Studies Hall K2 (L-2)

Pharmacoeconomic Modeling – Applications Hall K1 (L-2)

Patient Registries Hall F2 (L0)


18:30-19:30 EdUCATIONAL SYMPOSIUM (Open to all attendees) Hall F2 (L0)

How to Speed Up Health Technology Assessment (HTA) Decision-Making in Oncology – Balancing Patient Access with Uncertainty over Data (Sponsored by Bristol-Myers Squibb)

The ISPOr Short course Program, offered in conjunction with ISPOr meetings around the world as a series of 4- and 8-hour training courses, is designed to enhance your knowledge and technique in seven key topic areas (“Tracks”) related to health economics and outcomes research. Short courses range in level from introductory to advanced and are taught by leading experts in the field, many with hands-on training opportunities! Separate Short course registration is required!

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SATURDAY, 29 OCTOBER 2016

9:00-18:00 SHORT COURSE FULL dAY (Separate Registration Required)

INTRODUCTION TO HEALTH ECONOMIC / PHARMACOECONOMIC EVALUATIONS Hall E1 (L0)

tRACk Economic Methods

LEVEL Introductory. This course is suitable for those with little or no experience with pharmacoeconomics.

FACULtY Lieven Annemans, PhD Econ, MSc Health, Senior Full Professor of Health Economics, ICHER (Interuniversity Center for Health Economics Research), ghent University - Brussels University, ghent, Belgium

COURSE dESCRIPtION this course is designed to teach health care professionals, industry executives and new researchers how to incorporate health economics/pharmacoeconomics into the development of innovations in health care. Participants will review the basic principles and concepts of health economic evaluations, and discuss how to collect and calculate data on costs and effects of different alternatives. Both modelling techniques and prospective health economic evaluations will be discussed. Special attention is moreover given to specific issues such as uncertainty analyses, discounting, perspective of the analysis, and to how health economic evaluations are important within the entire life cycle of health innovations.


INTRODUCTION TO THE DESIGN & ANALYSIS OF OBSERVATIONAL STUDIES OF TREATMENT EFFECTS USING RETROSPECTIVE DATA SOURCES Hall E2 (L0)

tRACk Observational Data Methods

LEVEL Introductory.

FACULtY Linus Jönsson, PhD, MD, MSc, Vice President, Medical Affairs & Clinical development Centres, H. Lundbeck A/S, Valby, denmark; Bradley C. Martin, PharmD, RPh, PhD, Professor & Head, division of Pharmaceutical Evaluation and Policy, University of Arkansas for Medical Sciences College of Pharmacy, Little Rock, AR, USA

COURSE dESCRIPtION Retrospective studies require strong principles of epidemiologic study design and complex analytical methods to adjust for bias and confounding. this course will provide an overview of the structures of commonly encountered retrospective data sources with a focus on large administrative data, as well as highlight design and measurement issues investigators face when developing a protocol using retrospective observational data. Approaches to measure and control for patient mix, including patient comorbidity and the use of restriction and stratification, will be presented. Linear multivariable regression, logistic regression, and propensity scoring analytic techniques will be presented and include examples using SAS code that can later be used by participants. this course is an introductory course designed to prepare participants to take intermediate and advanced observational research courses.

INTRODUCTION TO PATIENT-REPORTED OUTCOMES ASSESSMENT: INSTRUMENT DEVELOPMENT & EVALUATION Hall K1 (L-2)

tRACk Patient-Reported Outcomes Methods

LEVEL Introductory. This is an entry level course which assumes only a passing familiarity with patient-reported outcomes.

FACULtY Kellee Howard, MA, MSc, Senior Principal, Patient Reported Outcomes, ICON Commercialisation & Outcomes, San Francisco, CA, USA; Jennifer Petrillo, PhD, Associate director, HEOR, global Market Access, Biogen, Cambridge, MA, USA; Helen A. Doll, MSc DPhil, Senior Principal, Clinical Outcomes Assessments, ICON Commercialisation and Outcomes, San Francisco, CA, USA

COURSE dESCRIPtION Patient-reported outcomes (PROs) are widely used to evaluate the impact of health technologies, practice innovations, or changes in health policy from the patients’ perspective. this course is designed to familiarize people with the range and scope of what PROs are used for, how they are developed and evaluated, what they measure, and how PRO data can be used to support licensing and reimbursement applications. this includes generic and disease-specific measures of health-related quality of life (HRQL) as well as measures of patient preference, systems, functioning, utility, and treatment satisfaction. the faculty will describe the steps that researchers generally go through in order to develop and test a new PRO. this will include qualitative work, item generation and testing, and then validation. Finally, in the last hour, faculty will frame this in terms of what the FdA and EMEA expect to see when PROs form an important part of a licensing submission. In addition, faculty will describe the approach of bodies such as NICE and how they review PRO data and use it to guide reimbursement decisions.

Annemans

MartinJönsson

DollPatrilloHoward

Indicates hands-on exercises requiring the use of your personal computer.

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Program & Schedule of Events: Saturday, 29 October


INTRODUCTION TO MODELING Hall K2 (L-2)

tRACk Modeling Methods

LEVEL Introductory. This course is designed for those with some familiarity with modeling techniques.

FACULtY Uwe Siebert, MD, MPH, MSc, ScD, Professor & Chair, department of Public Health and Health technology Assessment, UMIt - University for Health Sciences, Medical Informatics and technology, Austria, Adjunct Professor, Health Policy and Management, Harvard School of Public Health, Boston, MA, USA, and director, division for HtA, ONCOtYROL – Center for Personalized Cancer Medicine, Hall i.t., Austria

COURSE dESCRIPtION this course gives a brief overview of different decision-analytic model types and provides an introduction to Markov modeling techniques and their practical application in economic evaluation and outcomes research. Faculty will present analytic approaches including deterministic cohort simulation and Monte Carlo microsimulation, and will provide some technical instructions for modelers. Participants learn about the concepts of variability, uncertainty, probabilistic sensitivity analysis (PSA), and cost-effectiveness acceptability curves (CEAC). Additionally, faculty will use the recommendations of the ISPOR-SMdM Joint Modeling good Research Practices task Force to explore when and how modeling should be used in economic evaluation and which are the suitable model techniques.

STATISTICAL METHODS FOR PHARMACOECONOMICS & OUTCOMES RESEARCH Hall G1 (L-2)


LEVEL Introductory. This course is intended for participants with little (or rusty!) statistical training.

FACULtY Jim Lewsey, PhD, Reader, Medical Statistics and Programme director for HtA, Health Economics & technology Assessment, Institute of Health & wellbeing, University of glasgow, glasgow, Uk; Gerd K. Rosenkranz, PhD, Professor, Applied Mathematics, Probability theory, Statistics, Center for Medical Statistics, Informatics and Intelligent Systems, Medical University of Vienna, Vienna, Austria

COURSE dESCRIPtION this course will provide an introduction to statistical concepts with an emphasis on the use of techniques commonly employed in pharmacoeconomics and outcomes research. Faculty will begin by introducing the concept of random variables and will then proceed to discuss the foundations of statistical estimation and the testing of hypotheses, followed by a discussion of the importance of correlating between variables and the use of regression techniques. the differences between a classical (frequentist) approach to statistics and a Bayesian view of probability will also be outlined.

DEVELOPMENT OF CONCEPTUAL MODELS Hall G2 (L-2)


LEVEL Introductory.

FACULtY Neil Hawkins, PhD, CStat, Professor, Health Economics and Health technology Assessment, Institute of wellbeing, University of glasgow, glasgow, Uk; Elisabeth Fenwick, PhD, MSc, Principal, ICON Health Economics, Oxford, Uk; Paul Tappenden, PhD, MSc, Reader in Health Economic Modelling, Health Economics and decision Science, School of Health and Related Research (ScHARR), University of Sheffield, Sheffield, Uk; Beth Woods, MSc, Research Fellow, team for Economic Evaluation and Health technology Assessment (tEEHtA), Centre for Health Economics, University of York, Heslington, York, Uk; Mark S. Roberts, MD, MPP, Professor & Chair, department of Health Policy and Management, University of Pittsburgh graduate School of Public Health, Pittsburgh, PA, USA

COURSE dESCRIPtION within the context of health care, models may be used to inform decisions regarding reimbursement, pricing, and use of technologies. Models may be conceptual or quantitative: conceptual models identify and describe the important entities within a model, the nature of these entities and the relationships between them; quantitative models aim to represent these entities and their relationships numerically or mathematically. depending on the nature of a particular problem, a conceptual model may be sufficient to inform decisions regarding study design whereas a quantitative model may be needed to inform reimbursement decisions. the development of a clear conceptual model, an important pre-cursor to the development of quantitative models, is important is assisting to communicate and clarify the intent and structure of a proposed quantitative analysis. this course will reference and build on the report of the ISPOR-SMdM Modeling good Research Practices task Force on conceptual modeling. the course will review important practical aspects of the development of conceptual models using a series of case studies, which will illustrate the role of clear conceptual models in the iterative process of model development. the course will also illustrate the need to consider various aspects when developing conceptual models (including the decision problem, service framework, disease pathway, causal pathway, and quantitative model design aspects) and will provide overview of useful graphical tools for illustrating these aspects.

Siebert

RosenkranzLewsey

Woods

FenwickHawkins

Tappenden


Roberts

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ELEMENTS OF PHARMACEUTICAL / BIOTECH PRICING Hall F1 (L0)

tRACk Use of Pharmacoeconomic / Economic / Outcomes Research Information Methods

LEVEL Introductory. This course is designed for those with limited experience in the area of pharmaceutical pricing and will cover topics within a global context.

FACULtY Jack M. Mycka, global President & CEO, Medical Marketing Economics LLC (MME), Montclair, NJ, USA; Renato Dellamano, PhD, President, MME Europe & ValueVector (Value Added Business Strategies), Milan, Italy

COURSE dESCRIPtION this course will give participants a basic understanding of the key terminology and issues involved in pharmaceutical pricing decisions. It will cover the tools to build and document product value including issues, information, and processes employed (including pricing research), the role of pharmacoeconomics, and the differences in payment systems that help to shape pricing decisions. these tools will be further explored through a series of interactive exercises.





INTRODUCTION TO HEALTH TECHNOLOGY ASSESSMENT Hall F1 (L0)


LEVEL Introductory. This course is suitable for those with little or no experience with HTA.

FACULtY Uwe Siebert, MD, MPH, MSc, ScD, Professor & Chair, department of Public Health and Health technology Assessment, UMIt - University for Health Sciences, Medical Informatics and technology, Austria, Adjunct Professor, Health Policy and Management, Harvard School of Public Health, Boston, MA, USA, and director, division for HtA, ONCOtYROL – Center for Personalized Cancer Medicine, Hall i.t., Austria

COURSE dESCRIPtION this introductory course is designed to teach academic researchers, health policy decision makers, manufacturers, and clinicians about the key elements, methods, and language of health technology assessment (HtA). the course provides an overview of basic HtA principles including benefit assessment (biostatistics, clinical epidemiology, patient-relevant outcomes, risk-benefit assessment), economic evaluation (costing, cost-effectiveness analysis, pharmacoeconomic modeling, budget impact analysis, resource allocation), and ELSI (ethical, legal, and social implications). Using real world examples covering both drugs and devices, the course will review the practical steps involved in developing and using HtA reports in different countries and health care systems. group discussion will focus on the perspectives of different stakeholders and the implementation of HtA in health care decision making.

META-ANALYSIS & SYSTEMATIC LITERATURE REVIEW Hall G2 (L-2)

tRACk Outcomes Research Methods

LEVEL Intermediate

PREREQUISItE Previous attendance at the ISPOR Short Course “Statistical Methods for Pharmacoeconomics & Outcomes Research”, or equivalent knowledge, is recommended.

FACULtY Olivia Wu, PhD, MSc, deputy director, Health Economics and Health technology Assessment Research Unit, University of glasgow, glasgow, Uk; Neil Hawkins, PhD, CStat, Professor, Health Economics and Health technology Assessment, Institute of wellbeing, University of glasgow, glasgow, Uk

COURSE dESCRIPtION Meta-analysis may be defined as the statistical analysis of data from multiple studies for the purpose of synthesizing and summarizing results, as well as for quantitatively evaluating sources of heterogeneity and bias. A systematic literature review often includes meta-analysis and involves an explicit, detailed description of how a review was conducted. this course highlights and expounds upon four key areas: 1) impetus for meta-analysis and systematic reviews; 2) basic steps to perform a quantitative systematic review; 3) statistical methods of combining data; and 4) an introduction to methods for indirect comparisons. the material includes practical examples from the published literature relevant to pharmacoeconomic and PRO research. this course is designed for those with little experience with meta-analysis and includes interactive exercises.

DellamanoMycka

Siebert

HawkinsWu


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COST-EFFECTIVENESS ANALYSIS ALONGSIDE CLINICAL TRIALS Hall G1 (L-2)


LEVEL Introductory/Intermediate. Familiarity with economic evaluations will be helpful.

FACULtY Scott D. Ramsey, MD, PhD, Full Member, Cancer Prevention Program, Public Health Sciences division, Fred Hutchinson Cancer Research Center and Professor, School of Medicine, School of Pharmacy, and the Institute for Public Health genetics, University of washington, Seattle, wA, USA; Richard J. Willke, PhD, Chief Science Officer, International Society for Pharmacoeconomics and Outcomes Research (ISPOR), Lawrenceville, USA

COURSE dESCRIPtION the growing number of prospective clinical/economic trials reflects both widespread interest in economic information for new technologies and the regulatory and reimbursement requirements of many countries that now consider evidence of economic value along with clinical efficacy. this course will present the design, conduct, and reporting of cost-effectiveness analyses alongside clinical trials based on, in part, Good Research Practices for Cost-Effectiveness Analysis alongside Clinical Trials: The ISPOR RCT-CEA Task Force Reports. trial design, selecting data elements, database design and management, analysis, and reporting of results will all be presented. trials designed to evaluate effectiveness (rather than efficacy), as well as clinical outcome measures, will also be discussed, including how to obtain health resource use and health state utilities directly from study subjects and economic data collection fully integrated into the study. Analyses guided by an analysis plan and hypotheses, an incremental analysis using an intention to treat approach, characterization of uncertainty, and standards for reporting results will be presented.

USE OF PROPENSITY SCORES IN OBSERVATIONAL STUDIES OF TREATMENT EFFECTS Hall E2 (L0)


LEVEL Intermediate. This course is designed for those with little experience with this methodology but some knowledge of observational databases.

PREREQUISItE Previous attendance at the ISPOR short course “Introduction to the Design & Analysis of Observational Studies of Treatment Effects Using Retrospective Data Sources”, or equivalent knowledge, is recommended.

FACULtY John Seeger, PharmD, DrPH, Chief Scientific Officer, Epidemiology, Optum, waltham, MA, USA and Assistant Professor of Medicine, division of Pharmacoepidemiology and Pharmacoeconomics, Harvard Medical School/Brigham and women’s Hospital, Boston, MA, USA; Rishi Desai, PhD, MS, Instructor of Medicine, Harvard Medical School and Associate Epidemiologist, division of Pharmacoepidemiology and Pharmacoeconomics, Brigham and women’s Hospital, Boston, MA, USA

COURSE dESCRIPtION In observational research, issues of bias and confounding relate to study design and analysis in the setting of non-random treatment assignment where compared subjects might differ substantially with respect to comorbidities. No control over the treatment assignment and the lack of balance in the covariates between the treatment and control groups can produce confounded estimates of treatment effect. Faculty will explain how propensity scores can be used to mitigate confounding through standard observational approaches (restriction, stratification, matching, regression, or weighting). the advantages and disadvantages of standard adjustment relative to propensity score-based methods will be discussed. details of propensity score methodology (variable selection, use, and diagnostics) will also be discussed. the course will also elaborate briefly on risk adjustment models that collapse predictors of outcomes and their use relative to propensity scores.

NEW! COLLECTING HEALTH-STATE UTILITY ESTIMATES FOR ECONOMIC MODELS IN CLINICAL STUDIES Hall K2 (L-2)

tRACk Patient Preference Methods

LEVEL Intermediate. This course is for those with some experience with quality of life measures in health economic evaluation.

FACULtY Sorrel Wolowacz, PhD, Head, European Health Economics, RtI Health Solutions, Manchester, Uk; Andrew Briggs, DPhil, MSc, william R. Lindsay Chair of Health Economics, Health Economics & Health technology Assessment, Institute of Health & wellbeing, University of glasgow, glasgow, Uk; Andrew Lloyd, DPhil, director, Bladon Associates Ltd., Oxford, Uk; Lynda Doward, MRes, Head, European Health Economics, Patient-Reported Outcomes, RtI Health Solutions, Manchester, United kingdom

COURSE dESCRIPtION Health state utility (HSU) estimates are among the most important and uncertain data inputs in cost-utility models and are increasingly being used to inform health technology assessment, pricing, and reimbursement decisions in many countries. the ISPOR Outcomes Research Guideline, Collecting Health-State Utility Estimates for Economic Models in Clinical Studies, has been developed recently by an ISPOR task Force to help researchers plan the collection and analysis of health utility data in clinical studies in order to provide high quality HSU estimates appropriate for economic. this short course provides an opportunity to review and discuss the content of the guideline, with a view to improving the effectiveness of utility data measurement in clinical studies. the focus will be on optimizing the collection of utility data to provide HSU estimates for economic models.

DesaiSeeger

Doward

BriggsWolowacz

Lloyd

WillkeRamsey

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Specifically, the course will address key challenges surrounding study design, data collection and analysis. this will include how to anticipate and address common issues that may affect data quality, alignment with the needs of economic model, acceptability to the model audience, and how to apply good research practices for HSU estimation in future research. the course will not cover the fundamentals of utility theory, the development of generic or condition-specific preference-based multi-attribute utility instruments, or how to perform time trade-off or standard gamble experiments. Nor will it cover statistical methods for mapping/cross-walking from a condition-specific HRQL measure. the course will be of value for researchers actively involved in the design or implementation of HSU data collection or analysis, those involved in patient-reported outcomes research, economic modelling, economic evaluation or health technology assessment.

PHARMACOECONOMIC MODELING – APPLICATIONS Hall K1 (L-2)


LEVEL Intermediate

PREREQUISItE Previous attendance at, or familiarity with the topics discussed in the ISPOR Short Course, “Introduction to Modeling”, is required.

FACULtY Shelby Corman, PharmD, MS, BCPS, Associate director, Health Economics and Outcomes Research, Pharmerit International, Bethesda, Md, USA; Mark S. Roberts, MD, MPP, Professor & Chair, department of Health Policy and Management, University of Pittsburgh graduate School of Public Health, Pittsburgh, PA, USA

COURSE dESCRIPtION during this course, students will have hands-on experience in constructing and analyzing a decision analysis tree – including Markov models and one-way, two-way, and probabilistic sensitivity analysis – using treeAge Pro software. Instructors will provide a series of short lecture-based sessions followed by the opportunity for participants to engage in model-building exercises using the software. Sessions will demonstrate how to build a simple decision tree, extend a decision model to incorporate costs and utilities, and replace terminal nodes with state-transition (Markov) models to represent time-varying events. Other more advanced topics will be covered if time permits. Participants are required to bring their personal laptops equipped with software provided to course registrants.

PATIENT REGISTRIES Hall F2 (L0)


LEVEL Introductory. This course is designed for those with some or no experience with patient registries.

FACULtY Leanne Larson, MHA, Vice President & global Head, Observational Research, PAREXEL International, waltham, MA, USA; Angela Vinken, MSc, Senior director, Observational Research, PAREXEL International, Amsterdam, the Netherlands

COURSE dESCRIPtION this course is designed to provide an overview of patient registries and their applications in identifying real world clinical, safety, and patient-perspective issues. the advantages and disadvantages of patient registry versus other real world data collection will be presented. the course will address safety and clinical objectives as well as regulatory trends and requirements. key operational components, challenges, and measures of program success will be discussed. Management issues, including creating effective partnerships with patient-oriented organizations and facilitating long-term program operations within a changing organizational structure, will be addressed.


18:30-19:30 EdUCATIONAL SYMPOSIUM (Open to all attendees) Hall F2 (L0)

HOW TO SPEED UP HEALTH TECHNOLOGY ASSESSMENT (HTA) DECISION-MAKING IN ONCOLOGY – BALANCING PATIENT ACCESS WITH UNCERTAINTY OVER DATA

this symposium will discuss how to effectively assess the clinical and economic value of novel cancer therapies, in order to improve patient access to these innovative treatments. the challenges which HtA bodies face will be reviewed, including the issue of balancing rapid patient access with uncertainty over less mature evidence.

Moderator: David Chao, BMBCh, FRCP DPhil, the Royal Free Hospital, London, Uk

Speakers: Isabelle Durand-Zaleski, PhD, Professor of Health Economics, Hôpital de l’Hotel dieu, URC Eco, Paris, France Martin Buxton, BA, Emeritus Professor, Health Economics Research group (HERg), Brunel University, Uxbridge, Uk

Sponsored by: Bristol-Myers Squibb

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SCHEDULE AT-A-GLANCE 8:00-17:00 SHORT COURSE FULL dAY (Separate Registration Required)

Bayesian Analysis – Overview and Applications Hall G1 (L-2)


Using DICE Simulation for Health Economic Analyses Hall G2 (L-2)

Use of Instrumental Variables in Observational Studies of Treatment Effects Hall K1 (L-2)

Mixed Methods Approaches for Patient-Centered Outcomes Research: Group Concept Mapping Hall K2 (L-2)

Transferability of Cost-Effectiveness Data between Countries Hall E1 (L0)

Conjoint Analysis – Theory & Methods Hall E2 (L0)

Budget Impact Analysis I: A 6-Step Approach Hall D (L-2)

Risk-Sharing / Performance-Based Arrangements for Drugs and Other Medical Products Hall F1 (L0)

Understanding Survival Modeling with Application to HTA Hall F2 (L0)





Budget Impact Analysis II: Applications & Design Issues Hall D (L-2)

Advanced Methods for Addressing Selection Bias in Real-World Effectiveness and Cost-Effectiveness Studies Hall K1 (L-2)

Introduction to the Economic Analysis of Diagnostics Hall E1 (L0)

Network Meta-Analysis in Relative Effectiveness Research Hall K2 (L-2)

Risk-Sharing/Performance-Based Arrangements in Central & Eastern Europe: Implementation of Managed Entry Agreements Hall F1 (L0)

Adjusting for Time-Dependent Confounding and Treatment Switching Bias in Observational Studies and Clinical Trials: Purpose, Methods, Good Practices and Acceptance in HTA Hall G2 (L-2)

Reimbursement Systems for Pharmaceuticals in Europe Hall E2 (L0)

Using Multi-Criteria Decision Analysis in Health Care Decision Making: Approaches & Applications Hall F2 (L0)


17:30-18:30 EdUCATIONAL SYMPOSIUM (Open to all attendees) Hall D (L-2)

The Evolving Role of Real-World Data in Evidence Synthesis to Meet Demands for Evidence-Based Medicine (Sponsored by ICON plc)

18:45-19:45 EdUCATIONAL SYMPOSIUM (Open to all attendees) Hall D (L-2)

Balkans Towards Tomorrow: Paving Better Access for Patients (Sponsored by Takeda)

The ISPOr Short course Program, offered in conjunction with ISPOr meetings around the world as a series of 4- and 8-hour training courses, is designed to enhance your knowledge and technique in seven key topic areas (“Tracks”) related to health economics and outcomes research. Short courses range in level from introductory to advanced and are taught by leading experts in the field, many with hands-on training opportunities! Separate Short course registration is required!

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SUNDAY, 30 OCTOBER 2016

8:00-17:00 SHORT COURSE FULL dAY (Separate Registration Required)

BAYESIAN ANALYSIS – OVERVIEW AND APPLICATIONS Hall G1 (L-2)


LEVEL Introductory-Intermediate. This course is designed for those with a limited understand-ing of Bayesian statistical concepts or for those who want a refresher and more practical experience.

FACULtY Christopher S. Hollenbeak, PhD, Professor, Surgery and Public Health Sciences, Penn State College of Medicine, Hershey, PA, USA; Keith R. Abrams, PhD, Professor of Medical Statistics, department of Health Sciences, University of Leicester, Leicester, Uk

COURSE dESCRIPtION the first portion of this course is designed to provide an overview of the Bayesian approach and its applications to health economics/pharmacoeconomics and outcomes research. the course will cover basic elements of Bayesian statistics, contrasting briefly with classical (frequentist) statistics, and introduce available statistical packages. the second part of the course is a hands-on workshop where participants will be led through a series of exercises using the free Markov Chain Monte Carlo package winBUgS. Attendees will have the chance to apply the principles they have learned in the morning session to challenging data analysis problems, including the use of Bayesian generalized linear models (gLM) to analyze cost and outcomes data. Participants are encouraged to bring their personal laptops equipped with software provided to course registrants.


USING DICE SIMULATION FOR HEALTH ECONOMIC ANALYSES Hall G2 (L-2)


LEVEL Introductory. This course is designed for those with some familiarity with modeling.

FACULtY J. Jaime Caro, MDCM, FRCPC, FACP, Chief Scientist, Evidera, Lexington, MA, USA and Adjunct Professor of Medicine, Adjunct Professor of Epidemiology and Biostatistics, Mcgill University, Montreal, QC, Canada; Jörgen Möller, MSc Mech Eng, Vice-President, Modeling technologies and Simulation, Evidera, Hammersmith, Uk and Associate Researcher, division of Health Economics, Faculty of Medicine, Lund University, Lund, Sweden

COURSE dESCRIPtION this course will provide a basic understanding of the concepts of discretely-integrated condition event (dICE) simulation as it is applied in health technology assessment (HtA). topics to be covered are: what is the basic idea of dICE; what are its components; how does it work; how is it conceptualized; how are outcomes obtained; how to implement a dICE in EXCEL (including both discrete event simulation and Markov models, and their combination in a single structure); how to do structural sensitivity analyses; and what are the advantages and disadvantages of dICE.

USE OF INSTRUMENTAL VARIABLES IN OBSERVATIONAL STUDIES OF TREATMENT EFFECTS Hall K1 (L-2)


LEVEL Intermediate. This course is suitable for those with some knowledge of econometrics.

PREREQUISItE Previous attendance at the ISPOR Short Course “Introduction to the Design & Analysis of Observational Studies of Treatment Effects Using Retrospective Data Sources”, or equivalent knowledge, is recommended.

FACULtY Benjamin M. Craig, PhD, Associate Professor, department of Economics, University of South Florida and Assistant Member, Health Outcomes and Behavior, Moffitt Cancer Center, tampa, FL, USA; Bradley C. Martin, PharmD, RPh, PhD, Professor & Head, division of Pharmaceutical Evaluation and Policy, University of Arkansas for Medical Sciences College of Pharmacy, Little Rock, AR, USA; Antoine El Khoury, PhD, MS, director & Head, Market Access and Accounts Value Management, Janssen gCC, dubai, United Arab Emirates

COURSE dESCRIPtION In any non-randomized study, selection bias is a potential threat to the validity of conclusions reached. Failure to account for sample selection bias can lead to conclusions about treatment effectiveness or treatment cost that are not really due to the treatment at all, but rather to the unobserved factors that are correlated with both treatment and outcomes. Sample selection models provide a test for the presence of selection bias. these models also provide a correction for selection bias, enabling an investigator to obtain unbiased estimates of treatment effects. this course will discuss the various models and their applications and, in particular, will address instrument variables (two-stage least

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Program & Schedule of Events: Sunday, 30 October


squares, intuition, and randomized controlled trials (RCts)), including an overview of examples from the current literature. Participants will benefit from interactive exercises using instrumental variables and sample selection techniques using StAtA. For those who have STATA loaded on their laptops, you are encouraged to bring your laptop.

MIXED METHODS APPROACHES FOR PATIENT-CENTERED OUTCOMES RESEARCH: GROUP CONCEPT MAPPING Hall K2 (L-2)

tRACk Patient-Reported Outcomes / Preference Methods

LEVEL Advanced. This course assumes a basic understanding of qualitative interviewing methods and measurement properties of patient-reported outcomes (PRO) instruments.

FACULtY Louise Humphrey, MSc, director, Clinical Outcomes Assessment (COA), Clinical Outcomes Solutions Ltd., Manchester, United kingdom; Helen Kitchen, MSc, Senior Consultant & Specialist team Lead, Clinical Outcomes Assessment, dRg Abacus, Manchester, United kingdom; Sarah L Shingler, MSc, Consultant, Clinical Outcomes Assessment, decision Resource group (dRg), Oxfordshire, United kingdom

COURSE dESCRIPtION Mixed methods approaches are increasingly acknowledged by both regulatory authorities and the wider scientific community as an important part of the outcomes researcher’s toolkit. Yet there is currently a lack of guidance on how to conduct mixed methods research. this course will guide participants through the different approaches to mixed methods and in particular will expand upon group Concept Mapping (gCM) – a structured, mixed methods approach ideal for eliciting patient insight into their own disease and treatment experiences and understanding what is most important or burdensome from the patients’ perspective. gCM is a method that can be conducted online and performed in small samples, making it both convenient and cost-effective. Moreover, gCM methodology can be used beyond patient settings and is advocated for use in a diverse range of situations where complex decision making is required and the views of multiple stakeholders must be considered. the benefits and limitations of the innovative gCM approach will be discussed in context of FDA Guidance for Industry – Patient-Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims, and EMA Reflection Paper on the Regulatory Guidance on the Use of Health-Related Quality of Life (HRQL) Measures in the Evaluation of Medicinal Products. the course will also reference ISPOR Good Research Practices for Evaluating and Documenting Content Validity for the Use of Existing Instruments and Their Modifications PRO Task Force Report. during this short course, participants will take part in a practical exercise giving them real-life experience in conducting and analyzing gCM and allowing them to understand the methodology from the perspective of both a participant and a researcher.

TRANSFERABILITY OF COST-EFFECTIVENESS DATA BETWEEN COUNTRIES Hall E1 (L0)


LEVEL Advanced. This course is for those with advanced understanding of economic evaluations of health care programs and experience in the critical assessment of cost-effectiveness studies.

FACULtY Silvia Evers, PhD, LLM, Professor of Public Health technology Assessment, department of Health Services Research, CAPHRI School for Public Health and Primary Care and Netherlands School of Primary Care Research (CaRe), Maastricht University, Maastricht, Netherlands; Manuela A. Joore, PhD, Professor of Health technology Assessment & decision Making, department of Clinical Epidemiology and Medical technology Assessment, School for Public Health and Primary Care (CAPHRI), Faculty of Health, Medicine and Life Sciences, Maastricht University Medical Center, Maastricht University, Maastricht, Netherlands

COURSE dESCRIPtION Although the number of countries requiring an economic dossier as part of the submission dossier for public reimbursement of new drugs is growing, the pharmaceutical industry cannot conduct economic evaluations in every potential market. However, national decision makers require country-specific or region-specific data or relevant estimates on health care costs and patient outcomes. More and more, they are only willing to accept foreign or international data when transferable to their own decision-making context. However, little guidance exists on how to do this. this course starts with a discussion of factors that make economic data more difficult to transfer from one country to another than clinical data, and will focus on the report of the ISPOR good Practices on Economic data transferability task Force. In this respect, faculty will discuss the transferability of health state valuations based on the EQ-5d instrument and the transferability of lost productivity data. Next, faculty will review the methods that have been presented to assess the transferability of foreign cost, effects, and cost-effectiveness estimates and their pros and cons. this topic will be practically covered in a case-study while working in small groups. A stepwise procedure will illustrate how to select a foreign cost-effectiveness model for adaptation to your own decision-making context. Finally, a detailed approach on how to adapt a cost-effectiveness model calculation will be illustrated using the case of breast cancer treatment. during the course, faculty will present transferring issues encountered when assessing model-based economic evaluations. Please note: The statistical methods used to analyze multinational trial data and to transfer these data to a specific country are beyond the scope of this course.

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CONJOINT ANALYSIS – THEORY & METHODS Hall E2 (L0)

tRACk Patient Preference Methods

LEVEL Intermediate. This course is designed for clinicians, policymakers, researchers, and patient advocates/researchers with some familiarity with conjoint analysis or other stated-preference methods.

FACULtY A. Brett Hauber, PhD, Senior Economist & Vice President, Health Preference Assessment, RtI Health Solutions, Research triangle Park, NC, USA; Juan Marcos Gonzales, PhD, Senior Research Economist, Health Preference Assessment, RtI Health Solutions, RtI, NC, USA

COURSE dESCRIPtION Course participants will learn the conceptual and empirical basis for using conjoint analysis to elicit preferences in outcomes research. the course will introduce participants to both the conceptual basis for quantifying decision-maker preferences for medical interventions and the practical design and analytical issues that must be addressed in order to obtain valid empirical preference estimates. the course will be structured following the good research practice guidelines and discussion prepared by the ISPOR good Research Practices for the Application of Conjoint Analysis in Health task Force. the course will include lectures and interactive group exercises and group discussion.

BUDGET IMPACT ANALYSIS I: A 6-STEP APPROACH Hall D (L-2)


LEVEL Intermediate. This course is designed for those with some experience with pharmacoeconomic analysis.

FACULtY Stephanie Earnshaw, PhD, MS, Vice President, Health Economics, RtI Health Solutions, Research triangle Park, NC, USA; C. Daniel Mullins, PhD, Professor & Chair, Pharmaceutical Health Services Research, University of Maryland School of Pharmacy, Baltimore, Md, USA; Anita J Brogan, PhD, Head, decision-Analytic Modeling, RtI Health Solutions, Research triangle Park, NC, USA

COURSE dESCRIPtION this course will describe the methods used to estimate the budget impact of a new health care technology, and will present six basic steps for estimating budget impact: 1) estimating the target population; 2) selecting a time horizon; 3) identifying current and projected treatment mix; 4) estimating current and future drug costs; 5) estimating change in disease-related costs; and 6) estimating and presenting changes in annual budget impact and health outcomes. Both static and dynamic methods for estimating the budget and health impact of adding a new drug to a health plan formulary will be presented. these six steps will be illustrated using actual budget impact models.

RISK-SHARING / PERFORMANCE-BASED ARRANGEMENTS FOR DRUGS AND OTHER MEDICAL PRODUCTS Hall F1 (L0)

tRACk Use of Pharmacoeconomics / Economic / Outcomes Research Information Methods

LEVEL Intermediate

PREREQUISItE It would be helpful for individuals taking this course to have completed the ISPOR Short Course “Elements of Pharmaceutical/Biotech Pricing” or to be familiar with both the key determinants of pharmaceutical pricing and the main international health systems.

FACULtY Lou Garrison, PhD, Professor, Pharmaceutical Outcomes Research and Policy Program, department of Pharmacy, University of washington, Seattle, wA, USA; Adrian Towse, MA, MPhil, director, Office of Health Economics, London, Uk; Paolo Siviero, Senior Advisor & Fund Manager, Principia III SRg, Rome Italy

COURSE dESCRIPtION there is significant and growing interest among both the payers and producers of medical products for arrangements that involve a “pay-for-performance” or “risk-sharing” element. these payment schemes involve a plan by which the performance of the product is tracked in a defined patient population over a specified period of time and the level of reimbursement is tied by formula to the outcomes achieved. Although these agreements have an intrinsic appeal, there can be substantial barriers to their implementation. Issues surrounding theory and practice, including incentives and barriers, will be analyzed along with several examples of performance-based schemes from Europe, the United States, and Australia. A hypothetical case study will be used in an interactive session to illustrate a systematic approach to weighing their applicability and feasibility.

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NEW! UNDERSTANDING SURVIVAL MODELING WITH APPLICATION TO HTA Hall F2 (L0)


LEVEL Intermediate

FACULtY Christopher Parker, MSc, Lead Health Economist, ICON Health Economics & Epidemiology, Abingdon, Uk; Andrew Briggs, DPhil, MSc, william R. Lindsay Chair of Health Economics, Health Economics & Health technology Assessment, Institute of Health & wellbeing, University of glasgow, glasgow, Uk; Andrew Davies, MSc, director of Health Economics, ICON Health Economics & Epidemiology, Oxford, United kingdom

COURSE dESCRIPtION time-to-event (survival) analysis is an important element in many economic analyses of health care technologies. this is particularly true in oncology given the requirement to estimate lifetime costs and outcomes (i.e. extrapolate) beyond the follow-up typically observed in clinical trials. Cost-effectiveness estimates can be sensitive to the methods applied in modelling survival data. Recommendations for selecting a parametric survival model have been recently been published; following a review of extrapolation modelling in National Institute for Health and Care Excellence (NICE) technology appraisals. the purpose of this course is to provide participants with an understanding of the fundamentals of survival analysis and key issues to be considered when comparing alternative survival models for inclusion in cost-effectiveness analysis. this will include an understanding of differences between partitioned survival and Markov-based approaches.





BUDGET IMPACT ANALYSIS II: APPLICATIONS & DESIGN ISSUES Hall D (L-2)


LEVEL Intermediate. This course is designed for those who have basic knowledge of budget impact analyses and desire exposure to these analyses in Excel.

PREREQUISItE Previous attendance at, or familiarity with the topics discussed in, the ISPOR Short Course “Budget Impact Analysis I: A 6-Step Approach” is recommended.

FACULtY Stephanie Earnshaw, PhD, MS, Vice President, Health Economics, RtI Health Solutions, Research triangle Park, NC, USA; Anita Brogan, PhD, Head, decision-Analytic Modeling, Health Economics, RtI Health Solutions, Research triangle Park, NC, USA; Thor-Henrik Brodtkorb, PhD, Senior director, Health Economics, RtI Health Solutions, Ljungskile, Sweden

COURSE dESCRIPtION this course provides hands-on experience utilizing an Excel workbook-based approach to working with and modifying budget impact analysis models. Participants will receive an actual Excel-based budget impact analysis developed for use in the real world in order to gain greater understanding of applications of the 6-step approach presented in the complementary introductory course. Participants will be able to actively interpret the model’s results and adapt the analysis to include new inputs and calculations to handle important issues such as patient copayments, adherence, and generics. topics such as issues to consider when adapting to another country, inclusion of a companion diagnostic or use of off-label drugs, and sensitivity analyses will also be covered. this course will provide a key opportunity for attendees to gain exposure to the more practical/applied aspects of performing budget impact analyses. Participants who wish to gain hands-on experience must bring their personal laptops with Microsoft Excel for Windows installed.

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NEW! ADVANCED METHODS FOR ADDRESSING SELECTION BIAS IN REAL-WORLD EFFECTIVENESS AND COST-EFFECTIVENESS STUDIES Hall K1 (L-2)

tRACk Observational Methods

LEVEL Intermediate.

FACULtY Richard Grieve, PhD, Professor of Health Economics Methodology, London School of Hygiene and tropical Medicine, London, Uk; Noemi Kreif, PhD, Assistant Professor, Public Health and Policy, London School of Hygiene and tropical Medicine, London, Uk

COURSE dESCRIPtION Reimbursement agencies require real-world evidence on the effectiveness and cost-effectiveness of new drugs and medical devices. In many settings, randomised controlled trial (RCt) data is unavailable or insufficient. where non-randomised data is used to estimate treatment effectiveness and cost-effectiveness, the main methodological challenge is selection bias from confounding by indication. Standard regression or propensity score methods are frequently used to adjust for selection bias, but estimates of treatment effectiveness may be highly sensitive to the chosen parametric form of these models, and evidence that relies on such methods may be viewed as insufficient by reimbursement agencies. while new, more advanced methods for allowing for confounding cannot offer a panacea, they have been shown to provide estimates of treatment effectiveness that are relatively robust. this course offers an in-depth description of ‘cutting edge’ methods for addressing this form of selection bias. these methods include flexible regression which uses machine learning for model selection, propensity score matching with regression adjustment, and genetic Matching, a recently developed approach that extends propensity score matching. the course introduces the participants to these methods using the R software, through a series of real world data examples. Faculty will also demonstrate sensitivity analyses that convey to decision makers the extent to which the estimates of effectiveness and cost-effectiveness are robust to that assumption of no unobserved confounding. Participants who wish to have hands-on experience must bring their personal laptops with appropriate software installed.

INTRODUCTION TO THE ECONOMIC ANALYSIS OF DIAGNOSTICS Hall E1 (L0)


LEVEL Introductory/Intermediate.

FACULtY John E. Schneider, PhD, Chief Executive Officer & Founder, Avalon Health Economics, Morristown, NJ, USA; Andrew Briggs, DPhil, MSc, william R. Lindsay Chair of Health Economics, Health Economics & Health technology Assessment, Institute of Health & wellbeing, University of glasgow, glasgow, Uk

COURSE dESCRIPtION there has been dramatic progress in the science and applications of diagnostics in recent years, especially in the areas of molecular and genomic diagnostics and personalized medicine. the new generation of tests offers opportunities to improve patient care and treatment outcomes. However, there remain a number of challenges in translating technological advances in diagnostics to improved patient care, and the impact of the new generation of diagnostics on the costs of care and payer budgets is variable. One of those challenges is establishing the economic value of new tests. the economic evaluation of diagnostics follows the same basic structure of any economic evaluation of medical care interventions, but has several important additional considerations, including clinical decision making, test applications, test performance, tested populations, outcome measurement, data, and evidence requirements. this course is designed to expand upon economic evaluation of diagnostic devices, including companion diagnostics, molecular diagnostics, rapid point-of-care tests, and so on.

NETWORK META-ANALYSIS IN RELATIVE EFFECTIVENESS RESEARCH Hall K2 (L-2)

tRACk Outcomes Research Methods

LEVEL Intermediate. This course requires at least a basic knowledge of meta-analysis and statistics.

FACULtY Jeroen P. Jansen, PhD, MSc, Chief Scientist, Evidence Synthesis and decision Modeling, Precision Health Economics, San Francisco, CA, USA; Steve Kanters, MSc, director, Health Analytics, Precision Health Economics, San Francisco, CA, USA

COURSE dESCRIPtION For several medical questions of interest, many treatment options exist for the same indication. these treatments may have been compared against placebo or against each other in clinical trials. knowing whether one specific treatment is better than placebo or some other specific comparator is only a fragment of the big picture, which should incorporate all available information. Ideally, one would know how all the treatment options rank against each other and the level of differences in treatment effects between all the available options. Network meta-analysis provides an integrated and unified method that incorporates all direct and indirect comparative evidence about treatments. Based in part on the ISPOR task Force Reports on Indirect treatment Comparisons, the fundamentals and

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concepts of network meta-analysis will be presented. the evaluation of networks presents special challenges and caveats, which will also be highlighted in this course. the material is motivated by instructive and concrete examples. the ISPOR-AMCP-NPC questionnaire for assessing the credibility of a network meta-analysis will also be introduced.

RISK-SHARING/PERFORMANCE-BASED ARRANGEMENTS IN CENTRAL & EASTERN EUROPE: IMPLEMENTATION OF MANAGED ENTRY AGREEMENTS Hall F1 (L0)


LEVEL Intermediate.

FACULtY Zoltán Kaló, PhD, Professor of Health Economics, Eötvös Loránd University (ELtE), Budapest, Hungary; Rok Hren, PhD, MSc IHP (HE), Professor,

University of Ljubljana, Ljubljana, Slovenia; Katarzyna Kolasa, PhD, Market Access director Region East, Lundbeck, warszawa, Poland and department of Health Economics, Collegium Medicum, the Nicolaus Copernicus University, Bydgoszcz, Poland

COURSE dESCRIPtION during the recent years, Managed Entry Agreements (MEAs) have become instrumental in ensuring the access of the innovative medicines. this course is designed for health care professionals (including public decision-makers, academia and industry) involved in pricing and reimbursement decisions who are wishing to understand the applicability and technical aspects of managed entry agreements (MEAs) in countries with severe economic constraints and explicit cost-effectiveness criterion. the topic will be introduced with key features of pricing and reimbursement systems in Central-Eastern European countries to understand why special methods are needed to facilitate evidence-based reimbursement policies of new health technologies. Faculty will present an economic model to explain the methodology and implications of managed entry agreements in cost-effectiveness and budget impact analysis. Participants will then have the opportunity to apply what they have learned through a hands-on exercise on making pricing and reimbursement decisions. A decision algorithm will be presented to support evidence and value based policy decisions of high-cost new technologies in CEE countries. A series of password protected economic models will add more and more complexity to a pragmatic case study on a new pharmaceutical product in oncology. to close the course faculty will lead a discussion on the applicability of a pragmatic decision tool illustrating the pros and cons of different managed entry agreements and their usefulness in CEE settings. Participants who wish to gain hands-on experience must bring their personal laptops with Microsoft Excel for Windows installed.

NEW! ADJUSTING FOR TIME-DEPENDENT CONFOUNDING AND TREATMENT SWITCHING BIAS IN OBSERVATIONAL STUDIES AND CLINICAL TRIALS: PURPOSE, METHODS, GOOD PRACTICES, AND ACCEPTANCE IN HTA Hall G2 (L-2)

tRACk Observational Methods

LEVEL Intermediate.

FACULtY Uwe Siebert, MD, MPH, MSc, ScD, Professor & Chair, department of Public Health and Health technology Assessment, UMIt - University for Health Sciences, Medical Informatics and technology, Austria, Adjunct Professor, Health Policy and Management, Harvard School of Public Health, Boston, MA, USA, and director, division for HtA, ONCOtYROL – Center for Personalized Cancer Medicine, Hall i.t., Austria; Nicholas Latimer, MSc, PhD, Senior Research Fellow, Health Economics, ScHARR, University of Sheffield, Sheffield, Uk; Felicitas Kühne, MSc, Senior Scientist, Institute of Public Health, Medical decision Making and Health technology Assessment, department of Public Health, Health Services Research and Health technology Assessment, UMIt, Hall i.t., Austria

COURSE dESCRIPtION In specific situations, clinical studies need causal inference methods to estimate a valid causal effect of a health intervention. Causal adjustment is needed if there is confounding-by-indication in observational studies or when Itt analyses lead to biased effect estimates in RCts with noncompliance/treatment switching. Since first HtA agencies have accepted and requested the use of causal methods, a paradigm shift is taking place, and the selection of the appropriate method has become crucial to yield patient access to innovative treatments. this course will (1) introduce causal diagrams as a tool for causal assessment, (2) give an overview on causal methods (e.g., rank preserving structural failure time models, marginal structural models, two-stage approach), (3) present lessons learned from applied cases examples in HtA, (4) provide recommendations regarding when to use which methods, and (5) discuss acceptance and barriers from an HtA agency perspective.

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estimating health-State Utility for economic Models in clinical Studies, a NEW Task Force report, was published in Value in health in September/October

2016 and a Short Course on the topic premieres at ISPOR Vienna. http://www.ispor.org/Estimating-Health-State-Utility-Economic-Models-Clinical-Studies-guidelines.asp

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REIMBURSEMENT SYSTEMS FOR PHARMACEUTICALS IN EUROPE Hall E2 (L0)


LEVEL Intermediate. This course is designed for individuals with intermediate experience within a single health care system wishing to broaden their appreciation of other reimbursement systems.

FACULtY Mondher Toumi, MD, PhD, MSc, Professor, Public Health, Faculté de Médecine, Laboratoire de Santé Publique, Aix-Marseille Université, Université de la Méditerranée, Marseille, France

COURSE dESCRIPtION Unlike marketing authorization for pharmaceuticals, mainly regulated at the European level by EMA, pricing and reimbursement decisions in Europe are managed by individual member states. Health care services are generally covered by a single public health insurer operating under the Ministry of Health supervision. As a monopoly buyer, this situation provides a leading position for the public health insurer to set reimbursement conditions. therefore, based on each country’s set of regulations, processes, and values, wide variations exist in pricing and reimbursement decisions of pharmaceuticals. Using up-to-date governmental regulation sources and the ISPOR global Health Care Systems Roadmap, this course will discuss health technology decision-making processes for reimbursement decisions for pharmaceuticals in France, germany, Hungary, Italy, Poland, Spain, Sweden, and the Uk. the course will describe these reimbursement systems, as well as compare, and bring into contrast their key characteristics.

USING MULTI-CRITERIA DECISION ANALYSIS IN HEALTH CARE DECISION MAKING: APPROACHES & APPLICATIONS Hall F2 (L0)


LEVEL Introductory. Participants should have an understanding of decision analysis.

FACULtY Maarten Ijzerman, PhD, Professor & Head, department of Health technology & Services Research, University of twente, Enschede, the Netherlands; Nancy Devlin, PhD, director of Research, Office of Health Economics, London, Uk; Martina Garau, MSc, Senior Economist, Office of Health Economics, London, Uk

COURSE dESCRIPtION Many health care decisions – such as portfolio optimization, benefit-risk assessment (BRA), health technology assessment (HtA), and shared decision making (SdM) – require a careful assessment of the underlying options and the criteria used to judge these options. this assessment can be challenging given the tradeoffs between multiple value criteria. In light of this, many decision makers have begun investigating the use of multi-criteria decision analysis (MCdA) in support of these decisions. this course reviews the current MCdA landscape, including a review of MCdA studies in health care and the different approaches employed. Best practices for conducting MCdA will also be outlined, as well as issues related to selecting the right data approach. Steps involved in conducting MCdA (such as criteria definition, scoring performance, weighting criteria, and uncertainty analysis), and current and future applications in health care decision making will be discussed. Faculty will draw from a number of real world examples and will reference the ISPOR good Practice guidelines for MCdA.

17:30-18:30 EdUCATIONAL SYMPOSIUM (open to all attendees) Hall D (L-2)

THE EVOLVING ROLE OF REAL-WORLD DATA IN EVIDENCE SYNTHESIS TO MEET DEMANDS FOR EVIDENCE-BASED MEDICINE

Health technology assessment agencies are increasingly relying on real world data (Rwd) to inform decision making. while Rwd informing treatment effectiveness is often unavailable for newly licensed agents, such data may exist for current standards of care. In this symposium, we will discuss the types of Rwd that are most useful to health care decision makers, the benefits of using Rwd to contextualize treatment effectiveness versus efficacy, and emerging methods and challenges associated with synthesizing Rwd and RCts. we will discuss the implications of early drug approval on HtA evaluations, case studies of the use of real world evidence to support HtA decisions, and the challenges to adopting real world evidence in HtA.

the benefits and disadvantages of identifying and utilizing Rwd for use in evidence synthesis and comparative effectiveness will be debated. In particular we will focus on the payer perspective and how Rwd may contribute to a greater understanding of the clinical effectiveness of treatments in practice. In presenting this perspective we will also give consideration to the challenges associated with meta-analysis of this data alongside clinical trials and the current and potential methodologies in development for overcoming these issues. In conclusion we will focus on interpreting and critiquing such studies as relates to their potential for reducing uncertainty in the decision making process.

Speakers: Juliette C Thompson, BSc, Lead Systematic Reviewer, ICON Health Economics & Epidemiology, Abingdon, Uk Olivia Wu, PhD, deputy director, HEHtA Research Unit, Health Economics and Health technology Assessment, University of glasgow, glasgow, Uk Sarah M Goring, MSc, director, Epidemiology, ICON Epidemiology, Vancouver, BC, Canada Neil Hawkins, PhD, MSc, Professor in HE and HtA, Institute of Health and wellbeing, University of glasgow, glasgow, Uk

Sponsored by: ICON Plc

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18:45-19:45 EdUCATIONAL SYMPOSIUM (open to all attendees) Hall D (L-2)

BALKANS TOWARDS TOMORROW: PAVING BETTER ACCESS FOR PATIENTS

Although countries in the Balkans region show uneven progress in health technology assessment, most of them face similar financial barriers and dynamic environment. In this framework, the speakers of this educational symposium will try to pinpoint current patient access constrains, while proposing pragmatic solutions for improving health outcomes in the future. during the symposium, the audience will have the opportunity to capture a variety of perspectives offered by distinguished members of the panel, originating from different geographies and backgrounds. Benchmarking versus other European countries will also offer greater understanding of the current differences in terms of time and quality of access for patients.

Mr. koehring will look at barriers to patient access to care accross the region, while highlighting case studies from several countries. Professor dimopoulos will try to highlight the opportunities for patient access through clinical trials and early access programmes. Professor Maniadakis will touch upon greek reforms and translated outcomes for patients. dr. Marius geanta will share expert opinion and case studies from the Romanian perspective.

Moderator: Ioannis Petrakis, MPharm, MSc, MPH, Market Access, HEOR & government Affairs Head, MCO Balkans, takeda MCO Balkans, Marousi Athens, greece

Speakers: Martin Koehring, MA, Senior Editor & global Editorial Lead, Healthcare, the Economist Intelligence Unit, London, Uk

Meletios A. Dimopoulos, MD, PhD, Professor, Alexandra Hospital, department of Clinical therapeutics, National and kapodistrian University of Athens, Athens, greece

Nikos Maniadakis, Professor, Athens, greece, department of Health Services Management, National School of Public Health, Athens, greece

Marius Geanta, MD, President & Co-Founder, Center for Innovation in Medicine, Bucharest, Romania

Sponsored by: Takeda



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SCHEDULE AT-A-GLANCE 7:30-8:30 EdUCATIONAL SYMPOSIUM Hall D (L-2)

The Biosimilar Effect: How Real-World Evidence Will Influence Adoption of Biosimilar Specialty Therapies (Sponsored by Cardinal Health)

8:45-14:15 POSTERS - SESSION I Hall X2-X3 (L-2)

8:45-10:45 WELCOME & FIRST PLENARY SESSION Hall A (L2)

What Synergies Could Be Created between Regulatory and Health Technology Assessments?

10:45-11:15 BREAK, EXHIBITS & POSTERS - SESSION I Hall X2-X3 (L-2)

11:15-12:15 BREAKOUT SESSION

IP1: Patient-Centered Decision-Making with Multi-Criteria Decision Analysis: Should We Be Trying to Quantify The Patient Voice for Use in Health Technology Assessment? Hall A (L2)

IP2: National HTA Process and European Cooperation on HTA – Fit for Purpose? (Invited Issue Panel) Hall D (L-2)

W1: The New NICE Cancer Drugs Fund Technology Appraisal Process: Your Questions Answered Hall E1 (LO)

W2: Moving the Science Forward: Psychometric Considerations and Study Designs for Understanding Meaningful Change and Conducting Mixed Methods Research Hall E2 (LO)

W3: Utilities in Economic Evaluation: Using Best Practices Where International Guidelines Provide Insufficient Detail Hall F1 (L0)

P1: Modeling Methods Hall F2 (L0)

12:15-14:15 LUNCH, EXHIBITS & POSTERS - SESSION I Hall X2-X3 (L-2)

12:30-13:45 OPEN MEETING: STATISTICAL METHOdS IN HEALTH ECONOMICS ANd OUTCOMES RESEARCH SPECIAL INTEREST GROUP Hall E1 (L0)

12:45-13:45 ISPOR STUdENT RESEARCH SHOWCASE Hall F2 (L0)

Having a High Impact on Managing Access to Medical Innovation: Strengthening the Methodology-Policy Nexus

12:45-13:45 EdUCATIONAL SYMPOSIUM Hall D (L-2)

Increasing EuroQol (EQ-5D) from 3 to 5 Levels: Implications for Users - Does “New” Mean “Better”? (Sponsored by EuroQol Research Foundation)

13:15-14:15 POSTER AUTHOR dISCUSSION HOUR - SESSION I Hall X2-X3 (L-2)


IP3: Does Conservatism by Registration Authorities in Their Requirements for Outcome Measures in Pain Trials Hamper Drug Development in That Area? Hall E2 (L0)

IP4: Does European Real World Data Require a ‘Digital Schengen’ to Support Federated Access, Assessment, and (Re)Use, Opening Borders at the Institute to Cross-Country? Hall D (L-2)

W4: Understanding the Challenges Facing the Value Assessment of Medical Devices Hall E1 (L0)

W5: New Approaches to Survival Modeling in Oncology Hall A (L2)

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P2: Studies on HTA Approaches Hall F1 (L0)

P3: Utility Studies Hall F2 (L0)

15:15-15:45 BREAK & EXHIBITS Hall X2-X3 (L-2)

15:45-19:45 POSTERS - SESSION II Hall X2-X3 (L-2)


IP5: A “Federal” Standard for Valuing Health in a Post-Referendum Europe? Hall A (L2)

IP6: From Testimonials to Qualitative Research Embedded in Clinical Trials: How Do Health Technology Assess-ment Bodies Consider the Voice of Rare Disease Patients When Granting Access to Orphan Drugs? Hall E1 (L0)

W6: Bridging the Gap Between Efficacy and Effectiveness: Methods to Identify Drivers of Effectiveness Before Launch Hall D (L-2)

W7: Appropriate Model Time Horizons: Theory, Empirical Results, and the Perspective of Decision Makers Hall E2 (L0)

P4: Cardiovascular Outcomes Research Studies Hall F1 (L0)

P5: Pricing Policy Studies Hall F2 (L0)


IP7: How Should Biosimilars Be Valued and Should They Undergo Health Technology Assessment? Hall D (L-2)

IP8: Is the Goal of Universal Comparative Effectiveness Evidence across Jurisdictions Achievable? Hall E1 (L0)

W8: The Importance of Relevance in Health Economic Evaluations: Challenges and Ways Forward Hall A (L2)

P6: Medication Adherence Studies Hall F1 (L0)

F1: Extending Cost-Effectiveness Analysis, Partial Optimization Modelling, and Fiscal Modelling in Vaccine Value Assessments Hall F2 (L0)

18:00-19:45 EXHIBITORS’ OPEN HOUSE RECEPTION & POSTERS - SESSION II Hall X2-X3 (L-2)


F2: Patient Engagement: Stopping to Define It Hall D (L-2)

F3: Generating Evidence of the Added Value of ‘Precision’ Medicine Hall A (L2)

F4: Burden of Hepatitis C in Central and Eastern European Countries Hall F2 (L0)

F5: Drug Pricing in Adriatic Countries – Is Reference Pricing the Best Option? Hall F1 (L0)

F6: The Economic Burden of Counterfeit Medicines in Africa: Situation Analysis and Proposed Solutions Hall E1 (L0)

F7: A Structured Debate Regarding the National Health Economics Guidelines in Southern Europe Hall E2 (L0)

18:45-19:45 POSTER AUTHOR dISCUSSION HOUR - SESSION II Hall X2-X3 (L-2)

19:45-21:00 ISPOR STUdENT WELCOME RECEPTION Hall K Foyer

19:45-21:00 ISPOR CENTRAL & EASTERN EUROPE (CEE) NETWORK WELCOME RECEPTION Hall G Foyer

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MONDAY, 31 OCTOBER 2016


THE BIOSIMILAR EFFECT: HOW REAL-WORLD EVIDENCE WILL INFLUENCE ADOPTION OF BIOSIMILAR SPECIALTY THERAPIES

As biosimilar specialty therapies have been available in Europe for the past decade and are beginning to gain approval in the US, many questions remain about their potential adoption by providers, patients and payers. with a different threshold of traditional clinical research required for regulatory approval than their branded counterparts, real-world health economics and outcomes research becomes paramount to make critical value comparisons and effective decisions on therapy use. this symposium will explore how stakeholder value assessments will be vital to compare and position biosimilars and their branded counterparts, with a focus on the specialty therapeutic areas of oncology and rheumatology.

Moderator: Bruce A Feinberg, DO, Vice President & Clinical Affairs Chief Medical Officer Specialty Solutions, Cardinal Health, dublin, OH, USA

Speakers: Sue Naeyaert, BPharm, Grad.Dip.Sc(Pharm), MCom, Senior director Biosimilars Policy North America, EMd Serono, washington, dC, USA

Andrea Nicholson, BA, Marketing director, Biosimilars, Merck Serono, geneva, Switzerland

Graham Foxon, MBA, PhD, Managing director, Remap Consulting, Cheshire, Uk

Carole A. Jones, MBA, Principal Consultant & Strategy Lead, Market Access Solutions, Envision Pharma group, London, Uk

Sponsored by: Cardinal Health

8:45-14:15 RESEARCH POSTER PRESENTATIONS - SESSION I Hall X2-X3 (L-2)

(See page 78 for Research Poster Presentation information)

8:45-10:45 WELCOME & FIRST PLENARY SESSION Hall A (L2)

WELCOME FROM ISPOR CEO/EXECUTIVE DIRECTOR

(See page 87 for biographical information)

Nancy S Berg, BSc, CEO/Executive director, ISPOR, Lawrenceville, NJ, USA

PRESIDENTIAL ADDRESS


Lou Garrison PhD, 2016-2017 ISPOR President, Professor, Pharmaceutical Outcomes Research and Policy Program, department of Pharmacy, University of washington, Seattle, wA, USA

CONGRESS PROGRAM OVERVIEW


Hans-Georg Eichler, MD, MSc, Program Committee Co-Chair and Senior Medical Officer, European Medicines Agency (EMA), London, Uk

Tomasz Hermanowski, PhD, Program Committee Co-Chair and InterQuality Project Leader and Professor & Head, department of Pharmacoeconomics, Medical University of warsaw, warsaw, Poland

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Program & Schedule of Events: Monday, 31 October


FIRST PLENARY SESSION: WHAT SYNERGIES COULd BE CREATEd BETWEEN REGULATORY ANd HEALTH TECHNOLOGY ASSESSMENTS?

(See pages 86-89 for biographical information)

decisions taken by regulators and health care payers, the latter informed by HtA bodies, determine which patient groups have access to new therapies and at what point in time. while these decision makers have different roles, they often rely on almost the same scientific data about new products; they also share the broad goal of enabling access for patients to beneficial therapies. Yet, formal interactions and collaboration between regulators and the HtA bodies that inform payers have only started in recent years in the European Union (EU) and are mostly in a pilot stage. this plenary session explores hitherto unrealised synergies in the work and processes of regulators and HtA bodies. Panelists will also address the roadblocks in the EU health sector ecosystem that need to be removed in order to realise the synergies while respecting their different roles.

Moderator: Hans-Georg Eichler, MD, MSc, Senior Medical Officer, European Medicines Agency (EMA), London, Uk Speakers: Guido Rasi, Executive director, European Medicines Agency (EMA), London, Uk Wim Goettsch, PhD, Secretariat director, EUnetHtA JA3, diemen, the Netherlands Andrzej Rys, director, Health Systems, Medical Products and Innovation, European Commission, Brussels, Belgium Jens Grueger, PhD, Vice President & Head of global Pricing & Market Access, F. Hoffmann-LaRoche, Basel, Switzerland

10:45-11:15 BREAK, EXHIBITS & RESEARCH POSTER PRESENTATIONS VIEWING - SESSION I Hall X2-X3 (L-2)



n IP1: PATIENT-CENTERED DECISION-MAKING WITH MULTI-CRITERIA DECISION ANALYSIS: SHOULD WE BE TRYING TO QUANTIFY THE PATIENT VOICE FOR USE IN HEALTH TECHNOLOGY ASSESSMENT? Hall A (L2)Moderator: J Jaime Caro, MDCM, FRCPC, FACP, Chief Scientist, Evidera, Lexington, MA, USA and Adjunct Professor of Medicine, Adjunct Professor of Epidemiology and Biostatistics, Mcgill University, Montreal, QC, Canada Panelists: Lars Sandman, PhD, Professor, National Centre for Priority Setting in Health-Care, Linköping University, Linköping, Sweden; Peter L. Kolominsky, MD, PhD, MBA, Professor and director, Interdisciplinary Centre for Health technology Assessment (HtA) and Public Health, University of Erlangen - Nürnberg, germany, Erlangen, germany; Alaa Hamed, MD, MPH, MBA, Head, Rare disease, Patient Outcomes and Medical Economics, genzyme, a Sanofi Company, Cambridge, MA, USA

ISSUE: decision makers have been making strides to meaningfully incorporate the patient voice into health technology assessment (HtA). the panel will debate the role of the patient voice in HtA, and if multi-criteria decision analysis (MCdA) can facilitate this use of the patient voice. the panel reflects the diversity of perspectives on the topic. Peter kolominsky presents the case for a greater role for the patient voice as part of HtA, and outline ways achieve this. Lars Sandman provides a critical perspective, problematizing the role of patients in HtA and their ability to address the trade-offs required of HtA. Alaa Hamed provides an industry perspective, illustrating ongoing pilots on systematically capturing the patient voice in the rare disease space. Each panelist will speak for 10 minutes on the opportunities and challenges associated with incorporating the patient voice into HtA. this will be followed by a 15-minute panel discussion, and 15 minutes of Q&A with the audience.

OVERVIEW: Consideration of patients in health care decisions generally sounds like a positive aspiration, supported by reference to central ethical values like autonomy and patients’ best interest (from their own point of view). However, how to best (and the extent to which we should) consider patient perspectives in HtA is still up for debate. MCdA has been proposed as a means to involve patients in determining what factors should be considered in HtA. However, this also raises a number of challenges, including: what legitimacy and role do patient preferences have in HtA in relation to other values; how to deal with patient heterogeneity and the fact that the outcome of the HtA is associated with an alternative cost for other patient groups, which are difficult to identify; which MCdA methods are best for eliciting patients’ preferences; and how to combine patients’ preferences with those of other stakeholders.

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n IP2: NATIONAL HTA PROCESS AND EUROPEAN COOPERATION ON HTA – FIT FOR PURPOSE? (INVITED ISSUE PANEL) Hall D (L-2)Moderator: Finn Børlum Kristensen, MD, PhD, Professor, University of Southern denmark, Hilleroed, denmark Panelists: Dominik Schnichels, Head of Unit, Health Systems, Medical Products and Innovation, dg SANtE, European Commission, Brussels, Belgium; Zoe Garrett, MRes, technical Adviser, Centre for Health technology Evaluation, National Institute for Health and Care Excellence (NICE), London, Uk; Rui Santos Ivo, Vice-President, Executive Board, National Authority of Medicines and Health Products (INFARMEd), Lisbon, Portugal; Tomas Tesar, PharmD, PhD, MBA, MSc, Member, Reimbursement Committee, Slovak Ministry of Health, Union Health Insurance Fund, Bratislava, Slovak Republic

ISSUE: the European cooperation on HtA through the work of EUnetHtA has delivered methodological and process support tools that facilitate joint scientific work and production of the HtA information that can be shared across borders. the HtA Network Strategy and recent council conclusions have also provided the political support to strengthen the EU cooperation. A few important questions still need to be answered in order to deliver a permanent solution for a sustainable mechanism of the HtA cooperation in Europe. How can the joint work and output produced at the European level fit into the national HtA and decision-making processes? How to ensure that the European cooperation process contributes effectively and efficiently to the HtA processes in the participating countries? what are the obstacles, opportunities, and concrete plans to address the issues of synergy between the European cooperation on HtA and national HtA and decision-making processes? Regional cooperation efforts between member states are emerging, how can they be supported by EU cooperation?

OVERVIEW: the methodological aspects of joint HtA work and scientific process support tools have been addressed and developed in the previous joint actions on HtA, the third Joint Action focuses on strengthening joint production and will also address organizational issues to make proposals for a permanent solution for EU cooperation. decision making on patient access to health technologies is and will remain a sole national competence of the EU member states. the national HtA process informs and adheres to the organisation of the national decision-making processes. these can be similar but also differ substantially between the EU member states, thus influencing how to cooperate on HtA across borders effectively and realise the full European added value of such cooperation. Perspectives, positions, and experiences or plans for specific activities addressing this issue will be presented and discussed by a EUnetHtA partner organisation, the European Commission and EU member state health care decision maker.

n W1: THE NEW NICE CANCER DRUGS FUND TECHNOLOGY APPRAISAL PROCESS: YOUR QUESTIONS ANSWERED Hall E1 (LO)Discussion Leaders: Meindert Boysen, PharmD, MSc, Professor, Health Services Research & Policy, London School of Hygiene & tropical Medicine, London, Uk; David Tyas, PhD, Associate director, Health Economics and Outcomes Research, Bristol-Myers Squibb, Uxbridge, Uk; Caroline Ling, PhD, Senior director, Market Access and Outcomes Strategy, RtI Health Solutions, Manchester, Uk; Sorrel Wolowacz, PhD, Head, European Health Economics, RtI Health Solutions, Manchester, Uk

PURPOSE: From April 2016, cancer drugs that appear promising in terms of cost effectiveness, but for which the clinical evidence is not strong enough for routine commissioning, may be recommended by NICE. Such drugs will be made available through the Cancer drugs Fund (CdF) for a limited time while more evidence is gathered. NICE has implemented a new technology appraisal process and methods for the new CdF. this workshop will provide an overview of the new CdF operating model, guidance on how manufacturers can best prepare for NICE’s appraisal for a cancer drug when a conditional recommendation for use within the CdF is anticipated, and an extended Q&A session to answer audience questions about the new process.

DESCRIPTION: this session will start with an introduction to changes to the technology appraisal process to take account of the CdF. the circumstances under which NICE may issue a recommendation for use within the CdF will be described. we then will discuss how manufacturers can best prepare for appraisal if a recommendation for use within the CdF seems likely. topics covered will address any differences in the content of the manufacturer’s evidence submission; approach to evaluating whether (given uncertainty in the clinical data) the ICER has the “plausible potential” to lie within the range normally considered a cost-effective use of NHS resources; and the assessment and implications of end-of-life criteria. Consideration also will be given to the kind of study or data collection that could be feasible within the limited time period, the review of the guidance after data collection, and the commercial access arrangements under the new CdF. the workshop will include an extended interactive Q&A session, during which the audience will have the opportunity to discuss aspects of the CdF with the panel.

n W2: MOVING THE SCIENCE FORWARD: PSYCHOMETRIC CONSIDERATIONS AND STUDY DESIGNS FOR UNDERSTANDING MEANINGFUL CHANGE AND CONDUCTING MIXED METHODS RESEARCH Hall E2 (LO)Discussion Leaders: Stacie Hudgens, PhD, Managing Partner, Strategic Lead, Clinical Outcomes Solutions, tucson, AZ, USA; Tara Symonds, PhD, COA Strategy Lead & Partner, Clinical Outcomes Solutions Ltd., Folkestone, kent, Uk; Lori McLeod, PhD, director of Psychometrics, RtI Health Solutions, Research triangle Park, NC, USA; Cheryl Coon, PhD, Principal, Outcometrix, tucson, AZ, USA

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PURPOSE: the purpose of this workshop is to address two methodological issues facing the regulatory and scientific community in the field of clinical outcome assessment (COA)—derivation of meaningful change thresholds and mixed methods research—and to examine recent deliberations and present recommendations aimed at building scientific consensus on these issues.

DESCRIPTION: A panel of measurement specialists was convened to consider these two issues, which were identified by academics, industry, and regulators as scientifically challenging in the context of developing, evaluating, and interpreting data from COA tools. the issues (and specific questions) considered by this panel included: (1) Proposed methods for determining clinically meaningful change and evaluation of potential anchors. what defines a good anchor? How should potential anchors be evaluated? what parameters should be included in the anchor evaluation? How can distribution-based methods be used to support anchor-based analyses to determine meaningful change at the within patient level? Are qualitative studies a more direct way of deriving meaningful change based on patients’ perspectives? what is the appropriate role for cumulative distribution functions? (2) definition of mixed methods and mixed methods study designs for COA tool development. what is the definition for mixed methods in this field of research? what is the value of mixed methods research in COA tool development? which research designs should be considered to provide an efficient way of developing content for new measures? when is a qualitative sample sufficient for exploratory quantitative analysis? the discussion leaders will outline the issues and describe the panel discussions, noting areas where agreement was achieved, where agreement is close but not yet achieved, and where additional research is needed. discussion leaders will engage attendees to share their perspectives, as well as to provide insight gained from their own research, to move toward scientific consensus.

n W3: UTILITIES IN ECONOMIC EVALUATION: USING BEST PRACTICES WHERE INTERNATIONAL GUIDELINES PROVIDE INSUFFICIENT DETAIL Hall F1 (L0)Discussion Leaders: John Brazier, PhD, MSc, Professor of Health Economics, School of Health and Related Research (ScHARR), University of Sheffield, Sheffield, Uk; Roberta Ara, MSc, Senior Research Fellow, School of Health and Related Research, the University of Sheffield, Sheffield, Uk; Helene Chevrou-Severac, PhD, global Head of Health Economics and HtA, takeda Pharmaceuticals International Ag, glattpark-Opfikon, Switzerland

PURPOSE: the workshop will identify gaps in current international guidelines for health economic evaluation in the identification of utility values and the incorporation of these values into economic models. workshop participants will become familiar with proposed solutions for meeting these gaps based on current best practice and the literature, and critically evaluate these based on their own views and experiences.

DESCRIPTION: the workshop will outline the use of best practice to inform the use of utility values in economic models including estimating utility values for comorbidities and adverse events, and encourage audience participation to inform the debate. Professor Brazier will summarize gaps in international guidelines in economic evaluation for identifying the source of utility values and how these utility values should be incorporated into the economic model. Ms. Ara will use current literature, available recommendations, and previous submissions to NICE to propose solutions to filling these gaps, focusing upon (1) obtaining source data using clinical trials and/or systematic reviews, (2) incorporating the identified utility values into the economic model including adjustments for comorbidities, adverse events and baseline evidence. dr. Chevrou-Severac will discuss the solutions from the perspective of an international pharmaceutical company, and outline the importance of providing transparent and consistent international guidelines for economic models. Fifteen minutes at the end of the session will be devoted to audience participation including critical evaluation of the proposals from participants own experiences to achieve an inclusive and international perspective. workshop participants will gain further understanding of where gaps exist in international guidelines in the identification and usage of utility values, and contribute to the debate on how to best fill these gaps.

n P1: MODELING METHODS Hall F2 (L0)

MO2 CONSIDERING OR NOT ADVERSE EVENTS IN HEALTH ECONOMIC MODELS: A PRAGMATIC APPROACH 11:15-11:30 Roze S, Cartier-Bechu C, gherardi A, Monnier R, Pignata M, Petijean A, Sivignon M, HEVA HEOR Sarl, Lyon,

France

MO3 THE IMPACT OF DYNAMIC TRANSMISSION MODELLING ON THE ESTIMATED COST-EFFECTIVENESS OF 11:30-11:45 TREATMENT FOR CHRONIC HEPATITIS C IN THE UNITED KINGDOM Madin-Warburton M1, Pitcher A1, Martin N2, 1IMS Health, London, Uk, 2University of California San diego,

San diego, CA, USA

MO4 THE IMPACT OF EXTRAPOLATING SURVIVAL BASED ON CURE MODELS: COMPARING MEAN INCREMENTAL 11:45-12:00 SURVIVAL AND CURE RATES IN DIFFERENT DATASETS van Oostrum I1, Postma MJ2, Buskens E3, Heeg BM1, 1Ingress-health Netherlands, Rotterdam, the

Netherlands, 2University of groningen, groningen, the Netherlands, 3University Medical Center groningen, groningen, the Netherlands

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12:15-14:15 LUNCH, EXHIBITS & RESEARCH POSTER PRESENTATIONS VIEWING - SESSION I Hall X2-X3 (L-2)


Lunch Sponsored by BaseCase Management GmbH

12:30-13:45 OPEN MEETING: STATISTICAL METHOdS IN HEALTH ECONOMICS ANd OUTCOMES RESEARCH SPECIAL INTEREST GROUP Hall E1 (L0)

All ISPOR members with an interest in statistical methodology are welcome to attend this newly formed Special Interest group focusing on strengthening the use of appropriate statistical methodology and evaluating and improving the analytic techniques used in real world data analysis.

12:45-13:45 ISPOR STUdENT RESEARCH SHOWCASE Hall F2 (L0)

HAVING A HIGH IMPACT ON MANAGING ACCESS TO MEDICAL INNOVATION: STRENGTHENING THE METHODOLOGY-POLICY NEXUS

this showcase session will feature four outcomes research studies, conducted by ISPOR student members and presented during the ISPOR 19th Annual European Congress. A brief summary of the research study and conclusions will be presented by each student author followed by a discussion on Having a High Impact on Managing Access to Medical Innovation: Strengthening The Methodology-Policy Nexus.

Moderators: Dennis Raisch, PhD, Professor, College of Pharmacy, University of New Mexico, Albuquerque, NM, USA; Laura Pizzi, PhD, Professor, College of Pharmacy, thomas Jefferson University, Philadelphia, PA, USA; Zeba M. Khan, RPh, PhD, Vice President, Celgene Corporation, Summit, NJ, USA

Speakers: Amr Makady, the National Healthcare Institute (ZIN), diemen, the Netherlands; Bettina wulff Risør, University of Southern denmark, Odense, denmark; Frank Moriarty, Royal College of Surgeons in Ireland, dublin, Ireland; Gerrit L. Merkens, Utrecht University, Utrecht, the Netherlands


INCREASING EUROQOL (EQ-5D) FROM 3 TO 5 LEVELS: IMPLICATIONS FOR USERS - DOES “NEW” MEAN “BETTER”?

Over the past 25 years EQ-5d has virtually become the de facto standard generic measure of health-related quality of life in clinical and economic evaluation of healthcare interventions. Its initial design was dictated by the need for instrument brevity and compactness. However, as a reaction to concerns about potential lack of sensitivity in the original 3L system, the number of response levels per EQ-5d dimension has been increased from 3 to 5, raising in turn the number of EQ-5d health states from 243 to 3,125. this change was expected to lead to improved performance in the new 5L version. despite improvements in technical attributes in the 5L version, for example in ceiling effects, it cannot be assumed that these automatically lead to improved performance in its use as an HrQoL outcome measure, particularly when used in cost-effectiveness applications.

there is no straightforward relationship between improved measurement properties and reduced ceiling effects and outcomes relevant for users such as discriminative power, responsiveness and impact on cost-effectiveness. Evidence is now emerging that reveals the consequences of moving from one version of EQ-5d to another. In this symposium, we examine the interplay between the level structure, value set characteristics, and population characteristics. Studies that employed both the 3 and 5 level versions will be used to illustrate the impact of using different versions of the EQ-5d on cost-effectiveness.

the symposium will be structured around the key questions: what changes might result from any alterations in the value set for the original 3L version? what consequences occur when the 3L descriptive system is replaced by the 5L version? How does the use of a new 5L value set based on the revised descriptive system impact on cost-effectiveness evaluation?

these topics are not specific to EQ-5d alone but are relevant when considering the possible substitution of any HrQoL measure with an alternative. they raise fundamental issues for instrument developers and end-users alike. In short - does “new” always mean “better”?

Moderator: Andrew Lloyd, DPhil, director, Bladon Associates Ltd, Oxford, Uk Speakers: Paul Kind, MPhil, Professor of Health Outcome Measurement, Academic Unit of Health Economics, Institute of Health Sciences, University of Leeds, Leeds, Uk; Bas Janssen, PhD, Senior Researcher, EuroQol Office, EuroQol Research Foundation, Rotterdam, the Netherlands; Allan Wailoo, PhD, Professor of Health Economics, School of Health and Related Research, University of Sheffield, Sheffield, Uk

Sponsored by: EuroQol Research Foundation

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13:15-14:15 POSTER AUTHOR dISCUSSION HOUR - SESSION I Hall X2-X3 (L-2)



n IP3: DOES CONSERVATISM BY REGISTRATION AUTHORITIES IN THEIR REQUIREMENTS FOR OUTCOME MEASURES IN PAIN TRIALS HAMPER DRUG DEVELOPMENT IN THAT AREA? Hall E2 (L0)Moderator: R.L Akehurst, PhD, Strategic director, Sheffield, BresMed Health Solutions, Sheffield, Uk Panelists: Will Dunlop, MEc, Head of Market Access, Mundipharma International Ltd, Cambridge, Uk; C. Daniel Mullins, PhD, Professor & Chair, Pharmaceutical Health Services Research, University of Maryland School of Pharmacy, Baltimore, Md, USA; Ben van Hout, Professor of Health Economics, School of Health and Related Research (ScHARR), University of Sheffield, Sheffield, Uk

ISSUE: does conservatism by registration authorities in their requirements for outcome measures in pain trials hamper drug development in that area?

OVERVIEW: In the therapeutic area of pain relief, a recent survey commissioned by Mundipharma International Limited has shown that superiority trials are in a minority and the outcome measures available are often not helpful in making economic cases for new drugs (Rycroft et al. 2015, Value in Health). the study was based on a literature review that identified 356 suitable pain studies. Only 46% of the ongoing/recently completed trials that did have an active comparator were designed as superiority studies. Payer-relevant end points were not reported in the majority of published and ongoing/recently completed studies: preference-weighted quality of life (36% and 42%), resource use (2% and 8%), physical function (28% and 39%), and psychological function (25% and 24%). the lack of payer relevant outcomes seen in pain studies could be seen as a state of affairs caused by registration authorities being conservative about both trial designs and choice of outcome measures. But it could also reflect unique challenges with pain therapy; including the possibility to titrate comparative therapies and the lack of appropriate outcome measures. declaration of financial interests: Profs Mullins and Akehurst have received honoraria for themselves or their company for participation in seminars and research in this area conducted by Mundipharma International Limited. will dunlop is an employee of Mundipharma International Limited. Prof van Hout has no interests to declare.

n IP4: DOES EUROPEAN REAL WORLD DATA REQUIRE A ‘DIGITAL SCHENGEN’ TO SUPPORT FEDERATED ACCESS, ASSESSMENT, AND (RE)USE, OPENING BORDERS AT THE INSTITUTE TO CROSS-COUNTRY? Hall D (L-2)Moderator: Ömer Saka, MD, MSc, Partner, Market Access Strategy and HEOR, deloitte, diegem, Belgium Panelists: Sarah Garner, PhD, BPharm, Associate director of Science Policy and Research, National Institute for Health and Care Excellence (NICE), London, Uk; Hans-Georg Eichler, MD, MSc, Senior Medical Officer, European Medicines Agency, London, Uk; Johan van der Lei, MD, PhD, Chair of the department of Medical Informatics, Medical Informatics, Erasmus University Medical Center Rotterdam, Rotterdam, the Netherlands

ISSUE: Europe needs to see breakthroughs in data access and sharing within and across its borders to enable opportunities of real-world data, as well as changes to address territorialism, lack of data interoperability, need for common data models, privacy concerns, and building of sustainable platforms. without such initiatives, Europe will see both a holding back of basic research and insights into health outcomes, as well as its competitiveness on the global arena of real-world data utilisation.

OVERVIEW: Europe/the EU is in a relatively unique position of increasing harmonisation of political, economic, and social aspects of society (inclusive of health care), but fraught with challenges in all domains compared with the United States, Asia Pacific, and other regions worldwide. despite moves to address fragmentation of both governance and application, such as the recent general data Protection Regulation (gdPR), moves to a common digital market and greater collaboration on research and allied programmes (i.e., within the Innovative Medicines Initiative), we remain far from an ideal position to see greater access, aggregation, and utilisation of health data for research across the pharmaceutical industry and life sciences, and academia. though two key drivers for use of real-world data, pharmacovigilance and safety surveillance, and outcomes research for reimbursement, have been significant in their impact and focus for some key stakeholders, access to data and biological material to support discovery and development, as well as intra-disease area and inter-therapeutic area research remain very challenging. with a data tsunami from disparate sources and technologies to a methods and outputs blizzard, we also face an expertise drought that is not helping to solve the issue of widespread data sharing in Europe or to improve the efficiency of regulatory and HtA processes.

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n W4: UNDERSTANDING THE CHALLENGES FACING THE VALUE ASSESSMENT OF MEDICAL DEVICES Hall E1 (L0)Discussion Leaders: Richard Charter, MSc, Head of Market Access & Pricing diabetes Care Europe, Becton dickinson Ag, Allschwil, Switzerland; Carla Zema, PhD, director, Health Policy and Economics, ZOLL, Pittsburgh, PA, USA; Chantale Lessard, RPh, MSc, PhD, DcomplD, Adjunct Professor, department of Health Management, Evaluation and Policy, School of Public Health, University of Montreal, Montreal, QC, Canada

PURPOSE: this workshop will highlight issues in the value assessment of medical devices including differing regulatory and health technology assessment (HtA)/reimbursement requirements, challenges with assuming that randomized controlled trials (RCts) are the gold standard for clinical evidence, why pharmaceutical standards are not always appropriate for devices, and the challenges of prescribing similar requirements to the wide variety of medical devices (e.g., implantable devices, capital equipment, diagnostics, medical equipment and supplies, and consumables). Participants will begin to discuss potential solutions to these challenges. this workshop would benefit all stakeholders interested in the value assessment of medical devices including regulatory agencies, HtA organizations, payers and reimbursement organizations, and health care decision makers.

DESCRIPTION: while there is no disagreement regarding the importance of value assessment of medical devices, lack of alignment of stakeholder needs and requirements creates many issues and challenges in market access of medical devices. Regulatory agencies focusing on safety and effectiveness have different standards than HtA and reimbursement organizations. Furthermore, applying pharmaceutical standards and requirements, such as RCts that are not always feasible for medical devices, may be a significant barrier. Moreover, one set of standards will likely not be applicable to the range of different types of medical devices. In discussing those challenges, the workshop will not only inform participants, but will also provide input to the ISPOR Value Assessment of Medical device working group’s manuscript in addressing these challenges.

Presented by the ISPOR Medical Devices and Diagnostics Special Interest Group

n W5: NEW APPROACHES TO SURVIVAL MODELING IN ONCOLOGY Hall A (L2)Discussion Leaders: Andy Briggs, PhD, william R. Lindsey Chair, Health Economics & Health technology Assessment, University of glasgow, glasgow, Uk; Jack Ishak, PhD, Senior Research Leader, Modeling & Simulation, Evidera, Montreal, QC, Canada; Federico Felizzi, PhD, HtA Statistician, gPMA, F. Hoffmann La Roche, Basel, Switzerland; Aline Gauthier, MSc, Managing director, Health Economics and Market Access, Amaris, London, Uk; Victoria Federico Paly, MHS, Senior Health Economist, ICON Health Economics & Epidemiology, New York, NY, USA

PURPOSE: given the nature of oncology trial design and conduct, overall survival effects of treatments are often not directly measured. However, estimates of these survival effects are important for economic evaluation. this workshop was constructed to provide those interested in this area a selection of recent research efforts that address this issue.

DESCRIPTION: the four papers in this session reflect separate studies on various aspects of estimating or modeling overall survival effects in oncology treatment. topics include parametric and simulation modeling tailored to mechanism of action, use of registry data for background survival estimation, adjusting for varying follow-up times and sample sizes, integrated survival modeling across treatments, and applications to cost-effectiveness and budget impact modeling.

n P2: STUDIES ON HTA APPROACHES Hall F1 (L0)

HT1 ALIGNED AND FLEXIBLE? A COMPARATIVE REVIEW OF SMC AND NICE DECISION-MAKING 14:15-14:30 Johnson H1, Spoors J2, Johnson J1, 1Helen Johnson Consulting Ltd, welwyn garden City, Uk, 2RJw &

Partners, Royston, Uk

HT2 A REVIEW OF THE USE OF NETWORK META-ANALYSIS IN NICE SINGLE TECHNOLOGY APPRAISALS 14:30-14:45 Fleetwood K1, glanville J2, McCool R2, wood H2, wilson k2, Marshall C2, Yellowlees A1, James d1, toupin S1,

McCabe R1, 1Quantics Consulting Ltd, Edinburgh, Uk, 2York Health Economics Consortium Ltd, York, Uk

HT3 ACTUARIAL APPROACHES TO MODELLING AND MITIGATING FINANCIAL UNCERTAINTY IN RECOMMENDING 14:45-15:00 NEW DRUGS AND HEALTH TECHNOLOGIES Serre D, Buckle J, Milliman, London, Uk

HT4 IMPLEMENTATION OF CONDITIONAL REIMBURSEMENT SCHEMES IN HTA PRACTICE: EXPERIENCES FROM 15:00-15:15 THE NETHERLANDS Makady A1, Nijmeijer H2, de Boer A3, Hillege JL4, klungel O5, goettsch w1, 1the National Healthcare

Institute (ZIN), diemen, the Netherlands, 2Radboud University Medical Centre, Nijmegen, the Netherlands, 3Utrecht University, Utrecht, the Netherlands, 4University Medical Center groningen, groningen, the Netherlands, 5Utrecht University, UtRECHt, the Netherlands

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n P3: UTILITY STUDIES Hall F2 (L0)

UT1 UTILITY BY TREATMENT LINE IN MULTIPLE MYELOMA; ANALYSIS OF OVER 9000 EQ-5Q-3L 14:15-14:30 QUESTIONNAIRES FROM THE EMMOS REGISTRY Hatswell AJ1, Couturier C2, Ito t3, 1BresMed, Sheffield, Uk, 2Janssen Medical Affairs, Paris, France, 3Janssen

Health Economics & Market Access EMEA, High wycombe, Uk

UT2 A META REGRESSION ANALYSIS OF UTILITY WEIGHTS FOR BREAST CANCER 14:30-14:45 Gong JR, Bae S, Ewha womans University, Seoul, South korea

UT3 PROSPECTIVE UTILITY STUDY OF PATIENTS WITH MULTIPLE CARDIOVASCULAR EVENTS 14:45-15:00 Pockett RD1, McEwan P2, Ray J3, tran I4, Shutler S5, Martin S6, Yousef Z7, Bakhai A8, 1Swansea University,

Swansea, Uk, 2Health Economics and Outcomes Research Ltd, Cardiff, Uk, 3F. Hoffmann-La Roche, Basel, Switzerland, 4Roche Products Ltd, welwyn garden City, Uk, 5F. Hoffmann-La Roche Ltd., Basel, Switzerland, 6Peterborough and Stamford Hospitals NHS Foundation trust, Peterborough, Uk, 7University Hospital of wales, Cardiff, Uk, 8Royal Free London NHS Foundation trust, Barnet, Uk

UT4 MAPPING QUALITY OF LIFE SCORES FROM FACT-G, FAACT AND FACIT-F ONTO PREFERENCE-BASED 15:00-15:15 UTILITIES USING THE 5-LEVEL VERSION OF EQ-5D QUESTIONNAIRE Meregaglia M1, Borsoi L1, Cairns J2, tarricone R1, 1Bocconi University, Milan, Italy, 2London School of Hygiene

and tropical Medicine, London, Uk

15:15-15:45 BREAK & EXHIBITS VIEWING Hall X2-X3 (L-2)

15:45-19:45 RESEARCH POSTER PRESENTATIONS - SESSION II Hall X2-X3 (L-2)



n IP5: A “FEDERAL” STANDARD FOR VALUING HEALTH IN A POST-REFERENDUM EUROPE? Hall A (L2)Moderator: Meindert Boysen, PharmD, MSc, Professor, Health Services Research & Policy, London School of Hygiene & tropical Medicine, London, and Programme director, Centre for Health technology Evaluation, National Institute for Health and Care Excellence (NICE), London, Uk Panelists: Paul Kind, Professor, Centre for Health Economics, Management and Policy, HSE University, St. Petersburg, Russia; Ben van Hout, PhD, Professor of Health Economics, School of Health and Related Research (ScHARR), University of Sheffield, Sheffield, Uk

ISSUE: Should there be a standard European-wide method of determining the value of health benefits?

OVERVIEW: By now, the result of the Uk referendum is a matter of fact. A far-reaching debate about EU membership failed to grapple with one central issue that ought to concern citizens across Europe, namely the methods used to determine the value of health benefits. National decisions made by regulatory agencies that include the evaluation of cost effectiveness depend upon two key factors – the availability of appropriate evidence and the capacity to analyse it. given the constraints on both these factors it would be reasonable to consider ways of improving the efficiency of economic evaluation by moving towards a standard “reference case” approach that could be required in all jurisdictions. As a first step in achieving this, it would be useful to consider adopting a standard European approach towards the valuation of health benefits. three key questions will be considered during this issues panel. which method should be adopted as the standard mechanism for determining the “value” of health? How should values from participating countries be aggregated? Should the issue be left to the general public, or to the informed elite? As with the Uk referendum, there are (at least) two points of view for all three questions. Underlying this debate is a European challenge—do we keep acting as we do as part of some type of laissez-faire arrangement or do we adopt a more positive system of cross-national working? the session will conclude with a referendum in which participants will be able to choose between two alternatives: the right one and the wrong one.

n IP6: FROM TESTIMONIALS TO QUALITATIVE RESEARCH EMBEDDED IN CLINICAL TRIALS: HOW DO HEALTH TECHNOLOGY ASSESSMENT BODIES CONSIDER THE VOICE OF RARE DISEASE PATIENTS WHEN GRANTING ACCESS TO ORPHAN DRUGS? Hall E1 (L0)Moderator: Benoit Arnould, PhD, Senior director, Patient-Centered Outcomes, Mapi group, Lyon, France Panelists: Sheela Upadhyaya, MSc, Associate director, Centre for Health technology Evaluation, Highly Specialised technologies, National Institute for Health and Care Excellence, London, Uk; Christine Lavery, MBE, group Chief Executive, the Society for Mucopolysaccharide diseases, London, Uk; Samantha Parker, MBA, Senior Vice President, Patient Access Officer, Lysogene, Neuilly sur Seine, France

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ISSUE: the panelists, from an HtA body, a patient advocacy group, and a pharmaceutical company, will be invited to debate the following questions: to what extent do patient testimonials impact health technology assessment (HtA) decisions? Is this sufficient to ensure reliable decision making? would qualitative research fill a gap?

OVERVIEW: the process resulting in market authorization for orphan drugs is driven by specific considerations, including: 1) critical unmet needs, 2) importance of giving patients a chance to slow or stop the progression of their disease, and 3) limited number of patients. As a result, HtA bodies are presented dossiers that frequently lack essential information concerning clinical outcomes. when clinical outcomes are documented, they may lack comprehensiveness, specificity, and documented clinical meaningfulness. Patients and their representatives play an essential role in sharing their experience in terms of priorities, risk/benefit assessment, and meaningfulness of outcomes. However, there is a gap in the way this information is provided to the authorities: in the absence of evidence, based on appropriate standardized patient-centered outcome measures, patients (or their representatives) frequently present their perspective in the form of testimonials. In the near future, this gap might trigger an increased level of rejection by HtA bodies of potentially important innovative therapeutics. there is a growing acknowledgement in the value of including disease-specific qualitative research in trial design. this approach—which pertains to the rapidly progressing field of mixed-methods research —might provide a critical contribution of scientific based evidence.

n W6: BRIDGING THE GAP BETWEEN EFFICACY AND EFFECTIVENESS: METHODS TO IDENTIFY DRIVERS OF EFFECTIVENESS BEFORE LAUNCH Hall D (L -2)Discussion Leaders: Chris Chinn, MSc, ACA, Head of Real world Investigations, Sanofi, guildford, Uk; Clementine Nordon, MD, PhD, Senior Epidemiologist, LASER Analytica, Paris, France; Lifang Liu, MD, PhD, Epidemiologist, EORtC, Brussels, Belgium; Mikkel Z. Ankarfeldt, PhD, Post doc, Novo Nordisk A/S, Soeborg, denmark

PURPOSE: Awareness on potential discrepancies between efficacy and effectiveness (“efficacy-effectiveness gap”) of new drugs being launched has grown among health technology assessment and regulatory bodies. the European Innovative Medicines Initiative launched the getReal project in order to provide scientific and operational solutions to inform on the effectiveness of drugs at an earlier stage of drug development. this project involves more than 30 public and private stakeholders (the EMA, the HAS, ZIN, NICE, academic researchers and pharma industry) and aims at providing methods to assess the effectiveness of drugs, before and just after launch.

DESCRIPTION: In the first session, the speakers will introduce the concept of “drivers of effectiveness,” which are defined as patient-related, drug use-related or health care system-related factors (e.g., follow-up strategies) that interact with the drug’s effect and may account for an efficacy-effectiveness gap if inadequately assessed or measured before the launch the drug. In the second session, the speakers will present the methods that can be used to identify these “drivers of effectiveness” at an early stage of drug development. these methods include: (1) literature reviews and experts’ interviews; and (2) patient-level or aggregate data analyses. the strengths and limitations of these methods will be discussed in the light of 3 case studies that were conducted for the getReal project (drivers of effectiveness in glucose-lowering drugs in diabetes, antipsychotic drugs in schizophrenia, and anti-cancer therapeutic strategies in Hodgkin’s lymphoma over 40 years). the workshop will conclude with a discussion in which workshop participants will be encouraged to share their understanding and perception of the methods presented, as well as the anticipated acceptability by various stakeholders.

n W7: APPROPRIATE MODEL TIME HORIZONS: THEORY, EMPIRICAL RESULTS, AND THE PERSPECTIVE OF DECISION MAKERS Hall E2 (L0)Discussion Leaders: Anthony J Hatswell, MSc, Principal Consulting Economist, department of Statistical Science, University College London, London, Uk; Uwe Siebert, MD, MPH, MSc, ScD, Professor & Chair, department of Public Health and Health technology Assessment, UMIt - University for Health Sciences, Medical Informatics and technology, Austria, Adjunct Professor, Health Policy and Management, Harvard School of Public Health, Boston, MA, USA, and director, division for HtA, ONCOtYROL – Center for Personalized Cancer Medicine, Hall i.t., Austria; Ash Bullement, BSc, Health Economist, BresMed Health Solutions, Sheffield, Uk; Matthew Taylor, MSc, PhD, director, York Health Economics Consortium, Heslington, York, Uk

PURPOSE: this workshop brings together the theoretical arguments (and guidelines) related to the choice of the time horizon for an economic model, empirical research on the effect of different time horizons on model results, the perspective of different decision makers on the appropriateness of modelled results and the characterization of uncertainty associated with long-term extrapolation.

DESCRIPTION: Economic modelling frequently requires extrapolation beyond the time horizon for which evidence is available modelling guidelines suggesting that the appropriate timeline be ‘enough to capture relevant benefits and costs’. Professor Siebert will begin the workshop with an overview of available guidance from modelling guidelines, how these were created, and theoretical arguments that the guidance was based on. Ash Bullement will then present work on the effect of varying time horizons on models and subsequent results in different disease areas (ranging from cancer to vaccinations), which includes alternative implementations of a ‘lifetime’ horizon. dr. taylor will then discuss the challenges of the appropriate time horizon from his perspective as a member of the NICE Public Health Advisory Committee. Anthony Hatswell will then lead a roundtable discussion (with audience participation) on what time horizons are appropriate for different models, how these should be practically implemented by modelers, and the challenges faced in the justification of extrapolations to non-economist audiences.

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n P4: CARDIOVASCULAR OUTCOMES RESEARCH STUDIES Hall F1 (L0)

CV1 COMPARISON OF ORAL ANTI-COAGULANTS FOR STROKE PREVENTION IN NON-VALVULAR ATRIAL FIBRILLATION: TWO MULTI-CRITERIA DECISION ANALYSES

15:45-16:00 Tervonen T1, Ustyugova AV2, Lip g3, Verdecchia P4, Sri Bhashyam S1, Heinrich-Nols J5, gropper S5, kwan R6, Marsh k1, 1Evidera Ltd, London, Uk, 2Boehringer Ingelheim gmbH, Ingelheim am Rhein, germany, 3University of Birmingham, Birmingham, Uk, 4Hospital of Assisi, Assisi, Italy, 5Boehringer Ingelheim Pharma gmbH & Co. kg, Ingelheim am Rhein, germany, 6Boehringer Ingelheim (Canada) Ltd, Burlington, ON, Canada

CV2 USING SUBPOPULATION TREATMENT EFFECT PATTERN PLOT TO IDENTIFY MORE EFFICIENT RESOURCE 16:00-16:15 ALLOCATION POLICIES Cao Q1, Hillege JL2, Postma MJ2, Buskens E2, Postmus d3, 1University of groningen, groningen, the

Netherlands, 2University Medical Center groningen, groningen, the Netherlands, 3University of groningen, University Medical Center groningen, groningen, the Netherlands

CV3 POLICY OBJECTIVE OF GENERIC MEDICINES FROM THE INVESTMENT PERSPECTIVE: THE CASE OF 16:15-16:30 CLOPIDOGREL Elek P1, Harsányi A2, Zelei t3, Csetneki k3, Kaló Z3, 1Eötvös Loránd University (ELtE), Budapest,

Hungary, 2Eötvös Loránd University, Budapest, Hungary, 3Syreon Research Institute, Budapest, Hungary

CV4 ARE COMPONENT ENDPOINTS EQUAL? A STUDY INTO THE PRACTICE OF COMPOSITE END POINTS IN 16:30-16:45 CLINICAL TRIALS Vaanholt MC1, von Birgelen C2, kok M3, weernink Mg1, van Til J2, 1University twente, Enschede, the

Netherlands, 2University of twente, Enschede, the Netherlands, 3Medisch Spectrum twente, Enschede, the Netherlands

n P5: PRICING POLICY STUDIES Hall F2 (L0)

PR1 ASSOCIATION BETWEEN THE PRICES OF ORPHAN DRUGS IN ONCOLOGY AND THE PATIENT POPULATION 15:45-16:00 SIZES Jarosławski S, Toumi M, Aix-Marseille University, Marseille, France

PR2 PAY FOR PERFORMANCE: A PROPOSAL FOR AND SIMULATION OF REAL TIME OUTCOMES-BASED 16:00-16:15 PHARMACEUTICAL PRICING USING ROUTINELY COLLECTED DATA Butt T1, Lee A2, tufail A3, 1University College London, London, Uk, 2University of washington, Seattle, wA,

USA, 3Moorfields Eye Hospital NHS Foundation trust, London, Uk

PR3 DIFFERENCES IN PRICING POLICIES FOR GENERIC AND BIOSIMILAR MEDICINES 16:15-16:30 Vogler S, Schneider P, gombocz M, Zimmermann N, gesundheit Österreich gmbH / Austrian Public Health

Institute, Vienna, Austria

PR4 THE DETERMINANTS OF INNOVATIVE DRUGS PRICES: THE CASE OF ONCOLOGY DRUGS, COMPARATIVE 16:30-16:45 ANALYSIS Aissaoui A1, Levy P2, 1Paris dauphine University, PSL, Paris, France, 2Université Paris-dauphine, Paris, France


n IP7: HOW SHOULD BIOSIMILARS BE VALUED AND SHOULD THEY UNDERGO HEALTH TECHNOLOGY ASSESSMENT? Hall D (L -2)Moderator: Jeanette Kusel, MA, MSci, MSc, Head of HtA and Health Economics, Costello Medical Consulting Ltd, Cambridge, Uk Panelists: Emi Psachoulia, MSc, PhD, Senior Manager Market Access, Biogen International gmbH, Zug, Switzerland; Frank McKenna, MD, FRCP, Consultant Rheumatologist, trafford general Hospital, Central Manchester University Hospitals, Manchester, Uk; Andrew Walker, PhD, Health Economist, Robertson Centre for Biostatistics, University of glasgow, glasgow, Uk

ISSUE: the issue under debate will be whether biosimilars should undergo health technology assessment (HtA), and if they should, then what form this should take. the perspectives of a biosimilar manufacturer, prescriber, and HtA body will be covered.

OVERVIEW: due to the reduced requirement for clinical evidence for regulatory approval, biosimilars can be priced lower than the originator brand and therefore have the potential to deliver significant cost savings. How payers value biosimilars is likely to differ across countries. Being cost-saving does not necessarily mean they will automatically be cost-effective, as biosimilars still have high price tags compared to many other medicines. For example, in the Uk the infliximab biosimilars have been recently rejected by NICE for the treatment of moderate rheumatoid arthritis. HtA agencies already have different approaches to handling biosimilars; for example, within the Uk, NICE only assesses biosimilars through multiple technology appraisals, whereas in Scotland, biosimilars whose reference product is not recommended are assessed

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individually. Some countries, such as Poland, do not have a published process. the panelists will give their views on how biosimilars should be valued, whether they should undergo HtA, and how this might differ across markets. If HtA is deemed necessary, then the panelists will expand on whether this is only in certain cases and when this should occur with respect to marketing authorisation. the experts will be challenged on whether appraising biosimilars is an effective use of public money and what data should be required by payers. Additionally, the panelists will be asked how they think the patient and clinician perspective should be incorporated into decision making. the audience will get a chance to share views and pose questions to the panel. there will be an audience vote on whether biosimilars should undergo HtA.

n IP8: IS THE GOAL OF UNIVERSAL COMPARATIVE EFFECTIVENESS EVIDENCE ACROSS JURISDICTIONS ACHIEVABLE? Hall E1 (L0)Moderator: Pall Jonsson, PhD, MRes, Senior Scientific Adviser, Science Policy and Research Programme, National Institute for Health and Care Excellence (NICE), Manchester, Uk Panelists: Rob Thwaites, MA, Senior director, takeda, London, Uk; Francesca Cerreta, MChem, MPharm, Senior Scientific Officer EMA, European Medicines Agency, London, Uk; Sarah Garner, PhD, BPharm, Associate director of Science Policy and Research, National Institute for Health and Care Excellence (NICE), London, Uk

ISSUE: A key aspiration that is shared between regulators, health technology assessment (HtA) agencies, and the pharmaceutical industry is to have evidence that will allow patients earlier access to new effective medicines across all jurisdictions. this requires a global development strategy that produces evidence of effectiveness to meet the differing needs of regulatory and HtA agencies. the panel will debate the minimum requirements for this to be achievable, making reference to current and recent collaborative initiatives. Pall Jonsson will moderate and introduce key themes and issues. Rob thwaites will represent the industry perspective and describe how the Innovative Medicine Initiative’s getReal project is exploring the acceptability of real-world evidence (RwE) in effectiveness research. Francesca Cerreta will discuss the regulatory perspective and whether RwE has a role in regulation. Sarah garner will provide a health technology assessment perspective and discuss whether collaborative solutions can be developed to foster the development of Medicines Adaptive Pathways to Patients (MAPPs).

OVERVIEW: Evidence on comparative effectiveness is a necessary condition for effective and cost-effective health care. In order for the development of such evidence to be viable in different jurisdictions, a number of minimum requirements have to be met, including: agreement on outcomes; infrastructure to capture patient-level outcomes; methodologies to analyse the data; and agreement that the data are acceptable and what role they will play in decision-making. Views on relevance and acceptability of different types of real-world data, evidence and methods vary across stakeholders and jurisdictions. the panel will reflect on their different perspectives and debate with the audience whether a convergence of real-world data methods and polices can be achieved across jurisdictions.

n W8: THE IMPORTANCE OF RELEVANCE IN HEALTH ECONOMIC EVALUATIONS: CHALLENGES AND WAYS FORWARD Hall A (L2)Discussion Leaders: Herbert J.A. Rolden, PhD, Postdoctoral Researcher, Radboud Institute for Health Sciences, department for Health Evidence, Radboudumc, Nijmegen, the Netherlands; J. Jaime Caro, MDCM, FACP, FRCPC, Adjunct Professor, Medicine, Epidemiology, and Biostatistics, Mcgill University, Montreal and Chief Scientist, Evidera, Inc., Lexington, MA, USA; Manuela A. Joore, PhD, Professor of Health technology Assessment & decision Making, department of Clinical Epidemiology and Medical technology Assessment, School for Public Health and Primary Care (CAPHRI), Faculty of Health, Medicine and Life Sciences, Maastricht University Medical Center, Maastricht University, Maastricht, the Netherlands; Janneke P.C. Grutters, PhD, Assistant Professor, Radboud Institute for Health Sciences, department for Health Evidence, Radboudumc, Nijmegen, the Netherlands

PURPOSE: the aim of this workshop is to familiarize participants with the concept of relevance in model-based health economic evaluations. Participants will also gain insight into the main problems we encountered when we reviewed model-based economic evaluations for relevance; as well as ways to avoid these problems in the future.

DESCRIPTION: As model-based health economic evaluations are used to make decisions that greatly affect citizens, it is not only imperative that the underlying economic models are sound, but also that model inputs are representative of actual clinical practice, or in other words, relevant for the decision context. In the first half of the workshop, Jaime Caro will provide background information on the concept of relevance, and what factors should be taken into account for a health economic evaluation to be relevant. thereafter, Herbert Rolden will present the results of a systematic review addressing the relevance of model-based economic evaluations of dabigatran for atrial fibrillation. Manuela Joore will then discuss the concept of relevance in relation to framing a health economic evaluation, and will provide insight into the main relevance issues in model-based economic evaluations of trastuzumab for early breast cancer. Afterwards, Jaime Caro will reflect on the previous presentations and together we will discuss ways to increase relevance when performing a health economic evaluation. In the second half of the workshop, participants will be asked to reflect on the problems with relevance, whether they have encountered such problems, and what they propose as ways to avoid these problems. this interactive workshop will prove to be useful for those performing model-based health economic evaluations, both from industry and academia, as well as those reviewing and utilizing such economic evaluations, (i.e., members of reimbursement agencies, peer reviewers, and journal editors).

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n P6: MEDICATION ADHERENCE STUDIES Hall F1 (L0)

AD1 REAL-WORLD IMPACT OF GENDER, AGE AND SOCIO-ECONOMIC STATUS ON TYPE-2 DIABETES MELLITUS 17:00-17:15 (T2DM) PATIENTS DISEASE ENGAGEMENT AND ADHERENCE WITH TREATMENT REGIMENS Higgins V, Leith A, Benford M, Siddall J, Piercy J, Adelphi Real world, Bollington, Uk

AD2 A FRAMEWORK FOR MEASURING ADHERENCE TO MULTIPLE MEDICATIONS 17:15-17:30 Pednekar P1, Agh t2, Malmenas M3, Peterson AM4, 1University of the Sciences, Philadelphia,

PA, USA, 2Syreon Research Institute, Budapest, Hungary, 3PAREXEL International, Stockholm, Sweden, 4University of the Sciences in Philadelphia, Philadelphia, PA, USA

AD3 MEDICATION ADHERENCE AND PERSISTANCE IN TYPE 2 DIABETES MELLITUS (T2DM): PATIENTS 17:30-17:45 PERSPECTIVE IN THE SPANISH HEALTH CARE SYSTEM Labrador Barba E1, Hernandez Mijares A2, Alonso Moreno FJ3, Rodriguez de Miguel M1, Orera Peña ML1,

Aceituno Mata S4, Faus dader MJ5, 1Mylan, Barcelona, Spain, 2dr. Peset Hospital, Valencia, Spain, 3Sillería Health Center, toledo, Spain, 4Outcomes’10, Castellon, Spain, 5Faculty of Pharmacy, granada, Spain

AD4 ADHERENCE TO TREATMENT AND MODIFIABLE RISK FACTORS IN ACUTE CORONARY SYNDROME (ACS) 17:45-18:00 PATIENTS REGISTERED IN THE PGRX REAL WORLD DATASETS Cuervo J1, Nordon C2, Rossignol M3, Morisot N2, Benichou J4, danchin N5, Abenhaim L6, Grimaldi-Bensouda

L2, 1HEOR, Oviedo, Spain, 2LASER Analytica, Paris, France, 3Mcgill University, Montreal, QC, Canada, 4Centre Hospitalier Universitaire de Rouen, Paris, France, 5Hôpital Européen georges Pompidou, Assistance Publique-Hôpitaux de Paris, Paris, France, 6LASER Analytica, London, Uk

n F1: EXTENDING COST-EFFECTIVENESS ANALYSIS, PARTIAL OPTIMIZATION MODELLING, AND FISCAL MODELLING IN VACCINE VALUE ASSESSMENTS Hall F2 (L0)Presented by the ISPOR Economic Evaluation of Vaccines Designed to Prevent Infectious Disease: Good Practices Task Force

Moderator: Josephine A. Mauskopf, PhD, MHA, MA, Vice President, Health Economics, RtI Health Solutions, Research triangle Park, NC, USA Speakers: Baudouin Standaert, MD, PhD, director, Health Economics, gSk Vaccines, wavre, Belgium; Mark Connolly, PhD, Senior Research Scientist, PharmacoEconomics and PharmacoEpidemiology Unit, University of groningen and Managing director, global Market Access Solutions, Switzerland and US, groningen, the Netherlands; Mark Jit, PhD, Reader, department of Infectious disease Epidemiology, London School of Hygiene and tropical Medicine, London, Uk; Paul Revill, MSc, Senior Research Fellow, Centre For Health Economics, University of York, Heslington, York, Uk

DESCRIPTION: the decision to introduce a new vaccination program in a country is a process in which multiple decision makers participate. Each decision maker considers the value of the new vaccination program from different perspectives and is, therefore, interested in different measures of economic value. these measures include value for money and net present value and can be considered to be part of a complete assessment of economic value. the ISPOR task Force on the Economic Evaluation of Vaccines for Infectious diseases has selected 3 methods currently being used to assess the value of new vaccination programs (cost-effectiveness analysis, partial optimization modelling, and fiscal modelling). At this forum, we will present an initial set of guidelines (perspective, comparator, time horizon, discounting, model structure, data requirement, outcome measures, uncertainty evaluation, transparency, and validation) for each of these methods, as well as an exploration of how they can be extended beyond a focus on individual health outcomes to include a broader set of outcomes for the individual, household, and the community. we will ask forum participants to give the task Force feedback on the initial guidelines for the traditional and extended value assessments.

18:00-19:45 EXHIBITORS’ OPEN HOUSE RECEPTION & RESEARCH POSTER PRESENTATIONS VIEWING - SESSION II Hall X2-X3 (L -2)


Reception Sponsored by Evidera


n F2: PATIENT ENGAGEMENT: STOPPING TO DEFINE IT Hall D (L -2)Presented by the ISPOR Patient Centered Special Interest Group

Moderator: Todd Berner, MD, Senior Medical director, Head global Medical Affairs Strategy, Immunology, Baxalta, Inc., IL, USA Speakers: Eleanor M. Perfetto, PhD, MS, Senior Vice President, Strategic Initiatives, National Health Council, washington, dC, USA and Professor, Pharmaceutical Health Services Research, School of Pharmacy, University of Maryland, Baltimore, Md, USA; Maya L. Hanna, MPH, doctoral Student, School of Pharmacy, University of Maryland, Baltimore, Md, USA;

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Rob Camp, BS, Communications Manager, European Patients’ Academy (EUPAtI), Barcelona, Spain; Russell Wheeler, Patient Advocate, Leber Hereditary Optic Neuropathy, winchester, Uk

DESCRIPTION: Recently, the terms “patient engagement” and “patient centered” have been used extensively, but rarely defined or commonly understood in the context of health care and research. to involve patients in research and health care delivery with the goal of improving health outcomes important to them, users need to understand the full scope of patient engagement and to define the attributes of these terms. the Patient Engagement in Research working group conducted a systematic review to identify existing definitions used over the past 10 years for patient engagement and centeredness, and 14 other patient-related terms in the context of health care research and practice. the working group screened 1,371 abstracts and reviewed full-text articles seeking definitions. this forum will allow the working group to present the results from the systematic review and the resulting analyses used to identify emergent themes. Preliminary results of definitions for patient-related terms in the scope of health economics and outcomes research will be presented for audience discussion.

n F3: GENERATING EVIDENCE OF THE ADDED VALUE OF ‘PRECISION’ MEDICINE Hall A (L2)Presented by the ISPOR Personalized / Precision Medicine Special Interest Group

Moderator: Katherine Payne, PhD, MSc, DipClinPharm, BPharm, MRPharmS, Professor of Health Economics, the University of Manchester, Manchester, Uk Speakers: Eric Faulkner, MPH, Vice President, Precision and transformative technology Solutions, Value demonstration, Access and Commercial, Evidera, and Assistant Professor, Institute for Pharmacogenomics and Individualized therapy, University of North Carolina at Chapel Hill, Chapel Hill, SC, USA; Uwe Siebert, MD, MPH, MSc, ScD, Professor & Chair, department of Public Health and Health technology Assessment, UMIt - University for Health Sciences, Medical Informatics and technology, Austria, Adjunct Professor, Health Policy and Management, Harvard School of Public Health, Boston, MA, USA, and director, division for HtA, ONCOtYROL – Center for Personalized Cancer Medicine, Hall i.t., Austria; Anke-Peggy Holtorf, PhD, MBA, Managing director, Health Outcomes Strategies, gmbH, Basel, Switzerland; Gurmit Sandhu, BPharm (Hons), MBA, MPH, Patient Engagement Specialist, gurmit Sandhu Consulting gmbH, Basel, Switzerland

DESCRIPTION: different terms have emerged into practice (i.e., precision, personalized, stratified, individualized medicine) all generally used to refer to the use of technology to more effectively target health care interventions to subgroups of people that are more likely to accrue more benefits than harm. given the potential for increasing numbers of new technologies and interventions that promise to deliver precision medicine and that will impact health care budgets, it is vital to generate evidence of their added value. A number of challenges have been identified, but to date, there have been few evidence-based suggestions on how to meet these challenges. the aim of this interactive session will be to understand the audience’s view on what precision medicine is and present some potential solutions to key types of challenges under the headings: methodological, technical, practical and organizational, and the patient perspective.

the session will start with the moderators asking the audience to indicate their view on suggested definitions of personalized, stratified, individualized and precision medicine. Anke-Peggy Holtorf will start the presentations by describing some examples of methodological challenges and suggest a research agenda to address these. Uwe Siebert will describe the technical challenges involved when developing decision-analytic models for benefit-harm analysis and economic evaluation. Recent examples from the area of oncology will be presented to show some potential solutions. Eric Faulkner will describe the practical and organizational challenges from the perspective of industry and health care systems that need to be solved to generate a sufficient and timely evidence base, such as the need to address budget silos and developing timely and effective services. Eric will also show how different approaches, such as headroom analysis or the use of observational data can be used to solve practical challenges. gurmit Sandhu will focus on why it is important to take into account the patient’s perspective when introducing precision medicine into clinical practice. the session will conclude with an interactive session, in which the audience is invited to contribute to developing a future research agenda to generate an evidence base to understand the added value of precision medicine.

n F4: BURDEN OF HEPATITIS C IN CENTRAL AND EASTERN EUROPEAN COUNTRIES Hall F2 (L0)Presented by the ISPOR CEE Network

Moderator: Zoltán Kaló, PhD, Professor, department of Health Policy and Health Economics,Eötvös Loránd University (ELtE), Budapest, Hungary Speakers: Guenka Petrova, DSci, Professor, Social Pharmacy, Medical University Sofia, Faculty of Pharmacy, and President, ISPOR Bulgaria Chapter, Sofia, Bulgaria; Lubov Krasnova, MD, PhD, Senior Researcher, department of Hematology & geriatrics, First Sechenov State Medical University, Moscow, Russian Federation; Anush Perikhanyan, MPH, Researcher, Pharmaceutical Management, Yerevan State Medical University, and President, ISPOR Armenia Chapter, Yerevan, Armenia; Elena Pyadushkina, PharmD, Researcher, Russian Presidential Academy of National Economy and Public Administration, Moscow, Russian Federation

DESCRIPTION: the medical and economic burden of hepatitis C is more significant in lower-income countries than in high-income economies in Europe. this forum will focus on introducing highly effective new medicines in this field, discussing better understanding of disease burden, and trade-offs between health, affordability and equity objectives. Speakers will aim to review existing information on the burden of hepatitis C in Central and Eastern European (CEE) countries and identify evidence gaps to facilitate informed policy decisions about new medicines.

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n F5: DRUG PRICING IN ADRIATIC COUNTRIES – IS REFERENCE PRICING THE BEST OPTION? Hall F1 (L0)Presented by the ISPOR CEE Network

Moderator: Tarik Catic, PhD(s), Past President, ISPOR Bosnia and Herzegovina Chapter, Sarajevo, Bosnia Speakers: Rok Hren, PhD, MSc IHP (HE), President, ISPOR Slovenia Chapter, and Professor, University of Ljubljana, Ljubljana, Slovenia; Ljubica Suturkova, PhD, President, ISPOR Republic of Macedonia Chapter, and Professor, Faculty of Pharmacy, UkIM-Skopje, Skopje, Macedonia; Pero Draganic, PhD, MD, President, ISPOR Croatia Chapter, and Assistant Professor, HALMEd, Zagreb, Croatia; Dragana Atanasijevic, MD, MSc, President, ISPOR Serbia Chapter, and Consultant, HtA & Healthcare Quality Improvement, Belgrade, Serbia

DESCRIPTION: drug pricing rules and trends will be presented from the perspective of countries in the Adriatic region. Speakers will discuss each country’s experience and the impact of prices on access to medicines, its quality, and pharmaceutical expenditure. Since most of the countries in the region share similar health care organization and financing systems, it will be an opportunity to discuss trends and propose which model is the most suitable for these countries in order to effectively distribute pharmaceutical budgets and ensure access to medicines.

n F6: THE ECONOMIC BURDEN OF COUNTERFEIT MEDICINES IN AFRICA: SITUATION ANALYSIS AND PROPOSED SOLUTIONS Hall E1 (L0)Presented by the ISPOR Africa Network

Moderator: Mahmoud Diaa Elmahdawy, PharmD, President, ISPOR Egypt Chapter, director, AMAC Market Access, Novartis, Health Economics, and Lecturer of Clinical and Hospital Pharmacy, Misr International University, Cairo, Egypt Speakers: Anthony Waka Udezi, PhD, President, ISPOR Nigeria Chapter, and Associate Professor & Assistant dean, department of Clinical Pharmacy, University of Benin, Benin City, Nigeria; Ilse Truter, DCom, BPharm, MSc, PhD, MPS, Professor in Pharmacy & Leader, drug Utilization Research Unit (dURU), department of Pharmacy, School of Medicinal Sciences, Faculty of Health Sciences, Nelson Mandela Metropolitan University, Port Elizabeth, South Africa; Kasem S. Akhras, PharmD, Head, Market Access, Middle East and North Africa (MENA), Novartis Pharma Services Ag, dubai, UAE

DESCRIPTION: trade of counterfeit and substandard medicines is a multi-billion dollar business worldwide. their impact in Africa, where only very limited resources for laboratory identification of these medications exist, have not been quantified in terms of clinical, humanistic, and economic outcomes. In this forum, speakers from Africa will discuss the current real-life situations of counterfeit medicines in their countries with emphasis on the economic burden and solutions that are being explored to address the problem and to reduce the number of counterfeit and substandard medicines on the African market.

n F7: A STRUCTURED DEBATE REGARDING THE NATIONAL HEALTH ECONOMICS GUIDELINES IN SOUTHERN EUROPE Hall E2 (L0)Presented by the ISPOR Portugal Chapter, ISPOR Spain Chapter, ISPOR Italy-Milan Chapter, and ISPOR Italy-Rome Chapter

Moderator: Carlos Gouveia Pinto, PhD, Associate Professor, ISEg, Lisbon School of Economics and Management and President, ISPOR Portugal Chapter, Lisbon, Portugal Speakers: Jaime Espín, PhD, Professor, Andalusian School of Public Health, granada, Spain; Luis Silva Miguel, MSc, PhD, Researcher, Research Centre on the Portuguese Economy, CISEP, Lisbon School of Economics & Management, University of Lisbon, Lisbon, Portugal; Lorenzo G. Mantovani, DSc, Associate Professor of Public Health, Research Centre on Public Health, University of Milano-Bicocca, Monza, Italy; Francesco Saverio Mennini, PhD, Professor, Faculty of Economics, Centre for Economic Evaluation and HtA, CEIS, University of Rome tor Vergata, Rome, Italy

DESCRIPTION: the ISPOR tool - Pharmacoeconomic guidelines Around the world - features a listing and description of international official guidance regularly shaping formulary decisions. the periodic review of guidelines raises a few questions, such as: what are the methodological challenges and political contestation involved in the establishment, review and use of the guidance. this forum will therefore explore the latest controversies regarding national health economic evaluation guidelines in the context of southern European regions via a moderated debate among experts. In doing so, this session seeks to provide analytical insight for analyzing and revisiting the national guidelines presented.

18:45-19:45 POSTER AUTHOR dISCUSSION HOUR - SESSION II Hall X2-X3 (L -2)


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19:45-21:00 ISPOR STUdENT WELCOME RECEPTION Hall K Foyer

All students and faculty are welcome to attend! One of the main goals of the ISPOR Student Network is to increase the connection among student members and faculty. Please join us to continue the success and increase your networking connections!

Reception co-sponsored by Amgen and PHMR

19:45-21:00 ISPOR CENTRAL & EASTERN EUROPE (CEE) NETWORK WELCOME RECEPTION Hall G Foyer

Join ISPOR colleagues for a great opportunity to interact, share ideas, and network! ISPOR CEE Network connects over 3700 HEOR professionals from 23 ISPOR Regional Chapters sharing ISPOR values and supporting its vision and mission. All attendees interested in learning about the CEE Network, its role in the HEOR community, current activities and initiatives, are welcome to attend this event. For more information visit www.ispor.org >> Regional Chapters/Networks >> ISPOR Networks Index >> CEE Network.


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TUESDAYSCHEDULE AT-A-GLANCE 7:30-8:30 OPEN MEETING: ISPOR STATEd PREFERENCE METHOdS SPECIAL INTEREST GROUP Hall G1 (L-2)


New Value Frameworks in the United States: Insights from Payers, Considerations for Manufacturers, and Impli-cations for Other Regions of the World (Sponsored by Xcenda)

8:45-13:45 POSTERS - SESSION III Hall X2-X3 (L-2)


IP9: Incentivising Research into the Effectiveness of Medical Devices Hall E1 (L0)

W10: The Potential and Pitfalls of Using Multi-Criteria Decision Analysis to Support Health Technology Assessment Hall A (L2)

W11: Let’s Go Fly a Kite – Managing the Winds of Change in Real World Evidence Studies Hall D (L-2)

W12: Rethinking What Missing Patient-Reported Outcome (PRO) Data Can Teach Us about Outcomes and Survival in Oncology Clinical Trials Hall E2 (L0)

P7: Neurological Disorders Studies Hall F1 (L0)

P8: Patient Preference Studies Hall F2 (L0)

9:45-10:15 BREAK, EXHIBITS & POSTERS - SESSION III Hall X2-X3 (L-2)

10:15-12:00 WELCOME & SECONd PLENARY SESSION Hall A (L2)

Differential Pricing of Medicines in Europe: Implications for Access, Innovation, and Affordability

12:00-13:45 LUNCH, EXHIBITS & POSTERS - SESSION III Hall X2-X3 (L-2)

12:15-13:30 OPEN MEETING: PATIENT ENGAGEMENT, PATIENT CENTRIC, WHAT dOES IT ALL MEAN? Hall E1 (L0)


Novel Approaches to Evidence-Driven Design and Study Sample-Frame Validation (Sponsored by IMS Health)

12:45-13:45 POSTER AUTHOR dISCUSSION HOUR - SESSION III Hall X2-X3 (L-2)


IP10: Adaptive Pathways and Patient Access – Pushing Payer Boundaries or Facilitating New Payment Models? Hall A (L2)

IP11: Emerging US Value Frameworks: Are There Lessons from - or for - Europe? (Invited Issue Panel) Hall D (L-2)

W13: Changing Our Perspective on Patient-Reported Outcomes in Oncology: It’s More Complex Than Traditionally Conceptualized or Analyzed Hall E1 (L0)

W14: Choice Defines Value: How to Analyse and Disseminate Evidence on the Importance of Multiple Criteria from Multiple Perspectives to Inform an Appraisal Process in Health Technology Assessment Hall E2 (L0)

P9: Economic Evaluation Studies Hall F2 (L0)

P10: HTA & Value Assessment Studies Hall F1 (L0)

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TUESDAY SCHEDULE AT A GLANCE CONTINUED14:45-15:15 BREAK & EXHIBITS Hall X2-X3 (L-2)

15:15-19:15 POSTERS - SESSION IV Hall X2-X3 (L-2)


IP12: Valuing Transformative Medicines in Rare Diseases: Methods and Madness Hall F1 (L0)

W15: Building and Applying Constrained Optimization Models in Health Care: A Case Study of Optimal Kidney Matching Hall E1 (L0)

W16: How to Transfer Economic Evidence to Low and Middle-Income Countries? Working under Capacity Restrictions Hall A (L2)

W17: New Challenges for High-Risk Medical Devices in Europe: How to Achieve the Balance between the Demand for Early Product Launch and Safety? Hall E2 (L0)

P11: Database Use in Outcomes Research Studies Hall D (L-2)

P12: Health Care Expenditure & Reimbursement Studies Hall F2 (L0)


IP13: Real World Evidence to Support Value Proposition and Reimbursement at Launch: The Aspirational Meets the Impractical? Hall A (L2)

W18: Methodologies for Evaluating Geographic Variation in Health Care Outcomes Research Hall E2 (L0)

W19: Strengthening the Role of Value of Information Analysis in Health Technology Assessment: Known Challenges and Proposed Solutions Hall E1 (L0)

W20: Predicting Treatment Effectiveness over Time in Real World from Trial Efficacy Data Hall D (L-2)

W21: Doubly Robust Estimation for Comparative Effectiveness Research: Getting an Extra Shot at Correctly Specifying the Treatment-Outcome Model Hall F1 (L0)

P13: Medical Device & Diagnostic Research Studies Hall F2 (L0)

17:30-19:15 EXHIBITORS’ WINE & CHEESE RECEPTION & POSTERS - SESSION IV Hall X2-X3 (L -2)


F8: New Issues and Emerging Trends in HEOR: Revising the ISPOR Code of Ethics Hall E1 (L0)

F9: Uses, Applications, and Future Directions of the ISPOR Digest of International Databases Hall F1 (L0)

F10: Health Economic Modeling in Oncology Hall A (L2)

F11: Results from MCDA Payer Criteria: Weights and Preferences in the CEE Region Hall E2 (L0)

F12: The Value of Multi-Stakeholder Partnership in Advancing Patient Access in Central and Eastern Europe Hall D (L-2)

F13: The Spanish Experience in Hepatitis C: Friends or Foes? Hall F2 (L0)

18:15-19:15 POSTER AUTHOR dISCUSSION HOUR - SESSION IV Hall X2-X3 (L -2)

20:00-23:30 ISPOR SOCIAL EVENT (Separate Registration Required) Off Site Venue

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TUESDAY, 1 NOVEMBER 2016

7:30-8:30 OPEN MEETING: ISPOR STATEd PREFERENCE METHOdS SPECIAL INTEREST GROUP Hall G1 (L -2)

Stated-preference methods are increasingly used to support health care decision making across Europe. Multiple methods can be used to measure preferences of patients and other stakeholders. the next project is a manuscript mapping the use of stated preference methods by regulatory and reimbursement decision makers in Europe. Examples include: IQwig’s benefit assessments requiring elicitation of patient preferences using discrete choice experiment (dCE) or the analytical hierarchy process (AHP) and the use of direct weighting methods to elicit decision makers’ preferences to inform reimbursement decisions by HtA agencies in Hungary and Italy. If you are interested in the topic and /or have case studies to contribute, please join the discussion!

7:30-8:30 EdUCATIONAL SYMPOSIUM Hall D (L -2)

NEW VALUE FRAMEWORKS IN THE UNITED STATES: INSIGHTS FROM PAYERS, CONSIDERATIONS FOR MANUFACTURERS, AND IMPLICATIONS FOR OTHER REGIONS OF THE WORLD

Prior to mid-to-late 2015, there was little interest in the application of formal value assessments in the United States (US), despite efforts to implement healthcare reform at the national level. this fundamentally changed in 2015 with the release of several US-focused value constructs, including the Memorial Sloan kettering Cancer Center (MSkCC) drugAbacus, American Society of Clinical Oncology (ASCO) Value Framework, and the Institute for Clinical and Economic Review (ICER) Evidence Reports. Each has since refined and released – formally or informally – updated tools and methodologies. Moreover, many manufacturers, payers, and other stakeholders have garnered at least one year of tangible experience with drugs that have been evaluated using these methodologies. the MSkCC drugAbacus and ASCO’s net health benefit (NHB) evolved specifically in response to the rising cost of oncology therapies, whereas the ICER framework is more broadly applicable, with the goal of informing population level policy decisions. ICER conducted its first evaluation of oncology drugs in an assessment of multiple myeloma therapies earlier this year, thereby further underscoring the impact of these therapies. the specific enduring implications of these value constructs on stakeholder decision-making remains to be determined; however, it is evident that the landscape has been transformed. we will present these constructs, discuss the strengths and weaknesses of each, share perspectives regarding how pharma and US payers view value constructs, and examine implications for other regions of the world.

Moderator: Jay Jackson, PharmD, MPH, Vice President, global Health Economics and Outcomes Research, Xcenda, Palm Harbor, FL, USA

Speakers: Denise Globe, PhD, Executive director & Head of Health Economics & Outcomes Research, US Oncology Cd&MA Health Economics, Novartis Pharmaceuticals, East Hanover, NJ, USA

Kristen Migliaccio-Walle, BS, director, global Health Economics, Xcenda, LLC, Palm Harbor, FL, USA

Ken O’Day, PhD, MPA, director, global Health Economics, Xcenda, LLC, Palm Harbor, FL, USA

Daniel C. Malone, PhD, RPh, FAMCP, Professor of Pharmacy, College of Pharmacy & Mel and Enid Zuckerman College of Public Health, University of Arizona, tucson, AZ, USA

Sponsored by: Xcenda

8:45-13:45 RESEARCH POSTER PRESENTATIONS - SESSION III Hall X2-X3 (L -2)



n IP9: INCENTIVISING RESEARCH INTO THE EFFECTIVENESS OF MEDICAL DEVICES Hall E1 (L0)Moderator: Rosanna Tarricone, PhD, Professor, Centre for Research on Health and Social Care Management (CERgAS), Bocconi University, Milan, Italy Panelists: Michael F Drummond, PhD, Professor of Health Economics, Centre for Health Economics, University of York, Heslington, York, Uk; Mirella Marlow, MBA, MA, Programme director, devices and diagnostics Systems, NICE (National Institute for Health and Clinical Excellence), London, Uk; Adrian Griffin, MSc, Vice President HtA & Reimbursement Policy, Johnson & Johnson, High wycombe, Uk

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Program & Schedule of Events: Tuesday, 1 November


ISSUE: Medical devices often obtain market authorization with less evidence on effectiveness than other health technologies. the lack of effectiveness evidence, especially comparative effectiveness evidence, limits the possibilities for health technology assessment (HtA). therefore, it is important to discuss what incentives can be given to improve the quality and quantity of the effectiveness evidence for medical devices.

OVERVIEW: Medical devices often obtain market authorization with much less evidence on clinical effectiveness than other health technologies. this is mainly because of the lack of a legal requirement to conduct adequately controlled clinical studies. Also, HtA agencies often accept claims of equivalence, which further reduces the incentives to manufacturers to conduct adequately controlled clinical studies, since they could spend time and effort collecting clinical evidence that a ‘fast-followers’ can claim also applies equally to their own product. therefore, although device manufacturers have patent protection, they are not granted data exclusivity in the same way as pharmaceuticals. the lack of effectiveness evidence, especially comparative effectiveness evidence, limits the possibilities for health technology assessment, although effectiveness evidence can be gathered pre-market (i.e., through conducting controlled clinical trials in an experimental setting), or post-market (through clinical studies undertaken in regular clinical practice). Post-market effectiveness research may be more important for medical devices than pharmaceuticals, as the performance of the device often depends on the interaction with the user (the so-called learning curve). this suggests that the solution to the problem of inadequate effectiveness evidence should address the issue of conducting clinical research in both the pre- and post-market phase. this panel will discuss the incentives that could be given to increase the range and quality of effectiveness evidence both pre- and post-marketing of medical devices.

n W10: THE POTENTIAL AND PITFALLS OF USING MULTI-CRITERIA DECISION ANALYSIS TO SUPPORT HEALTH TECHNOLOGY ASSESSMENT Hall A (L2)Discussion Leaders: Janine A. van Til, PhD, Assistant Professor Preference Research, Health technology and Services Research, University of twente, Enschede, the Netherlands; Rob Baltussen, PhD, Associate Professor, Health Economics, department for Health Evidence, Radboud University Medical Center, Nijmegen, the Netherlands; Michele Tringali, MD, director, HtA Program, Lombardy Region Health directorate, Milan, Italy; Susanne Schmitz, PhD, Postdoctoral Fellow, department of Population Health / Health Economics and Evidence Synthesis Research Unit, Luxembourg Institute of Health, Strassen, Luxembourg

PURPOSE: this workshop will focus on practical examples of supporting health technology assessment (HtA) and reimbursement decisions with multi-criteria decision analysis (MCdA). In the workshop, both the value of MCdA to support HtA decisions, as well as the pitfalls encountered in applying MCdA to real-life decision contexts will be discussed.

DESCRIPTION: workshop participants will be familiarized with how and why applications of different methods of MCdA are explored in countries divergent in current HtA structuring, experience, legislation, and culture. the workshop will address (1) the fit between MCdA principles and the principles of HtA; (2) the current HtA process in these countries; (3) share experiences of introducing MCdA to the actual HtA decision process; and (4) whether MCdA keeps its promise to increase structure, transparency and comprehensiveness to the HtA decision process. dr. van til will reflect on the apparent fit between MCdA and HtA decision making, and on actual testing of a mathematical MCdA framework in the dutch context. dr. Baltussen will talk about the use of a deliberative approach to MCdA, involving stakeholder consultation, and will present a number of case studies from the Netherlands, thailand, and Indonesia. dr. tringaly will explain the information framework aimed at structuring assessment reports for appraisal activities adopted by the Lombardy Healthcare directorate, and share experiences with implementation. dr Schmitz will present the results of a retrospective analysis to identify potential important drivers of reimbursement decisions in Ireland; she will illustrate the challenges of using such information to inform an actual MCdA framework. Participants will be encouraged to share their experience and perspectives during the workshop. this interactive and informative workshop will be valuable to researchers in the field of MCdA and regulators who are interested in understanding recent developments in the application of MCdA in the HtA context.

n W11: LET’S GO FLY A KITE – MANAGING THE WINDS OF CHANGE IN REAL WORLD EVIDENCE STUDIES Hall D (L -2)Discussion Leaders: Alison Bourke, MSc, Scientific director Real-world Evidence Solutions, IMS Health, London, Uk; Andrew Bate, PhD, Senior director Epidemiology, worldwide Safety, Pfizer Ltd, tadworth, Uk; Brian C Sauer, PhD, Associate Professor, division of Epidemiology, department of Family Practice Medicine, University of Utah School of Medicine, Salt Lake City, Ut, USA; Gillian C Hall, PhD, Consultant in Pharmacoepidemiology, gillian Hall Epidemiology Ltd, London, Uk

PURPOSE: Sustainability issues (i.e., data continuity and access) and associated methodology can impact on many health economic/outcomes studies. this workshop will highlight these issues and discuss how internal and external factors, such as clinical practice and legal frameworks, should be considered during study design. the workshop will provide guidance on how to minimize the impact of change.

DESCRIPTION: In our continually evolving research environment, change is inevitable; such changes commonly involve the addition of more recent data, but also may relate to alterations of the data model, tools, data elements, or even health care environment. these changes can impact our research, but are we good at anticipating and managing such change? the importance of change management is recognized in a recent publication providing guidance and a checklist to help plan

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for change in observational health care database studies (Bourke et al, Pharmacoepi and Drug Safety. In press). A panel of researchers and data providers will first explain change issues and illustrate why sustainable design is a key consideration in real-world data (Rwd) research. the importance of change management to the validity, transparency and reproducibility of database studies will be outlined, then the audience will be split into working groups to use the published checklist as a tool to identify and consider change across simulated HEOR studies. the discussion leaders will facilitate an interactive conversation with workshop participants incorporating feedback from the working groups on how changes can affect studies and whether such changes can be anticipated. this interactive workshop will help to plan strategies for sustainability for both researchers and database providers. the workshop will provide participants with change management competencies by creating an interactive environment for attendees to learn about the issues and to practice effectively planning Rwd studies

n W12: RETHINKING WHAT MISSING PATIENT-REPORTED OUTCOME (PRO) DATA CAN TEACH US ABOUT OUTCOMES AND SURVIVAL IN ONCOLOGY CLINICAL TRIALS Hall E2 (L0)Discussion Leaders: Mark E. Boye, PhD, Principal Scientist, Eli Lilly and Company, Indianapolis, IN, USA; Katherine Houghton, MSc, Associate director, Health Economics, RtI Health Solutions, durham, NC, USA; Donald E Stull, PhD, Head, data Analytics and design Strategy, Health Economics, RtI Health Solutions, durham, NC, USA

PURPOSE: this workshop will discuss the importance of missing patient-reported outcome (PRO) data in oncology clinical trials; describe why implementation of methods that make correct assumptions is important; present novel methods to identify heterogeneous groups of treatment responders informed by missing PRO data patterns and their link with survival outcomes; and present examples using these methods. the anticipated audience includes those familiar with PRO analyses who want to learn and incorporate methods that show more accurate and compelling results.

DESCRIPTION: Although much attention has been paid to the development and administration of PRO questionnaires, largely unrecognized is the explicit analysis of missing data and their impact on clinical trials. Pattern mixture models (PMMs) are recommended as a sensitivity analysis when one suspects that data are not missing at random. these models build in covariates to account for differential missing data patterns and allow the derivation of an adjusted mean effect. this workshop presents an extension to PMMs (ePMM) within a latent variable framework: heterogeneity is explicitly examined at the patient level in terms of intercepts and changes over time, while simultaneously building in the effect of missing data patterns. data-driven subgroups can be identified that allow analysts to determine whether missing data leads to different PRO results. Once identified, survival can be compared between the subgroups. Identifying subgroups who are more, or less, likely to complete oncology clinical trials and assessing the relationship with survival can play a key role in study design and the development of personalized medicine. we will present models, show the effects on survival outcomes, and review randomized clinical trial examples. Following the presentation, the audience will be encouraged to discuss the pros and cons of these methods compared to currently used approaches in the design and analysis of oncology clinical trials.

n P7: NEUROLOGICAL DISORDERS STUDIES Hall F1 (L0)

ND1 BURDEN AND WORK PRODUCTIVITY LOSS IMPAIRMENT FROM PROVIDING CARE TO ALZHEIMER’S DISEASE 8:45-9:00 PATIENTS Hu X1, Ritchie C2, wood R3, Jones E3, Black CM1, khandker Rk1, Ambegaonkar BM1, 1Merck & Co., Inc.,

Rahway, NJ, USA, 2University of Edinburgh, Edinburgh, Uk, 3Adelphi Real world, Bollington, Uk

ND2 ADVANCED PARKINSON’S DISEASE IN STOCKHOLM COUNTY, SWEDEN – HOW MANY ARE THEY AND 9:00-9:15 WHAT ARE THE REAL-LIFE HEALTH CARE COSTS? Eriksson JK1, Anell B2, 1karolinska Institute, Stockholm, Sweden, 2Parexel International, Stockholm, Sweden

ND3 THE COST OF MULTIPLE SCLEROSIS IN 16 EUROPEAN COUNTRIES: FUNCTIONAL STATUS, SYMPTOMS AND 9:15-9:30 MENTAL FACTORS DRIVE COSTS Berg J1, gannedahl M1, Capsa d1, Eriksson J2, thompson A3, kobelt g4, 1Mapi, Stockholm, Sweden, 2Mapi

group, Stockholm, Sweden, 3University College London, London, Uk, 4European Health Economics, Mulhouse, France

ND4 EXCESS COSTS ASSOCIATED WITH OBSTRUCTIVE SLEEP APNEA IN THE ELDERLY 9:30-9:45 Menzin J, Park SS, Boston Health Economics, waltham, MA, USA

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n P8: PATIENT PREFERENCE STUDIES Hall F2 (L0)

PP1 NINE TESTS FOR ASSESING VALIDITY OF A DISCRETE-CHOICE EXPERIMENT 8:45-9:00 Janssen EM, Bridges JF, Johns Hopkins Bloomberg School of Public Health, Baltimore, Md, USA

PP2 HETEROGENEOUS PREFERENCES FOR DELAYING ONSET OF ALZHEIMER’S DISEASE AMONG OLDER ADULTS 9:00-9:15 IN THE US Reed SD1, Yang J1, disantostefano R2, Streffer J3, Levitan B2, Johnson FR1, 1duke Clinical Research Institute,

durham, NC, USA, 2Janssen R&d, titusville, NJ, USA, 3Janssen R&d, Beerse, Belgium

PP3 PATIENTS’ PREFERENCES FOR CHARACTERISTICS OF PERIODONTAL DISEASE AND ITS’ TREATMENT: A 9:15-9:30 DISCRETE CHOICE EXPERIMENT Vennedey V1, danner M1, Civello d1, Schwalm A2, Seidl A2, Hiligsmann M3, Stock S1, 1University Hospital

Cologne, Cologne, germany, 2Institute for Quality and Efficiency in Health Care (IQwig), Cologne, germany, 3Maastricht University, Maastricht, the Netherlands

PP4 COMPARING PREFERENCES OF PATIENTS WITH RHEUMATIC DISEASES, OF EXPERIENCED 9:30-9:45 RHEUMATOLOGISTS, NURSES AND PHARMACISTS TOWARD THE TREATMENT OF RHEUMATIC DISEASES

WITH BIOLOGICAL AGENTS: RESULTS FROM THE CARA STUDY Scalone L1, Cortesi PA1, Sarzi-Puttini P2, Sinigaglia L3, Montecucco C4, giacomelli R5, Lapadula g6, Olivieri I7, giardino AM8, Mecchia M8, Mantovani Lg1, 1University of Milano-Bicocca, Monza, Italy, 2Rheumatology Unit, ASSt Fatebenefratelli - Sacco, L. Sacco University Hospital, Milan, Italy, 3department of Rheumatology, gaetano Pini Institute, Milan, Italy, 4University of Pavia, Pavia, Italy, 5University of L’Aquila, L’Aquila, Italy, 6University of Bari, Bari, Italy, 7Rheumatology department of Lucania, San Carlo Hospital of Potenza and Madonna delle grazie Hospital of Matera, Matera, Italy, 8MSd Italy, Rome, Italy

9:45-10:15 BREAK, EXHIBITS & RESEARCH POSTER PRESENTATIONS VIEWING - SESSION III Hall X2-X3 (L -2)


10:15-12:00 WELCOME & SECONd PLENARY SESSION Hall A (L2)

WELCOME FROM ISPOR PRESIDENT



WELCOME FROM ISPOR CHIEF SCIENCE OFFICER


Richard J. Willke, PhD, Chief Science Officer, ISPOR, Lawrenceville, USA

2016 ISPOR MARILYN DIX SMITH LEADERSHIP AWARD

(See page 90 for award information and biographical information)

Presented by: Scott D. Ramsey, MD, PhD, Chair, ISPOR Marilyn dix Smith Leadership Award Committee

AWARDEE: J. Jaime Caro, MDCM, FRCPC, FACP, Chief Scientist, Evidera, Lexington, MA, USA and Adjunct Professor of Medicine, Adjunct Professor of Epidemiology and Biostatistics, Mcgill University, Montreal, QC, Canada

Garrison

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SECONd PLENARY SESSION: dIFFERENTIAL PRICING OF MEdICINES IN EUROPE: IMPLICATIONS FOR ACCESS, INNOVATION, ANd AFFORdABILITY


Each year only 30 to 40 new patent-protected medicines are launched worldwide. From an economic perspective, they are unique global public goods—with high average fixed costs of development and low marginal costs of production and distribution. given differences among countries in their ability and willingness to pay for healthcare, health economists have long argued that differential pricing for medicines across countries could improve global dynamic efficiency. But law in the European Union supporting the free movement of goods makes it difficult to maintain different prices in different countries. Countries have resorted to referencing prices in other countries to support their local pricing policies and negotiations, and have developed schemes that allow them to obtain confidential discounts. the resulting patterns of price differences and access limitations are falling far short of what a coherent approach might produce. this session will explore options for a defined and systematic approach to promoting efficient differential pricing in Europe. Operational and political feasibility are key considerations in moving toward a sustainable policy.

Moderator: Lou Garrison, PhD, Professor, Pharmaceutical Outcomes Research & Policy Program, School of Pharmacy, University of washington, Seattle, wA, USA Speakers: Sabine Vogler, PhD, Program Coordinator , Pharmacoeconomics and Pharmaceutical Policy Analysis, Head of the wHO Collaborating Centre for Pharmaceutical Pricing and Reimbursement Policies, gesundheit Österreich gmbH (gÖg / Austrian Public Health Institute), Vienna, Austria Jo De Cock, Chief Executive Officer, National Institute of Health and disability Insurance (NIHdI), Brussels, Belgium Elias Mossialos, Brian Abel-Smith Professor of Health Policy, department of Social Policy, London School of Economics and Political Science, London, Uk Adrian Towse, MA, MPhil, director, Office of Health Economics, London, Uk

12:00-13:45 LUNCH, EXHIBITS & RESEARCH POSTER PRESENTATIONS VIEWING - SESSION III Hall X2-X3 (L -2)


12:15-13:30 OPEN MEETING: PATIENT ENGAGEMENT, PATIENT CENTRIC, WHAT dOES IT ALL MEAN? Hall E1 (L0)

Join the ISPOR Patient Centered Special Interest group for a discussion on their findings from a systematic review conducted on patient engagement and related terms and definitions, especially in the context of research, drug development, and health care decision making. Attendees interested in this topic are encouraged to provide input and feedback on the common definitions and identify key attributes that should be included in definitions.

12:30-13:30 EdUCATIONAL SYMPOSIUM Hall D (L -2)

NOVEL APPROACHES TO EVIDENCE-DRIVEN DESIGN AND STUDY SAMPLE-FRAME VALIDATION

Already for two decades, shortening the time to market is a mantra for pharmaceutical companies, benefiting both the society and manufacturers. key drivers of improved development timelines and better managed pipeline value attrition have been organizational change programs, substantial regulatory realignment and also fundamentally different approaches in research.

But there is still scope for improvement. Real-world data (Rwd) starts to complement classical methods for clinical development which revolved around understanding clinical outcomes from published studies and key opinion leader insights.

during this symposium, we will explore the value and show practical cases of how Rwd can drive efficiency directly (e.g. understanding competing recruitment pressure or selecting the right sites) and indirectly (protocol endpoint feasibility) as well as improve the effectiveness of studies, for example through increasing their external validity. the latter is especially important – and critical – for post authorization safety studies, as regulators and payers continue to demand proofs of effectiveness and safety in the real world where observational, non-interventional studies are still abundant. Panelists will showcase how real-world evidence-driven design improves clinical development and late phase studies from three angles: Impact on time to market from the pharmaceutical industry point of view, how a CRO can become a smarter one using Rwd to drive study design, and how a regulator perceives needs and epidemiological options for better external validation.

Faculty will include senior experts from the pharmaceutical industry, regulators and IMS Health.

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Moderator/Speaker: Jacco Keja, PhD, Senior Principal, Real-world Evidence Solutions & HEOR, EPI, QMS, London, Uk and Lecturer Erasmus University, IMS Health, Rotterdam, the Netherlands

Speakers: Natalia Balko, Principal, Real-world Evidence Solutions, IMS Health, London, Uk

Andrew Bate, PhD, Senior director, Epidemiology group Lead, Analytics & worldwide Safety, Pfizer Ltd, Surrey, Uk

Solomon Iyasu, MD, MPH, Vice President, Pharmacoepidemiology, Center for Observational Real-world Evidence, Merck and Company, North wales, PA

Sponsored by: IMS Health

12:45-13:45 POSTER AUTHOR dISCUSSION HOUR - SESSION III Hall X2-X3 (L -2)



n IP10: ADAPTIVE PATHWAYS AND PATIENT ACCESS – PUSHING PAYER BOUNDARIES OR FACILITATING NEW PAYMENT MODELS? Hall A (L2)Moderator: Jacoline Bouvy, PhD, Scientific Adviser, National Institute for Health and Care Excellence (NICE), London, Uk Panelists: Hans-Georg Eichler, MD, MSc, Senior Medical Officer, European Medicine Agency, London, Uk; Ad Schuurman, MSc, MBA, President of MEdEV, Zorginstituut Nederland, diemen, the Netherlands; Claudine Sapede, PharmD, MSc, global HtA & Payment Policy Lead, F. Hoffmann-La Roche Ltd, Basel, Switzerland

ISSUE: Adaptive pathways to medicines development could enable patients to have earlier access to promising treatments in areas of high unmet medical needs. However, the implications of such pathways for access decisions at the national or regional levels remain to be explored. the panel will address how health technology assessment (HtA) bodies, payers, and manufacturers will deal with product value uncertainty and how this may affect solutions in the form of managed-entry agreements (MEAs). Learnings from payers, HtA agencies, and industry’s experience with MEAs will be shared along with perspectives on the challenges and enablers on applicability of MEAs to possible adaptive scenarios.

OVERVIEW: Medicines Adaptive Pathways to Patients (MAPPS) seeks to foster access to beneficial treatments for the right patient groups at the earliest appropriate time in the product life-span in a sustainable fashion. From an access perspective, the iterative process of MAPPS implies that stakeholders (regulators, HtA agencies and payers, manufacturers, patient groups, clinicians, etc.) find implementable solutions for decision on pricing and coverage while dealing with remaining uncertainties regarding the product therapeutic and economic value, warranting additional evidence generation in real life. Solutions may include more flexible approaches to pricing and reimbursement than those currently used. will there be more use of outcome-based agreements that tie the price of the medicine to its results? these are questions that the panel will discuss.

n IP11: EMERGING US VALUE FRAMEWORKS: ARE THERE LESSONS FROM - OR FOR - EUROPE? (INVITED ISSUE PANEL) Hall D (L -2)Moderator: Richard J. Willke, PhD, Chief Science Officer, International Society for Pharmacoeconomics and Outcomes Research (ISPOR), Lawrenceville, NJ, USA Panelists: Peter J. Neumann, ScD, Professor & director, Center for the Evaluation of Value and Risk in Health, Institute for Clinical Research and Health Policy Studies, tufts University, Boston, MA, USA; Michael F Drummond, PhD, Professor of Health Economics, Centre for Health Economics, University of York, Heslington, York, Uk; Finn Børlum Kristensen, MD, PhD, Professor, University of Southern denmark, Hilleroed, denmark

ISSUE: An ISPOR Special task Force is currently working on an initiative to identify and discuss key methodological issues in defining and applying value frameworks to health care resource allocation issues, and will collaborate to produce a white paper that advises on the appropriate definition and use of high-quality value frameworks. A number of methodological issues have been identified that have created concerns about the validity of current US value frameworks for decision-making from various perspectives. However, a number of European countries have essentially been using types of value assessments for decision-making, and many of these same concerns have already been considered in those countries. the issue panel will discuss how the ISPOR Special task Force should consider European approaches and pick the most applicable from among them. the panel will also consider whether there are other areas where the US should adapt and potentially improve on European approaches in order to address the concerns that have stimulated the creation of these frameworks.

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OVERVIEW: In recent years, a number of US-based organizations have put forth Value Assessment Frameworks, employing a variety of methodologies and perspectives. Most, if not all of the issues they have been addressing have already been considered in existing European HtA guidelines, such as the EUnetHtA Core Model, although some US-based frameworks have adopted considerably different approaches, more oriented towards shared clinician-patient decision-making. Based on these approaches, it appears that conventional cost-utility analyses will not completely account for all the factors felt to be important in US value frameworks.

n W13: CHANGING OUR PERSPECTIVE ON PATIENT-REPORTED OUTCOMES IN ONCOLOGY: IT’S MORE COMPLEX THAN TRADITIONALLY CONCEPTUALIZED OR ANALYZED Hall E1 (L0)Discussion Leaders: Mark E. Boye, PhD, Principal Scientist, Eli Lilly and Company, Indianapolis, IN, USA; Donald E Stull, PhD, Head, data Analytics and design Strategy, Health Economics, RtI Health Solutions, durham, NC, USA; Claire Ainsworth, BSc, Research Analyst, Health Economics, RtI Health Solutions, MANCHEStER, Uk

PURPOSE: this workshop will introduce participants to path modeling and its ability to examine direct and indirect effects of symptoms of cancer and its treatment on health-related quality of life (HRQL) outcomes. workshop participants will become familiar with the concepts of direct, indirect, and total effects and the importance of conceptualizing and analyzing multidimensional phenomena appropriately.

DESCRIPTION: It’s not uncommon to find little or no relationship between symptoms or their change and selected HRQL outcomes when analyzing oncology trial data. One reason, we argue, is that the relationships among these variables are more complex than the analyses would imply or can evaluate. that is, the hypothesis that symptoms affect overall quality of life (QoL) may not be supported (or only marginally so) because the analyses assume a direct effect of symptoms on QoL. However, thinking through the logic among these variables suggests a “causal cascade,” whereby intervening variables mediate the causal pathway between symptoms and QoL or other dimensions of HRQL. thus, as will be demonstrated, symptoms such as pain or appetite loss affect fatigue, which affects QoL. Path analyses are needed to evaluate these more complex causal relationships and obtain total effects of symptoms on the various domains of HRQL. the result is a more accurate understanding of treatment effects and how that affects HRQL. dr. Boye will discuss the implications this conceptual and analytic approach has for refining our understanding of efficacy of oncology treatments. dr. Stull will provide background on path analysis, and Ms. Ainsworth will give an empirical example from two trials of treatment for lung cancer. the audience will be encouraged to discuss and explore their own examples as they relate to endpoint models and conceptual frameworks and how these methods may help shed light on null or marginal results they have obtained in trials.

n W14: CHOICE DEFINES VALUE: HOW TO ANALYSE AND DISSEMINATE EVIDENCE ON THE IMPORTANCE OF MULTIPLE CRITERIA FROM MULTIPLE PERSPECTIVES TO INFORM AN APPRAISAL PROCESS IN HEALTH TECHNOLOGY ASSESSMENT Hall E2 (L0)Discussion Leaders: Benjamin M. Craig, PhD, Associate Professor, department of Economics and Assistant Member, Health Outcomes and Behavior, Moffitt Cancer Center, University of South Florida, tampa, FL, USA; Axel Mühlbacher, PhD, Professor, Health Economics and Health Care Management, IgM, Hochschule Neubrandenburg, Neubrandenburg, germany; Juan Marcos Gonzalez, PhD, Senior Research Economist, RtI Health Solutions, Research triangle Park, NC, USA; Juan Manuel Ramos-Goñi, MSc, Senior Researcher, EuroQol Research Foundation, Rotterdam, the Netherlands

PURPOSE: the paradigm shift in health technology assessment (HtA) towards including multiple perspectives can be fulfilled only when their views are systematically taken into account. to safeguard the public health, HtAs originally assessed health outcomes and relied on the judgment of professionals and policy makers concerning the trade-offs between benefits and risks. More recently, the focus has shifted toward the patient voice and addressing the problems of weighing multiple decision criteria, such as clinical efficacy, severe side effects and varying modes of administration. A key challenge in HtA is weighting multiple criteria from multiple perspectives to inform their decisions.

DESCRIPTION: At the ISPOR 21st Annual International Meeting, the presenters gave a workshop on multi criteria decision analysis (MCdA). In complement to their didactic introduction, they conducted a live MCdA using hand-held response system and interpret its results in real time. the proposed workshop has 4 components. (1) Using the previous responses (paired comparison and best-worst scaling [BwS]), they will expand upon the first by demonstrating the analysis, interpretation, and dissemination of the results Although conducting MCdA using audience responses has limitations and challenges, this analytical demonstration is clearly relevant and will serve to introduce a deliberative approach adaptable for multiple settings (e.g., expert panel, one-on-one interviews, online). (2) the audience will be given a hands-on exercise regarding the interpretation of MCdA results and the merits between methods (paired comparisons vs. BwS). (3) with this background, the presenters will introduce examples and open discussion to the audience to ask questions and express concerns regarding MCdA. (4) to aid the greater community, the responses and discussion will recorded, transcribed, de-identified, summarized, and disseminated to ISPOR members (conditional on acceptance by ISPOR’s Value & Outcomes Spotlight) by the presenters. through audience engagement and demonstration, the proposed workshop will give attendees a hands-on understanding of the underlying issues surrounding MCdA.

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n P9: ECONOMIC EVALUATION STUDIES Hall F2 (L0)

EE1 ECONOMIC EVALUATION FOR THE UNITED KINGDOM OF SYSTEMIC CHEMOTHERAPIES AS FIRST-LINE 13:45-14:00 TREATMENT FOR METASTATIC PANCREATIC CANCER gharaibeh M1, McBride A2, Alberts d2, Slack M1, Erstad B1, Abraham I1, 1University of Arizona, tucson, AZ,

USA, 2Arizona Cancer Center, tucson, AZ, USA

EE2 IS IT REALLY COST-EFFECTIVE TO RISK-ASSESS ALL HOSPITALIZED PATIENTS FOR PRESSURE ULCERS EVERY 14:00-14:15 NURSING-SHIFT? Padula WV1, Onyekwere U1, Makic MB2, wald HL2, Epstein Z3, Meltzer dO4, 1Johns Hopkins Bloomberg

School of Public Health, Baltimore, Md, USA, 2University of Colorado, Aurora, CO, USA, 3Pomona College, Claremont, CA, USA, 4University of Chicago, Chicago, IL, USA

EE3 THE COST-EFFECTIVENESS OF BARIATRIC SURGERY IN GERMANY, FRANCE, ITALY AND THE UNITED 14:15-14:30 KINGDOM Belarbi S1, kusel J2, thomas Mg2, 1Ethicon SAS, Issy-Les-Moulineaux, France, 2Costello Medical Consulting

Ltd, Cambridge, Uk

EE4 COST EFFECTIVENESS OF NIVOLUMAB MONOTHERAPY FOR THE TREATMENT OF ADVANCED MELANOMA 14:30-14:45 PATIENTS IN THE UNITED KINGDOM Meng Y1, Hertel N2, Ellis J2, Johnson H3, Philips Z1, Roskell N1, Lee d1, 1BresMed Health Solutions, Sheffield,

Uk, 2Bristol-Myers Squibb Pharmaceuticals, Uxbridge, Uk, 3Helen Johnson Consulting Ltd, welwyn garden City, Uk

n P10: HTA & VALUE ASSESSMENT STUDIES Hall F1 (L0)

HT5 DEVELOPMENT OF A MULTI-CRITERIA DECISION ANALYSIS (MCDA) FRAMEWORK FOR HEALTH CARE 13:45-14:00 DECISION-MAKING IN CATALONIA (SPAIN): PILOT STUDY FOCUSED IN ORPHAN DRUGS gilabert-Perramon A1, torrent-Farnell J2, Catalan A3, Prat A4, Fontanet M2, Puig-Peiró R5, Merino-Montero

S6, khoury H7, goetghebeur MM8, Badia X6, 1Catalan Health Service, government of Catalonia, Barcelona, Spain, 2Hospital de la Santa Creu i Sant Pau, Barcelona, Spain, 3Agència de Qualitat i Avaluació Sanitàries de Catalunya (AQuAS), Barcelona, Spain, 4Servei Català de la Salut (CatSalut), Barcelona, Spain, 5Catalan Health Service (CatSalut), Barcelona, Spain, 6Omakase Consulting, Barcelona, Spain, 7LASER Analytica, Montreal, QC, Canada, 8LASER Analytica and School of Public Health, University of Montreal, Montreal, QC, Canada

HT6 CRITERIA DRIVING VALUES ASSESSMENTS IN MULTIPLE SCLEROSIS MEDICINES 14:00-14:15 Visintin E1, kanavos P2, 1London School of Economics and Political Sciences, London, Uk, 2London School of

Economics and Political Science, London, Uk

HT7 HTA AGENCIES PERSPECTIVE ON PROGRESSION-FREE-SURVIVAL (PFS) 14:15-14:30 Schmitter S1, Holzerny P2, Brock E2, günzel C3, Ruckdäschel S2, 1Pfizer deutschland gmbH, Berlin,

germany, 2HealthEcon Ag, Basel, Switzerland, 3Pfizer Pharma gmbH, Berlin, germany

HT8 DEFINING THE VALUE: DO THE NEW ONCOLOGY FRAMEWORKS IN THE US AIM AT OBJECTIVE VALUATION? 14:30-14:45 – A CASE STUDY IN MULTIPLE MYELOMA Forsythe A1, Pezalla EJ2, 1PS HtA, New York, NY, USA, 2Enlightenment BioConsult, LLC., wethersfield, Ct, USA

14:45-15:15 BREAK & EXHIBITS VIEWING Hall X2-X3 (L -2)

15:15-19:15 RESEARCH POSTER PRESENTATIONS - SESSION IV Hall X2-X3 (L -2)



n IP12: VALUING TRANSFORMATIVE MEDICINES IN RARE DISEASES: METHODS AND MADNESS Hall F1 (L0)Moderator: Paul Hodgkins, PhD, Vice President, Vertex Pharmaceuticals Incorporated, Boston, MA, USA Panelists: Ron Akehurst, DSc, Strategic director, BresMed Health Solutions, Sheffield, Uk; Alastair Kent, OBE, director, genetic Alliance Uk, London, Uk; Maarten Postma, PhD, Professor Pharmacoeconomics, Pharmacy department, University of groningen, groningen, the Netherlands

ISSUE: Innovative medicines for rare diseases are often transformative for patients, especially when they are the first medicines designed to treat the underlying cause of disease. they may offer significant value to patients, caregivers, and society. However, the ability to demonstrate clinical benefit and cost effectiveness at the time of regulatory approval using

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existing methodologies can be challenging. Paul Hodgkins (moderator) will introduce this issue and the panel. Ron Akehurst will present the case for largely adhering to current methods and evidence standards. Maarten Postma will consider alternative methodological approaches and data sources that have been and can be used. Alastair kent will focus on patient engagement and the justification for adaptation of existing HtA processes to better evaluate innovative medicines.

OVERVIEW: Evolution of the regulatory pathways for transformative therapies is enabling access to medicines at an earlier stage than ever before. to benefit from advances in clinical research in rare diseases and to take advantage of this evolving regulatory framework, an appropriately timed and conducted value assessment of these therapies is required. A balance is needed between early access, evidence of clinical benefit, acceptable cost effectiveness, and the application of integrative and iterative methodologies for assessment. the issues faced in rare diseases are exemplified when a therapy may primarily offer survival benefits that are many years in the future and potentially subject to relevant uncertainty, but costs accrue immediately. Can faster patient access to medicines be achieved whilst satisfying the need for demonstration of clinical and economic value of transformative medicines at time of approval? what can be learned from recent HtAs of rare diseases? does this require decision makers to accept higher degrees of uncertainty within a broader context of benefits? this panel will review the opportunities and challenges for assessment of innovative medicines for rare diseases.

n W15: BUILDING AND APPLYING CONSTRAINED OPTIMIZATION MODELS IN HEALTH CARE: A CASE STUDY OF OPTIMAL KIDNEY MATCHING Hall E1 (L0)Discussion Leaders: William H. Crown, PhD, Chief Scientific Officer, Optum Labs, Cambridge, MA, USA; Alec Morton, PhD, Professor, Management Science, University of Strathclyde, glasgow, Uk; William V. Padula, PhD, Assistant Professor, Health Policy & Management, Johns Hopkins Bloomberg School of Public Health, Baltimore, Md, USA; Praveen Thokala, MASc, PhD, Research Fellow, Health Economics and decision Science (HEdS), School of Health and Related Research (ScHARR), University of Sheffield, Sheffield, Uk

PURPOSE: to demonstrate the steps and relevance of building constrained optimization models in the context of addressing important health care decisions, such as kidney matching. Session content draws from the second paper of the ISPOR Constrained Optimization Methods in Health Services Research task Force, which broadly illustrates the development and evaluation of constrained optimization models in health care. the session is intended both for modelers and for consumers of modeling.

DESCRIPTION: there is growing interest in using optimization modeling to improve clinical and economic outcomes in health care, but there are not yet standard guidelines for modeling and reporting. Moreover, most health care applications of optimization methods have focused on traditional operations research problems such as facilities management, minimizing supply costs, etc. that commonly arise in health care operations. the workshop will focus on the role that optimization models can have in improving clinical outcomes. we will illustrate the steps in building and evaluating model performance using problems arriving in organ donation. this case study is drawn from a published influential kidney matching model that has been widely adopted and estimated to have saved hundreds of lives (Anderson et al., 2015). topics covered will include background on the complexity of kidney matching, structuring the model, estimating key parameters, model validation and sensitivity analysis. we will discuss the importance of communicating results and translating them into action. In the optimal kidney matching case, for example, overcoming skepticism and resistance within the medical community required strong trans-collaboration between teams of physicians and operations researchers. the workshop will include an interactive discussion about the ability of optimization methods to address real-world problems versus oversimplified versions of these instances—in particular, the tension between model simplification and the usefulness of optimization modeling in application. Finally, we will outline open questions and challenges in using optimization methods to model and analyze health care decisions.

Presented by the ISPOR Optimization Methods in Health Services Research Emerging Good Practices Task Force

n W16: HOW TO TRANSFER ECONOMIC EVIDENCE TO LOW AND MIDDLE-INCOME COUNTRIES? WORKING UNDER CAPACITY RESTRICTIONS Hall A (L2)Discussion Leaders: Zoltan Kalo, MD, PhD, Professor, department of Health Policy and Health Economics, Eötvös Loránd University, Budapest, Hungary; Johan L. Severens, PhD, Professor of Evaluation in Health Care, Institute of Health Policy & Management, Institute of Medical technology Assessment (iMtA), Erasmus University Rotterdam, Rotterdam, the Netherlands; Olena Mandrik, PhD, Postdoc Researcher, Institute of Health Policy & Management, Erasmus University Rotterdam, Rotterdam, the Netherlands; Saskia Knies, PhD, Advisor Pharmacoeconomics, National Health Care Institute, diemen, the Netherlands

PURPOSE: the workshop is designed to share the theoretical and practical experience of transferring economic data to and between low- and middle-income countries (LMICs). workshop participants will become familiar on recent developments in transferability of economic evaluations, approaches towards inputs transferability, its facilitators and barriers in LMICs. the participants will be able to critically evaluate the transferability of evidence from the other countries.

DESCRIPTION: As more decision makers worldwide seek information on economic impact of health care interventions, the importance of research transferability grows. LMICs have limited capacity in health technology assessment (HtA), and so have higher needs for research transferability. the workshop will address challenges, such as how to transfer

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economic evidence under conditions of the limited HtA-resources; how to transfer the published results to the jurisdiction of interest; and how to improve transferability of the research conducted in health care settings of LMICs? during the workshop, participants will receive a contemporary information on: (a) developments in HtA in LMICs, reasons to study transferability, and its basic principles; (b) availability and quality of economic evidence in LMICs, critical appraisal in health care decisions; (c) transferability of inputs when the relevant guidelines are not conclusive, generalizability of utilities and productivity losses; (d) approaches in the evaluation of studies and the selection of the right models for local economic evaluations. Audience participation will include an inquiry of attendees on their experience with data transferability; a survey on factors important in HtA-based decision making; and case-studies in several disease areas. the audience will be asked to estimate an impact of variability in input parameters on the results of economic studies having variable volume of critical information. the workshop is oriented to HtA-experts from business, state, or academia segments operating in environments with limited HtA-capacity and who require a good understanding of data transferability.

n W17: NEW CHALLENGES FOR HIGH-RISK MEDICAL DEVICES IN EUROPE: HOW TO ACHIEVE THE BALANCE BETWEEN THE DEMAND FOR EARLY PRODUCT LAUNCH AND SAFETY? Hall E2 (L0)Discussion Leaders: Bernard Avouac, MD, Former president of transparency Commission, Medecin des Hopitaux de Paris, Paris, France; Jenifer Ehreth, PhD, MHA, Executive & Scientific Vice President, LASER Analytica, Paris, France; Rosanna Tarricone, PhD, Professor, Centre for Research on Health and Social Care Management (CERgAS), Bocconi University, Milan, Italy; Katerina Zakrzewska, PhD, Senior director, Strategic and Medical Affairs, EMEA, diabetes Care Companies, Johnson & Johnson, Zug, Switzerland

PURPOSE: this workshop will focus on the challenges that high-risk (class III) medical devices (Md) are confronted with. workshop participants will be introduced in the certification process of Md, the definition and requirements for different types of new Mds (i.e., me-too, modification, and innovative products), and will learn about the impact of the on-going revision of the medical device directives (Mdds) on manufacturers.

DESCRIPTION: Mds are used to improve the quality of life or to safe lives of patients. to protect patients from threats caused by Mds and to safeguard the intended performance, devices must comply with the EU directives and be CE marked before entering the European market. Bernard Avouac will present the experience of the approval process for the reimbursement of high-risk Mds in France. during the past few years, numerous severe issues initiated by implanted Mds unsettled both physicians and patients, and forced the European Commission to revise the Mdd. Based on publicly available examples (e.g., infusible bone grafts) Jenifer Ehreth presents examples of class III Mds that had to be withdrawn from the market because of serious adverse events occurring after their launch and the consequences for patients, physicians, and manufacturers. due to limited or missing clinical data and the short life-cycle of Mds, the level of clinical evidence is frequently not as high as for pharmaceuticals. Rosanna tarricone will discuss the challenge of clinical evidence for Mds in HtA from a research perspective and katerina Zakrzewska will discuss the view of a Md company regarding requirements of the new Mdd and illustrates the potential consequences for patients and physicians. this interactive workshop will be of interest for manufacturers of Mds, clinicians, and HtA analysts, who are interested in understanding recent developments of the evaluation process of Md in the EU.

n P11: DATABASE USE IN OUTCOMES RESEARCH STUDIES Hall D (L -2)

DB1 MORTALITY EXCESS DUE TO CLOSTRIDIUM DIFFICILE INFECTION - A NATIONAL DATABASE ANALYSIS 15:15-15:30 Bouee S1, Levy Bachelot L2, Ravonimbola H2, Longepierre L1, godard C2, gourmelen J3, Barbut F4,

1CEMkA, Bourg La Reine, France, 2MSd France, Courbevoie, France, 3UMS 011 - Inserm - UVSQ, Villejuif, France, 4Laboratory for Clostridium difficile, Paris, France

DB2 A RETROSPECTIVE STUDY ON ASSOCIATION BETWEEN CHANGE IN BMI AND INCIDENCE OF HYPERTENSION 15:30-15:45 USING A HEALTH CARE DATABASE IN JAPAN Yamamoto Y1, tanabe k2, takahashi S2, Ii Y2, kitazaki S1, Fujimoto Y2, 1MinaCare Co. Ltd, tokyo,

Japan, 2Pfizer Japan Inc, tokyo, Japan

DB3 ACCURACY OF NATURAL LANGUAGE PROCESSING-BASED CLASSIFIERS FOR AUTOMATED IDENTIFICATION 15:45-16:00 OF ABSTRACTS OF STUDIES ON HUMANISTIC AND ECONOMIC BURDEN OF DISEASE Krohn J1, Martin A2, Martin C2, 1krohn Consulting Ltd, Coventry, Uk, 2Crystallise Ltd., London, Uk

DB4 USE OF DATA-MINING TO PERFORM A REAL WORLD COST ANALYSIS OF HER2-POSITIVE BREAST CANCER IN 16:00-16:15 IRAN Ansaripour A1, Zendehdel k2, tadayon N3, Sadeghi F4, Uyl-de groot C5, Redekop wk6, 1Erasmus University

Rotterdam, Rotterdam, the Netherlands, 2tehran Medical Sciences and Medical Education University, tehran, Iran, 3Shahid Beheshti University of Medical Sciences, tehran, Iran (Islamic Republic of), 4tehran Medical Sciences and Medical education University, tehran, Iran, 5National Health Care Institute, diemen, the Netherlands, 6National University of Singapore, Singapore, Singapore

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n P12: HEALTH CARE EXPENDITURE & REIMBURSEMENT STUDIES Hall F2 (L0)

HC1 MODELING THE IMPACT OF REFORM TO THE CANCER DRUGS FUND 15:15-15:30 Karlsberg Schaffer S, garau M, O’Neill P, Bianchi S, Office of Health Economics, London, Uk

HC2 ECONOMIC BURDEN OF DISEASES IN FRANCE: ANALYSING THE TRENDS FROM 2012 TO 2014, USING THE 15:30-15:45 FRENCH HEALTH INSURANCE DATABASE (SNIIRAM) Gastaldi Menager C1, drouin J2, Pestel L3, Fagot-Campagna A2, gissot C3, 1CNAMtS, Paris, France, 2CNAMtS

(National Health Insurance), Paris Cedex 20, France, 3CNAMtS (National Health Insurance), Paris, France

HC3 THE RELATIONSHIP BETWEEN MEDICAL INNOVATION AND HEALTH EXPENDITURES 15:45-16:00 Cinaroglu S1, guzel E2, Baser O3, 1Hacettepe University, Ankara, turkey, 2Eastern Michigan University,

Ypsilanti, MI, USA, 3Columbia University/MEF University/StAtinMEd Research, New York, NY, USA

HC4 COMPARISON OF TIME TO REIMBURSEMENT DECISION OF INNOVATIVE PHARMACEUTICALS IN EUROPE 16:00-16:15 Hernandez J, Nientker k, Hensen M, Pharmerit International, Rotterdam, the Netherlands


n IP13: REAL WORLD EVIDENCE TO SUPPORT VALUE PROPOSITION AND REIMBURSEMENT AT LAUNCH: THE ASPIRATIONAL MEETS THE IMPRACTICAL? Hall A (L2)Moderator: Kari Edwards, PhD, Managing Partner, Evidence, Value, and Access, Harbinger Consulting, Calabasas, CA, USA Panelists: Adrian R. Levy, PhD, Professor & Head, Community Health and Epidemiology, dalhousie University, Nova Scotia, AL, Canada; Arie Barlev, PharmD, MS, Senior director, Health Economics and Outcomes Research, Medivation, Inc., San Francisco, CA, USA; Andrew Briggs, DPhil, william R Lindsay Chair of Health Economics and Professor of Health Economics, University of glasgow, glasgow, Uk

ISSUE: Real–world evidence (RwE) is the latest in a series of buzzwords among teams responsible for demonstrating the value of new products at launch. driven by requirements of payers for RwE that demonstrate effectiveness and safety among populations in which products will be used, such requirements are highly aspirational. we know that quality evidence on effectiveness and safety of an intervention—compared with the relevant comparator, in the population of interest, outside the randomized controlled trial setting—is ideally what reimbursement authorities seek. But just how practical is this as a requirement in the face of the methodological challenges and competing demands faced by companies bringing new products to market?

OVERVIEW: In this panel, we explore the tension between the aspirational and practical elements of generating RwE in a timely fashion to support reimbursement at product launch. kari Edwards will moderate and provide context for the debate through several illustrative case studies. Adrian Levy will provide the payer perspective, arguing in favor of the provision of RwE to allow timely assessment of likely effectiveness to support reimbursement submissions upon product launch. Arie Barlev will provide an industry perspective on practical challenges associated with collecting evidence within a short post-approval timeframe and will highlight the problem of selection bias when measuring relative effect in populations exposed to newly approved agents compared with standards of care. Andrew Briggs will represent the health economics perspective, demonstrating the use of modelling techniques to exploit the rigorous nature of clinical trial data while making the reimbursement story fit for purpose, including the incorporation of RwE into modelling approaches to further demonstrate product value.

n W18: METHODOLOGIES FOR EVALUATING GEOGRAPHIC VARIATION IN HEALTH CARE OUTCOMES RESEARCH Hall E2 (L0)Discussion Leaders: Rajesh Balkrishnan, PhD, Professor, Public Health Sciences, University of Virginia School of Medicine, Charlottesville, VA, USA; Gregoire Mercier, MD, PhD, Head, Economic Evaluation Unit, CHU Montpellier, Montpellier, France; Vera Georgescu, PhD, Head, Economic Evaluation Unit, CHU Montpellier, Montpellier, France

PURPOSE: In large database studies of health services and outcomes, significant variation in utilization is seen because of differential geographical access. traditionally used measures of geospatial variation using provider/facility to population ratios or travel times have significant limitations which necessitate the use of newer methodology.

DESCRIPTION: we will discuss the evaluation of newer measures and techniques like the two-step floating catchment area (2SFCA), geographic hot spot analyses, and geographic weighted regression (gwR) in evaluating health care outcomes such as medication adherence and preventable hospitalizations. we will present two research examples, one a study examining adjuvant hormone therapy adherence and patient outcomes in the rural Appalachian region of the United States, and the second, an analysis of geographic variation in potentially avoidable hospitalizations in France. the 2SFCA approach first identifies a prescriber catchment area and then computes a prescriber to population ratio for each physician’s catchment. the step one ratios within a population’s catchment are then summed, resulting in an access score for each population location. geographical hot spot analyses can help identify geographic clustering patterns of medication use. gwR, in which weights can vary as a function of geographical location, can be used to examine spatial non-stationarity of

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the relationships between predictors and medication use outcomes. we will present results of comparative analyses and discuss practical approaches to implementing and using these methodologies for health care policy analyses and decision making. A methodological shortcoming for most studies on geographic variations using regression analysis is the lack of accounting for spatial autocorrelation across regions. they assume independence between regions, thus ignoring possible interactions. Since the region boundaries are often administrative and not defined according to the studied phenomenon, this assumption of independence is false. Adjusting for spatial autocorrelation often leads to wider confidence intervals, thus studies without such adjustments could be falsely positive.

n W19: STRENGTHENING THE ROLE OF VALUE OF INFORMATION ANALYSIS IN HEALTH TECHNOLOGY ASSESSMENT: KNOWN CHALLENGES AND PROPOSED SOLUTIONS Hall E1 (L0)Discussion Leaders: Elisabeth Fenwick, PhD, Principal of Health Economics, ICON Health Economics & Epidemiology, Abingdon, Uk; Claire Rothery, PhD, Senior Research Fellow in Health Economics, Centre for Health Economics, University of York, York, Uk; Hendrik Koffijberg, PhD, Associate Professor, department of Health technology & Services Research, MIRA institute for Biomedical technology and technical Medicine, University of twente, Enschede, the Netherlands; David Glynn, MSc, Phd student, Centre for Health Economics, University of York, York, Uk

PURPOSE: to illustrate the role of value of information analysis for overcoming challenges associated with making research prioritization and coverage with evidence development decisions. the workshop will focus on proposed solutions to more challenging situations: (1) the assessment of medical devices, as compared to drugs; (2) making decisions where formal cost effectiveness analysis is not explicitly used in the decision making process; (3) illustrating the interpretation and comparison of value of information outcomes using a new reporting tool. Participants will be actively engaged in discussion of the challenges and proposed solutions.

DESCRIPTION: the workshop will set out the challenges for the evaluation of uncertainty in health technology assessment (HtA) and demonstrate the role of value of information analysis for overcoming these challenges. the workshop will demonstrate that value of information analysis can be used across different types of technologies (e.g., medical devices vs. pharmaceuticals) and health systems (e.g., inclusion of formal cost-effectiveness analysis vs. absence of economic analysis). dr Fenwick will describe recent developments which have prompted a need to consider the value of further research. dr Rothery will present a framework for characterising uncertainty and the value of evidence for informing coverage with evidence development decisions for medical devices compared with pharmaceuticals. Consideration will be given to rapid incremental innovation, learning effects, upfront irrecoverable costs, which present a challenge for the evaluation of devices. Mr glynn will present a framework for characterising uncertainty in the absence of formal cost-effectiveness analysis. dr koffijberg will present a novel checklist for reporting value of information outcomes and demonstrate its application to case studies. these new developments will serve as a starting point for engaging interactive discussion on the implications for decision making. the workshop is intended to be valuable to researchers, decision makers, and industry analysts who are involved in supporting and making research prioritization and coverage decisions.

Presented by members of the ISPOR Value of Information Analysis for Research Decisions Emerging Good Practices Task Force

n W20: PREDICTING TREATMENT EFFECTIVENESS OVER TIME IN REAL WORLD FROM TRIAL EFFICACY DATA Hall D (L -2)Discussion Leaders: Keith Abrams, PhD, Professor of Medical Statistics, department of Health Sciences, University of Leicester, Leicester, Uk; Mark Belger, BSc, Principal Research Scientist, gSS, Eli Lilly, Ascot, Uk; Michael Happich, PhD, director HtA BioMeds, Canada & Europe, Lilly deutschland gmbH, Bad Homburg, germany; Eva-Maria Didden, PhD, Researcher, Institute of Social and Preventive Medicine, University of Bern, Bern, Switzerland

PURPOSE: this workshop will give participants an understanding of important methodological key deliverables achieved by the IMI getReal team (www.imi-getreal.eu). Part of the project has been devoted to bridging the efficacy-effectiveness gap between treatment outcomes in clinical trial and real-world populations, which includes the development of a predictive modelling framework. with the aid of selected case studies, the workshop leaders will demonstrate how different sources of evidence can be used to predict real-world treatment effects from trial efficacy data.

DESCRIPTION: Mark Belger will present an approach based on propensity re-weighting of randomized clinical trial (RCt) data to more appropriately reflect the baseline characteristics of a real-world population. this approach will be illustrated using a RCt and observational study in non-small cell lung cancer (NSCLC). Eva-Maria didden will present a modelling approach that allows prediction of the effect of a new biologic agent in rheumatoid arthritis (RA) patients who will likely receive this agent in the real world of a health care system. the modelling concept relies on the assumption that only trial efficacy data on the new treatment are available, but not yet any observational evidence on its effectiveness. Observational studies on similar biologic RA medications are used to identify treatment decision criteria. keith Abrams will present an approach to generalizing RCt data to the real world both with respect to population (using propensity re-weighting) and time (using extrapolation of RCt survival data informed by real-world data via a Bayesian model averaging approach). this combination of methods will be illustrated with the same NSCLC RCt and observational study. Michael Happich will chair the workshop and facilitate audience participation with respect to whether various stakeholders could envisage using such approaches in their decision making process, as well as how to communicate the implications of such approaches to especially non-technical decision makers and stakeholders.

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n W21: DOUBLY ROBUST ESTIMATION FOR COMPARATIVE EFFECTIVENESS RESEARCH: GETTING AN EXTRA SHOT AT CORRECTLY SPECIFYING THE TREATMENT-OUTCOME MODEL Hall F1 (L0)Discussion Leaders: Patrick Lefebvre, MA, Managing Principal, groupe d’analyse, Ltée, Montreal, QC, Canada; Maral DerSarkissian, PhD, Associate, Analysis group, Inc., Los Angeles, CA, USA; Melvin “Skip” Olson, PhD, Head, Rwd Strategy and Innovation, Novartis Pharma Ag, Basel, Switzerland; Valéry Risson, PhD, MBA, director, HEOR Excellence, Novartis Pharma Ag, Basel, Switzerland

PURPOSE: Since randomized controlled trials are not always feasible, observational studies are often relied upon to evaluate the comparative effectiveness of treatments in real-world settings. the ultimate goal of comparative effectiveness research is causal analysis to assess the relationship between a treatment and outcome. Appropriate control of confounding is essential to causal analysis, though correct model specification with respect to covariate selection can be a difficult task. the validity of causal inference based on observational data hinges on this fundamental yet untestable assumption which cannot be verified using statistical tests. doubly robust (dR) estimation combines a model for the outcome (i.e., outcome regression) and a model for the treatment exposure (i.e., propensity score), offering investigators with two chances to fulfill the correct model specification assumption. Provided one of the models is correctly specified, the dR estimator will be robust to misspecification of the other model. that is, if either the outcome regression model or the propensity score model for the treatment is correctly specified, one can still get unbiased estimates of the association between treatment and outcome.

DESCRIPTION: the workshop will consist of four topics. First, confounding bias, model misspecification, general causal assumptions, and different adjustment techniques (including outcome regression and inverse probability of treatment weighting) will be discussed by way of introduction. Second, a conceptual overview of dR estimation will be presented, and estimators with the dR property, including the augmented inverse probability weighted estimator, will be explored. third, a study using dR estimation to compare the effect of oral versus BRACE therapies on relapse in multiple sclerosis will be presented and discussed. Fourth, audience members will be invited to participate in building dR models (e.g., by suggesting covariates for control) for the case example as workshop moderators run live sensitivity analyses to demonstrate the implementation of dR estimation.

n P13: MEDICAL DEVICE & DIAGNOSTIC RESEARCH STUDIES Hall F2 (L0)

MD1 MEDICAL DEVICES: TIMELY ACCESS AND REIMBURSEMENT - CAN NATIONAL HEALTH TECHNOLOGY 16:30-16:45 ASSESSMENT BODIES BE PART OF THE SOLUTION? Macaulay R, Shaw S, Parexel Access Consulting, London, Uk

MD2 TOWARDS IMPROVED CERVICAL CANCER PRIMARY SCREENING IN AUSTRIA - A DECISION-ANALYTIC 16:45-17:00 BENEFIT-HARM ANALYSIS Sroczynski G1, Esteban E1, widschwendter A2, Oberaigner w3, Borena w2, von Laer d2, Hackl M4, Endel

g5, Siebert U6, 1UMIt - University for Health Sciences, Medical Informatics and technology/ ONCOtYROL - Center for Personalized Cancer Medicine, Hall in tyrol/ Innsbruck, Austria, 2Medical University Innsbruck, Innsbruck, Austria, 3tirol kliniken Innsbruck, Innsbruck, Austria, 4Statistics Austria, Austrian National Cancer Registry, directorate Social Statistics, Statistics Austria, Vienna, Austria,5Main Association of Austrian Social Insurance Institutions, Vienna, Austria, 6and director, division for HtA, ONCOtYROL – Center for Personalized Cancer Medicine, Hall i.t., Austria

MD3 ADOPTION OF TRANSCATHETER MITRAL VALVE REPAIR IN GERMANY: UTILIZATION PATTERNS AND CASE 17:00-17:15 VOLUMES COMPARED TO MITRAL VALVE SURGERY IN THE PERIOD 2010-2014 Pietzsch JB1, weber SA2, Pietzsch ML2, Conradi L3, 1wing tech Inc., Irvine, CA, USA, 2Cellogic gmbH, Berlin,

germany, 3University Heart Center Hamburg, Hamburg, germany

MD4 DECISION UNCERTAINTY AND THE NEED FOR FURTHER RESEARCH: A CASE STUDY IN FENESTRATED 17:15-17:30 ENDOVASCULAR ANEURYSM REPAIR FOR COMPLEX ABDOMINAL AORTIC ANEURYSMS Ciani O1, Epstein d2, Rothery C3, taylor RS1, Sculpher M3, 1University of Exeter Medical School, Exeter,

Uk, 2University of granada, granada, Spain, 3University of York, Heslington, York, Uk

17:30-19:15 EXHIBITORS’ WINE & CHEESE RECEPTION & RESEARCH POSTER PRESENTATIONS VIEWING - SESSION IV Hall X2-X3 (L -2)

(See page 78 for Research Poster Presentation information) Reception sponsored by Quintiles

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n F8: NEW ISSUES AND EMERGING TRENDS IN HEOR: REVISING THE ISPOR CODE OF ETHICS Hall E1 (L0)Presented by the ISPOR Code of Ethics Task Force

Moderator: Richard J. Willke, PhD, Chief Science Officer, ISPOR, Lawrenceville, NJ, USA Speakers: Jessica Santos, PhD, global Compliance and Quality director, kantar Health, Epsom, Uk; Michael Drummond, MCom, DPhil, Professor of Health Economics, Centre for Health Economics, University of York, Heslington, York, Uk; Louise Parmenter, PhD, Vice President, Epidemiology & Outcomes Research, Real-world & Late Phase Research, Quintiles, Inc., Reading, Uk; Gurmit Sandhu, BPharm (Hons), MBA, MPH, Patient Engagement Specialist, gurmit Sandhu Consulting gmbH, Basel, Switzerland

DESCRIPTION: the explosion of big data, the rise of health It, genomic information, and social media, as well as the increased focus on patient centricity, privacy issues, and reproducibility of research results, has rendered the current ISPOR Code of Ethics outdated. In addition to the changes in the market, ISPOR has grown tremendously in membership and geographic reach since its 2008 publication. ISPOR’s influence on global health policy is likely to increase in the coming years. this potential could be undermined by perceptions of bias or other ethical issues surrounding the conduct of HEOR. Speakers will discuss the additions to the Code, the publications section, and the increased role of patients and other stakeholders on ISPOR’s Code of Ethics. Comments and feedback from the audience are appreciated!

n F9: USES, APPLICATIONS, AND FUTURE DIRECTIONS OF THE ISPOR DIGEST OF INTERNATIONAL DATABASES Hall F1 (L0)Presented by the ISPOR Digest of International Databases Special Interest Group

Moderator: Carl Asche, PhD, MSc, director, University of Illinois College of Medicine, Center for Outcomes Research, Peoria, IL, USA Speakers: Elisabeth M. Oehrlein, BA, Phd Candidate, Pharmaceutical Health Services Research, University of Maryland, School of Pharmacy, Baltimore, Md, USA; Brian Seal, RPh, MBA, PhD, director, global Outcomes Research, Millennium Pharmaceuticals, Inc., Cambridge, MA, USA

DESCRIPTION: the digest of International databases, originally developed by ISPOR in 2008, provides a summary of key attributes of health care databases around the world. In order for the digest to remain a useful resource to researchers, the information provided must be accurate, up-to-date, and comprehensive. the ISPOR Special Interest group on digest of databases is working to improve the format, search, and print functions, while also working to ensure that information is up-to-date and the list of databases is comprehensive. the group is also working to provide student-specific information, such as discounted costs. the audience will be invited to comment and provide feedback on future directions on our progress to date, which includes revised digest domains, an updated list of databases, incorporation of peer review, and revised processes for keeping the information current.

n F10: HEALTH ECONOMIC MODELING IN ONCOLOGY Hall A (L2)Presented by the ISPOR Oncology Health Economic Modeling – Post-Progression Working Group

Moderator: Noemi Muszbek, MSc, Senior Research Scientist, Evidera, London, Uk Speakers: Sorrel Wolowacz, PhD, Senior director, Market Access and Outcomes Strategy, RtI Health Solutions, Manchester, Uk; Agnes Benedict, MSc, Executive director, Evidera, Budapest, Hungary

dESCRIPtION: the increasing attention on assessing the value of oncology products has resulted in close scrutiny of the validity of health economic models evaluating the cost effectiveness of new interventions. the field of oncology outcomes research is complicated by the diversity of diseases within oncology, the rapidly changing nature of treatments, and the complexities of measuring cost and quality of life/patient-reported outcomes. the Oncology Health Economic Modeling working group structured a systematic literature review to focus on contemporary and existing health economic modeling methods in advanced oncology and the availability of data on health utility, disease management, treatment patterns, resource use and costs in the post-progression/post-response period. this forum will present the literature review, the search criteria, and challenges from the point of view of multiple stakeholders. the audience will be invited to comment and provide feedback on the project. the presentation may be of interest to health economists, modelers, outcomes researchers and anyone involved in health technology assessment of oncology therapies.

n F11: RESULTS FROM MCDA PAYER CRITERIA: WEIGHTS AND PREFERENCES IN THE CEE REGION Hall E2 (L0)Presented by the ISPOR CEE Network

Moderator: Vladimir Zah, Phd Candidate & Chair, ISPOR CEE Network Executive Committee, Health Economist, Belgrade, Serbia Speakers: Oresta Piniazhko, MSPharm, Phd Candidate & Assistant Professor, department of Management and Economy of Pharmacy, Medicine technology and Pharmacoeconomics, danylo Halytsky Lviv National Medical University, Lviv, Ukraine; Tomas Dolezal, MD, PhD, Scientific director, Institute of Health Economics and technology Assessment, iHEtA, Prague, Czech

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Republic; Ioannis Yfantopoulos, PhD, President, ISPOR greece Chapter, and Professor of Health Economics, Economics and Political Science, University of Athens, Athens, greece; Aleksandra Zawodnik, MSc Pharm, Phd Candidate, department of Experimental and Clinical Pharmacology, Medical University of warsaw, warsaw, Poland

DESCRIPTION: In this forum, panelists will present and discuss findings of the collected MCdA (multi-criteria decision analysis) payer preferences across different CEE countries, relating to oncology, rare diseases, and medical devices. Comparison will be made between different countries criteria prioritization. Furthermore, speakers will explain national payer’s MCdA perspective and the impact of different criteria as a potential CEE “core” MCdA model, with demonstration of intra-CEE countries transferability.

n F12: THE VALUE OF MULTI-STAKEHOLDER PARTNERSHIP IN ADVANCING PATIENT ACCESS IN CENTRAL AND EASTERN EUROPE Hall D (L -2)Presented by the ISPOR CEE Network

Moderator: Dominik Tomek, PharmD, MPH, PhD, President, ISPOR Slovakia Chapter, and Senior Researcher, Faculty of Medicine, Slovak Medical University, Bratislava, Slovak Republic Speakers: Nicola Bedlington, Secretary general, European Patients’ Forum and Co-Founder, the Patient Access Partnership PACt, Brussels, Belgium; Stanimir Hasurdjiev, MD, Secretary-general, Patient Access Partnership, Brussels, Belgium; Tamas Agh, MD, PhD, Principal Researcher, Syreon Research Institute, Budapest, Hungary; Martin Višnanský, PharmDr., MBA, PhD, MSc, Lecturer, University of Veterinary Medicine and Pharmacy, kosice, Slovakia

DESCRIPTION: Over the past three decades CEE countries have made great improvements in modernizing their health care systems and policies by rapidly adopting new methods, medications, and innovative health technologies. However, despite these improvements, many still face significant challenges in the functioning and organization of their health systems: lack of resources, health technology assessment implementation, lack of personnel, etc. One of the main challenges is the patient access to basic health care. this forum will highlight patients’ and experts’ views on advancing access to health care in the CEE region.

n F13: THE SPANISH EXPERIENCE IN HEPATITIS C: FRIENDS OR FOES? Hall F2 (L0)Presented by the ISPOR Spain Chapter

Moderator: Carme Pinyol, MD, PhD, MSc, director INNOVA StRAtEgIC CONSULtINg, President ISPOR Regional Spain Chapter, Barcelona, Spain Speakers: Pedro Gómez-Pajuelo, Health Economist, Ministry of Health, Madrid, Spain; Álvaro Hidalgo, PhD, Professor, Universidad de Castilla la Mancha, toledo, Spain; Toni Gilabert, PhD, general director of Medicines, Catalan Health Services, Barcelona, Spain; Iñaki Betolaza, director of Pharmacy, Health department of Basque government, Vitoria-gasteiz, Spain

DESCRIPTION: Last year, the Spanish Ministry of Health launched the Strategic Plan for Hepatitis C to ensure access to new treatments to all patients who need them. In the beginning, the estimated number of people affected by hepatitis C was determined: 95,524 diagnosed, of which 51,964 were patients with fibrosis in F2, F3 and F4 grade, which are those who have been given priority when receiving treatment. At this moment, 52.000 patients have been treated with these drugs. Spain has more patients treated for hepatitis C than any other European country.

together with the regional government, the Ministry of Health and the Ministry of Finance established a specific plan of financing for ensuring that prioritized VHC patients receive new antivirals. Negotiations with pharmaceutical companies included different mechanism of financing these drugs, CAP, price for treatment and price-volume agreement.

In this forum, we want to analyze the Spanish plan and its deficiencies, different formulas used for negotiation at national and regional level and the real data obtained in registries of patients. we want also to consider how to deal with new treatment and how to plan the elimination of hepatitis C.

18:15-19:15 POSTER AUTHOR dISCUSSION HOUR - SESSION IV Hall X2-X3 (L -2)


20:00-23:30 ISPOR SOCIAL EVENT (Separate registration required) Off Site Venue

Join us at the historic grand Festival Hall of Vienna’s City Hall for dinner, dancing and fun! this gothic building is one of the most splendid in the city, with a tower reaching almost 98 meters high. Lighted by magnificent chandeliers, you will take a trip back in time with your ISPOR colleagues.

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WEDNESDAYSCHEDULE AT-A-GLANCE 7:30-8:30 EdUCATIONAL SYMPOSIUM Hall F2 (L0)

Value Optimization in HCV: Beyond Health Economics (Sponsored by AbbVie)

8:45-13:45 POSTERS - SESSION V Hall X2-X3 (L-2)


IP14: Extending the Use of Biosimilar Drugs: Are We Willing to Accept the Uncertainty Related to Switching in Order to Improve Patient Access to Modern Medicines? Hall F1 (L0)

IP15: Is Balancing Value Demonstration for Payer and Patient Interests a Feasible Notion? Hall E1 (L0)

W22: Value of Information Analysis to Support Coverage With Evidence Development (CED) Schemes: Industry Versus Payer Perspective Hall E2 (L0)

W23: All Models Are Wrong, But Some Are Less Wrong: Using a Verification Protocol to Find These Less Wrong Ones on the Model Farm? Hall A (L2)

W24: Adapting to Evolving Evidence Requirements in Global Medical Device Development Programs Hall F2 (L0)

9:45-10:00 BREAK, EXHIBITS & POSTERS - SESSION V Hall X2-X3 (L-2)


IP16: Should Health Technology Assessment Guidelines Recommend Inclusion of Future Medical Costs? Hall E1 (L0)

IP17: Can We Really Compare and Aggregate Patient-Reported Outcome Data between People and Settings? Implications for Clinical Trials and Health Technology Assessment Hall A (L2)

W25: Sphere of Influence: Russia’s Emerging Health Technology Assessment and Its Influence over Access in CIS Countries Hall E2 (L0)

W26: Biosimilar Value Generation or Value Destruction? A Workshop Demonstrating Uptake to Date and Quantifying Savings Made Hall F1 (L0)

W27: Guidelines for Analyzing Published Summary Time to Event Data Hall F2 (L0)

11:15-12:45 WELCOME & THIRd PLENARY SESSION Hall A (L2)

How to Control Costs and Improve Access to Medicines: Lessons from the InterQuality Project

12:45-13:45 LUNCH, EXHIBITS & POSTERS – SESSION V Hall X2-X3 (L-2)

12:45-13:45 POSTER AUTHOR dISCUSSION HOUR – SESSION V Hall X2-X3 (L-2)


IP18: Patient Preferences in Drug Evaluation: Which Method Should We Use? Hall E1 (L0)

IP19: Using Observational (‘Real World’) Data in Health Technology Assessment: Route to Confusion or Better Decisions? Hall A (L2)

W28: Health-Economic Evaluation of Genomic Technologies: Which Issues Arise? Hall E2 (L0)

W29: Translating Value over the Lifecycle of a Therapy: Developing Evidence across Multiple Indications Hall F1 (L0)

W30: Measuring Multiple Medication Adherence – Which Measure When? Hall F2 (L0)

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WEDNESDAY SCHEDULE AT A GLANCE CONTINUED14:45-15:00 BREAK Hall X2-X3 (L-2)


IP20: Is Real-World Data as an Indispensable Source for the Assessment of New Oncology Treatments Possible? Hall F2 (L0)

IP21: Is Off-Label Drug Use Enhancing or Limiting Access for Patients With Rare Diseases? Hall E1 (L0)

W31: Determining Utility of Multi-Attribute Health States: New Measurement and Analytic Approaches Hall E2 (L0)

W32: How to Incorporate Economic Evaluations in Clinical Practice Guidelines: A Practical Workshop on Research Methods Hall F1 (L0)

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WEDNESDAY, 2 NOVEMBER 2016

7:30-8:30 EdUCATIONAL SYMPOSIUM Hall F2 (L0)

VALUE OPTIMIZATION IN HCV: BEYOND HEALTH ECONOMICS

Since 2014, with the introduction of direct Acting Antiviral agents (dAA’s) the hepatitis C virus (HCV) landscape has dramatically changed and many patients have been treated since the introduction of these products. In many countries however, to date, treatment has been restricted to more severe patients. Furthermore in most of the countries a significant proportion of patients are still undiagnosed. this educational symposium will discuss some of the health economics aspects of treating HCV patients with dAA’s. Furthermore, experts in the field will present if and how disease eradication can become a reality and the different actions stakeholders can take to make disease eradication a realistic ambition.

Moderator: Zoltan Kalo, MD, PhD, Professor of Health Economics & Head of the Institute of Economics, Eötvös Loránd University, Budapest, Hungary

Speakers: Homie Razavi, PhD, MBA, Managing director, Center for disease Analysis, denver, CO, USA

Rafael Bengoa, PhD, director, Institute for Health & Strategy, Bilbao, Spain

Sponsored by: AbbVie

8:45-13:45 RESEARCH POSTER PRESENTATIONS - SESSION V Hall X2-X3 (L -2)



n IP14: EXTENDING THE USE OF BIOSIMILAR DRUGS: ARE WE WILLING TO ACCEPT THE UNCERTAINTY RELATED TO SWITCHING IN ORDER TO IMPROVE PATIENT ACCESS TO MODERN MEDICINES? Hall F1 (L0)Moderator: Rok Hren, PhD, MSc IHP(HE), Assistant Professor, University of Ljubljana, Ljubljana, Slovenia Panelists: Tomas Tesar, PharmD, PhD, MBA, Member of the Reimbursement Committee of the Slovak Ministry of Health, Union Health Insurance Fund, Bratislava, Slovakia; Andras Inotai, PharmD, PhD, Senior Pharmacoeconomist, Syreon Research Institute, Budapest, Hungary; Duša Hlade Zore, MD, Representative of Patients’ Rights, Ministry of Health, government of the Republic of Slovenia, Ljubljana, Slovenia

ISSUE: As prices of modern biological treatments are established in high income countries, they are often not justifiable in Central Eastern Europe (CEE). therefore, many of these drugs are only available with various access limits in the region. Increased use of biosimilar drugs, especially in countries with limited health care resources may contribute to improved patient access. Biosimilars offer therapeutic equivalence with original biologics at reduced drug price for treatment naive patients. However, as opposed to small-molecule generic drugs, biosimilars cannot be considered identical to their originators. therefore, switching patients receiving maintenance drug therapy with original biological drugs to biosimilars may not be an obvious option for clinicians, regulators, and payers due to fear of adverse immunological reactions or reduced therapeutic effect.

OVERVIEW: Mandatory phase III trials test equivalent efficacy and safety of biosimilar drugs compared to original biological drugs in treatment naive patients in one indication. Even if biosimilars are tested among maintenance patients, these trials may not be adequately powered to detect adverse immunologic reactions due to limited number of patients and follow-up period. Extensive use of biosimilars may pose a trade-off for decision makers: either taking the risk of uncertain effects related to switching biopharmaceuticals or accepting the opportunity cost from unrealised savings and improvement in patient access. Panelists will discuss: (1) how to improve the evidence-based reimbursement decision making on biosimilars; (2) how to balance handling risks of switching and benefits from potential savings; and (3) how to implement this decision-making process in practice. the first panelist is a payer and member of reimbursement committee of a CEE country. the second panelist will represent the perspective of a researcher. the third panelist is a patients’ rights expert appointed by government from one of the most developed jurisdictions in CEE and who will present the perspective of patients.

n IP15: IS BALANCING VALUE DEMONSTRATION FOR PAYER AND PATIENT INTERESTS A FEASIBLE NOTION? Hall E1 (L0)Moderator: Kathleen E. Hughes, MBA, Vice President, Health Economics and Outcomes Research, Avalere Health LLC, washington, dC, USA Panelists: Sachin Kamal-Bahl, PhD, Vice President & Head, global Health & Value Innovation Center, Pfizer, Collegeville, PA, USA; Adrian Towse, MPhil, director, Office of Health Economics, London, Uk; Alastair Kent, OBE, director, genetic Alliance Uk, London, Uk

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Program & Schedule of Events: Wednesday, 2 November


ISSUE: Maintaining patient focus in health care decision making is a universally accepted approach to ensuring positive outcomes. “Value frameworks” share building blocks: health outcomes of interest; evidence to measure effect of treatment on outcomes; combination of outcomes into single health benefit measures; and comparison of care costs with health benefits. ESMO framework is exceptional in excluding costs. Framework developers and health technology assessment (HtA) organizations claim differences in “valuation” tool orientation to patient interests. Even frameworks claiming patient-centricity are criticized for over-emphasizing methods to incorporate payer versus patient perspectives. while tension between payer and patient perspectives is inevitable, many agree frameworks can be improved and diverse interests reconciled therein. Others claim two viewpoints cannot be reconciled in a single framework and separate patient-centric frameworks should be developed.

OVERVIEW: Moderator will provide a brief overview of existing value frameworks and HtA approaches, characterizing methodology and payer/patient perspective balance. Panelists will critique frameworks/methods on modifications inclusive of patient-focused elements and/or patient-centric use and possibility of reconciling patient and payer interests within a framework. Finally, panelists will debate how addressing payer and patient interests simultaneously could impact research functions: broader evidence generation, patient-reported outcomes development, and establishment of quality measures encompassing payer/patient perspectives.

n W22: VALUE OF INFORMATION ANALYSIS TO SUPPORT COVERAGE WITH EVIDENCE DEVELOPMENT (CED) SCHEMES: INDUSTRY VERSUS PAYER PERSPECTIVE Hall E2 (L0)Discussion Leaders: Leyla Mohseninejad, MSc, PhD, HEOR Manager, Creativ-Ceutical, Rotterdam, the Netherlands; Saskia Knies, PhD, Policy Advisor Health Economics, National Health Care Institute (ZiN), diemen, the Netherlands; Mondher Toumi, MD, PhD, MSc, Professor, Public Health department, Aix-Marseille University, Marseille, France

PURPOSE: this workshop will discuss the application of value of information (VOI) methods in coverage with evidence development (CEd) schemes, where access to the new technology can be only guaranteed in face of new evidence. we will address the policy implications of the VOI methods for both industries and payers in order to support them in setting an optimal CEd scheme.

DESCRIPTION: CEd has become increasingly popular to address uncertainties and to secure ongoing coverage for promising technologies at time of launch. VOI provides a robust framework to quantify the uncertainty and to analyze its consequences. However, to date few countries beyond the Netherlands use VOI to inform the nature of evidence to be developed. VOI methods have been recommended in the Netherlands (ZIN) with guidelines developed for implementation. By mimicking a real discussion about a virtual case study between the industry and the payer, we will enlighten participants on challenges and solutions when implementing VOI. Leyla Mohseninejad will represent the industry perspective. She will present a hypothetical case of an economic evaluation followed by VOI results. She will use the VOI to show how evidence is expected to evolve over time in future, making CEd valuable for payers. Saskia knies, the payer representative, will challenge the work presented by industry with regards to barriers in real practice to achieve the expected value. She will point out the remaining gaps in the evidence development scheme suggested by the industry. Mondher toumi, the academic HtA expert, will conclude the session by balancing the risks and advantages of using VOI methods in CEd agreements. He will advise payers and industries on how to optimally use VOI methods in CEd schemes. Finally, we will invite the audience to participate in this discussion by providing feedback and sharing their experience on VOI methods and CEd schemes.

n W23: ALL MODELS ARE WRONG, BUT SOME ARE LESS WRONG: USING A VERIFICATION PROTOCOL TO FIND THESE LESS WRONG ONES ON THE MODEL FARM? Hall A (L2)Discussion Leaders: Maiwenn J. Al, PhD, Assistant Professor, Institute for Medical technology Assessment (iMtA), Erasmus University Rotterdam, Rotterdam, the Netherlands; Nasuh Buyukkaramikli, PhD, Senior Researcher, Institute for Medical technology Assessment (iMtA), Erasmus University, Rotterdam, the Netherlands; Rachid Rafia, PhD, Senior Researcher, Sheffield University, Sheffield, Uk; Dawn Lee, MMath, MSc, Head of Health Economics Analysis, BresMed Health Solutions, Sheffield, Uk

PURPOSE: the purpose of this workshop is to introduce the audience to model errors/credibility threats, methods for cost effective improvement of model validation/review processes, giving examples from real-life cases. In particular, the workshop will include discussion on how protocols can systemize verification efforts for models and present a new model verification assessment protocol, tECH-VER Protocol 1.0.

DESCRIPTION: Validation of health economic models is essential, especially if models are used in decision making. Verification is a fundamental step for model validation, ensuring that the conceptual model is implemented correctly and behaves accordingly to concept without errors. Procedures used for model verification within industry will be presented with focus given to the trade-off between time spent and accuracy. Following this, a new operational protocol for model users/reviewers to assess the quality assurance and verification status of the technical implementation for HE decision analytical models will be presented. An initial beta version of the protocol was developed based on the findings from the literature and authors’ previous modelling/appraisal experience. the beta version was iteratively revised based on oral/written feedback from other health economists and after each execution of the protocol on a different model. In this workshop, we will first introduce model error/ credibility threat types through a taxonomy of errors and mitigation strategies to avoid them. then, we will

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present the developed protocol, tECH-VER Protocol 1.0. with the help of the examples from implemented cases, we will then demonstrate how the protocol had systemized the verification efforts and helped in the model validation/review process and in identifying model/reporting errors. Finally, the possible added values and cost effectiveness of such verification protocols will be discussed from different (e.g., academia, consultancy, decision-maker) perspectives with the audience.

n W24: ADAPTING TO EVOLVING EVIDENCE REQUIREMENTS IN GLOBAL MEDICAL DEVICE DEVELOPMENT PROGRAMS Hall F2 (L0)Discussion Leaders: Thomas Goss, PharmD, Sr. Vice President, Boston Healthcare Associates, Boston, MA, USA; Mark Campbell, MPhil, Associate director - Medical technologies Evaluation Programme, Centre for Health technology Evaluation, National Institute for Health and Care Excellence, Uk, Manchester, Uk; Liesl Cooper, RPh, MBA, PhD, Vice President, Market Access, ResMed, San diego, CA, USA; Perry Bridger, MHS, Vice President, global Value, Payer Access and Public Policy, Edwards Lifesciences, Irvine, CA, USA

PURPOSE: to discuss changes in clinical and economic evidence requirements for innovative medical technologies and what companies must do to gain market access.

DESCRIPTION: the global marketplace for medical technology is increasingly focused on value as a prerequisite for market access and reimbursement. the demand for increased evidence to prove clinical or economic value is typically higher in established markets with systematic methods in place to evaluate quality and cost, with a focus on comparative and/or incremental value. Additionally, as risk shifts from payers to providers, more health care systems are centralizing purchasing decisions, taking decisions out of the hands of the clinician and seeking to achieve more standardization while balancing cost reduction and quality improvement goals. Medical device innovators must become more efficient at appraising a product’s likely evidence requirements early in development. Considering the likely return on investments in evidence development is becoming a key component in evaluating ongoing development decisions at the portfolio level. Accordingly, innovative medical device companies are enhancing capabilities in evidence-based evaluation to align value determination, demonstration, and capture activities with clinical and economic evidence development. Industry representatives will present case studies using evidence-based value as a key input to portfolio management, product development, and commercial launch processes. Additionally, for innovative devices, health technology assessment bodies increasingly are key stakeholders. An invited speaker from the Uk, NICE will discuss how NICE’s approaches to medical technology evaluation can facilitate access through early and sustained engagement with technology developers; a constructive approach to topic selection; flexibility in assessing all relevant information including ‘low-level’ evidence; and investment in addressing evidence gaps which prevent it from making comprehensive recommendations for use. Further, the discussion will examine how medical device innovators are coordinating evidence-based value building activities globally and discuss strategies for integrating evidence development to address the unique features of medical device development.

9:45-10:00 BREAK, EXHIBITS & RESEARCH POSTER PRESENTATIONS VIEWING - SESSION V Hall X2-X3 (L -2)



n IP16: SHOULD HEALTH TECHNOLOGY ASSESSMENT GUIDELINES RECOMMEND INCLUSION OF FUTURE MEDICAL COSTS? Hall E1 (L0)Moderator: Andrew Briggs, DPhil, MSc, william R Lindsay Chair of Health Economics and Professor of Health Economics, University of glasgow, glasgow, Uk Panelists: Alec Morton, PhD, Professor, Management Science, University of Strathclyde, glasgow, Uk; Pieter van Baal, PhD, Associate Professor, Institute for Health Policy and Management (iBMg), Erasmus University Rotterdam, Rotterdam, the Netherlands; Ad Antonisse, MSc, director Economic Affairs (Market Access & Public Affairs), AstraZeneca, Zoetermeer, the Netherlands

ISSUE: New medical technologies that prolong life result in additional health care use in life years gained. Currently, many health technology assessment (HtA) guidelines recommend that “unrelated future costs” of a medical technology are excluded from an appraisal (so the costs of caring for a patient’s dementia after preventing their death from stroke would not be included in a cost-effectiveness analysis of thrombolysis treatment). Recently, dutch guidelines for HtA have changed and recommend inclusion of future unrelated medical costs. this begs the question whether other HtA guidelines should also recommend inclusion of future unrelated medical costs?

OVERVIEW: the panelists will present and discuss the pros and cons of including future unrelated costs in HtA. Alec Morton will summarize theoretical arguments for and against inclusion of future unrelated medical costs. Pieter van Baal will discuss how these costs can be estimated in practice. Finally, Ad Antonisse will present the industry point of view. the audience will be invited to participate in the discussion whether HtA guidelines should recommend inclusion of future unrelated medical costs.

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n IP17: CAN WE REALLY COMPARE AND AGGREGATE PATIENT-REPORTED OUTCOME DATA BETWEEN PEOPLE AND SETTINGS? IMPLICATIONS FOR CLINICAL TRIALS AND HEALTH TECHNOLOGY ASSESSMENT Hall A (L2)Moderator: Nancy Devlin, PhD, director of Research, Office of Health Economics, London, Uk Panelists: Andrea Manca, PhD, MSc, Professor of Health Economics, Centre for Health Economics, University of York, Heslington, York, Uk; Michael Herdman, MSc, director, Insight Consulting and Research, Mataró, Spain; Paula Lorgelly, PhD, deputy director, Office of Health Economics, London, Uk

ISSUE: Patient-reported outcomes (PROs) are routinely collected in clinical trials, cohort studies, and population health surveys. they are used to compare health across heterogeneous populations (e.g., across countries, different cultural settings and socio-demographic groups). this panel looks at whether PRO data are truly comparable across different groups of individuals and the implications e.g. for aggregating PRO data from multi-country randomized controlled trials (RCts) to provide an overall assessment of treatment efficacy. we examine how comparability can be improved and discuss the implications for using PRO evidence to inform health policy.

OVERVIEW: this panel will discuss the comparability of PROs from their conceptualization through statistical methods. Using examples from the literature and his own experience in adapting PRO instruments, particularly the EQ-5d for use in other countries, Mike Herdman will discuss the importance of taking into account conceptual and linguistic issues when using instruments cross-culturally. He will also present methods for assessing and improving comparability, particularly in relation to preference-based measures, and will discuss possible reasons for a lack of comparability and implications for cross-cultural comparisons and data transferability within the context of HtA. Further, PRO data may not be comparable if groups of individuals systematically differ in their use of response categories, due to response-scale heterogeneity or differential item functioning (dIF), etc. Paula Lorgelly will present her work using anchoring vignettes to identify response bias and dIF in self-assessed health and the EQ-5d in order to improve comparability. Andrea Manca will further explore the issue of heterogeneity, what specifically drives heterogeneity in PROs, and what data we need to be able to disentangle that heterogeneity. the panel will conclude with a discussion on the importance of evaluating and enhancing the comparability of PRO instruments and results across different cultural and socio-demographic groups and how the issue should be handled, given an increasingly global context for RCts and HtA.

n W25: SPHERE OF INFLUENCE: RUSSIA’S EMERGING HEALTH TECHNOLOGY ASSESSMENT AND ITS INFLUENCE OVER ACCESS IN CIS COUNTRIES Hall E2 (L0)Discussion Leaders: Cyrus A. Chowdhury, CEO & Managing director, CBPartners, New York, NY, USA; Malwina Holownia, MPharm, Senior Health Economist, Moscow department of Health, Moscow, Russian Federation; Elena Subbotina, MIM, MSc, Consultant, CBPartners, London, Uk

PURPOSE: the purpose of this workshop will be to explore how health technology assessment (HtA) / pharmacoeconomic policy in Russia influences policy and access decisions on high value / orphan disease therapeutics in CIS countries.

DESCRIPTION: Although having one of the lowest willingness-to-pay for high-value drugs in the European region, Russia has been characterised as a country with the highest cost-effectiveness threshold within the CIS. Currently, the policy for HtA assessment and methodological developments in Russia are being influenced by several economic and political factors, which include (1) the creation of a common market with harmonised legislation within the Eurasian Economic Commission (ECC), (2) the political shift towards so-called “importozamescheniye” – an increased push from the government to switch to locally produced medicines and support local pharmaceutical manufacturers, (3) the ongoing push for more comprehensive HtA methodology for assessing the drugs in the face of a stringent health care budget. during the workshop the participants will be reviewing how such HtA policy developments in Russia may impact policy and decision-making with regard to access for high-value, rare disease therapies in the CIS region. As a market with common rules and a larger population may be of greater interest in the pursuit of access, particular emphasis during the workshop will be paid to explore the current status of HtA policy harmonisation across the countries in the CIS region and the forecasted changes with the establishment of the ECC.

n W26: BIOSIMILAR VALUE GENERATION OR VALUE DESTRUCTION? A WORKSHOP DEMONSTRATING UPTAKE TO DATE AND QUANTIFYING SAVINGS MADE Hall F1 (L0)Discussion Leaders: Michael Drummond, MCom, DPhil, Professor of Health Economics, Centre for Health Economics, University of York, Heslington, York, Uk; Monique Martin, PharmD, MSc, MBA, Managing director PMA Europe, inVentiv Health, London, Uk

PURPOSE: Biologics, large molecule drugs derived from living organisms, have made a substantial contribution to health care and have markedly improved the outlook for patients diagnosed with conditions like rheumatoid arthritis, cancer and growth hormone deficiency (gHd). Patents for some of these biologics have now expired or will be expiring soon, allowing the entry of biosimilars. this could potentially allow health care systems to offer biologics in a financially more sustainable manner and to use saved funds to provide access to new technologies.

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DESCRIPTION: the workshop will discuss the current paradigm where biosimilars are entering the market in Europe (EU-5), US, Canada, and Australia and the issues manufacturers are facing. we will present those biologics where patents have expired, and those nearing patent expiry. A comparison between market access and pricing regulations in Europe and other major HtA markets will be presented and discussed, differences pointed out and implications for manufacturers identified. then several case studies will be presented in a range of indications based on data from EU-5 countries. data on general adoption trends, market share development and price changes (originator and biosimilars) will be presented and discussed, demonstrating how varying market conditions can affect market adoption and price levels. the workshop will end by discussing the value of biosimilars to health care in general; we will quantify the savings made from the various examples and discuss with the audience how these funds should be used. A number of options will be provided to facilitate audience participation.

n W27: GUIDELINES FOR ANALYZING PUBLISHED SUMMARY TIME TO EVENT DATA Hall F2 (L0)Discussion Leaders: Jack Ishak, PhD, Senior Research Leader, Modeling and Simulation, Evidera, Montreal, QC, Canada; Martin Hoyle, PhD, Associate Professor of Health Economics, Medical School, University of Exeter, Exeter, Uk; Arman Altincatal, MS, Senior Statistician, Evidera, Lexington, MA, USA

PURPOSE: to help researchers understand how published kaplan-Meier curves can be augmented with other statistics (e.g., event counts, numbers at risk, median time-to-event, hazard ratio) to improve estimation of time-to-event data, and

to illustrate how various approaches to generating analyzable data from the curves perform in parametric fitting/projection and comparative analyses.

Examples will be used to demonstrate and compare the various approaches, and to highlight their strengths and limitations. Attendees will be asked to respond to questions based on the presented material via a web-enabled application; a summary of responses will be shown and used for further discussion and clarifications, where necessary.

DESCRIPTION: Economic evaluations often rely on published data for model inputs. In particular, time-to-event distributions are often taken from publications and subjected to parametric fitting analyses to project unobserved portions of the curve. A standard, but somewhat crude approach is to perform least-squares regressions on coordinates derived by digitizing the published curves. two approaches are available, however, to derive, virtual patient-level (VPL) data in the form of interval censored, or specific event/censoring times. VPL data can be used for parametric fitting to project incomplete kaplan-Meier curves or derive comparative measures in pooled analyses of data from different curves. Analyses can also produce standard errors of parameter estimates, which are used in probabilistic sensitivity analyses. the approach used to generate data from curves can affect the accuracy of derived estimates. For instance, analyses of coordinates using least-squares regression is prone to bias with all types of distributions, while actual event times may be more accurate than interval censored data for log-normal data. Examples will be used to demonstrate the VPL data generation process from curves for which actual patient data are available. Virtual and actual patient data will be analyzed to compare the accuracy of approaches.

11:15-12:45 WELCOME & THIRd PLENARY SESSION Hall A (L2)

WELCOME FROM ISPOR PRESIDENT



ISPOR SERVICE AWARDS

Presented by: Lou Garrison PhD, 2016-2017 ISPOR President, Professor, Pharmaceutical Outcomes Research and Policy Program, department of Pharmacy, University of washington, Seattle, wA, USA

CONGRESS RESEARCH PRESENTATION AWARDS

Presented by: Paolo A. Cortesi, PhD, Researcher, Research Centre on Public Health, University of Milano - Bicocca, Milan, Italy

Presented by: Anthony J. Hatswell, MSc, Principal Consultant (HtA Methodology), BresMed, department of Statistical Science, University College London, Uk, Sheffield, Uk

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ISPOR 20TH ANNUAL EUROPEAN CONGRESS ANNOUNCEMENT


THIRd PLENARY SESSION: HOW TO CONTROL COSTS ANd IMPROVE ACCESS TO MEdICINES: LESSONS FROM THE INTERQUALITY PROJECT


this session will describe a number of important themes emerging from the InterQuality Project. One key finding was the importance of equity of access to health services and medicines. For example, the proportion of households with “catastrophic” out-of-pocket health spending in Poland was much higher than in either denmark or germany, and concentrated in the worst-off groups of senior citizens. the new Minister of Health launched a program of free medicines for senior citizens of Poland. A second important theme was how evidence on patients’ preferences can be integrated into health technology assessment (HtA) using efficiency frontier concept to identify the most efficient strategy within a disease class in regulatory decision-making in germany. Finally, while most European Union (EU) member states promote the implementation of innovative analytical methods or e-health tools, such as e-prescribing, these efforts are not part of an integrated package. Currently, no single agent manages insured patients’ access to medicines and healthcare in a coordinated manner. More attention should be paid by EU member states to an institutional framework integrating the various methods and e-health tools to enhance benefits to both individuals and societies.

Moderator: Tomasz Hermanowski, PhD, InterQuality Project Leader and Professor & Head, department of Pharmacoeconomics, Medical University of warsaw, warsaw, Poland Speakers: Anna Zawada, MSc, director, transparency and tariff Councils Office, Agency for Health technology Assessment and tariff System (AOtMit), warsaw, Poland; Joanna Lis, MSc, MBA, PhD, director, Market Access, Sanofi-Aventis, warsaw, Poland; Axel Muehlbacher, PhD, Professor, Neubrandenburg University, Neubrandenburg, germany; Brian K. Solow, MD, FAAFP, Chief Medical Officer, Optum Life Sciences, Irvine, CA, USA

12:45-13:45 LUNCH, EXHIBITS & RESEARCH POSTER PRESENTATIONS VIEWING – SESSION V Hall X2-X3 (L -2)


12:45-13:45 POSTER AUTHOR dISCUSSION HOUR – SESSION V Hall X2-X3 (L -2)



n IP18: PATIENT PREFERENCES IN DRUG EVALUATION: WHICH METHOD SHOULD WE USE? Hall E1 (L0)Moderator: Heather L. Gelhorn, PhD, Senior Research Scientist, Outcomes Research, Evidera, Bethesda, Md, USA Panelists: Tommi Tervonen, PhD, Senior Research Associate, Evidera Ltd, London, Uk; Axel C. Mühlbacher, PhD, MBA, Professor, Health Economics and Health Care Management, Institute Health Economics and Health Care Management, IgM, Hochschule Neubrandenburg, Neubrandenburg, germany; Douwe Postmus, PhD, Researcher, department of Epidemiology, University of groningen, University Medical Center groningen, groningen, the Netherlands

ISSUE: How should patient preferences be elicited for use in comparative treatment evaluation?

OVERVIEW: Evaluating treatments based on clinical profiles and convenience characteristics brings treatment choice closer to the patient than generic evaluation frameworks such as quality-adjusted life year. when no dominant treatment option exists, such valuation exercises must establish trade-offs between profiles of competing treatments. Various health authorities such as the US Food and drug Administration and the Institute for Quality and Efficiency in Healthcare have highlighted the importance of eliciting the trade-offs directly from patients. Multiple techniques, such as discrete choice experiments and swing weighting, are applicable for eliciting patient trade-off preferences. Currently, there is no guidance

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on which elicitation method is most appropriate in different circumstances. this panel asks which elicit method is most appropriate, and when, taking into account of both the theoretical and practical differences between the methods. Panelists will draw on their experience from ISPOR conjoint analysis experimental design task force (Mühlbacher), European Medicines Agency preference-based benefit-risk pilot (Postmus) and methodological development (tervonen) to defend their points of view.

n IP19: USING OBSERVATIONAL (‘REAL WORLD’) DATA IN HEALTH TECHNOLOGY ASSESSMENT: ROUTE TO CONFUSION OR BETTER DECISIONS? Hall A (L2)Moderator: Sarah Garner, PhD, Associate director of Science Policy and Research, National Institute for Health and Care Excellence (NICE), London, Uk Panelists: Mark Sculpher, PhD, Professor of Health Economics, Centre for Health Economics & director, Programme on Economic Evaluation and Health technology Assessment, University of York, Heslington, York, Uk; Keith R Abrams, PhD, Professor of Medical Statistics, department of Health Sciences, University of Leicester, Leicester, Uk; Michael Seewald, PhD, global Head Real world Evidence, Novartis, Basel, germany

ISSUE: Regulators are increasingly planning to rely on observational (‘real-world’) evidence to inform licensing, which also becomes central to funding decisions. this promises a low-cost means of shortening the period before a new medicine is available. However, the lack of randomization in these datasets risks biased estimates of treatment (cost)-effectiveness. the session will debate the strengths and weaknesses of increasing use of real-world evidence. garner will moderate and set out the evolving policy landscape and opportunities offered by such data. Sculpher will argue that there are risks associated with non-randomized evidence and methods are needed to incentivize appropriate studies. Abrams will outline novel methods to facilitate reliable use of real-world evidence, particularly when randomized controlled trials (RCts) are challenging to conduct. Seewald will provide a manufacturer’s perspective and highlight that appropriate use of real-world evidence can reduce the costs of drug development.

OVERVIEW: to make access to some medicines more timely, regulators are licensing some products (e.g., those with high unmet need) without RCt evidence. they may make such decisions conditional on further data collection that is generally observational in nature. Health systems are obliged to rely on effectiveness evidence that is generated for regulatory purposes, whether RCts or observational in nature. Furthermore, many systems are hoping that uncertainty associated with the value of products at launch can be addressed by using routine observational (‘real-world`) data (e.g., the reformed Cancer drugs Fund in England). Observational data offer potential strengths in terms of low costs and representativeness. However, they risk providing biased estimates of treatment effectiveness. the impact of real-world data on the quality of funding decisions is a matter of debate. Risks could be reduced by better methods to analyze such data and/or by seeking novel ways to incorporate routine data in RCts.

n W28: HEALTH-ECONOMIC EVALUATION OF GENOMIC TECHNOLOGIES: WHICH ISSUES ARISE? Hall E2 (L0)Discussion Leaders: Kjm van Nimwegen, MSc, department for Health Evidence, Radboud Institute for Health Sciences, Radboud University Medical Center, Nijmegen, the Netherlands; Rene Sluiter, MSc, department for Health Evidence, Radboud University Medical Center, Nijmegen, the Netherlands; Gerardus WJ Frederix, PhD, Julius Centre, Utrecht University, Utrecht, the Netherlands; Sarah Wordsworth, PhD, Associate Professor, Health Economics Research Centre, Nuffield department of Population Health, University of Oxford, Oxford, Uk

PURPOSE: to present and discuss the issues surrounding the health economic evaluation of genomic technologies. this will be illustrated by evaluations of genomic technologies in both diagnostics and pharmacogenetics.

DESCRIPTION: genomic technologies are rapidly advancing and genomic testing is increasingly being discussed for use in clinical practice. However, internationally, adoption rates for innovative technologies vary considerably, which is partly due to a lack of economic evidence. Since technological innovations are known to be a major cost driver in health care, and health care expenditures are rapidly increasing, there is a growing need for health economic evaluation of genomic innovations such as whole-genome sequencing. However, certain specific problems arise in the health economic evaluation of genomic technologies. First, kirsten van Nimwegen describes the issues in early health technology assessment (HtA) surrounding genomic diagnostics which might not result in QALY gains. then, geert Frederix shows an economic evaluation of whole-exome sequencing in complex paediatric neurology. Subsequently, Rene Sluiter presents a cost-utility analysis of genetic screening as a tool to individualize patient treatment trough medical selection or dose adjustment based on a patient’s genetic profile. Finally, Sarah wordsworth will reflect on the issues encountered in the presented cases, and elaborate on which issues require special attention if the economic evaluation of genomic technologies is to be successful. Finally, there will be room for discussion in which the audience is encouraged to share their experiences and thoughts on health economic evaluation of genomic technologies.

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n W29: TRANSLATING VALUE OVER THE LIFECYCLE OF A THERAPY: DEVELOPING EVIDENCE ACROSS MULTIPLE INDICATIONS Hall F1 (L0)Discussion Leaders: Caroline Solon, MSc, Senior Associate, CBPartners, San Francisco, CA, USA; Meghan Gallagher, director, global Health Economics and Outcomes Research, Oncology, Sanofi, Cambridge, MA, USA; Cyrus A. Chowdhury, Chief Executive Officer & Managing director, CBPartners, New York, NY, USA

PURPOSE: the purpose of this workshop will be to explore how evidence generation can be optimised across multiple indications pursued over time. the discussion will be conducted based on a series of case studies based on first-hand and secondary experience belonging to the discussion leaders.

DESCRIPTION: Multi-application health care products are increasingly common, and the nature of the different applications of the product is becoming more divergent across disparate indications that deal with varied pathologies and associated health care stakeholders. Often, these therapeutics only gain multi-indication labels via post-marketing authorisation expansion—that is, value perception and evidence is developed at different points in time, as is the general availability of evidence for different patient populations. Evidence requirements and decision-making processes for HtA were originally designed for single product, single indication submissions; however, as more products are developed across multiple indications, holistic evidence packages and multi-indication approaches to demonstrating value may offer manufacturers a more efficient evidence generation process and potentially help facilitate access activities over time. Nevertheless, it remains unclear how payers will receive such evidence packages or how far in advance evidence generation strategies must be implemented for holistic packages to be robust and achievable. A variety of topics will be explored in conjunction with perspective shared by the workshop participants, including early consultation on future indication pursuit, phase III clinical study design and implications, and real-world evidence generation. Additionally, discussion leaders will explore contradictory value message development and evidence positioning, as well as holistic value story creation and budget impact modelling approaches to mitigate the challenges of multi-indication label evolution. the payer and manufacturer perspective on these issues will be generously discussed by the discussion leaders, and feedback from the audience via written survey and first-hand experience sharing will support a robust workshop.

n W30: MEASURING MULTIPLE MEDICATION ADHERENCE – WHICH MEASURE WHEN? Hall F2 (L0)Discussion Leaders: Priti Pednekar, MPharm, Student, Health Policy, University of the Sciences, Philadelphia, PA, USA; Tamas Agh, MD, PhD, Principal Researcher, Syreon Research Institute, Budapest, Hungary; Maria Malmenas, MSc, director Hemu, HERON Commercialization, PAREXEL International, Stockholm, Sweden; Bryan Bennett, PhD, director, Patient Centered Outcomes, Adelphi Values Ltd, Bollington, Uk

PURPOSE: to provide a discussion on the various methods used to estimate adherence to multiple medications (AtMM). Methods currently employed in the AtMM literature will be presented followed by a discussion of pros and cons of the methods and the calculations used to derive the measure of adherence.

DESCRIPTION: In a systematic review undertaken by the ISPOR Medication Adherence Special Interest group, 151 relevant studies were identified on AtMM. Of these, 81 studies used a form of Morisky adherence scale and 54 used either the proportion of days covered (PdC) or medication possession ratio (MPR), each with varying methods to calculate AtMM. Other measures were also identified and several studies used multiple measures. this workshop will present the statistical methods and identify the different ways of deriving multiple medication adherence measures. discussion will be undertaken of whether the measurements affected the results and if there were measurements that provided more accurate results compared to the others. this will be followed by an audience interaction on the advantages and disadvantages of using different identified methods and calculations. the concluding period will allow for wrap up, opportunities for questions and answers and examine recommendations for the next steps.

Presented by the Medication Adherence and Persistence Special Interest Group

14:45-15:00 BREAK Hall X2-X3 (L -2)


n IP20: IS REAL-WORLD DATA AS AN INDISPENSABLE SOURCE FOR THE ASSESSMENT OF NEW ONCOLOGY TREATMENTS POSSIBLE? Hall F2 (L0)Moderator: Stefano Capri, PhD, Adjunct Professor, School of Economics and Management, LIUC University, Castellanza VA, Italy Panelists: David Chao, BMBCh, FRCP, DPhil, Consultant in Medical Oncology, Royal Free Hospital, London, Uk; Ken Redekop, PhD, Associate Professor, Institute for Medical technology Assessment, Erasmus University Rotterdam, Rotterdam, the Netherlands

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ISSUE: Randomized controlled trials (RCts) are the gold standard for assessing efficacy and safety of new treatments for health technology assessment (HtA) bodies and payers. However, RCts may not always provide sufficient evidence to validate a treatment’s benefit, particularly in an era of numerous therapeutic advances, where approvals are granted more rapidly and with less mature data. Real-world data (Rwd) are seen as a means of reducing perceived uncertainty in RCt data, achieving long-term outcomes or providing additional information on the value of treatments; nevertheless, they also raise new challenges, including the potential for multiple decision points, and deciding which sorts of Rwd are most appropriate for HtA. Should Rwd be required in all circumstances, or only where further evidence is required?

OVERVIEW: the rapidly evolving landscape of oncology therapies raises challenges for HtA bodies and payers. Increased demand from patients to gain earlier access to innovative treatments has triggered faster regulatory approvals, meaning new therapies are becoming available with less mature RCt data or non-comparative phase II trials. Constrained health care resources and an ageing population place ever-greater importance on pricing and reimbursement decisions. Harnessing Rwd provides an opportunity to gain powerful insight into how a therapy can perform in real-life clinical settings, and where to accelerate access. However, use of Rwd has its challenges, with both trial design and decision-making. In many cases, Rwd studies aim to provide better understanding of the distribution of costs during the different phases of care, according to the main variables from epidemiological and resource utilization perspectives. Stefano Capri will moderate and provide comments based on Italy’s extensive experience with Rwd in HtA; david Chao will present what is currently being implemented in England with the Cancer drugs Fund and the Systemic Anti-Cancer therapy dataset; and ken Redekop will describe the Netherlands’ approach.

n IP21: IS OFF-LABEL DRUG USE ENHANCING OR LIMITING ACCESS FOR PATIENTS WITH RARE DISEASES? Hall E1 (L0)Moderator: Annabel Griffiths, PhD, Senior Analyst, Costello Medical Consulting Ltd, Cambridge, Uk Panelists: Jack Scannell, DPhil, Co-Head European Pharmaceuticals, UBS Investment Bank, London, Uk; Victoria Parker, PhD, MBBS, MRCP, Honorary Consultant Endocrinologist, Cambridge University Hospital trust, Cambridge, Uk; Pilar Pinilla-Dominguez, MSc, technical Adviser, NICE Scientific Advice, National Institute for Health and Care Excellence, London, Uk

ISSUE: Of the 7,000 recognized rare diseases, only ~400 have currently licensed treatments, meaning clinicians often have no choice but to prescribe drugs off-label. Although providing a short-term solution for some individuals, off-label use can theoretically have a negative impact on long-term patient access by potentially reducing the incentive to conduct time-consuming and costly evidence-generation processes in order to inform licensing or reimbursement applications. the potential failings in the current system in terms of off-label drug use in rare diseases and their impact on patient access will be discussed, and strategies suggested to improve the process at the stages of drug development, clinical practice, and reimbursement. Annabel griffiths will moderate and provide an overview of the current system. Jack Scannell will present the financial perspective and the role of off-label treatments in drug development for rare diseases. Victoria Parker will voice the clinical perspective, highlighting challenges associated with developing a more robust evidence base. Pilar Pinilla-dominguez will represent the HtA perspective and discuss the impact of off-label drugs on the methodologies NICE uses for evaluations.

OVERVIEW: Off-label prescriptions are particularly common in rare diseases, with estimates suggesting that 90% of all prescribed treatments for rare diseases lack specific FdA approval. the use of off-label treatments can, however, be detrimental to long-term patient access, limiting the patient population eligible for inclusion in clinical trials and possibly reducing the incentive for formal licensing and reimbursement. this issue panel will explore the impact of off-label prescriptions on patient access in rare diseases, highlighting issues faced by industry, clinicians, and payers, and asking what changes could improve the system for all stakeholders. the audience will vote on their opinion on the title question at the beginning and end of the issue panel; discussion time will be included, and questions from the audience encouraged throughout.

n W31: DETERMINING UTILITY OF MULTI-ATTRIBUTE HEALTH STATES: NEW MEASUREMENT AND ANALYTIC APPROACHES Hall E2 (L0)Discussion Leaders: Nan Luo, PhD, Associate Professor, Saw Swee Hock School of Public Health, National University of Singapore, Singapore; Kim Rand-Hendriksen, PhD, CPsychol, Post-doctoral Fellow, department of Health Management and Health Economics, University of Oslo, Oslo, Norway; Mark Oppe, PhD, Senior Researcher, EuroQol Research Foundation, Rotterdam, the Netherlands; Juan Manuel Ramos Goñi, MSc, Senior Researcher, EuroQol Research Foundation, Rotterdam, the Netherlands

PURPOSE: this workshop focuses on new measurement and statistical methods for determining the utility of multi-attribute health states such as those defined by preference-based instruments. workshop attendees will become aware of the challenges in valuation of such health states as well as data analysis and be informed of new approaches to tackle those challenges.

DESCRIPTION: Attendees will obtain an overview of recent developments in health-state valuation methods. the workshop will review (a) how computer technology can be used to make time trade-off (ttO) procedures easy to administer and understand; (b) how to harness computer technology to monitor and improve data quality, and (c) new models that may improve the estimation for unmeasured health states. dr. Nan Luo will demonstrate a new ttO procedure designed for

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administration with a software program. He will review the development process and discuss with attendees about ways to further improve the procedure. dr Mark Oppe will introduce a quality control process that has been designed for use in large health-state valuation studies. dr. kim Rand-Hendriksen will describe a type of new models for analyzing ttO values of multi-attribute health states defined using similar descriptors. Mr. Juan M. Ramos-goñi will introduce the concept and rationale of censored models, interval regression models, and ‘hybrid’ models which use both ttO and discrete choice experiment data, and demonstrate how to prepare raw valuation data to estimate those models. this workshop will be valuable to researchers who are interested in collecting primary health-state utility data or developing new valuation procedures or preference-based instruments.

n W32: HOW TO INCORPORATE ECONOMIC EVALUATIONS IN CLINICAL PRACTICE GUIDELINES: A PRACTICAL WORKSHOP ON RESEARCH METHODS Hall F1 (L0)Discussion Leaders: Jos Kleijnen, MD, PhD, Professor, kleijnen Systematic Reviews Ltd., York, Uk; Ghislaine APG van Mastrigt, PhD, Senior HtA Researcher, department of Health Services Research, Maastricht University, Maastricht, the Netherlands; Ben Wijnen, MSc, HtA researcher, department of Health Services Research, Maastricht University, Maastricht, the Netherlands; Frederick Thielen, Msc, HtA Researcher, Institute for Medical technology Assessment, Erasmus University, Rotterdam, the Netherlands

PURPOSE: Although it is recommended, economic evaluations (EEs) are not routinely incorporated in clinical practice guidelines. One of the reasons could be lack of knowledge on how to identify EEs and assess their quality by guideline developers. the purpose of this workshop is to provide hands-on training on how to identify relevant EEs and how to evaluate their quality.

DESCRIPTION: this workshop is based on a series of three papers on “How to Prepare a Systematic Review (SR) of EE for Clinical Practice guidelines,” in which a five-step-approach for conducting a SR of EE is proposed. Participants will first be introduced to the five-step-approach and will be given brief information regarding the several steps. Next, all participants will be asked to develop a search strategy in small groups based on a (pre)defined topic to identify studies regarding clinical effectiveness data combined with a validated search filter for EE identification. there will be guideline experts available to assist them. the most important topic/difficulties encountered in doing these searches will be discussed. Afterwards, an outline will be given on how to evaluate methodological quality of identified EEs and participants will be asked to assess the quality of a predetermined EE. this will be done in small groups supervised by experienced researchers. the last part of the workshop will focus on incorporating EE in clinical guidelines and to on problems/difficulties which one may encounter when performing a SR of EE.

ISPOR has a comprehensive list of guidelines for conducting outcomes research or its use in health care decisions, developed by multiple scientific organizations at the ISPOR Outcomes Research Guideline Index on www.ispor.org

You can contribute to the expert consensus nature of ISPOR knowledge products by joining an ISPOR Scientific and Health

Policy Working Group. http://www.ispor.org/sigs/sigsindex.asp and http://www.ispor.org/taskForces/TFindex.asp

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ISPOR INVITATIONAL GROUP MEETINGSPlease note these meetings are by prior invitation only

SUNdAY, 30 OCTOBER

8:30-18:00 ISPOR HTA Roundtable Room: Hall N (L1)

11:30-12:30 ISPOR Publications Management Advisory Board and Journal Editors-In-Chief Joint Business Meeting Room: 1.85-86 (L1)

12:00-13:00 Lunch on your own for short course delegates

12:00-13:00 ISPOR Councils Joint Lunch Room: Hall N Foyer (L1)

13:00-16:00 ISPOR Institutional Council Roundtable Room: 1.85-86 (L1)

16:00-17:00 ISPOR Turkish SCP Chapter Room: Hall M (L1)

17:15-18:15 ISPOR Africa Network Room: Hall M (L1)

18:30-19:30 ISPOR Asia Consortium Leadership Room: Hall M (L1)

MONdAY, 31 OCTOBER

7:30-8:30 ISPOR Asia Consortium Business Meeting Room: Hall M (L1)

7:30-8:30 ISPOR Rare Disease: Challenges in Assessment and Appraisal Room: 1.85-86 (L1) of Diagnostics & Treatments Working Group

7:30-8:30 ISPOR Economic Evaluation of Vaccine Task Force Room: -2.16 (L-2)

7:30-8:30 ISPOR Patient Engagement in Research Working Group Room: -2.31 (L-2)

7:30-8:30 ISPOR Value & Outcomes Spotlight Editorial Advisory Board Room: -2.32-33 (L-2)

7:30-8:30 ISPOR Oncology Health Economic Modeling Post-Progression Working Group Room: Hall N (L1)

10:45-11:45 ISPOR Slovenia Chapter Room: 1.85-86 (L1)

10:45-11:45 ISPOR Slovakia Chapter Room: -2.16 (L-2)

12:00-14:00 ISPOR Value in health Editorial Board and Editorial Advisory Board Room: -2.32-33 (L-2)

12:15-13:15 ISPOR Digest of International Databases Working Group Room: Hall M (L1)

12:15 - 14:15 Lunch for delegates served in the exhibit Poster hall (hall X2-X3, Level -2)

12:30-13:30 ISPOR Value Assessment of Medical Devices Working Group Room: -2.16 (L-2)

12:15-13:45 ISPOR CEE Network Research, Education, and Publication Working Committees Room: Hall G2 (L-2)

12:30-17:00 ISPOR Patient Representative Roundtable Room: Hall N (L1)

14:00-15:30 ISPOR Spain Chapter Room: Hall G1 (L-2)

14:00-16:45 ISPOR Medical Nutrition: Terms, Definitions, Regulations Working Group Room: -2.31 (L-2)

continued on next page >

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ISPOR Invitational Group Meetings continued

MONdAY, 31 OCTOBER Continued

14:00-15:00 ISPOR Arabic Network Room: 1.85-86 (L1)

15:30-16:30 ISPOR Ukraine, Georgia, Russia, and Ukraine Student Chapters Room: Hall M (L1)

15:45-16:45 ISPOR Code of Ethics Task Force Room: -2.16 (L-2)

16:45-17:45 ISPOR Hungary Chapter Room: Hall G1 (L-2)

16:45-17:45 ISPOR Portugal Chapter Room: Hall G2 (L-2)

17:00-18:30 ISPOR Value of Information Analysis for Research Decisions Task Force Room: -2.16 (L-2)

18:15-20:00 ISPOR HTA Council Working Group Room: -2.31 (L-2)

TUESdAY, 1 NOVEMBER

7:30-8:30 ISPOR Precision Medicine: Assessing the Value Working Group Room: -2.16 (L-2)

7:30-8:30 ISPOR Patient Engagement in Research Working Group Room: -2.31 (L-2)

8:30-10:00 ISPOR Real World Evidence Brainstorming Session Room: 1.85-86 (L1)

9:00-10:00 ISPOR Italy-Milan Chapter Room: Hall N (L1)

12:00- 13:45 Lunch for delegates served in the exhibit/Poster hall (hall X2-X3, Level -2)

12:00-13:00 ISPOR Student Network/Faculty Advisor Luncheon Room: 1.85-86 (L1)

12:00-13:30 ISPOR CEE Network Executive Committee Room: Hall N (L1)

12:15-13:30 ISPOR HTA Council: Medical Device Initiative Room: -2.31 (L-2)

12:30-14:15 ISPOR Optimization Methods in Health Services Research Task Force Room: -2.16 (L-2)

13:45-15:15 ISPOR Value in health regional Issues Editorial Board Room: Hall N (L1) & Editorial Advisory Board (CEEWAA)

15:30-17:00 ISPOR Russia HTA, Belarus, Kazakhstan, Armenia, Kyrgyzstan Chapters Room: Hall G1 (L-2)

15:30-17:00 ISPOR Greece Chapter Room: 1.85-86 (L1)

WEdNESdAY, 2 NOVEMBER

7:30-8:30 ISPOR Multiple Medication Adherence Measurement Working Group Room: -2.16 (L-2)

12:45 - 13:45 Lunch for delegates served in the exhibit Poster hall (hall X2-X3, Level -2)

13:00-14:30 ISPOR Russia, Serbia, Slovakia, and Poland Chapters Room: 1.85-86 (L1)

13:00-17:30 ISPOR HTA Council Room: -2.16 (L-2)

Please note: Invitees will receive an email reminder and notification of any changes to this ISPOr Group Meetings schedule

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RESEARCH POSTER PRESENTATIONS OVERVIEW page 78

EXHIBIT PROGRAM OVERVIEW page 79

EXHIBITING ORGANIzATIONS AND LOCATIONS page 80

EXHIBIT AND POSTER FLOOR PLANS page 81

RESEARCH POSTER PRESENTATIONS AND EXHIBIT PROGRAM OVERVIEW

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Over 2,200 poster presentations will be on display during the Congress in the Poster and Exhibit Hall: Hall X3 on Brown Level -2

• The poster hall is now organized in rows (A-L) and each poster board is numbered accordingly (e.g. A1, L15)

• Each poster presentation has been assigned a specific numbered board location, which is shown next to the poster presentation title. Please note this is different than the poster code (e.g. PHP1, PCV57), which was assigned to each poster presentation upon acceptance.

• Poster presentation titles and authors, as well as the numbered board location and abstract page reference in Value in health, are available on the myISPORVienna.zerista.com congress platform and mobile app. This information is also available as a PDF on the ISPOR website and as a handout at the Poster Help Desk (please note quantities are limited).

• An Author index is available in Value in health 19 (7), which is available near ISPOR registration and online at http://www.ispor.org/valueinhealth_index.asp.

• Poster board numbering is available on the floor plan on page 81 and row locations (by topic) are available in the table below.


RESEARCH POSTER PRESENTATIONS OVERVIEW

SESSION I: MONdAY, 31 OCTOBER 8:30-8:45 8:45-14:15 13:15-14:15 14:15

PRM: RESEARCH ON MEtHOdS ROwS A-g

PIH: INdIVIdUAL’S HEALtH ROwS g-H

PIN: INFECtION ROwS H-J

PNd: NEUROLOgICAL dISORdERS ROwS J-L

SESSION II: MONdAY, 31 OCTOBER 15:30-15:45 15:45-19:45 18:45-19:45 19:45

PHP: HEALtH CARE USE & POLICY StUdIES ROwS A-k

PgI: gAStROINtEStINAL dISORdERS ROwS k-L

PUk: URINARY/kIdNEY dISORdERS ROwS L-L

SESSION III: TUESdAY, 1 NOVEMBER 8:30-8:45 8:45-13:45 12:45-13:45 13:45

PMH: MENtAL HEALtH ROwS A-B

PMS: MUSCULAR-SkELEtAL dISORdERS ROwS B-d

PRS: RESPIRAtORY-RELAtEd dISORdERS ROwS d-F

PSS: SENSORY SYStEMS dISORdERS ROwS F-H

PSY: SYStEMIC dISORdERS/CONdItIONS ROwS H-L

SESSION IV: TUESdAY, 1 NOVEMBER 15:00-15:15 5:15-19:15 18:15-19:15 19:15

PHS: HEALtH SERVICES ROwS A-E

PCV: CARdIOVASCULAR dISORdERS ROwS E-I

PdB: dIABEtES/ENdOCRINE dISORdERS ROwS I-L

SESSION V: WEdNESdAY, 2 NOVEMBER 8:30-8:45 8:45-13:45 12:45-13:45 13:45

PMd: MEdICAL dEVICE/dIAgNOStICS ROwS A-d

PCN: CANCER ROwS d-L

POSTER PRESENTATION SESSIONS POSTER PRESENTER POSTER AUTHOR PRESENTER LOCATION SET UP TIME DISPLAY DISCUSSION DISMANTLE HOURS HOUR* TIME**

*Presenters are required to be with their posters during the Poster Author Discussion Hour.**Posters that are not removed at the scheduled dismantle times will be discarded.

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EXHIBITS VIEWING:

Exhibits will be on view in Hall X2 and Hall X3 on Brown Level -2Monday, 31 October: 8:30-19:45 Tuesday, 1 November: 8:30-19:15 Wednesday, 2 November: 8:30-15:00


EXHIBIT PROGRAM OVERVIEW

SCHEdULE:

SUNdAY, 30 OCTOBER

11:00-18:00 Exhibitor Set Up

MONdAY, 31 OCTOBER

8:30-19:45 Exhibits Viewing10:45-11:15 Coffee Break12:15-14:15 Lunch Sponsored by Basecase Management

Gmbh15:15-15:45 Coffee Break 18:00-19:45 Exhibitors’ Open House Reception Sponsored by evidera

TUESdAY, 1 NOVEMBER

8:30-19:15 Exhibits Viewing9:45-10:15 Coffee Break12:00-13:45 Lunch14:45-15:15 Coffee Break17:30-19:15 Exhibitors’ Wine & Cheese Reception Sponsored by Quintiles

WEdNESdAY, 2 NOVEMBER

8:30-15:00 Exhibits Viewing9:45-10:00 Coffee Break12:45-13:45 Lunch14:45-15:00 Coffee Break15:00 Exhibitor Dismantle

ISPOR BOOTH, NETWORKING AREAS, CHARGING STATIONS, AND INTERNET STATIONS:Please stop by the ISPOR Booth located in the Exhibit Hall, as well as enjoy the networking areas, charging stations, and internet stations located throughout the hall.

charging Stations Sponsored by Ingress-health hWM Gmbh, Precision health economics, and Truven health Analytics.

Wi-Fi and Internet Stations Sponsored by Pharmerit International.

Exhibitor and Sponsor VIRTUAL BOOTHS

Attendees are encouraged to visit the Exhibitor and Sponsor

VIRTUAL BOOTHS available on the ISPOR event website and in the

mobile app/web platform. Virtual Booths offer attendees in one

click more detailed information on a company – including contact

information, collateral material, social media links, and web links

to document and videos.

If you were not able to connect with an exhibitor onsite, you will

have the opportunity to follow up with them during and after the

event through their virtual booth and the mobile app.

Below is an example, “the ISPOR Student Network Virtual Booth”.

NEW for 2016

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Access Infinity 517

Adelphi Real World 503

Adelphi Values 504,505

Advanced Clinical Recruitment 206

AMARIS 511

AMICULUM T-15

Amplexor Life Sciences 416

Analysis Group 800,801

APM Health Europe 14

Barrington James Ltd 811,812

BaseCase Management GmbH* 400,401

Basel Institute for Clinical Epidemiology & Biostatistics 17

BCN HEALTH 107

Boston Health Economics 310

BresMed 101,102,103,201,202,203

Bristol-Myers Squibb 6

Cardinal Health 5

CEMKA-EVAL 11

Clinical Practice Research Datalink (CPRD) 13

Consulting at McCann Health 515,516,603,604

Contact Singapore T-5

Context Matters 501,502

Corporate Translations 210

Costello Medical Consulting 718,719

Covance* 305,306

Creativ-Ceutical 16

Crystallise Ltd T-18

Curo 701,702

Decision Resources Group 417,418

Digital Health Outcomes 512

Dymaxium 19

ECCO- European CanCer Organisation T-6

EPID Research 411

ERT, Inc. 402

Evalytica 804

Evidence Partners Inc 618

Evidencia Scientific 312

Evidera* 805,806,807

FACIT.org/FACITtrans 508

Future Science Group T-19

GalbraithWight 616

Gareth Lee (G&J Lee Recruitment) T-22

GfK 204,205

Glasgow City Marketing Bureau T-1

Health iQ Limited 412

HEVA GROUP 619,700

Hochschule Fresenius University of Applied Sciences T-7

HTA Consulting 507

ICON plc 316,317,318

IGES Group 602

Imperial College, Executive Education T-12

IMS Health 612,613,706,707

INC Research 816

Ingress-Health* 413,506

institute for Medical Technology Assessment (iMTA) 802

INTEXO 608

inVentiv Health 414,415

Ipsos Healthcare 209

ISPOR 100

ISPOR Student Network 100

ISPOR Value in health and Value in health regional Issues 100

Journal of Health Economics and Outcomes Research T-20

Kantar Health 3,4

LASER Analytica 1004,1005,1108,1107

MA Provider srl T-16

MAP BioPharma Limited T-14

Mapi* 211,212,303,304

Market Access Solutions 311

Market Access Transformation 808

MarksMan Healthcare Solutions T-13

Medicys Limited 408

Minerva Network 12

Mtech Access 307

Navigant Consulting 513

Numerus 406

Optum 809,810

Oxford PharmaGenesis 309

PAREXEL 518,519,600,601

Patient Access Solutions/ pharmaKARe T-10

pH Associates/Open Access Consulting 208

Pharmatelligence 15

Pharmerit International* 419,500

PHARMO Institute 712

PHMR* 104,105

Pope Woodhead & Associates Ltd 713,714

Precision Health Economics* 900,901,1000,1001

Prioritis Ltd 606,607

PRMA Consulting 7,8

ProClinical 711

Quantify Research 717

Quintiles* 609,610,611,708,709,710

RBW CONSULTING LLP 605

Remap Consulting 410

R-Squared Talent Solutions 715,716

RTI Health Solutions* 214,215,300,301

SEC Recruitment 509

Simon-Kucher & Partners 308

STATinMED Research 313,405

stève consultants 18

TALENTMARK T-17

Taylor & Francis Group T-9

The University of Sheffield 20,21

TransPerfect 614,615

TreeAge Software 106

Truven Health Analytics* 703,704,705

UBC 813,814

University of Glasgow T-21

Valid Insight 207

Wickenstones 213,302

Wing Tech Inc. 617

Wonder Drug Consulting Pty Ltd 815

Wyatt Health Management 407

Xcenda 314,315,403,404

YOLARX Consultants T-8

York Health Economics Consortium 9,10

zRx Outcomes Research Inc. 803


EXHIBITING ORGANIzATIONS AND LOCATIONSCOMPANY NAME EXHIBIT LOCATION # COMPANY NAME EXHIBIT LOCATION # COMPANY NAME EXHIBIT LOCATION #

* Exhibitors who are also sponsors

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INVITED SPEAKER BIOGRAPHICAL INFORMATION pages 86-90

AWARD RECIPIENT BIOGRAPHICAL INFORMATION page 90

INVITED SPEAKER AND AWARD RECIPIENT BIOGRAPHICAL INFORMATION

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ISPOR PRESIDENT BIOGRAPHICAL INFORMATION

Louis P. Garrison, Jr., PhD

Louis P. Garrison, Jr., PhD is a Professor in the Pharmaceutical Outcomes Research & Policy Program in the School of Pharmacy and Adjunct Professor in the Departments of Global Health and Health Services at the University of Washington, where he joined the faculty in 2004. He also co-directs the Global Medicines Program in Global Health.

For the first 13 years of his career, Dr. Garrison worked in non-profit health policy research, first at the Battelle Human Affairs Research Centers (Seattle), and then at the Project HOPE Center for Health Affairs (Virginia) where he was the Director from 1989-1992. Following this, he worked as an economist in the pharmaceutical industry for 12 years. From 2002-2004, he was Vice President and Head of Health Economics & Strategic Pricing in Roche Pharmaceuticals, based in Basel, Switzerland.

Dr. Garrison received a BA in Economics from Indiana University and a PhD in Economics from Stanford University. He has authored more than 100 publications in peer-reviewed journals.

From 2007-2009, Dr. Garrison served on the ISPOR Board of Directors. He co-chaired two ISPOR Good Practice Task Forces (Real-World Data, and Performance-Based Risk-Sharing Arrangements), chaired the ISPOR Health Science Policy Council from 2012 to 2015, and is Faculty Advisor for the UW ISPOR Student Chapter.

CONGRESS PROGRAM COMMITTEE CO-CHAIRS BIOGRAPHICAL INFORMATION

Hans-Georg Eichler, MD, MSc

Hans-Georg Eichler, MD, MSc, is the Senior Medical Officer at the European Medicines Agency in London, UK, where he is responsible for coordinating activities between the Agency’s scientific committees and giving advice on scientific and public health issues.

Prior to joining the European Medicines Agency, Dr. Eichler was at the Medical University of Vienna in Austria for 15 years. He was vice-rector for Research and International Relations since 2003, and professor and chair of the Department of Clinical Pharmacology since 1992. His other previous positions include president of the Vienna School of Clinical Research and co-chair of the Committee on Reimbursement of Drugs of the Austrian Social Security Association. His industry experience includes time spent at Ciba-Geigy Research Labs, UK, and Outcomes Research at Merck & Co., in New Jersey. In 2011, Dr. Eichler was the Robert E. Wilhelm fellow at the Massachusetts Institute of Technology’s Center for International Studies, participating in a joint research project under the MIT’s NEWDIGS initiative.

Dr. Eichler received his MD from Vienna University Medical School and his MS degree in toxicology from the University of Surrey in Guildford, UK. He trained in internal medicine and clinical pharmacology at the Vienna University Hospital, as well as at Stanford University.

Tomasz Hermanowski, PhD

Tomasz Hermanowski, PhD, earned a degree in economics from the Main School of Commerce in Warsaw, Poland. He obtained his PhD in 1974 and his Habilitation in Economics in 1988. He completed university training in socio-economic evaluation of medicines at the University of York, UK. He is currently the Head of the Pharmacoeconomics Department at the Medical University of Warsaw. Dr. Hermanowski is a prolific author of books, articles and reports regarding

international transfer of technology, pharmacoeconomics, drug policy and management. His research interests include application of marketing concepts to pharmaceutical policy formulation and strategic management in international business, drug utilization studies, pharmacoeconomics, HTA, health services research and integrated care. Dr. Hermanowski is a founding member and past president, of the Polish Society for Pharmacoeconomics. He is also a member of ISQuA, Academy Health, IHEA and ISPOR.

INVITED SPEAKER AND AWARD RECIPIENT BIOGRAPHICAL INFORMATION

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Invited Speaker and Award Recipient Biographical Information


INVITED SPEAKERS BIOGRAPHICAL INFORMATION

Nancy S. Berg

Nancy S. Berg is Chief Executive Officer (CEO) and Executive Director of the International Society for Pharmacoeconomics and Outcomes Research (ISPOR), the leading global scientific and educational organization for health economics and outcomes research. Ms. Berg has over 30 years of experience in scientific/technical association leadership, and has been an entrepreneur and business consultant to both commercial and nonprofit organizations. At ISPOR, Ms. Berg is

responsible for the global strategic direction and leadership of the Society. She has led the organization, in concert with the Board of Directors, to design and implement a new strategic plan, mission, and vision to guide the Society into the future.

Previously, Ms. Berg led the International Society for Pharmaceutical Engineering (ISPE) as President and CEO. During her tenure with ISPE, Ms. Berg was the architect of the Society’s Strategic Plan, focusing ISPE’s energies and expertise on high-value initiatives related to drug shortages, quality metrics, global manufacturing quality, facility and supply chain issues, and patient experiences in clinical trials. Prior to her role at ISPE, Ms. Berg served as Executive Director and CEO of the Society of Manufacturing Engineers (SME). She also previously founded a strategic and business development consultancy company.

Throughout her career, Ms. Berg has been recognized as a groundbreaking leader with a dynamic, hands-on style. During her tenure with SME, she was the youngest person ever to head a global technical/engineering organization. She has received a number of leadership awards including being named among the “PM360 ELITE” most influential leaders in the health care industry, PharmaVOICE 100 list of most inspirational leaders in the health care industry, one of Detroit’s “Top 100 Most Influential Women” by Crain’s Detroit Business, and one of “Michigan’s Top 50 Women” by Corp! Magazine. She also received the “Women of Achievement Award, Business and Industry” by the YWCA of Western Wayne County, Michigan.

Ms. Berg has been engaged in education and business issues in the U.S. and international levels. She has served on many government initiatives involving business, community, development, growth, revitalization, and labor issues. She is a supporter of the Leukemia and Lymphoma Society’s Team in Training Program cycling events and a patron of many other charities. Ms. Berg is a graduate of the University of Michigan-Flint.

Jo DeCock

Jo De Cock is CEO of the National Institute of Health and Disability Insurance (NIHDI) since 1995. He has obtained a master of law and a master of criminology from the Catholic University of Louvain, where he started his professional experience as a research assistant on the Institute of Social Security on the Faculty of Law (1977-1983). He continued his career by joining the Center for political, economical and social studies where he was researcher and political advisor.

From the mid eighties until the beginning of the nineties he worked as a deputy director and counselor of social affairs in the office of the Belgian Prime Minister (1985-1993). Later on he filled the position of adjunct general administrator of the National Social Security Office (1993-1995).

Wim Goettsch, PhD

Wim Goettsch, PhD, is the Director of the EUnetHTA JA3 Directorate. Between 2010 and 2015, he was the Project Leader of WP5 of the EUnetHTA JA1 and JA2 on Relative Effectiveness Assessments. Until the beginning of 2013, he was also the Deputy Secretary of the Medicinal Products Reimbursement Committee at Dutch National Health Care Institute. He has a PhD in immunology and an advanced education in (pharmaco)-epidemiology and pharmaco-economics. He has authored more than 60 publications in peer-reviewed international journals.

Jens Grueger, PhD

Jens Grueger, PhD, is Vice President & Head of Global Pricing and Market Access at F. Hoffmann-La Roche based in Basel, Switzerland. He and his team are in charge of demonstrating and capturing the value of Roche’s innovative product portfolio so that patients have fast and broad access to the medicines. Prior to this Dr. Grueger was Vice President and Head of Global Market Access Primary Care at Pfizer in New York and London (2009-2011), Head of Global Pricing &

Health Economics at Novartis Pharma in Basel, Switzerland (1999-2009), and Director of Health Economics at the German affiliate of SmithKline Beecham Pharma in Munich, Germany (1994-1997). He founded Diversified Health Systems, a start-up company providing internet-based disease management services to physician networks in Europe (1997-1999). He started his professional career in 1986 as a Senior Consultant with Dornier Systems GmbH, Friedrichshafen, Germany, where he directed health care services research and consulting projects for national and regional government agencies in Germany, Austria, and Switzerland. Dr. Grueger holds a Diplom in medical statistics and theoretical medicine, and a PhD in mathematical statistics from University of Dortmund, Germany. He lectured on epidemiology, stochastic processes, and mathematical statistics, and has more than 40 publications in biometrics, cancer epidemiology, and health economics. From 2004-2006, Dr. Grueger served as a Director on ISPOR’s Board of Directors.

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Joanna Lis, MSc, MBA, PhD

Joanna Lis, MSc, MBA, PhD, is an assistant professor in the Department of Pharmacoeconomics at the Medical University of Warsaw and a Director of Market Access in Sanofi Poland. Prior to joining the Medical University of Warsaw and Sanofi, Dr. Lis held various leadership positions in the health economics area at Johnson & Johnson and Eli Lilly.

Dr. Lis is a deputy Editor-in-Chief of the Journal of health Policy and Outcomes research and a member of the experts’ team of the Polish HTA Agency working on HTA guidelines updates (2016) for Poland. She is the President of the ISPOR Poland Chapter, as well as a member of the ISPOR Central and Eastern Europe (CEE) Network.

Dr. Lis holds a PhD in biostatistics and computer modelling in medicine, an MSc in mathematics and physics from the Jagiellonian University in Cracow, and an executive MBA from Kozminski University of Business and Management in Warsaw. She has published more than 70 articles and is a co-author of various books and reports.

As an active member of ISPOR, she has been heavily involved in the ISPOR Patient Registry Special Interest Group and the ISPOR Task Force for Transferability of Economic Evaluations across Jurisdictions. Dr. Lis has served as the Co-Chair of the Issue Panel Review Committee at ISPOR 13th Annual European Congress in Prague. Dr. Lis also co-organized the 5th Polish-Russian and Polish-Kazakh-Russian Forums on Pharmacoeconomics.

Elias Mossialos

Elias Mossialos is Brian Abel-Smith Professor of Health Policy within the Department of Social Policy at the London School of Economics and Political Science (LSE), and Director of LSE Health. He is also Professor of Health Policy and Management and Co-Director of the Centre for Health Policy at Imperial College London. His research interests concentrate on health systems and policy, addressing questions related to funding health care, private health insurance,

pharmaceutical policies, the impact of EU law on health care systems, cancer care and policy and antibiotics. His work has been translated into Japanese, Russian, Greek and Spanish. He has more than 200 publications, including books, book chapters and articles in peer-review journals in the fields of public policy, health policy and economics and political science.

He is a Fellow of the Faculty of Public Health (FFPH) and Fellow of the Royal Colleges of Physicians of London and Edinburgh, and Honorary NHS Consultant in Public Health (South East London NHS Strategic Health Authority). He is a Visiting Professor at the Harris School of Public Policy, University of Chicago, Affiliate Professor at Imperial College Business School and Honorary Professor at the University of Copenhagen, the London School of Hygiene & Tropical Medicine (LSHTM), and L›Ecole des Hautes Etudes en Santé Publique in France. Professor Mossialos is a member of ASPHER›s Honours Committee, the World Health Organization’s (WHO) European Advisory Committee on Health Research and the Health, Demographic Change and Well-being Advisory Group for the Horizon 2020 Research Programme of the European Commission.

Axel Muehlbacher, PhD

Axel Mühlbacher, PhD, is a professor of health economics and health care management at the Hochschule Neubrandenburg. Since 2012, he has been a Senior Research Fellow at the Center for Health Policy & Inequalities Research at Duke Global Health Institute at Duke University, Durham, North Carolina, USA. Dr. Mühlbacher was a 2010-2011 Harkness Fellow in Health Care Policy and Practice placed at Duke Clinical Research Institute and Fuqua

School of Business, Duke University. Prior to founding the Institute of Health Economics and Health Care Management in 2006, Dr. Mühlbacher had been an assistant professor at the department of economics and management at Technical University Berlin (2001-2004) and associate professor of economics, health economics and econometrics at Hochschule Neubrandenburg (2004-2006). His research focuses on health care decision making, benefit/utility assessment, patient preferences, HTA/economic evaluation methods, and organized healthcare programs.

Guido Rasi

Guido Rasi began his second term as Executive Director of European Medicines Agency (EMA) in November 2015. From 2014 to 2015, Professor Rasi served as EMA’s Principal Adviser in Charge of Strategy. From 2011 to 2014 he was the Executive Director of the EMA and was a member of its Management Board in the three years prior to this.

He was Director-General of the Italian Medicines Agency from 2008 to 2011 and member of the Management Board from 2004 and 2008. He was made full professor of microbiology at the University of Rome ‘Tor Vergata’ in 2008. From 2005 to 2008 he was Director of the Institute of Molecular Medicine of the National Research Council in Rome. From 1990 to 2005 he worked at the Institute for Experimental Medicine of the National Research Council, Italy. He did teaching and research at the University of California, Berkeley in 1999.

Professor Rasi holds a degree in medicine and surgery, with specialisations in internal medicine, allergology and clinical immunology, from the University of Rome. From 1978 to 1990, he worked as a physician in hospital, research and private practice. He is author of more than 100 scientific publications.

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Andrzej Rys

Andrzej Rys, is the Director of Health Systems, Medical Products and Innovation for the European Commission in Brussels, Belgium. He is a medical doctor who graduated from Jagiellonian University, Krakow, Poland where he specialized in radiology and public health. In 1991, he established the School of Public Health at the Jagiellonian University and served as the director until 1997. From 1997-1999, he took up the post of director of Krakow’s city health department. In

1995–1999, he was the Polish director of the “Harvard-Jagiellonian Consortium for Health,” – a project focusing on local governments’ role in health care. In 1999–2002, he became the deputy Minister of Health in Poland and developed a new system of emergency medicine and new education system for nurses. He was a member of the Polish accession negotiators team. In 2003, he established the Center for Innovation and Technology Transfer at Jagiellonian University, Krakow, Poland. He was also director for development of Diagnostic Ltd., executive director of the Polish Association of Private Health Care Employers and chief editor of the journal health and Management. He joined the European Commission in June 2006.

Brian K. Solow, MD

Dr. Brian K. Solow, MD, serves as Chief Medical Officer at Optum. Dr. Solow oversees clinical activities related to development, enhancement, and implementation of clinical programs that support formulary management at Prescription Solutions. Through the development of disease therapy-management and medication therapy management programs. Dr. Solow builds on its tradition of clinical excellence that emphasizes sound scientific evidence and reflects

balanced consideration for the clinical interests of patients, prescribing health care professionals, and employer groups offering health coverage. Dr. Solow serves as a Director of non-profit National Council for Patient Information and Education. Dr. Solow is board certified in the area of family practice, and completed his residency through the University of California, Los Angeles. His interests include research in the topics of appropriate medication usage and patient prescription education. He holds faculty appointments at the University of California, San Francisco School of Pharmacy and the University of Southern California. Dr. Solow is also a Clinical Professor for the School of Medicine at the University of California, Irvine.

Adrian Towse, MA, MPhil

Adrian Towse, MA, MPhil, is the Director of the Office of Health Economics (OHE), a UK-based research and consulting organization. OHE works in the related fields of health technology assessment (HTA), health system efficiency, and the economics of the biopharmaceutical and related health sciences industries. He is a visiting Professor at the London School of Economics and a Senior Researcher at the Nuffield Department of Population Health at the University of Oxford.

Mr. Towse has also been a visiting Professor at the University of York, and for 10 years he served as a Non-Executive Director of the Oxford University Hospitals NHS Trust, one of the UK’s largest teaching and research hospitals. He chaired the Governance Committee overseeing arrangements for delivering clinical quality.

Mr. Towse has published on risk-sharing arrangements between payers and manufacturers; value-based pricing; HTA development in emerging markets; the economics of stratified (personalized) medicine for payers and the industry; differential pricing, the use of ICERs to arrive at optimal pricing across countries; economic issues that affect both R&D for and access to treatments for diseases prevalent in the developing world; and the economics of medical negligence.

Mr. Towse was educated at Keble College, University of Oxford, Nuffield College, and the Oxford Centre for Management Studies (now the Said Business School), University of Oxford. He is also a Member of the Chartered Institute of Management Accountants. Mr. Towse served as President of ISPOR in 2014-2015. He previously served on the ISPOR Board of Directors (1999-2001) and subsequently on the journal’s Management Advisory Board. He has played an active role in the scientific life of ISPOR, presenting at ISPOR plenary sessions in the US and Europe as well as many issue panels and Workshops. He was a member of the Task Force on Prospective Observational Studies and the Co-Chair of the Task Force on Performance-Based Risk Sharing Agreements.

Sabine Vogler, PhD

Sabine Vogler, PhD, is Head of the World Health Organization (WHO) Collaborating Centre for Pharmaceutical Pricing and Reimbursement Policies affiliated to the Health Economics Department at the Austrian Public Health Institute. She is coordinator of the Pharmacoeconomics and Pharmaceutical Policy Analysis Program in the Health Economics Department. As a senior researcher in this field, Dr. Vogler has expertise and in-depth knowledge about European countries with

regard to pharmaceutical pricing/prices, reimbursement and distribution, as well as cost-containment reforms, access and affordability issues. She served as principal investigator of large projects, including the European Commission projects PPRI (Pharmaceutical Pricing and Reimbursement Information) project, the PHIS (Pharmaceutical Health Information System) project, and ‘Study on enhanced cross-country coordination in the area of pharmaceutical product pricing. She is involved in managing the PPRI network that is a network of competent authorities in the field of pharmaceutical pricing and reimbursement that celebrated its 10th anniversary last year. She published several scientific articles, studies and reports. She is a member of the Austrian Pharmacological Society, the WHO/HAI Global Pharmaceutical Pricing Group, the Piperksa group for promoting a rational use of medicines and is on board of scientific journals. Before joining the Austrian Public Health Institute in 1995, Dr. Vogler worked at the Department of Social Policies at the Vienna University of Business Administration and Economics where she obtained her PhD.

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Richard J. Willke, PhD

Richard J. Willke, PhD is Chief Science Officer of the International Society for Pharmacoeconomics and Outcomes Research (ISPOR). Dr. Willke has more than 25 years of experience in the life sciences arena and has specialized in outcomes research in a succession of group leadership roles with Pfizer and its legacy companies.

At ISPOR, Dr. Willke is responsible for designing and implementing strategic initiatives related to scientific research and content priorities that will advance the Society’s mission of promoting health economics and outcomes research excellence to improve decision making for health globally.

Previously, Dr. Willke was Vice President, Outcomes & Evidence Cluster Lead at Pfizer for its Global Health & Value division. He has also served in a number of leadership roles with affiliated organizations, including the Chair of ISPOR Institutional Council (2010), ISPOR Board of Directors (2007-2009), and Chair of the PhRMA Health Outcomes Committee (2002-2004).

Prior to joining industry, Dr. Willke served as Department Director in the Center of Health Policy Research at the American Medical Association and held research and teaching positions at The Ohio State University.

Dr. Willke earned a PhD and MA in economics from Johns Hopkins University. He has authored more than 80 scholarly publications that examine the science and methodologies of health economics and outcomes research.

Anna Zawada, MSc

Anna zawada, MSc, is the Director of the Office of Transparency and Tariff Councils, Agency for Health Technology Assessment and Tariff System (AOTMiT) in Warsaw, Poland.

She graduated from Warsaw University. While cooperating with Agency’s Councils, she leads the Division of Analytical Support and International Cooperation in AOTMiT. She is the AOTMiT representative at the ISPOR Europe HTA

Roundtable. As the representative of AOTMiT, she took part in EUnetHTA Joint Action 2 and Advance-HTA EC co-funded projects. She is skilled in HTA analysis performance and assessment, and experienced in health policy interpretation and implementation, as well as in consultancy on operational law description. She is an HTA educator (Warsaw University of Technology Business School); HTA researcher (Warsaw Medical University, field of interest: assessment of inequities in health care); a member of ISPOR Polish Chapter and co-editor of the Polish editions of ISPOR publications: ISPOR Book of Terms, and Therapeutic & Diagnostic Device Outcomes Research.

MARILYN DIX SMITH LEADERSHIP AWARD RECIPIENT BIOGRAPHICAL INFO2016 ISPOR MARILYN DIX SMITH LEADERSHIP AWARD The Marilyn Dix Smith Leadership Award was established in 2014 in honor of ISPOr’s Founding executive Director, Marilyn Dix Smith, rPh, PhD. The Award recognizes one individual each year that has provided extraordinary leadership to the Society.

J. Jaime Caro, MDCM, FRCPC

J. Jaime Caro, MDCM, FRCPC, is Chief Scientist at Evidera, Lexington, MA, USA and Adjunct Professor of Medicine, Adjunct Professor of Epidemiology and Biostatistics at McGill University, Montreal, QC, Canada

As Chief Scientist at Evidera, Dr. Caro is responsible for advancing Evidera’s leadership in developing and applying novel techniques in modeling, health economics, comparative effectiveness, epidemiology, and outcomes research. Dr.

Caro trained at McGill University, where he practiced internal medicine and continues as an Adjunct Professor in the Departments of Medicine and Epidemiology and Biostatistics. He established the graduate-level course in pharmacoeconomics, which he continues to direct and also lends his teaching ability to other academic institutions such as Thomas Jefferson University School of Population Health and the Massachusetts College of Pharmacy and Health Sciences.

Dr. Caro continues to pioneer new methodologies. Recently, he developed a new modeling technique, DICE simulation, tailored to problems in health technology assessment (HTA). Previously, Dr. Caro adapted an engineering technique (discrete event simulation) to model diseases and their treatment. This innovation has been extended further to simulate the design of clinical trials and other types of studies. This has been particularly effective in helping to design pragmatic clinical trials. He has also applied the technique to provide comparative effectiveness information in the absence of head-to-head trials in a new method called simulated treatment comparison. On behalf of the German government, he proposed an innovative approach to the assessment of health technologies. This method, involving the efficiency frontier, provides an alternative to the well-known cost per QALY technique and avoids many of the problems with the QALY calculation.

Given this trailblazing experience in modeling methods, Dr. Caro was asked to lead the Modeling Task Force, jointly sponsored by ISPOR and the Society for Medical Decision Making, to produce the new guidelines for good modeling practices. This has resulted in seven papers covering topics from the design, building, populating, and ultimately to the validation of models. In addition, he is the Chair of the ISPOR/AMCP/NPC Task Force that produced a tool for the quality assessment of models. Dr. Caro has been helping the World Bank Institute and the InterAmerican Court for Human Rights address the growing problem of Supreme Courts overriding health care system decisions and ordering health care providers to provide treatments that had been considered unwarranted. He has also been assisting governments in Latin America and elsewhere with implementation of HTA processes, bringing to bear newer techniques such as MCDA (multiple criteria decision analysis).

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CONGRESS REVIEW COMMITTEE

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CONGRESS REVIEW COMMITTEE MEMBERSPlease see page 5 for Congress Program Committee Chairs.The following ISPOR members were volunteer reviewers for this Congress.ISPOR would like to thank them for their contribution to the Congress.

Isaac Abah, BPharm, MSc, Assistant Director of Pharmacy, Jos University Teaching Hospital, Jos, Plateau, Nigeria

Seye Abogunrin, MB, MPH, MSc, Research Associate, Evidera Inc., London, UK

Abdalla Abotaleb, PhD, Technical Advisor, World Health Organization, Cairo, Egypt

Angela Acosta, MSc, Researcher, Universidad de Buenos Aires, Buenos Aires, Capital Federal, Argentina

Jorge Acosta-Reyes, MD, Professor, Director of Health Departament, Universidad del Norte, Barranquilla, Latin America and Caribbean, Colombia

Kenji Adachi, PhD, Heor, Japan

Alyce Adams, PhD, Research Scientist & Chief, Health Care Delivery and Policy, Kaiser Permanente Division of Research, Oakland, CA, USA

Oluwakayode Adejoro, MD, MPH, Senior Health Economics Researcher, Optum, Eden Prairie, Minnesota, USA

Michael Adena, PhD, Director, Datalytics Pty Ltd, Canberra, ACT, Australia

Ayoade Adeyemi, PhD

Eric Adjei Boakye, MA, Saint Louis University Center for Outcomes Research (SLUCOR), Saint Louis, Missouri, USA

Georges Adunlin, PhD, Postdoctoral Fellow, Virginia Commonwealth University, Richmond, Virginia, USA

Yasin Afify, RPH, MBA, MPP, Head of Technical Office, Ministry of Health, Cairo, Egypt

Bhagwan Aggarwal, PhD, MBA, Tedmed Scholar, TEDMED, Philadelphia, PA, USA

Akhil Agrawal, MD, Senior Resident, SKNMC, Pune, Mumbai, Maharashtra, India

Raquel Aguiar Ibanez, MSc, Senior HTA& OR Manager in Oncology, MSD, Hoddesdon, Hertfordshire, UK

Peter Agyei-Baffour, PhD, Senior Lecturer, Kwame Nkrumah University of Science & Technology (KNUST ), Kumasi, Ghana

Samir Ahid, Professor of Pharmacology, Medical and Pharmacy School, Mohammed V University, Rabat , Morocco

Rajiv Ahlawat, RPh, MPharm, PhD, Srf, National Institute of Pharmaceutical Education and Research (NIPER), S.A.S. Nagar (Mohali), Punjab, India

Mahmood Ahmad, PhD, Dean, Faculty Of Pharmacy & Alternative Medicine, The Islamia University of Bahawalpur, Bahawalpur, Punjab, Pakistan

Syed Muzzammil Ahmad, BPharm, MBA, Assistant Professor, Islam College of Pharmacy, Sialkot, Punjab, Pakistan

Amit Ahuja, MPharm, Consultant, PAREXEL, Chandigarh, India

Andrea Aiello, Economics, MSc, Manager, Price and Market Access, Creativ-Ceutical, Milan, Italy

Eleonora Aiello, PharmD, Independent Consultant, Freelance, Buenos Aires, Buenos Aires (Ciudad), Argentina

Mayank Ajmera, PhD, Health Outcomes Scientist, RTI Health Solutions, Research Triangle Park, North Carolina, USA

Muhammad Akhtar, PhD, Assistant Professor, The Islamia University of Bahawalpur, Bahawalpur, Punjab, Pakistan

Eileen Alexander, PhD, BSN, RN, Assistant Professor, Health Services Administration, Director HECOR, Xavier University Health Services Administration HECOR, Cincinnati, Ohio, USA

Ali Alhammad, PhD, Pharmacoeconomics and Health Outcomes Senior Consultant, Drug Policy & Economics Center, Riyadh, Saudi Arabia

Rasha Ali, BPharm, Pharmacist, Specorph Pharmaceuticals FZ, LLC, Dubai, United Arab Emirates

Alima Almadiyeva, MPH, Astana Medical University, Astana, Akmola Region, Kazakhstan

Sami Almedlej, PharmD, Post Pharmacy Director & Post Material Management Director, Security Foeces Hospital, Riyadh, Saudi Arabia

Yousef Alomi, BPharm, Msc Clin Pharm, BCPS, BCNSP, DiBA, DE, Head, National Clinical Pharmacy and Pharmacy Practice Program, Ministry of Health, Riyadh, Saudi Arabia

Kimberly Alsbrooks, RT (R), RN, BSN, VA-BC, Director of Health Economics and Market Access, CR BARD, Murray Hill, NJ, USA

Abdulkareem Al-Shami, MSc, Lecturer, Kulliyyah of Pharmacy, International Islamic University Malaysia, Kuantan, Pahang, Malaysia

Saleh Alyahya, MSc, MCPHS, Boston, MA, USA

Ibrahim Al-Zakwani, PhD, Associate Professor, Sultan Qaboos University, Muscat, Oman

Jaejin An, BPharm, PhD, Assistant Professor, Western University of Health Sciences, College of Pharmacy, Pomona, California, USA

Islam Anan, BScPh, Managing Director, Accsight, Cairo, Egypt

Anastassia Anastassopoulou, MSc, MBA, Manager Health Outcomes & New Products, GlaxoSmithKline GmbH & Co. KG, Munich, Germany

Milena Anatchkova, PhD, Research Scientist, Evidera, Lexington, MA, USA

Raquel Andrade, BSc, Analist, AxiaBio Consulting, São Paulo, Brazil

Ronald Anguzu, MBChB, MPH, Research Fellow, Makerere University School of Public Health, Kampala, Uganda

Cristina Antón Rodríguez, Researcher, Universidad Francisco de Vitoria, Pozuelo, Madrid, España

Rodrigo Antonini Ribeiro, MD, MSc, PhD, Professor, PPG Epidemiologia UFRGS and APCN Saúde Pública IMED, Porto Alegre, Brazil

Rasha Arabyat, PhD, Assistant Professor, Al-Yarmouk-University, Irbid, Jordan

Juan Asbun, MD, PhD, Professor, Escuela Superior de Medicina, IPN, Miguel Hidalgo, Ciudad de Mexico, Mexico

Daniel Asfaw, BPharm, Lecturer, University of Gondar, Gondar, Amhara, Ethiopia

Ammar Awadh, PhD, Assistant Professor, International Islamic University Malaysia (IIUM), Kuantan, Pahang, Malaysia

Lade Ayodele, MBBS, MPH, Manager, Epidemiology, Decision Resources Group, Burlington, Massachusetts, USA

Robert Babela, Head of Institute, St. Elizabeth University, Bratislava, BA, Slovakia

Benson Babu, PharmD, Intern, Manipal College of Pharmaceutical Sciences, Manipal, Karnataka, India

Trevor Bacon, MSc, Market Access Manager, Janssen, Dublin, Ireland

Seungjin Bae, ScD, Associate Professor, Ewha Womans University, College of Pharmacy, Seoul, Korea

Dragana Baltezarevic, MD, Market Access, Pharmacoeconomics Section, Belgrade, Serbia

Norbert Banik, Managing Director, Winicker Norimed Medical Research GmbH, Munich, Bavaria, Germany

Alexandre Baptista, MSc, Researcher, Faculty of Medicine of Lisbon, Lisbon, Portugal

Aleksandra Baran, MPharm, Poland

Kiran V. Barar, PhD, Senior Professor, Pharmacology, Sardar Patel Medical College, Bikaner, Rajasthan, India

Kristina, Bardenheuer, MSc, Senior Manager He&Or, Janssen-Cilag GmbH, Neuss, Germany

Preeti Barnwal, PhD, Junior Research Fellow, Department of Medical Elementology and Toxicology, Faculty of Science, Jamia Hamdard (Hamdard University), New Delhi, India

Varvara Baroutsou, MD, PhD, Chief Scientific Officer, Novartis Greece, Athens, Attiki, Greece

Rituparna Basu, PhD, Senior Research Associate, Medtronic, Natick, Massachusetts, USA

Francisco Batel Marques, PhD, Director, HTA, AIBILI, University of Coimbra, Coimbra, Portugal

Ariane Batscheider, Senior Consultant, IMS Health, Munich, Bavaria, Germany

RESEARCH REVIEW COMMITTEE MEMBERS

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Research Review Committee Members continued


Ekkehard Beck, PhD, Senior Analyst, Creativ-Ceutical, London, UK

Omid Beiki, MD, PhD, Researcher, Karolinska Institutet, Stockholm, Sweden

Mark Belger, BSc, Principal Research Scientist (Statistics), Eli Lilly, Windlesham, Surrey, UK

Tatyana Benisheva, President of Association, Bulgarian association for Drug Information, Sofia, Bulgaria

Andrea Berardi, MSc, Health Economics Manager, BMJ Technology Assessment Group, London, UK

Aurore Bergamasco, PharmD, Director, YolaRx Consultants, Paris, France

Klas Bergenheim, PhD, Global Group Director Health Economics Cv, AstraZeneca, Gothenburg, Sweden

Karin Berger, Senior Researcher, University Hospital of Munich, Med III, Muenchen, Germany

Karsten Berndt, MSc, Senior Project Manager HTA, Roche Diabetes Care, Mannheim, BW, Germany

Patrizia Berto, PharmD, MBA, Senior Consultant, LASER Analytica, Milano, Italy

Akshaya Bhagavathula, PharmD, Assistant Professor, University of Gondar, Gondar, Amhara, Ethiopia

Abhijeet Bhanegaonkar, PhD, MPH, Senior Manager, Vertex Pharmaceuticals, Boston, Massachusetts, USA

Rupinder Bharmi, MS, BME, Principal Scientist, St. Jude Medical, Sylmar, CA, USA

Bhavana Bhat, MPharm, MBA, Research Scholar, Manipal College of Pharmaceutical Sciences, Manipal, Karnataka, India

Manoj Bhatt, MA, General Secretary, Health Concern, Kathmandu Lalitpur, Nepal

Sandipan Bhattacharjee, BPharm, PhD, Assistant Professor, The University of Arizona, Tucson, Arizona, USA

Rituparna Bhattacharya, PhD, Analytics Consultant, Humana Inc, Dallas, TX, USA

Gouri Shankar Bhattacharyya, MD, MRCP, PhD, Hod, Medical Oncology, Fortis Hospital, Anadapur, Kolkata, West Bengal, India

Debajyoti Bhowmik, PhD, Global Health Economics Manager, Amgen Inc., Thousand Oaks, California, USA

Martin Bierbaum, PhD, Visiting Professor, HS Aalen, Germany

Eshetie Melese, Birru, MSc, Lecturer, University of Gondar, Gondar, Ethiopia

Chris Blanchette, PhD, Associate Professor, University of North Carolina at Charlotte, Charlotte, NC, USA

Hedwig Blommestein, PhD, Researcher, Erasmus University, institute for Medical Technology Assessment, Rotterdam, Zuid-Holland, The Netherlands

Vallish Bn, MD, Assistant Professor, Pharmacology, Velammal Medical College Hospital & Research Institute, Madurai, Tamil Nadu, India

Megan Bohensky, PhD, Senior Research Fellow, University of Melbourne, Parkville, Victoria, Australia

Elaine Boing, BPharm, Research Assistant, Rollins School of Public Health, Emory University, Atlanta, GA, USA

Susan Bolge, PhD, Director, Health Economics & Outcomes Research, Janssen Scientific Affairs, LLC, Raritan, NJ, USA

Machaon Bonafede, PhD, MPH, Senior Director Of Outcomes Research, Truven Health Analytics, Brentwood, New Hampshire, USA

Imre Boncz, MD, PhD, Professor, Director, Vice Dean, University of Pécs, Faculty of Health Sciences, Institute for Health Insurance, Pécs, Hungary

Nicola Bonner, MSc, Associate Director, Adelphi Values, Bollington, Macclesfield, Cheshire, UK

Isabelle Borget, PharmD, PhD, Health Economists, Gustave Roussy And University Paris-Sud, Villejuif, France

Luke Boulanger, MA, ABD, Head Health Economics and Outcomes Research, CovergeHEALTH by Deloitte, Newton, MA, USA

Steve Bradshaw, BSc (Hons), MBBChir, MRCOphth, CEO, Valid Insight, London, UK

Pascale Brasseur, MSc, HEOR Director, Medtronic plc, Tolochenaz, Vaud, Switzerland

Valentin Brodszky, Phd Habil, Associate Professor, Corvinus University of Budapest, Budapest, Pest, Hungary

Anthony Budden, BBHSc, Health Economist, CADTH, Ottawa, Ontario, Canada

Jefferson Buendia, PhD, Professor, University of Antioquia, Medellin, Antioquia, Colombia

Claire Burbridge, MSc, Senior Director, Clinical Outcomes Solutions, Folkestone, Kent, UK

Giorgio Buseghin, MSc, Market Access Manager, LivaNova, Milan, Italy

Maria Cabezas, MD, PhD, Professor, Pontifical Catholic University, Quito, Pichincha, Ecuador

Mary Lynn Cala, MS, Project Manager, Endpoint Outcomes, Boston, MA, USA

Horacio Capote, MD, FAPA, FASAM, Director, Division of Neuropsychiatry, Dent Neurologic Institute, Amherst, NY, USA

Paulo Carita, MSc, Head of Methods & Analytics, Global HEOR, Sanofi, Paris, France

Erico Carmo, PhD, Health Economics and Outcomes Research Manager, UCB BioPharma SA, São Paulo, Brazil

Francisco Javier Carrera Hueso, PharmD, Head, Hospital Dr Moliner, Serra, Valencia, Spain

Charles Carter, PharmD, MBA, Associate Professor, College of Pharmacy & Health Sciences, Campbell University, Buies Creek, North Carolina, USA

Michael Carter, MBA, Researcher, Carter-Lis Associates Ltd, Weybridge, Surrey, UK

Barbara Castelnuovo, PhD, Deputy Head, Department, Infectious Diseases Institute, Kampala, Uganda

Fatou Ceesay, MPH, Program Associate, PCORI, Washington, DC, USA

Oscar Cerezo, MSc, HEOR Manager, Novartis, Mexico City, Mexico

Arnab Chakraborty, MPharm, Research Scholar, Delhi Institute of Pharmaceutical Sciences and Research, New Delhi, India

Alanna Chamberlain, PhD, Assistant Professor, Epidemiology, Mayo Clinic, Rochester, MN, USA

Agnes Chan, PhD, Pharmacy Director, An Nan hospital, China Medical University, Tainan, Taiwan

Cheng Shyong Chang, MD, Attending Physician, Changhua Christian Hospital, Changhua, Taiwan

Tanushree Chaudhary Pavithran, Masters, Health Technology Assessment Specialist, NHSRC, Gurgaon, India

Rajinder Chawla, PhD, Director Cum Chief Executive Officer, Accuscript Consultancy, Ludhiana, Punjab, India

Li Li Chen, BPharm(Hon), MSC(Clin Pharm), Principal Clinical Pharmacist, Singapore General Hospital, Singapore

Abhishek Chitnis, MPharm, PhD, Associate Director, Johnson and Johnson, New Brunswick, New Jersey, USA

Huey Yi Chong, MSc, Monash University Malaysia, Bandar Sunway, Selangor Darul Ehsan, Malaysia

Rina Chotai, Post graduate Health Economics, Consultant, Double Helix, London, UK

Wojciech Chrosny, PhD, Director, Software Engineering, TreeAge Software Inc, Williamstown, MA, USA

Carole Chrvala, PhD, President, Health Matters, Inc., Pittsboro, NC, USA

Roberta Ciampichini, MSc, Research Assistant, University of Milan-Bicocca, Monza, Italy

Monica Cintra, MD, PhD, Clinical Research Unit Coordinator, UPC HC FMRP USP, Ribeirão Preto, São Paulo, Brazil

Merce Comas, PhD, Senior Statistician, IMIM - Hospital del Mar Medical Research Institute, Barcelona, Spain

Caroline Conti, PharmD, MBA, Market Access Director, GfK, London, Greater London, UK

Aisling Conwaylenihan, BA, Lecturer, Cork Institute of Technology, Cork, Ireland

Jordan Covvey, PharmD, PhD, BCPS, Assistant Professor , Pharmacy Administration, Duquesne University Mylan School of Pharmacy, Pittsburgh, PA, USA

Tara Cowling, MSc, Principal Consultant, Medlior Health Outcomes Research Ltd, Calgary, AB, Canada

Paolo Cozzolino, BSc, Researcher, University of Milan-Bicocca, Monza, Italy

James Crispo, MSc, PhD(c), Population Health, Doctoral Candidate & Research Assistant, University of Ottawa, Ottawa, Ontario, Canada

Cesar Cruz, PhD, Advisor, Health Services of PEMEX, Mexico City, Mexico

Marcell Csanadi, MSc, Researcher, Syreon Research Institute, Budapest, Hungary

Dan Daneasa, Msc, Independent Researcher, Free University of Brussels - Master of Management, Brussels, Belgium

Selena Daniels, PharmD, Social Scientist Analyst, FDA, Silver Spring, MD, USA

Vincent Daniels, PhD, Research Consultant, Atlas Data Systems, Merck & Co., Inc., Upper Gwynedd, Pennsylvania, USA

96

Saibal, Das, MD, Pg Registrar, Department of Pharmacology and Clinical Pharmacology, Christian Medical College, Vellore, Tamil Nadu, India

Anna D’Ausilio, BA, MSc, Ma Director, Creativ-Ceutical, Milan, Italy

Mary Lynn Davis-Ajami, PhD, MBA, Assistant Professor, Virginia Commonwealth University, Richmond, VA, USA

Marquita Decker, MD, MpH, Mental Health Economics Trainee, University of Wisconsin School of Medicine & Public Health, Madison, WI, USA

Laure Delbecque, PhD, Senior Scientist, PRO, Pharmerit international, Rotterdam, The Netherlands

Andrew Delgado, PharmD, Adjoint Assistant Professor, University of Texas Health Science Center at San Antonio, San Antonio, TX, USA

Pooja Desai, PhD, Health Economics Manager, Amgen, Thousand Oaks, California, USA

Prasanna Deshpande, PharmD, IDCRP, Assistant Professor, Dept. of Clinical Pharmacy, Poona College of Pharmacy, Bharati Vidyapeeth University, Pune, Maharashtra, India

Patrick Detzel, PhD, Health Economics Manager, Nestle Research Center, Lausanne, Vaud, Switzerland

Amol Dhamane, BPharm, Product Director, Health Economics And Outcomes Research, Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, Connecticut, USA

Devender Dhanda, RPh, MBA, Pharmacist, Rite Aid Corp., Kirkland, WA, USA

Sreedhar Dharmagadda, PhD, Associate Professor and Head, Manipal College of Pharmaceutical Sciences, Manipal, Karanataka, India

Paolo Di Rienzo, MSc, HEOR Manager, Bristol-Myers Squibb - Italy, Rome, Italy

Tatiana Dilla, PhD, Head of Health Outcomes, Lilly, Alcobendas, Madrid, Spain

Piyameth Dilokthornsakul, PhD, Department of Pharmacy Practice, Muang, Phitsanulok, Thailand

Slaveyko Djambazov, MD, MPH, MBA, Managing Director, HTA, Sofia, Bulgaria

Dafina Dobreva, MD, MPH, Scientific Project Manager, Medical Research Institute, Sofia, Bulgaria

Miryana Dobreva, Master, Pricing and Contracting Lead, Sanofi Italy, Milan, Italy

Zenobia Dotiwala, MS, Senior Manager, eMAX Health, White Plains, New York, USA

Samantha Dougherty, PhD, Senior Director, PhRMA, Washington DC, USA

Lynda Doward, MRes, European Head, Patient Reported Outcomes, RTI-Health Solutions, Manchester, UK

Scott Doyle, MSc, Director, GlaxoSmithKline, London, UK

Melina Dritsaki, PhD, Senior Health Economist, University of Oxford, Oxford, UK

Louise Drudy, PhD, Clinical Scientist, Dublin, Ireland

Dana Drzayich Jankus, MS, Research Consultant, Comprehensive Health Insights, Cleveland, Ohio, USA

Dmitry Dukhovny, MD MPH, Assistant Professor, Pediatrics, Oregon Health & Science University, Portland, OR, USA

Thomas Ecker, MA, PhD, General Manager, Ecker + Ecker GmbH, Hamburg, Germany

Andrew Eggleston, MMedSc(clin epi), Consultant, Sydney, New South Wales, Australia

Florian Eichmann, PhD, Principal Scientific Affairs & Real World Evidence, Late Stage, inVentiv Health, Munich, Germany

Randa Eldessouki, MBBCH, MD, Assistant Professor, Faculty of Medicine, Fayoum, Egypt

Fredrik Elg, PhD, Director, Pracupio, London, UK

Lina Eliasson, PhD, Lead Outcomes Researcher, ICON Plc, London, UK

Ahmed Elmelegy, PhD, Professor Emeritus, Faculty of Medicine, Sin Shams University, Cairo, Egypt

Gottfried Endel, MD, Head Team EBM/HTA, HVB, Vienna, Austria

Dora Endrei, MD, PhD, Assistant Professor, University of Pécs, Pécs, Hungary

Joanna Entwistle, PhD, Market Access Director, GfK, Melton Mowbray, Leicestershire, UK

Mujde Erten, PhD, Assistant Professor, University of Vermont, Burlington, Vermont, USA

Hariprasad Esam, HEOR Analyst, Marksman Healthcare Solutions, Mumbai, Maharashtra, India

Katherine Etter, PhD, Medical Devices Epidemiology Postdoctoral Fellow, Johnson & Johnson, New Brunswick, NJ, USA

Richard Fautley, PhD, Consultant, Deloitte, London, Great Britain

Javeria Fazal, MPharm, PharmD, Cosenza (Italy), Catanzaro, Italia

Inna Feldman, PhD, Senior Researcher, Uppsala University, Uppsala, Sweden

Federico Felizzi, PhD, HTA Statistician, Roche, Basel, Switzerland

Cristina Ferreira, MBA, Manager, Pfizer, São Paulo, Brazil

Sarah Figueira

Kelly Fleetwood, MSc, Principal Statistician, Quantics Biostatistics, Edinburgh, Scotland

Margreet Franken, PhD, Scientific Researcher, Institute for Medical Technology Assessment, Rotterdam, The Netherlands

Madeleine Fuchs, Bachelor, Manager Pricing & Reimbursement, Biotest AG, Dreieich, Hessen, Germany

Haruhisa Fukuda, MPH, PhD, Associate Professor, Kyushu University, Fukuoka, Japan

Rupert Gale, MA, Head Global Market Access, Respiratory, GSK, London, UK

Katy Gallop, MSc, Senior Research Manager, Acaster Consulting Ltd, Bristol, UK

Kiranmai Ganji, MS (Pharm), Research Analyst, Marksman Healthcare Solutions, Mumbai, Maharastra, India

Michael Ganz, MS, PhD, Senior Research Scientist, Evidera, Waltham, MA, USA

Wanzhen Gao, PhD, Director Of Healthcare Analytics, Amerihealth Caritas, Philadelphia, PA, USA

Benjamin Geisler, MD, MPH, Attending Physician, Massachusetts General Hospital, Boston, MA, USA

Christian Geneus, MS, MPH, Doctoral Student, Tulane University, New Orleans, Louisiana, USA

Zuo Genyong, PhD, Associate Professor, Shandong University, Jinan, Shandong, China

Jone Gerdvilaite

Christian Gericke, MD, PhD, MPH, MBA, FRCP, Professor, University of Queensland, Brisbane, Queensland, Australia

Christoph Gerlinger, PhD, Senior Director, Bayer Pharma AG, Berlin, Germany

Philipos Gile, Masters, Senior Lecturer, Senior Expert Of Planning, M&E, Higher Education Institutions’ Partnership, Addis Ababa, Ethiopia

Mamo Girma, MSc, Lecturer, Addis Ababa Science and Technology University, Addis Ababa, Ethiopia

Lara Gitto, PhD, Researcher, University of Rome “Tor Vergata”, Roma, Italia

Jennifer Glithero, BS, Senior Solution Specialist, Clinithink, Atlanta, Georgia, USA

Ashish Goel, PhD, Director, Real-World Evidence Solutions, IMS Health, Delhi, India

Paloma Gonzalez, PhD, HEOR Manager, Bristol-Myers Squibb, Madrid, Spain

Emma Goodall, PhD, Health Outcomes Manager, GlaxoSmithKline, Mississauga, Ontario, Canada

Bridgett Goodwin, PhD, Director, Merck, Upper Geynedd, Pa, USA

George Gourzoulidis, MSc, Research Fellow, Health Services Organization & Management Department, National School of Public Health, Athens, Attiki, Greece

Ravi Goyal, MS, BPharm, Senior Health Outcomes Scientist, RTI Health Solutions, RTI International, Research Triangle Park, NC, USA

Richa Goyal, M Pharmacy, Senior Manager, IMS Health, Mumbai, Maharashtra, India

Christopher Graham, MS, Senior Director, Health Economics, RTI Health Solutions, Research Triangle Park, NC, USA

Bernie Guan, Masters, Graduate Student, National University of Singapore Saw Swee Hock School of Public Health, Singapore

Jatin Gupta, MPharma, Senior Consultant, PAREXEL International, New Delhi, India

Subhajit Gupta, MSc, Manager, Economic Modeling, Novartis, Hyderabad, Telangana, India

Zalmai Hakimi, PharmD, Director Global HEOR, Astellas, Leiden, North Holland, The Netherlands

Louise Hansen, MMedSci, Research Assistant, Aalborg University, Aalborg, Denmark

Jing Hao, PhD, MD, MPH, Academyhealth Delivery System Science Fellow, Geisinger Health System, Danville, PA, USA

Brooke Harrow, PhD, Director, Health Economics and Outcomes Research, TESARO, Inc., Waltham, Massachusetts, USA

Raymond Harvey, MPH, Research Lead, Comprehensive Health Insights, New Orleans, LA, USA



97

Mahmoud Hashim, MD, MPH, Research Consultant, Ingress-Health, Wismar, Mecklenburg Vorpommern, Germany

Mohamed Hassanin, MSc, Health Economics and Pricing Manager, Novartis Oncology, Riyadh, Saudi Arabia

Jiangjiang He, PhD candidate, MPH, Deputy Executive Director, Department Of Health Policy Research, Shanghai Health Development Research Center, Shanghai, China

Jimmy He, PhD, Associate Director, Johnson and Johnson, Raritan, NJ, USA

Martin Henriksson, PhD, Associate Professor, Linköping University, Linköping, Sweden

Nina Hill, PhD, Executive Director Epidemiology, Heor & Observational Research, Relypsa, Redwood City, CA

Nadine Hillock, Master of Public Health, BPharm, DipClinPharm, Senior Pharmacist, Executive Officer, Sa Medicines Evaluation Panel, SA Health, Adelaide, South Australia, Australia

Dionne Hines, MPH, PhD, Senior Consultant, IMS Health, USA

Rosina Hinojosa, MSc, Vice President, ISPOR Peru, Lima, Peru

Masahiro Hirose, MD, PhD, Professor & Director, Shimane University Faculty of Medicine, Izumo, Shimane, Japan

Malwina Holownia, MPharm, Senior Health Economist, Moscow Healthcare Department, Moscow, Russia

Roksana Hoque, MPH, Research Officer, Center for the Rehabilitation of the Paralyzed (CRP), Dhaka, Savar, Bangladesh

Libby Horter, MPH, Research Consultant, Comprehensive Health Insights, Louisville, KY, USA

Xingdi Hu, PhD, Manager, HEOR, Shire, Cambridge, MA, USA

Wei Huang, PhD, Post-Doc Fellow, UCSF, San Francisco, CA, USA

Jinhai Huo, PhD, MD, MSPH, Halliburton Foundation Postdoctoral Research Fellow, The University of Texas MD Anderson Cancer Center, Houston, Texas, USA

Dan Huse, MA, Vice President, Truven Health Analytics, an IBM Company, Cambridge, MA, USA

Irshad Hussain, MPhil, Assistant Professor, SMBB Medical University, Larkana, Pakistan, Larkana, Sindh, Pakistan

Izhar Hussain, PhD, Director Executive Education, Institute of Business Administration, Karachi, Sindh, Pakistan

Salman Hussain, PhD, Research Scholar, Jamia Hamdard, Hamdard University, New Delhi, India

Minkyung Hyun, Assistant Professor, Dongguk University, Gyeongju, Gyeongsangbukdo, Korea

Laura Iadeluca, PhD, Senior Manager, Pfizer Inc, New York, NY, USA

Inas Ibrahim, MSC, PhD Candidate, Researcher, Universiti Sains Malaysia, Gelugor, Penang, Malaysia

Victoria Ignatyeva, MD, MPH, Senior Research Officer, The Russian Presidential Academy of National Economy and Public Administration, Moscow, Russian Federation

Muhammad Ilyas, MSc, Research Specialist, Aga Khan University, Karachi, Sindh, Pakistan

Shoeb Ahmed Ilyas, MPH, MPhil, HTA Consultant, Ruby Med Plus, Warangal, Telangana, India

Ali Imani, PhD, Faculty Member, Tabriz University of Medical sciences, Tabriz, Eeast Azerbaijan, Iran

Muhammad Zahid Iqbal, PharmD, MBA, Lecturer, Clinical Pharmacy and Pharmacy Practice, AIMST University Malaysia, Sungai Petani, Kedah, Malaysia

Qaiser Iqbal, MPhil, Assistant Professor, University of Balochistan Quetta, Quetta, Baluchistan, Pakistan

Lyna Irawati, MPharm, Universiti Sains Malaysia, Penang, Malaysia

Wanrudee Isaranuwatchai, PhD, Health Economist, St. Michael’s Hospital, Toronto, Ontario, Canada

John Isitt, MS, Independent Consultant, Health Economics & Outcomes Research, Newbury Park, California, USA

Neeraj Iyer, BPharm, PhD, Manager, HEOR, Novo Nordisk Inc, Bordentown, NJ, USA

Dena Jaffe, PhD, Manager, Kantar Health, Tel Aviv, Israel

Jessica Jalbert, PhD, Director, Pharmacoepidemiology, LASER Analytica, New York, NY, USA

Elizabeth, James, PharmD, PhD, Associate Director, Health Outcomes, Aventine Consulting, Edmonds, WA, USA

Syed Umer, Jan, PhD, Assistant Professor, UOB, Quetta, Balochistan, Pakistan

Slobodan, Jankovic, DSc, MD, Professor, Faculty of Medical Sciences, University of Kragujevac, Kragujevac, Serbia

Manthan, Janodia, MPharm, PhD, Associate Professor, MCOPS, Manipal University, Manipal, Karnataka, India

Andrej, Janzic, MPharm, Teaching Assistant, University of Ljubljana, Faculty of Pharmacy, Ljubljana, Slovenia

Rafal Jaworski, MDc, Associate Director Market Access, MSD, Warsaw, Mazovia, Poland

Ravishankar Jayadevappa, PhD, Associate Professor, University of Pennsylvania, Philadelphia, Pennsylvania, USA

Xiaolong Jiao, MD, MS, Senior Outcomes Researcher, McKesson Specialty Health, Houston, TX, USA

Ernst Johannes, MD, Head Market Access Europe, Grünenthal GmbH, Aachen, Germany

Denny John, MBA, MPH, Senior Technical Specialist, International Center for Research on Women (ICRW), New Delhi, India

Ian Johnson, BSc, Principal Consultant, Double Helix, Macclesfield, Cheshire, UK

Tricia Johnson, PhD, Professor, Rush University, Chicago, IL, USA

Clare Jones, PhD, MBA, Director, PRMA Consulting, Hampshire, UK

Pall Jonsson, PhD, MRes, Senior Scientific Adviser, NICE, Manchester, UK

Ashish Joshi, PhD, Senior Director, Value Evidence and Outcomes, GlaxoSmithKline, Collegeville, PA, USA

Namita Joshi, PhD Associate Scientist, Pharmerit International, Bethesda, Maryland, USA

Rolland Kacsoh, BSc, Senior Product Manager, Biopharm, Market Access Focus, Novo Nordisk Healthcare AG, Zurich, Switzerland

Ashish Kakkar, MD, Assistant Professor, Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi, Delhi, India

Hrishikesh Kale, Masters, PhD Student & Graduate Assistant, Virginia Commonwealth University, Richmond, Virginia, USA

Raju Kanukula, MPharm, HEOR Analyst, Marksman Healthcare Solution, Mumbai, Maharastra, India

Richard Kara, PhD, Direct, CR Bard, Salt Lake City, Utah, USA

Linda Karlsson, MSc, Project Leader, Quantify Research, Stockholm, Stockholm, Sweden

Peter Kaskel, MD, MBA, Senior Market Access Manager, MSD SHARP & DOHME GMBH, Haar (Munich), Bavaria, Germany

Moez Katet, PharmD, MPH, Analyst, London, UK

Iakovos Katsipis, Mcs Systems Engineering, Systems Engineer, INCOSE, Boston, Massachusetts, USA

Kirandeep Kaur, MBBS, MD, Associate Professor, Dayanand Medical College and Hospital, Ludhiana, India

Amer Hayat Khan, PhD, Senior Lecturer, Universiti Sains Malaysia, Penang, Malaysia

Farhjad Ali Khan, MBBS, MPH, MSC, PhD, Director, Epidemiology, Safety and Risk Management, IMS Health Sweden AB, Stockholm, Sweden

Victor Khangulov, PhD, Principal, Boston Strategic Partners Inc., Boston, MA, USA

Minchul Kim, PhD, Research Assistant Professor, University of Illinois College of Medicine at Peoria, Peoria, IL, USA

Sukyeong Kim, PhD, Senior Research Fellow, National Evidence-based Healthcare Collaborating Agency (NECA), Seoul, Korea

Sandeep Kiri, MSc, Health Outcomes / HTA Lead, Eli Lilly and Co Ltd, Basingstoke, Hampshire, UK

Jonathan Kish, PhD, MPH, Director HEOR, Cardinal Health Specialty Solutions, Dallas, TX, USA

Helen Kitchen, MSc, Senior Consultant, DRG Abacus, Manchester, UK

Jiri Klimes, PharmD, PhD, HEOR Manager, Novartis, Prague, Czech Republic

Andrew Klink, PhD, MPH, Manager, HEOR, Cardinal Health, Philadelphia, PA, USA

Brigitte Klinkenbijl, MSc, Director International Access, Dexcom, Essertines Sur Rolle, Vaud, Switzerland

Anne Knoof Shekhar, MSc, Market Access Manager, Amgen France, Boulogne-Billancourt, Ile-de-France, France

Russell Knoth, PhD, Director, Health Economics & Outcomes Research, Eisai Pharmaceuticals, Orange, CA, USA

Guvenc Kockaya, MD, PhD, Vice Chair, Turkish Health Economics & Policy Association, Ankara, Turkey



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Martin Kolek, MSc, HTA Manager, OAKS Consulting, Prague, Czech Republic

Yordanka Koleva, PhD, Research Data Manager, Tulane University Medical Center, New Orleans, Louisiana, USA

Oleksii Korzh, Head, Department of General Practice-Family Medicine, Kharkiv Medical Academy of Postgraduate Education, Kharkiv, UKraine

Melodi Kosaner Kliess, MRes, Scientific Publications Specialist, MED-EL, Innsbruck, Austria

Lyazzat Kosherbayeva, PhD, Head, Department, KazNMU, Almaty, Kazakhstan

Alexander Kostyuk, MD, PhD, Chief Executive & Scientific Officer, Kazakh Agency for Health Technology Assessment, Astana, Kazakhstan

Anirudh Kotlo, MPharm, Senior Researcher, GlobalData Plc, Hyderabad, Telangana, India

Alla Kotvitska, PharmD, First Vice-Rector For Scientific And Pedagogical Work, National University of Pharmacy, Kharkiv, UKraine

Irina (Iryna), Kozhanova (Kazhanava), MD, PhD, Lecturer, Belarusian State Medical University, Minsk, Belarus

Pim Kuizenga, MSc, Consultant, Wellmera AG, Basel, Switzerland

Sunil Kumar, MPharm, PhD, Assistant Professor, Kurukshetra University, Kurukshetra, Haryana, India

Bimal Kunwar, PharmD, MPhil, Junior Research Fellow, HEJ Research Institute of Chemistry, Karachi, Sindh, Pakistan

Joey Kwong, PhD, Associate Professor, West China Hospital, Sichuan University, Chengdu, Sichuan, China

Tarachand Lalwani, PharmD, Assistance Professor, K.B.I.P.E.R, Gandhinagar, Gujarat, India

Mohammed Lamorde, MRCP, PhD, Head, Department, Prevention Care And Treatment, Infectious Diseases Institute, Kampala, Uganda

Hui-Chu Lang, PhD, Professor, National Yang-Ming University, Taipei, Taiwan

Suzanne Laplante, BPharm, MSc, DLSHTM, Senior Director, Global Heor, Baxter Healthcare Corporation, Deerfield, IL, USA

Anandi Law, BPharm, MS, PhD, Professor and Chair, Department Of Pharmacy Practice and Administration, Western University of Health Sciences, College of Pharmacy, Pomona, California, USA

Hankil Lee, MS, RPh, Yonsei University, Incheon, South Korea

Jeff Lee, PharmD, FCCP, Associate Professor, Pharmacy Practice, Lipscomb University College of Pharmacy, Nashville, TN, USA

Sang-Soo Lee, MBA, Corporate Affairs Director, Medtronic Korea, Seoul, South Korea

Yu-Chen Lee, MSc, Research Fellow, Deakin University, Melbourne, Victoria, Australia

Edith Arely Lemus, MSc, Market Access Director, Celgene, Mexico City, Mexico

Carlo Giacomo Leo, Researcher, Italian National Research Council - Institute Of Clinical Physiology, Lecce, Italy

Benedicte Lescrauwaet, MSc, Director, Outcomes Research, Xintera Ltd, Cambridge, Cambridgeshire, UK

Nick Li, PhD, MBA, Manager, Analysis Group, Boston, Massachusetts, USA

Virendra Ligade, MPharm, PhD, Assistant Professor (Selection Grade), Manipal College of Pharmaceutical Sciences, Manipal University, Manipal, Karnataka, India

Nishkarsh Likhar, MPharm, Associate Consultant, MarksMan Healthcare Solutions, Navi-Mumbai, Maharasthra, India

David Lin, MBA, Director Of Market Access, Policy & Communications, Merck Sharp & Dohme, Kuala Lumpur, Federal Territory, Malaysia

Hsien-Chang Lin, PhD, Assistant Professor, Indiana University, Bloomington, Indiana, USA

Jennifer Haiang-Ling Lin, PhD, Associate Director, Janssen Scientific Affairs LLC, Titusville, NJ, USA

Junji Lin, PhD, MS, Scientist, Pharmerit, Bethesda, MD, USA

Steven Lister, MA, Senior Health Economist, Bristol-Myers Squibb, Uxbridge, Middlesex, UK

Leighann Litcher-Kelly, PhD, Associate Director, Adelphi Values, Boston, MA, USA

Andrew Lloyd, DPhil, Director, Bladon Associates Ltd, Oxford, UK

Alkesh Lokhande, Research Scholar, Department of Pharmacy Practice, Manipal College of Pharmaceutical Sciences, Manipal University, Manipal, India, Manipal, Karnataka, India

Stefania Lopatriello, PhD, Indipendent Consultant, Indipendent Market Access Consultant, Rome, Italy

Francisca Lopes, MPharm, Outcomes Research Manager, MSD Portugal, Lisboa, Portugal

Andrea Lorden, PhD, MPH, Assistant Professor, University of Oklahoma Health Sciences Center, Oklahoma City, OK, USA

Valentina Lorenzoni, PhD, Research Fellow, Scuola Superiore Sant’Anna, Pisa, Italy

Christine Lu, PhD, Assistant Professor, Harvard Medical School, Boston, Ma, USA

Graciela Luraschi, Titular Professor, Maimonides, Caba, Argentina

Carmen Lyttle-Nguessan, MS, MEd, Coodinator Admin, Florida A&M University, Tallahassee, Florida, USA

Tomasz Macioch, PhD, Partner, HealthQuest, Warsaw, Mazovia, Poland

Fabiana Madotto, PhD, Research Fellow, University of Milano-Bicocca, Milan, Italy

Raf Magar, MBA, President, AHMR INC, Buffalo, NY, USA

Marikannan Maharajan, BPharm, MPharm, PhD, University Lecturer, International Medical University Malaysia, Kuala Lumpur, Malaysia

Lamine Mahi, MD, PhD, Chief Medical Officer, Axelys Santé, Paris, France

Seyed Hamidreza Mahmoudpour, PharmD, Phd Candidate, Utrecht University, Utrecht, The Netherlands

Unnati Majethia, MS, Senior Manager Global Health Economics And HTA, Eisai Inc., Woodcliff Lake, NJ, USA

Peter Mallow, PhD, Program Director, Health Economics & Outcomes Research, Cardinal Health, Cincinnati, Ohio, USA

Carla Mamolo, PhD, Director, Outcomes & Evidence, Pfizer, Groton, CT, USA

Subhash Mandal, MPharm, PhD, Assistant Director, Directorate of Drugs Control, Kolkata, West Bengal, India

Stefania Manetti, MSc, Scuola Superiore Sant’Anna, Pisa, Italy

Andrea Marcellusi, PhD, Researcher, National Research Council, Rome, Italy

Jay Margolis, PharmD, Senior Research Scientist, Truven Health Analytics, Bala Cynwyd, Pennsylvania, USA

Sandra Margunato-Debay, PharmD, MBA, Global Market Access and HEOR, NJ, USA

Hugo Marin Piva, MD, MPH, Technical Secretary Central Pharmacotherapy Committee, Caja Costarricense de Seguro Social, San Jose, Costa Rica

Sophia Marsh, BPharm, HTA & Market Access Manager, Biocompatibles UK Ltd, Camberley, UK

Bradley Martin, PharmD, PhD, Professor, UAMS, Little Rock, AR, USA

Linda Gore Martin, PharmD, MBA, Professor, Social and Administrative Pharmacy (Ret), University of Wyoming, Laramie, Wyoming, USA

Carlos Martin Saborido, PhD, Director, HTA Unit Universidad Francisco de Vitoria, Madrid, Spain

Lisa Masucci, MSc, Health Economist, St. Micheal’s Hospital, Toronto, Ontario, Canada

Susan Mathias, MPH, President, Health Outcomes Solutions, Winter Park, FL, USA

Nikolay Matveev, MD, MPH, PhD, Professor, N. I. Pirogov Russian National Research Medical University, Moscow, Russia

Doreen Mcbride, PhD, Senior Director, RTI Health Solutions, Manchester, UK

Rebecca Mccracken, BS, MSPH, Sr. Scientific Director, The Lockwood Group, Helena, Alabama, USA

Karl Mcevoy, PhD, Manager, Health Outcomes, CRF Health (UK), London, England

Ethna Mcferran, BSC, Pha/Nci Health Economics Phd Fellow, Queens University Belfast, Belfast, UK

Lisa Mcgarry, MPh, Director HEOR, Ariad Pharmaceuticals, Inc., Cambridge, MA, USA

Jan Mckendrick, MSc, Director, PRMA Consulting Ltd, Fleet, Hampshire, UK

Stuart Mealing, MSc, EU Head of Health Economics, ICON Clinical Research Ltd., Oxford, UK

Hemalkumar Mehta, PhD, Assistant Professor, University of Texas Medical branch, Galveston, Texas, USA

Suyog Mehta, MBBS, MD (Pharmacology), Senior Director And Head Medical Affairs - India, Dr. Reddy’s Laboratories Ltd., Hyderabad, Telangana, India

Ievgeniia Melnyk, MA, Head, Department of Evidence-Based Medicine, State Expert Center of the Ministry of Health of Ukraine, Kyiv, UKraine



99

Humberto Mendez, Master, Encargado Departamento De Autorizaciones Medicas, Seguro Nacional de Salud, Distrito Nacional, Santo Domingo, República Dominicana

Joseph Menzin, PhD, President, Boston Health Economics, Waltham, MA

Andrew Metry, BScPharm, Pharmacoeconomics Unit Pharmacist, Central Administration for Pharmaceutical Affairs, Cairo, Egypt

Lucy Michael, PharmD, Managing Director, Applied Health Value Solutions, WA, USA

Luis Miguel, PhD, Researcher, Research Centre on the Portuguese Economy, Lisbon, Portugal

Matthew Mildred, MSc, MEd FHEA, Senior Health Economist, Boehringer Ingelheim, Bracknell, Berkshire, UK

Sandra Milev, MSC, Associate Director, Senior Researcher, Modeling and Simulation, Evidera, San Francisco, CA, USA

Jeffrey Miller, Director, Truven Health Analytics, an IBM Company, Cambridge, MA, USA

Lesley-Ann Miller, PhD, MBA, National Outcomes Liaison Director, Sanofi, Fishers, IN, USA

Ferg Mills, MSc, Principal Consultant, Wyatt Health Management, Mississauga, Ontario, Canada

Michael Minshall, MPH, Research Lead, Humana/CHI, Louisville, KY, USA

Deirdre Mladsi, BA, Head, Health Economics and Market Access, RTI Health Solutions, Rtp, NC, USA

Ahmed Mohamed, MD, MSc, Postgraduate Associate, Yale University, New Haven, CT, USA

Omneya Mohamed, PhD, Research Fellow, Rutgers University/Merck & Co Inc., Piscataway, New Jersey, USA

Mohamed Izham Mohamed Ibrahim, PhD, Full Professor, Qatar University College of Pharmacy, Doha, Doha, Qatar

Stella Mokiou, PhD, Research Scientist, UBC, London, UK

Balint Molics, PhD, Lecturer, University of Pecs, Faculty of Health Sciences, Pécs, Baranya, Hungary

Homero Monsanto, PhD, Latin America Outcomes Research Lead, Merck & Co., Carolina, Puerto Rico, USA

Kensuke Moriwaki, MS, PhD, Lecturer, Kobe Pharmaceutical University, Kobe, Hyogo, Japan

Samantha Morrison, BSC, Vice President, GfK, Melton Mowbray, Leistershire, UK

Essy Mozaffari, PharmD, MPH, MBA, Vice President, Market Access, Chimerix, Durham, North Carolina, USA

Victor Mudhune, BPharm, MBA, MPH, HIV Research Deputy Branch Chief (Operations and Management), Kenya Medical Research Institute, Kisumu, Nyanza, Kenya

Kerstin Mueller, PhD, Epidemiologist, ICON plc, Vancouver, BC, Canada

Kumar Mukherjee, PhD, Assistant Professor, Pharmacy Practice, Chicago State University, Chicago, IL, USA

Amarnath Mullapudi, MPharm, National Institute of Pharmaceutical education and Research, Mohali, Punjab, India

Suneel Mundle, PhD, Sci Director, Medical Affairs, Janssen Oncology, J&J Company, Horsham, PA, USA

Pradeep Manohar Muragundi, PhD, Assistant Professor Selection Grade, MCOPS, Manipal University, Manipal, Karnataka State, India

Aileen Murphy, PhD, Lecturer, University College Cork, Cork, Ireland

Salvatore Muschera, MBA, Oncology PRA Manager Italy, Eli Lilly, Rome, Italy

Conrad Musinguzi, Masters, Research Fellow/Research Officer, Baylor College of Medicine Uganda, Kampala, Uganda

Oana Mustatea, Pharmacist, Regulatory Sciences Manager, Bucharest, Romania, Romania

Pramit Nadpara, PhD, BPharm, Assistant Professor, Virginia Commonwealth University School of Pharmacy, Richmond, Virginia, USA

Anantha Nagappa, PhD, Professor, SCS College of Pharmacy, Harapanahalli, Karanataka, India

Shankar Prasad Nagaraju, DM Nephrology, Associate Professor, Kasturba Medical College, Manipal University, Manipal, Karnataka, India

Ranjit Nair, DPharm, Student, Malla Reddy Institute of Pharmaceutical Sciences, Hyderabad, Telangana, India

Lucas Najun Dubos, MD, Market Access Planning & Heor Manager, Roche Argentina, Buenos Aires, Buenos Aires, Argentina

Folashade Naku, PharmD, Principal, Naku Consulting, Brentwood, California, USA

Siva Narayanan, Executive Vice President, MKTXS, Potomac, MD, USA

Soumana Nasser, PharmD, Clinical Associate Professor, Lebanese American University, Blat, Byblos, Lebanon

Christel Naujoks, MPH, MBA, Executive Director Heor, Novartis Pharma AG, Basel, Switzerland

Saeed Nazir, PhD, Assistant Professor, University of Sargodha, Sargodha, Punjab, Pakistan

Onyinye Nduaguba, MSPharm, Doctoral Student, The University of Texas at Austin College of Pharmacy, Austin, TX, USA

Bertalan Nemeth, MSc, Senior Health Economist, Syreon research Institute, Budapest, Hungary

Chin Fen Neoh, MClinPharm, PhD, Senior Lecturer, Universiti Teknologi MARA, Puncak Alam, Selangor, Malaysia

Cheryl Neslusan, PhD, Director, Market Access, Janssen Global Services LLC, Raritan, NJ, USA

Weiyi Ni, PhD, Doctoral Fellow, University of Southern California, Los Angeles, California, USA

Mihaela Nica, MD, MBA, Value & Access Manager, Novartis Farma Italy, Origgio, Varese, Italy

Lars Nicklasson, PhD, Director Pricing And Market Access, Celgene Inernational, Boudry, Switzerland

Shinichi Noto, PhD, Professor, Niigata University of Health and Welfare, Niigata, Japan

Elly Nuwamanya, BSc, Research Analyst, Global Health Economics Ltd, Kampala, Uganda

Afra Nuwasiima, Bachelors of Statistics, Research Analyst, Global Health Economics Limited, Kampala, Uganda

Engels Obi, PhD, BPharm, Associate Director Heor, Novartis, East Hanover, New Jersey, USA

Judith O’Brien, RN, BSPA, Health Care Cost & Reimbursement Consultant, Independent, Lincoln, MA, USA

Josephine Ocran-Appiah, MD, MPH, Research Fellow, FDA - Office of Surveillance and Epidemiology, Silver Spring, MD, USA

Theresa Ofili, RN, BSPharm, PharmD, MPH, Assistant Professor, Pharmacy Practice, Texas A&M Irma Lerma Rangel College of Pharmacy, College Station, Texas, USA

Augustina Ogbonnaya, MPH, Associate Director, Xcenda, Jersey City, NJ, USA

Hiroyuki Okumura, PhD, Associate Medical Director, Astellas Pharma Inc., Tokyo, Japan

Busuyi Olotu, PhD, Postdoctoral Fellow, University of Kansas School of Pharmacy, Lawrence, KS, USA

Olumuyiwa Omonaiye, BPharm, MPH, Pharmacy Specialist, Howard University Pace Center/Sidhas Project, Calabar, Cross River, Nigeria

Yoshie Onishi, DrPH, Director, Creativ-Ceutical K.K., Tokyo, Japan

Ibrahim Oreagba, PhD, Assistant Professor, University of Lagos Nigeria, Lagos, Nigeria

Ahmed Osman, MSc, PhD Student, Tianjin University, Schools Of Pharmaceutical Science and Technology, Tianjin, China

Che Noriah Othman, MSc, Senior Lecturer, Universiti Teknologi Mara, Penang Branch, Bertam Campus, Kepala Batas, Penang, Malaysia

Asli Zeynep Ozdemir, MSc, Reimbursement Analyst, Medtronic, Istanbul, Turkey

Laurent Pacheco, MD, MBA, MSc, MHA, PhD, Vice President, GfK, London, UK

Ilaria Palla, MBA, Research Fellow, Scuola Superiore Sant’Anna, Pisa, Italy

Swetha Palli, MS, Senior Manager, CTI Clinical Trial and Consulting, Inc., Cincinnati, Ohio, USA

Andrew Palmer, BmedSci, MBBS, Chair, Health Economics, University of Tasmania, Hobart, Tas, Australia

Andrew Palsgrove, BA, Senior Pro Manager, PPD, Baltimore, MD, USA

Witesh Parekh, BPharm(hons), MSc Health Econ, Senior Health Economist (Eu-Heor Regional Health Economics Manager), Novo Nordisk, Crawley, W.Sx, UK

Harish Parihar, PhD, Assistant Professor Of Pharmacy Practice, PCOM GA-Campus School of Pharmacy, Suwanee, GA, USA

Niraj Parikh, MS, Director, Philips, Andover, MA, USA

Taehwan Park, PhD, Assistant Professor, St Louis College of Pharmacy, St Louis, MO, USA

Jamie Partridge, PhD, Director, Health Economics and Outcomes Research, Abbott, Columbus, Ohio, USA



100

Mira Patel, MS, University of Arizona, Tucson, Arizona, USA

Ayesha Pathan, PharmaD, Student, St. Peter’s Institute of Pharmaceutical Sciences, Hanamkonda, Warangal, Telangana, India

Sanjay Patil, MPharm, PhD, Associate Professor, SNJB’s Shriman Sureshdada Jain College of Pharmacy, Chandwad, Maharashtra, India

David Pau, MSc, Statistician, Roche, Boulogne-Billancourt, France

Linda Pauer, MBA, Global Director, Healthcare Economics and Market Access, TerumoBCT, Lakewood, Colorado, USA

Katherine Peace, BSc, Consultant, Prioritis, Paris France

Priti Pednekar, MPharm, Student, University of the Sciences, Philadelphia, Pennsylvania, USA

Isabel Peirano, MD, HEOR Head South Latam, Bayer, Buenos Aires, Argentina

Munawar Peringadi Vayalil, PharmD, Intern, Manipal University, Manipal, Udupi District, Karnataka, India

Lionel Perrier, PhD, Manager Innovations And Strategies, Cancer Centre Léon Bérard, Lyon, France

An Pham, PharmD, MBA, FAHA, Senior Health Economics And Outcomes Research Associate, Mallinckrodt, Seattle, WA, USA

Nadia Pillai, MPH, Analyst, IMS Health, Basel, Switzerland

Carlos Pinto, PhD, Research Coordinator, CISEP - Research Center on the Portuguese Economy, Lisboa, Portugal

Thomas Poder, PhD, Researcher At CRCHUS, CIUSSS de l’Estrie - CHUS, Sherbrooke, Quebec, Canada

Carlos Polanco, PhD, Health Economics & Outcomes Research Senior Manager, Merck KGaA, Madrid, Spain

Jiat Ling Poon, PhD, Senior Research Associate, Evidera, Bethesda, Maryland, USA

Rajasekhar Reddy Poonuru, PhD, Associate Professor, St. Peter’s Institute of Pharmaceutical Sciences, Hanamkonda, Telanagana, India

Oana Felicia Popescu, Student, University of Medicine and Pharmacy “Carol Davila” - Faculty of Pharmacy, Bucharest, Romania

Ana Popielnicki, BA, Clinical Outcome Assessments Specialist, TransPerfect, Boston, MA, USA

Roelien Postema, PharmD, Associate Director Worldwide Heor, Bristol-Myers Squibb, Uxbridge, UK

Xavier Pouwels, Master, Junior Research In Health Economics, KEMTA, MUMC+, Maastricht, Limburg, The Netherlands

Sunil Prajapati, MPharm, Lecturer, AIMST University, Bedong, Kedah, Malaysia

Lenka Pribylova, MSc, HTA Specialist, OAKS Consulting S.R.O., Prague, Czech Republic

Mark Price, MA, MEd, Senior Director, RTI Health Solutions, Research Triangle Park, NC, USA

Catia Proenca, PhD, Consultant, Wellmera, Basel, BS, Switzerland

Klaus Pugner, PhD, Executive Director Global Health Economics, Amgen, Zug, Switzerland

Rajeshwari Punekar, MPH, PhD, Senior Researcher, HealthCore, Inc., Andover, MA, USA

Elena Pyadushkina, Research Officer, The Russian Presidential Academy of National Economy and Public Administration, Moscow, Russia

Casey Quinn, PhD, Director, PRMA Consulting, Fleet, Hampshire, UK

Nicole Quon, PhD, Head, Global Payer Marketing & Market Development Biosimilars, Boehringer Ingelheim GbmH, Ingelhim Am Rhein, Germany

Mahendra Kumar Rai, MPharm, Group Leader- Market Access, Tata Consultancy Services, Mumbai, Maharashtra, India

Pal Rakonczai, PhD, Head Of Research And Data Analysis Department, Healthware Consulting Ltd., Budapest, Hunagary

K.V. Ramanath, MPharm, MBA, QIP Research Scholar, MCOPS & SACCP, Manipal, India

Ricardo Ramos, MSc Economics, Health Economist, INFARMED – National Authority of Medicines and Health Products, I.P., Portugal

Tao Ran, Phd, Research Fellow, Centers for Disease Control and Prevention, Atlanta, GA, USA

Karen Rascati, PhD, Professor, The University of Texas, Austin, TX, USA

Farhan Abdul Rauf, PhD, MD, MPH, Public Health Physician & Researcher, Our Own Public Health Institute (OOPHI), Karachi, Sindh, Pakistan

Lalit Raute, MPH, Process Expert - RWE & HEOR, Tata Consultancy Services, Mumbai, Maharashtra, India

Amit Raval, PhD, Senior Researcher, Healthcore, Inc., Wilmington, Delaware, USA

Soualmi Redouane, MPharm, Secretary & Treasurer, ISPOR Chapter Algeria, Algiers, Algeria

Emily Reese, PhD, MPH, Officer, Specialty Drugs Research Initiative, Pew Charitable Trusts, Washington, DC, USA

Jussi Repo, MD, Surgery Resident, PhD Candidate, Central Hospital of Central Finland, Jyväskylä, Finland, Jyväskylä, Suomi

Dean Reynecke, PhD, Epidemiologist, FPH Care, Auckland, New Zealand

Greg Rhee, PhD, MSW, Researcher, University of Minnesota College of Pharmacy, Minneapolis, Minnesota, USA

Scott Robinson, MA, MPH, PhD(c), Principal, Applied Research, Premier Research Services, Charlotte, NC, USA

Ursula Rochau, MD, MSc, Assistant Professor, UMIT - University for Health Sciences, Medical Informatics and Technology, Hall I.T., Austria

Jose-Manuel Rodriguez Barrios, PhD, MPH, Director Pricing, Economics & Market Access Strategy Europe, Daiichi Sankyo Europe, Munich, Bavaria, Germany

Alessandro Roggeri, BSc, Health Economist - Consultant, ProCure Solutions, Nembro, Bergamo, Italy

Sirikan Rojanasarot, PhD, University of Minnesota, Minneapolis, Minnesota, USA

Martin Romero, MSc, Research Director, Fundación Salutia, Colombia

Jessica Roydhouse, BA, MPH(Hons), PhD Candidate, Brown University, Providence, RI, USA

Stephane Roze, Msc, Chief Executive Officer, Heva HEOR, Lyon, Rhone, France

Lewis Ruff, MSc, Principal Consultant, Covance Market Access, London, UK

Miguel A. Ruiz, PhD, Associate Professor, Universidad Autónoma de Madrid, Madrid, Spain

Mason Russell, MAPE, Vice President, Strategic Consulting, Truven Health Analytics, Cambridge, MA, USA

Parimalakrsihnan S., PhD, Assistant Professor, Department of Pharmacy, Annamalai University, Annamalai Nagar, Tamil Nadu, India

Ramkanth S., PhD, Assistant Professor & Head, Annamacharya College Of Pharmacy, Rajampet, Andhrapradesh, India

Eduardo Sabate, MD, MBA, MPH, R&D Project Team Leader, F. Hoffmann - La Roche AG, Basel, Switzerland

Naomi Sacks, PhD, Senior Health Economist, Precision Health Economics, Boston, MA, USA

Alesia Sadosky, PhD, MPH, MBA, Senior Director, Global Health & Value, Pfizer Inc., New York, NY, USA

Sahar Saeed, Msc, PhD Candidate, McGill University, Montreal, Quebec, Canada

Prashant Sakharkar, PharmD, MPH, Post Doctoral Fellowship in HEOR, Assistant Professor, Roosevelt University College of Pharmacy, Schaumburg, IL, USA

Fahad Saleem, PhD, Senior Lecturer, University of Balochistan, Quetta, Balochistan, Pakistan

Ali Samiian, JD, MBA, MSc, Director, Global Market Access, Abbott Diabetes Care, San Francisco, CA, USA

Frank Sandmann, MSc, London School of Hygiene & Tropical Medicine, London, UK

Binai Sankar, MPharm, Assistant Professor, Acharya & BM Reddy College of Pharmacy, Bangalore, Karnataka, India

Marisa Santos, PhD, Coordinator, Institute Naciobal De Cardiologia, Rio De Janeiro, Rio De Janeiro, Brazil

Angel Sanz Granda, MSc, PharmD, Independant Consultant, Proyectos de Farmacoeconomía, Navacerrada, Madrid, Spain

Pedro Saramago, PhD, Research Fellow, Centre for Health Economics, University of York, York, North Yorkshire, UK

Vishal Saundankar, MS, BPh, PGDMM, Research Scientist, Comprehensive Health Insights, Franklin, Tennessee, USA

Ruta Sawant, MS, Graduate Student, University of Houston, Houston, Texas, USA

Sarah Schmitter, Diplom, Senior Manager Health Technology Assessment & Outcomes Research, Pfizer Deutschland GmbH, Berlin, Berlin, Germany

Mark Schulz, PhD, Market Access Director, Novartis, Sydney, New South Wales, Australia

Bjoern Schwander, BHS, MHEconomics, General Manager, AHEAD GmbH - Agency for Health Economic Assessment and Dissemination, Loerrach, BW, Germany

Katia Senna, Master, Nurse Researcher, Instituto Nacional de Cardiogia, Rio De Janeiro, RJ, Brasil



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Peter Serafini, MBA, MPH, Manager, Regional Market Access (Latin America), Biogen, Sao Paulo, Brazil

Christine Sevald, MS, PhD, Freelance Consultant, HEOR, ValueMetrics (recent graduate,Thomas Jefferson University , MS HEOR), Philadelphia, PA, USA

Oznur Seyhun, MSc, MFE, Regional Senior Market Access Manager, Abbott International, Istanbul, Turkey

Asrul Shafie, PhD, Associate Professor, Universiti Sains Malaysia, USM, Penang, Malaysia

Javed Shaikh, MPharm, Manager, HEOR, Novartis, Hyderabad, Telangana, India

Manvi Sharma, MBA, BPharm, University of Houston, Houston, TX, USA

James Shaw, PhD, PharmD, MPH, Director, Oncology, WWHEOR, Bristol-Myers Squibb, Princeton, NJ, USA

Natalia Shcherbakova, PhD, Assistant Professor, College of Pharmacy, Western New England University, Springfield, MA, USA

Irlene Shen, MSc, Associate Health Economics Manager, Xian-Jassen, Beijing, China

Shraddha Shinde, MPh, Global Health Economics Outcomes Researcher, Sanofi, Bridgewater, NJ, USA

Lei Si, PhD, Postdoctoral Research Fellow, University of Tasmania, Hobart, Tasmania, Australia

Mirko Sikirica, PharmD, Director, Value Evidence and Outcomes, GlaxoSmithKline, King Of Prussia, PA, USA

Luis Silva Miguel, PhD, Researcher, CISEP, Lisbon, Portugal

Nuno Silverio, PharmD, RPharm, MBA, Director Market Access & Governmental Affairs, Merck SA, Lisbon, Portugal

Robert Simko, PharmD, Research, WBA, Chicago, IL, USA

Liusine Simonian, PhD, Assistant, National University of Pharmacy, Kharkiv, UKraine

Tzahit Simon-Tuval, PhD, Senior Lecturer, Ben-Gurion University of the Negev, Beer-Sheva, Israel

Akhilesh Singh, PhD, SSW-I, Novartis, Hyderabad, Telangana, India

Ambrish Singh, MTech, Specialist, Therapy Access, St Jude Medical, Delhi, India

Rajpal Singh, MS, Business Process Lead, Tata Consultancy Services Pvt. Ltd, Mumbai, Maharashtra, India

Ruchi Singhal, MPharm, PhD Scholar, National Institute of Pharmaceutical Education and Research (NIPER), Mohali, Punjab, India

Palanisamy Sivanandy, MPharm, PhD, Lecturer, International Medical University, Kuala Lumpur, Malaysia

Renata Šmit, MSc, MBA, University of Groningen, Groningen, The Netherlands

Stelle Smith, MHA, Principal, IMS Health, Asbury Park, NJ, USA

Erkki Soini, MSc, Chief Executive Officer, Health Economist, ESiOR Oy, Kuopio, Finland

Fatemeh Soleymani, PhD, Assistant Professor, Tehran University of Medical Sciences, Tehran, Iran

Swee Sung Soon, BSc, PhD Candidate, National University of Singapore, Singapore

Isabella Sormani, MIHMEP, Consultant, Wellmera AG, Basel, BS, Switzerland

Christina Spivey, PhD, Assistant Professor, University of Tennessee College of Pharmacy, Memphis, TN, USA

Kannan Sridharan, MD, DM, Associate Professor, Fiji National University, Suva, Fiji

Einav Srulovici, PhD, Research Assistant, University of Haifa School of Nursing, Haifa, Israel

Panagiotis Stafylas, MD, MSc, PhD, Scientific Coordinator & Chief Executive Officer, Medical Research & Innovation LP (MRI LP), Thessaloniki, Greece

Francis Staskon, PhD, Senior Analyst, Walgreens, Deerfield, IL, USA

Stephen Stefani, MD, Head of Oncology, Hospital do Câncer Mãe de Deus, Porto Alegre, Brazil

Stephen Stemkowski, MHA, PhD, Research Manager, Comprehensive Health Insights, Inc. a Humana Co., Louisville, KY, USA

Donald Stull, PhD, Head, Data Analytics and Design Strategy, RTI Health Solutions, Research Triangle Park, NC, USA

Nuwadatta Subedi, MD, Assistant Professor, College of Medical Sciences, Bharatpur, Nepal

Sangam Subedi, MPharm, Pokhara, Nepal

Hae Sun Suh, MSc, MA, PhD, Professor, Pusan National University, Busan, South Korea

Jeff Sullivan, MS, Associate Director, Advanced Modeling, Precision Health Economics, Boston, MA, USA

Akash Syed, PharmD, MS, Comsats Institute of information technology, Abbottabad, KPK, Pakistan

Safura Sultana Syeda, MS, Senior Analyst, Novartis Healthcare PVt. Ltd., Hyderabad, Telangana, India

Monika Szkultecka-Debek, MD, PhD, Payer RWE Leader Region Europe, Roche

Muhammad Tahir, PharmD, MPhil, Student, University of Veterinary & Animal Sciences, Lahore, Punjab, Pakistan, Lahore, Punjab, Pakistan

Bik Wai Tai, PharmD, Assistant Professor, Caritas Institute of Higher Education, Hong Kong, China

Varun Talla, PhD, Head Department Of Clinical Pharmacy, Talla Padmavathi College Of Pharmacy, Warangal, Telangana, India

Chao-Hsiun, Tang, PhD, Professor, Taipei Medical University, Taipei, Taiwan

Jun Tang, PhD, HEOR Researcher, Lundbeck, Deerfield, IL, USA

Daniel Tavares Malheiro, BSc, Statistician, Hospital Israelita Albert Einstein, Sao Paulo, Brasil

Matthew Taylor, PhD, Director, York Health Economics Consortium, University of York, York, North Yorkshire, UK

Yonas Tefera, BPharm, Lecturer, University of Gondar, Gondar, Amhara, Ethiopia

Stephanie Tenkeu, PharmD, University of Maryland, Baltimore, MD, USA

Karunrat Tewthanom, PhD, Assistant Professor, Faculty of Pharmacy, Silpakorn University, Mueang, Nakhonpathom

Dixon Thomas, PhD, Assistant Professor & Clinical Pharmacist, Gulf Medical University, Ajman, United Arab Emirates

Gwilym Thompson, PhD, Health Economic Lead, Janssen UK, High Wycombe, UK

Teja Thorat, MPH, MSc, Senior Research Associate, Tufts Medical Center, Boston, Massachusetts, USA

Dominic Tilden, BCom, MPH, Director, THEMA Consulting, Sydney, New South Wales, Australia

Leopoldo Trieste, PhD, Research Fellow, Scuola Superiore Sant’Anna, Pisa, Italy

Noa Triki, PhD, Maccabi Healthcare Services, Israel

Isotta Triulzi, Pharmaceutical Chemistry, Research Fellow, Scuola Superiore sant’Anna, Pisa, Italy

Ilse Truter, DCom, BPharm, PhD, Professor In Pharmacy & Leader Of Drug Utilization Research Unit (DURU), Nelson Mandela Metropolitan University, Port Elizabeth, Eastern Cape, South Africa

Vicki Tse, MB, BS, BSc, FRACMA, FHKCCM, Director, Princeps Medical Consulting, Hong Kong, , Hong Kong

Dan Tucker, MBBS, FRACGP, FRSPH, Primary Care Physician &Health Economics Consultant, Costing Health Pty Ltd, Hobart, Tas, Australia

Anil Tumkur, PhD, Lecturer, International Medical University, Kuala Lumpur, Malaysia

Adina Turcu-Stiolica, PhD, Lecturer, University of Medicine and Pharmacy, Craiova, Romania

Assiya Turgambayeva, PhD, Professor, Astana Medical University, Astana, Kazakhstan

Asterie Twizeyemariya, PhD, Research Fellow, University of South Australia, Adelaide, South Australia, Australia

Nayanabhirama Udupa, MPharm, PhD, Research Director-Health Sciences, Manipal University, Manipal, Karnataka, India

Navneet Upadhyay, MS, Graduate Student, University of Houston, Houston, Texas, USA

Michael Urban, MBA, MSc, Team Leader Technology Assessment, MED-EL Medical Electronics GmbH, Innsbruck, Tyrol, Austria

Nirma Khatri Vadlamudi, MPH, Quality Specialist Ii, PAREXEL, Hyderabad, Telangana, India

Ghislaine Van Mastrigt, PhD, Post-Doc Researcher, Maastricht University, Maastricht, The Netherlands

Joe Vandigo, MBA, Director, Policy & Research, PhRMA, Washington, DC, USA

Stefan Varga, PharmD, Postdoctoral Health Economics and Outcomes Research Fellow, Thomas Jefferson University, Philadelphia, PA, USA

Sheeba Varghese Gupta, PhD, Assistant Professor, University of South Florida, Tampa, FL, USA

Nebibe Varol, PhD, Health Economist, AstraZeneca, Cambridge, Cambridgeshire, UK

Satyanarayana Murthy Vatturi, MPharm, Associate Consultant, Marksman Healthcare Solution, Mumbai, Maharastra, India



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Rathikanti Venkateswara Rao, PharamD, Assistant Professor, Chalpathi Institute of Pharmaceutical Sciences, Guntur, Andhra Pradesh, India

Thomas Verstraeten, MD, MSC, Managing Director, P95, Leuven, Belgium

Monica Vinhas De Souza, PhD, MD & Researcher, HCPA-UFRGS, Porto Alegre, Rio Grande do Sul, Brazil

Ricardo Vitorino, Gilead Sciences, Lisbon, Portugal

Amir Viyanchi, PhD, Budget Analyst, Hamedand University of Medical Sciences, Hamadan, Hamedan, Iran

Ami Vyas, PhD, Assistant Professor, University of Rhode Island, Kingston, Rhode Island, USA

David Walker, PhD, Director of Health Economics and Clinical Outcomes Research, Astellas, Northbrook, IL, USA

Surrey Walton, PhD, Associate Professor, UIC, Chicago, IL, USA

Han-I Wang, PhD, Research Fellow, University of York, York, Yorkshire, UK

Meng-Ting Wang, PhD, Associate Professor, School of Pharmacy, National Defense Medical Center, Taipei, Taiwan

Yan Wang, PhD, Health Economist, Greyhealth Group, New York, New York, USA

Alexandra Ward, PhD, MRPharmS, Senior Research Scientist, Evidera, Lexington, MA, USA

Diane Whalley, PhD, Senior Director, Patient Reported Outcomes, RTI Health Solutions, Manchester, UK

Thomas Wilke, PhD, Head Of Institute, IPAM, University of Wismar, Wismar, Germany

Jennifer Wing, Masters, Consultant, Crawford Research, Paris, France

Saranrat Wittayanukorn, PhD, Postdoctoral Fellow, ORISE, Food and Drug Administration, Silver Spring, MD, USA

Andrew Worsfold, BSc (Hons), Independent Researcher, Independent, Cambridge, UK

Samantha Wronski, MSc, Senior Consultant, Curo Consulting, New York, NY, USA

Jun Wu, PhD, Associate Professor, Presbyterian College School of Pharmacy, Clinton, South Carolina, USA

Xiaoping Xie, MSc, Senior Health Economics & Outcomes Research Manager, Pfizer China, Beijing, China

Kun Yang, PharmD, Post-Doctoral Fellow, Biogen, Boston, MA, USA

Hui Yee Yeo, MPharm, Postgraduate Student, University Sains Malaysia, Penang, Malaysia

Atakan Yesil, MSc, Head of Patient Access, Baxalta, Istanbul, Turkey

Shirley Yeung, BSc, ACPR, MSc, Vancouver, British Columbia, Canada

Rong Yi, PhD, Director, Milliman, Inc., New York, NY, USA

Tania Yuka Yuba, MSc, PhD Candidate, University of São Paulo School of Medicine, São Paulo, Brazil

Mohammed Zabiuddin Ahad, PharmD, Student (INTERN), MCOPS, Udupi, Karnataka, India

Pardis Zaboli, PharmD, PhD Candidate of Pharmacoeconomics and Pharmaceutical Administration, Tehran University Of Medical Sciences, Tehran, Iran

Günther Zauner, MSc, Team Leader Health Care Modelling, DWH GmbH, Member of DEXHELPP, Vienna, Austria

Ahmed Zazaa, MBA, BCs, Market Access Director, Novartis, Basel, Switzerland

Ruizhi Zhao, MS, BSPharm, PhD Candidate, University of Minnesota, Minneapolis, Minnesota, USA

Xiaohui Zhao, Graduate Assistant, West Virginia University, Morgantown, WV, USA

Zhongyun Zhao, PhD, Director, Amgen, Thousand Oaks, CA, USA

Lixian Zhong, PhD, Assistant Professor, Texas A&M University, College Station, Texas, USA

Yue Zhong, MD, PhD, Project Director, Tufts Medical Center, Boston, Massachusetts, USA

Ning (Julia) Zhu, MPH, Senior Analyst, Walgreens Co., Deerfield, Ill, USA

Che Zin, PhD, Lecturer, International Islamic University Malaysia, Kuantan, Pahang Darul Makmur, Malaysia



WORKSHOP REVIEW COMMITTEE

Linda Abetz-Webb, MA, Chief Executive Officer, Senior Research Director, Patient-Centered Outcomes Assessments, Bollington, Macclesfield, UK

Shohei Akita, PhD, Technical Expert, PMDA, Osaka, Japan

Rajesh Balkrishnan, PhD, Professor, University Of Virginia School Of Medicine, Charlottesville, VA, USA

Sanjeev Balu, PhD, MBA, BPharm, Director, HEOR, Sandoz, Princeton, NJ, USA

Jawahar Bapna, PhD, Professor, SMS Medical College, Jaipur, Rajasthan, India

Mickael Basson, MD, MSc, MPH, Senior Associate, Lilly France, Neuilly Sur Seine, France

Amélie Beaudet, BPharm, MSc, Associate Director, Global Market Access & Pricing, Actelion Pharmaceuticals, Allschwill, Switzerland

Murtuza Bharmal, BPharm, PhD, Director, Merck KGAA, Darmstadt, Hessen, Germany

Adam Bouras, MSc, Project Director, University Of Missouri, Columbia, MO, USA

Lance Brannman, PhD, Health Economics Group Director, AstraZeneca, Gaithersburg, Maryland, USA

Nathalie Bruck, PhD, Marketing Manager, Transgene, Strasbourg, France

Ivana Cattaneo, Director Market Access And External Affairs Rare Disease Europe, Novartis, Milano, Italy

Akriti Chahar, MSc, Consultant (Health Technology Assessment), National Health Systems Resource Centre, New Delhi, India

Cheryl Coon, PhD, Principal, Outcometrix, Tucson, Arizona, USA

Shelby Corman, PharmD, MS, Associate Director, HEOR, Pharmerit International, Bethesda, MD, USA

Makesha Cropper, MSc, Senior Manager, Product Management, RWES, IMS Health, Plymouth Meeting, PA, United States

Jamiu Olusola Dada, PhD, Director, Silver-Ray Global Incorporation, Ikeja, Lagos, Nigeria

Prithwiraj Das, MBBS, MSc, Senior Health Economist, Boehringer Ingelheim Ltd., Bracknell, Berkshire, UK

Ghadeer Dawwas, MBA, BPharma, PhD Student, University Of Florida, Gainesville, FL, USA

Shiva Devarakonda, MD, Senior Resident, Armed Forces Medical College, Pune, Maharashtra, India

Tan Doan, BPharm, MHEcon, PhD, Research Fellow, University Of Melbourne, Brisbane, Queensland, Australia

Caty Ebel Bitoun, MD, President, Acvfit Helpaging, Rueil Malmaison, Ile de France, France

Christopher Evans, PhD, Senior Research Leader, Endpoint Outcomes, Boston, MA, USA

Opeoluwa Fagbemi, PharmD, Pharmacist, University Of Maryland, Baltimore, Maryland, USA

Tao Fan, PhD, Director, Global HEOR, Sanofi, Bridgewater, New Jersey, USA

Ahmed Fathelrahman, PhD, Assistant Professor, College Of Pharmacy, Qassim University, Buraidah, AlQassim, Saudi Arabia

Jorge Felix, MSc, Director, Exigo, Lisbon, Portugal

Salah Ghabri, PhD, Health Economist, Haute Autorité De Santé (HAS), Paris, France

Ramiro Gilardino, MSc, Health Economics & Market Access Lead, Johnson & Johnson Medical Southern Region Latam, San Isidro, Buenos Aires, Argentina

Gerd Gottschalk, Health Economist, Reimbursement Director International, Autonomic Technologies, Munich, Germany

Dan Greenberg, PhD, Associate Professor, Ben-Gurion University Of The Negev, Beer-Sheva, Israel

Catharina Groothuis-Oudshoorn, PhD, Assistant Professor, University Of Twente, Enschede, The Netherlands

Sandra Guedes, MSc, Associate Director Epidemiology, Merck KGAA, Frankfurt, Hesse, Germany

Sumeet Gupta, PhD, Professor & Head, M M College Of Pharmacy, M M University, Mullana, Ambala, Haryana, India

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Tamas Agh, MD, MSc, PhD, Principal Researcher, Syreon Research Institute, Budapest, Hungary

Julia Aledort Gaebler, PhD, Vice President, Health Advances, LLC, Weston, MA, USA

Alex Artyomenko, PhD, Director RWE and Late Phase Research, Medpace, London, UK

Kagan Atikeler, MPharm, Pharmacist, HTA Departmen, Ministry of Health Turkey, Hacettepe University ISPOR SC, Ankara, Turkey

Louise Binder, BA, LLB, Health Policy Consultant, Canadian Cancer Survivors Network, Toronto, Ontario, Canada

Christian Brettschneider, PhD, Working Group Leader, University Medical Center Hamburg-Eppendorf, Hamburg, Germany

Bernd Brueggenjuergen, MD, MPH, Head Institute for Health Economics, Steinbeis University Berlin, Berlin, Germany

Stephanie Chen, PhD, Director, Health Economics and Payer Analytics, AstraZeneca, Gaithersburg, MD, USA

Michael Depietro, MD, Medical Director US Medical Affairs, AstraZeneca, Wilmington, DE, USA

Edward Drea, PharmD, Director, Sanofi, Phoenix, AZ, USA

William Dreitlein, PharmD, Director of Pharmaceutical Policy, Institute for Clinical and Economic Review (ICER), Boston, MA, USA

Sandeep Duttagupta, PhD, Vice President, CBPartners, New York, NY, USA

Yan Feng, PhD, Senior Economist, Office of Health Economics, London, UK

Maren Gaudig, MSc, Associate Director Market Access, Janssen, Neuss, Germany

Sean Gavan, MSc, BA(Hons), PhD Researcher (Health Economics), The University of Manchester, Manchester, UK

Bineet Gupta, PhD, Assistant Professor, Shri Ramswaroop Memorial University, Barabanki UP, Uttar Pradesh, India

Thomas Hach, MD, Director Healthcare Systems, Novartis International AG, Basel, Switzerland

Melinda Hanisch, BA, MPP, Director, Research Dissemination, Merck & Co., Inc., Lebanon, NJ, USA

Ansgar Hebborn, PhD, Head, Global HTA & Payment Policy, F. Hoffmann-La Roche AG, Basel, Switzerland

Mirjana Huic, MD, PhD, Assistant Director & Head of Department for Development, Research and Health Technology Assessment, Agency for Quality and Accreditation in Health Care and Social Welfare, Zagreb, Croatia

Sonia Indacochea, MD, Physician, Hospital Nacional Edgardo Rebagliati Martins, Lima, Perú

John Irwin, MSc, Senior Director Market Access, Zogenix Inc., Maidenhead, UK

Nahila Justo, MPhil, MBA, Associate Director, MAPI Sweden, Stockholm, Sweden

Sachin Kamal-Bahl, PhD, Vice President & Head, Global Health & Value Innovation Center, Pfizer, Inc., Collegeville, PA, USA

Nasreen Khan, PhD, Principal, Real World & Economics Consultancy, East Hanover, NJ, USA

Workshop Review Committee continued


Hanna Gyllensten, PhD, Postdoc Researcher, Karolinska Institutet, Stockholm, Sweden

Asha Hareendran, PhD, Senior Research Leader, Outcomes Research, Evidera, London, UK

Henry Henk, PhD, Vice President, Research, Optumlabs, Eden Prairie, MN, USA

Nick Hicks, Masters, Director, Commutateur Advocacy Communications, Paris, France

Anke-Peggy Holtorf, PhD, MBA, Managing Director, Health Outcomes Strategies Gmbh, Basel, Switzerland

Katherine Houghton, MSc, Associate Director, Health Economics, RTI Health Solutions, Raleigh-Durham, NC, USA

Diwakar Jha, MPharm, Analyst, Delhi, India

Rohit Khanna, BA, MBA, MSc, Managing Director, Catalytic Health, Toronto, Ontario, Canada

Omar Kigenyi, MHSR, Regional Supervisor-PMA Project, Makerere University School Of Public Health, Kampala, Uganda

Joonsu Kim, Mpharm, PhD candidate, Head Of Market Access(Director), Abbvie Korea, Seoul, South Korea

Saskia Knies, PhD, National Health Care Institute, The Netherlands

Monica Kobayashi, MBMA, Consultant, Parexel, Durham, NC, USA

Elena Lanati, PharmD, Managing Director, Ma Provider, Milan, Italy

Pamela Landsman-Blumberg, MPH, Senior Director Real World Evidence, Xcenda LLC, Palm Harbor, FL, USA

Dawn Lee, MMath, MSc, Head Of Health Economics, BresMed, Sheffield, S Yorks, UK

Xinliang Liu, PhD, Assistant Professor, University Of Central Florida, Orlando, FL, USA

David Mawdsley, PhD, Senior Research Associate, University Of Bristol, Bristol, UK

Jennie Medin, MPH, PhD, World Wide HEOR Director, Novartis, Basel, Switzerland

Kristen Migliaccio, BS, Director, GHEOR, Xcenda, Palm Harbor, Florida, USA

Aurelie Millier, PhD, Associate Director, Creativ-Ceutical, Paris, France

Gaëlle Nachbaur, MSc, HEOR Director, GSK, Marly Le Roi, France

Irina Odnoletkova, MA, MBA, Director Health Economics & Outcomes, PhD Fellow, Plasma Protein Therapeutics Association, University Of Leuven, Gent, België

Motolani Ogunsanya, MS, Doctoral Candidate, The University Of Texas At Austin, Austin, Texas, USA

Sherry Oluchina, Senior Lecturer, Jomokenyatta University Of Agriculture And Technology, Nairobi, Kenya

Amer Omar, DVM, HTA Director, Shire Pharmaceutical, Iver, Buckinghamshire, UK

Iwen Pan, PhD, Assistant Professor, Baylor College Of Medicine, Houston, Texas, USA

Cristina Parau, MSc, Drug Safety Associate, Pure Drug Safety Ltd., Grantham, UK

Vardhaman Patel, PhD, Manager, Health Technology Assessment, Eisai Inc., Woodcliff Lake, New Jersey, USA

Hemant Phatak, PhD, Senior Director, US HEOR - Oncology, EMD Serono, Rockland, MA, USA

Olaf Pirk, MD, PhD, Assistant Lecturer, TH Nuremberg Georg Simon Ohm, Nuremberg, Bavaria, Germany

Yeesha Poon, BSc, MSc, MBA, Toronto, Ontario, Canada

Ingvil Saeterdal, PhD, Senior Researcher, Norwegian Institute Of Public Health, Oslo, Norway

Antonio Sarria-Santamera, MD, PhD, Professor, National School Of Public Health, Madrid, Spain

Paul Scuffham, PhD, Director, Centre For Applied Health Economics, Griffith University, Brisbane, Queensland, Australia

Nandini Selvam, PhD, MPH, Senior Director, Healthcore, Inc, Alexandria, VA, USA

Dhvani Shah, MS, Senior Health Economist, ICON, New York, USA

Manpreet Sidhu, BA, PhD, MBA, Divisional Principal, ICON Health Economics And Epidemiology, New York, USA

Marco Soro, PharmD, Corporate Market Access, Angelini Spa, Rome, Italy

Jessica Stahl, DBH, Assistant Dean And Clinical Assistant Professor, University Of Arizona, Tucson, AZ, USA

Chloe Stengel, PhD, Consultant, Dolon, Paris, France

Mary Szalkowski, MS, Retired, Prisma Corp Previously, Parma, Ohio, USA

Naoko Tomita, MA, Senior Researcher, National Institute Of Public Health, Wako, Saitama, Japan

Domenico Valle, MD, MSc, Regulatory & Price Reimbursement Access Director, Eli Lilly, Rome, Lazio, Italy

Richard White, PhD, MPH, Senior Director HEOR, Celldex Therapeutics, Hampton, NJ, USA

Eric Wittbrodt, PharmD, MPH, Director, HEOR, AstraZeneca, Fort Washington, PA, USA

Jingchuan Zhang, PhD, Manager, Pacira Pharmaceuticals, Parsippany, NJ, USA

ISSUE PANEL REVIEW COMMITTEE

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Issue Panel Review Committee continued


Anusha Kheir, MPH, Head, Health Technology Assessment Center, Director, Global Health Economics, Global Value Access & Policy, Amgen, Thousand Oaks, CA, USA

Kathrin Kreyenberg, PSI CRO, Munich, Germany

Lincy Lal, PhD, Director, HEOR, Optum, Missouri City, Texas, USA

Karen, Lee, MA, Director, Health Economics, CADTH, Ottawa, ON, Canada

Bengt Liljas, PhD, Global Price & Reimbursement Director, AstraZeneca, Gaithersburg, MD, USA

Deborah Marshall, PhD, Professor, University of Calgary, Calgary, Canada

Alan Martin, MSc, Director, Value Evidence and Outcomes, GlaxoSmithKline, Uxbridge, Middlesex, UK

Steve Marx, BS, MS, PharmD, Director HEOR, Abbvie, North Chicago, IL, USA

Uday Venkat Mateti, PharmD, PhD, Assistant Professor and Incharge Pharm D Program, NGSMIPS, Nitte University, Mangalore, Karnataka, India

Josephine Mauskopf, PhD, Vice President, Health Economics, RTI Health Solutions, Research Triangle Park, NC, USA

Edward Mills, PhD, Division Chief, Precision Global Health, Vancouver, British Columbia, Canada

Shevani Naidoo, BPharm, MSc, Director Medical Affairs Global (HEOR), Astellas, Chertsey, Surrey, UK

Claudia Nicolay, PhD, Group Leader within European Statistics, Eli Lilly, Bad Homburg, Hessia, Germany

Beth O’Leary, BSc Hons, MAACB, MPH, Executive Director, Covance, London, UK

Diego Ossa, Global Market Access Director, Novartis, Basel, Swizerland

Ida Palsberg, MSc, Global Market Access Manager, LEO Pharma, Copenhagen, Denmark

George Papadopoulos, BSc(Hons), Managing Director, Emerald Corporate Group, McMahons Point, New South Wales, Australia

Adam Parnaby, MSc, Director Pricing & Market Access, Celgene International Sarl, Paris, France

Jeetvan Patel, PhD, Senior Manager, Amgen, Thousand Oaks, California, USA

Fred Peyerl, PhD, MBA, Partner, Boston Strategic Partners, Centennial, CO, USA

Barbara Ramos, PhD, Associate Director, Medical Affairs, Astellas Pharma, Markham, ON, Canada

Bruno Riveros, MSc, Student, Federal University of Parana, Curitiba, Parana, Brazil

Raúl Sánchez Kobashi, MA, HEOR Manager, GSK, Mexico, Mexico City, Mexico

Luciana Scalone, PhD, Researcher, University of Milano Bicocca, Monza, Italy

Enrique Seoane-Vazquez, PhD, Associate Professor, Massachusetts College of Pharmacy, Boston, MA, USA

Karen Smoyer, PhD, Strategic Director, HEOR and RWE, Envision Pharma Group, Philadelphia, PA, USA

Eldon Spackman, PhD, Assistant Professor, University of Calgary, Calgary, Alberta, Canada

Dong-Churl Suh, PhD, Professor & Director, Chung-Ang University, Seoul, South Korea

Million Tegenge, PhD, Pharmacologist, United States Food and Drug Administration, Silver Spring, MD, USA

Tomas Tesar, Associate Professor, Head of Department of Organisation and Management of Pharmacy, Pharmaceutical Faculty, Comenius University, Bratislava, Slovakia

Simu Thomas, MS, PhD, Executive Director, Global Head Market Access and HEOR, CGTU, Novartis, East Hanover, NJ, USA

Pramil Tiwari, MPharm, PhD, Professor & Head, Department of Pharmacy Practice, National Institute of Pharm Education (NIPER), SAS Nagar, Punjab, India

Laura Vinuesa, DVM, MSc, Market Access Analyst, Decision Resources Group, London, UK

Lixia Wang, PhD, Senior Vice President, Biometrics and HEOR, CTI Biopharma Corp, Seattle, WA, USA

Dana Weiss, MA, Director of Linguistic Validation, AMPLEXOR Life Sciences, Glencoe, Illinois, USA

Thomas Weiss, Executive Director, Merck, West Point, PA, USA

Durhane Wong-Rieger, PhD, President & Chief Executive Officer, Institute for Optimizing Health Outcomes, Toronto, Ontario, Canada

Jipan Xie, MD, PhD, Vice President, Analysis Group, Inc., Los Angeles, CA, USA

Kaoru Yamabe, MSc, RPh, Senior Director, Tekeda Pharmaceutical Company Ltd., Tokyo, Japan

Hongbo Yuan, MD, PhD, Scientific Advisor, Canadian Agency for Drugs and Technologies in Health, Ottawa, ON, Canada

Vladimir, Zah, PhD(c), Health Economist, ZRx Outcomes Research Inc., Belgrade, Serbia

Carla Zema, PhD, Director, Health Policy and Economics, ZOLL, Pittsburgh, PA, USA


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2016-2017 ISPOR LEADERSHIP DIRECTORY

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ISPOR LEADERSHIP DIRECTORY

President (2016-2017)Lou Garrison, PhDProfessor, Pharmaceutical Outcomes Research & Policy Program, School of Pharmacy University of WashingtonSeattle, WA, USA President-Elect (2016-2017)Shelby D. Reed, RPh, PhDProfessor, Duke UniversityDurham, NC, USA

Past President (2016-2017)Daniel C. Malone, RPh, PhDProfessor of Pharmacy, College of Pharmacy& Associate Professor in Mel & Enid Zuckerman College, University of ArizonaTucson, AZ, USA Director (2015-2017)Nancy Devlin, PhDDirector of ResearchOffice of Health EconomicsLondon, UK Director (2015-2017)Manuel Espinoza, MD, MSc, PhD Professor, Department of Public Health & Chief, HTA Unit, Catholic University of Chile, Santiago, Chile and Honorary Visiting Fellow, Centre for Health Economics, University of York York, UK Director (2015-2017)Dana Goldman, PhDLeonard D. Schaeffer Director’s Chair & Director, Schaeffer Center for Health Policy& Economics, University of Southern California Los Angeles, CA, USA

Director (2016-2018)Joanna Lis, MSc, MBA, PhDDirector of Market AccessSanofi-Aventis Warsaw, Poland

Director (2016-2018)Gordon G. Liu, PhDPKU Yangtze River Scholar Professor of Economics Peking University National School of Development; Director, PKU China Center for Health Economic Research Beijing, China

Director (2016-2018)Rosanna Tarricone, MSc, PhDAssociate ProfessorBocconi UniversityMilan, Italy

Director (2016-2018)John Watkins, MPH, PharmDFormulary ManagerPremera Blue Cross Mountlake Terrace, WA, USA

Treasurer (2013-2017)Zeba M. Khan, RPh, PhDVice President Celgene CorporationSummit, NJ, USA

CEO & Executive DirectorNancy S. BergCEO & Executive DirectorInternational Society for Pharmacoeconomicsand Outcomes Research (ISPOR) Lawrenceville, NJ, USA

ISPOR 2016-2017 Board of Directors

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2016-2017 ISPOR BOARD COMMITTEE CHAIRS

gOVERNANCE INItIAtIVEAdrian Towse, MA, MPhil, director, Office of Health Economics, London, Uk

AUdIt COMMIttEEDana Goldman, PhD, Leonard d. Schaeffer, director’s Chair & director, Schaeffer Center for Health Policy & Economics, University of Southern California, Los Angeles, CA, USA

FINANCE COMMIttEEZeba M. Khan, RPh, PhD, Vice President, Celgene Corporation, Summit, NJ, USA

NOMINAtIONS COMMIttEEAdrian Towse, MA, MPhil, director, Office of Health Economics, London, Uk

PUBLICAtIONS MANAgEMENt AdVISORY BOARdNancy Devlin, PhD, Professor, director of Research, OHE, London, Uk

ISPOR MEETING PROGRAM COMMITTEE CHAIRS

ISPOR 21st ANNUAL INtERNAtIONAL MEEtINg Bradley C. Martin, PharmD, RPh, PhD, Professor & Head, division of Pharmaceutical Evaluation and Policy, University of Arkansas for Medical Sciences College of Pharmacy, Little Rock, AR, USA

Eleanor M. Perfetto, PhD, MS, Senior Vice President, Strategic Initiatives, National Health Council, washington, dC and Professor, Pharmaceutical Health Services Research, School of Pharmacy, University of Maryland, Baltimore, Md, USA

ISPOR 7th ASIA PACIFIC CONFERENCE Wai Keung Chui, PhD, Head of department of Pharmacy in National University of Singapore, Singapore

Ahmad Fuad Afdhal, PhD, director of Center for Socio-Economic Studies in Pharmacy, Jakarta, Indonesia

Syed Aljunid, MD, PhD, Professor, Health Economics & Public Health Medicine, and Head, International Centre for Casemix and Clinical Coding, Faculty of Medicine, National University of Malaysia, kuala Lumpur, Malaysia

ISPOR 19th ANNUAL EUROPEAN CONgRESS Hans-Georg Eichler, MD, MSc, Senior Medical Officer, European Medicines Agency (EMA), London, Uk

Tomasz Hermanowski, PhD, InterQuality Project Leader and Professor & Head, department of Pharmacoeconomics, Medical University of warsaw, warsaw, Poland

ISPOR EDUCATION COUNCIL CHAIRS

CHAIRSean Sullivan, PhD (2015-2017), Stergachis Family Professor & director, Pharmaceutical Outcomes Research and Policy Program, University of washington, Seattle, wA, USA

ISPOR AWARDS COMMITTEE CHAIRS

CHAIRSean Sullivan, PhD (2015-2017), Stergachis Family Professor & director, Pharmaceutical Outcomes Research and Policy Program, University of washington, Seattle, wA, USA

AVEdIS dONABEdIAN AwARd COMMIttEEMark J. Sculpher, MSc, PhD, (2015-2017), Professor of Health Economics, Centre for Health Economics, University of York, Heslington, York, Uk

MARILYN dIX SMItH LEAdERSHIP AwARd COMMIttEEScott D. Ramsey, MD, PhD, (2015-2017), Member, Fred Hutchinson Cancer Research Center; Professor, School of Pharmacy, School of Medicine, Institute for Public Health genetics, University of washington, Seattle, wA, USA

ISPOR BERNIE J. O’BRIEN NEw INVEStIgAtOR AwARd COMMIttEEJalpa A. Doshi, PhD, (2015-2017), Associate Professor of Medicine, director, Economic Evaluations Unit, Center for Evidence-based Practice, director, Value-based Insurance design Initiatives, Center for Health Incentives and Behavioral Economics, Associate director, ECRI-Penn AHRQ Evidence-based Practice Center, University of Pennsylvania, Philadelphia, PA, USA

ISPOR MEEtINg tRAVEL gRANtVlad Zah, Phd (c), (2016-2018), Health Economics Consultant, Belgrade, Serbia

RESEARCH EXCELLENCE AwARdS COMMIttEE

MEtHOdOLOgY IN PHARMACOECONOMICS ANd HEALtH OUtCOMES RESEARCHFederico Augustovski, MD, MSc, PhD, (2015-2017), director, Economic Evaluations and HtA department, Institute for Clinical Effectiveness and Health Policy (IECS), Professor of Public Health, University of Buenos Aires and Staff Physician, Family & Community Medicine division, Hospital Italiano de Buenos Aires, Buenos Aires, Argentina

APPLICAtION OF PHARMACOECONOMICS ANd HEALtH OUtCOMES RESEARCHDan Greenberg, PhD, MSc, BA, (2015-2017), department Chairman, Ben- gurion University of the Negev, Beer-Sheva, Israel

ISPOR PUBLICATIONS

VALUE IN HEALTH CO-EdItORS-IN-CHIEFMichael Drummond, MCom, DPhil, (2014-2018), Professor of Health Economics, Centre for Health Economics, Alcuin College, University of York, Heslington, York, Uk

C. Daniel Mullins, PhD, (2014-2018), Professor, Pharmaceutical Health Services Research, School of Pharmacy, University of Maryland, Baltimore, Md, USA

VALUE IN HEALTH REGIONAL ISSUES CO-EdItORS-IN-CHIEFFederico Augustovski, MD, MSc, PhD, (2015-2017), director, Economic Evaluations and HtA department, Institute for Clinical Effectiveness and Health Policy (IECS), and Professor of Public Health, University of Buenos Aires Buenos Aires, Argentina

Bong-Min Yang, PhD, (2015-2017), Professor of Health Economics, Health Economics School of Public Health, Executive director, Institute of Health and Environment, Seoul National University, Seoul, South korea

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Dan Greenberg, PhD, (2016-2018), Associate Professor, department of Health Systems Management, Faculty of Health Sciences, Ben-gurion University of the Negev, Beer-Sheva, Israel

VALUE & OUTCOMES SPOTLIGHT EdItOR-IN-CHIEFDavid Thompson, PhD, (2016-2020), Senior Vice President, inVentiv Health, Burlington, MA, USA

ISPOR ADVISORY COUNCILS

HEALtH SCIENCE POLICY COUNCIL CHAIRScott Ramsey, MD, PhD, (2015-2017), Member, Fred Hutchinson Cancer Research Center & Professor, School of Pharmacy, School of Medicine, Institute for Public Health genetics, University of washington, Seattle, wA, USA

HEALtH tECHNOLOgY ASSESSMENt COUNCIL CHAIRFinn Børlum Kristensen, MD, PhD, (2014-2017),

Former EUnetHtA Executive Committee Chairman and EUnetHtA Secretariat director and Professor, Faculty of Health Sciences, University of Southern denmark, Copenhagen, denmark

INStItUtIONAL COUNCIL CHAIR James Murray, PhD (2016), Research Fellow, global Health Outcomes and COE, Eli Lilly and Co., Carmel, IN, USA

StUdENt CHAPtER FACULtY AdVISORY COUNCIL CHAIRDennis Raisch, PhD, RPh, BS, MS, (2015-2017), Professor, University of New Mexico, College of Pharmacy, New Mexico, Albuquerque, NM, USA

NETWORKS

ISPOR CENtRAL & EAStERN EUROPE NEtwORk EXECUtIVE COMMIttEE CHAIRVlad Zah, Phd (c), (2015-2017), Health Economics Consultant, Belgrade, Serbia

ISPOR ARABIC NEtwORk EXECUtIVE COMMIttEE CHAIRAbdulaziz H. Al-Saggabi, MSc, PharmD, (2016-2018), director, drug Policy & Economics Center, Ministry of National guard Health Affairs, Riyadh, Saudi Arabia

ISPOR AFRICA NEtwORk EXECUtIVE COMMIttEE CHAIRMahmoud Elmahdawy, PharmD, (2016-2018), director, Market Access and Health Economics, Novartis, Lecturer of Clinical & Hospital Pharmacy, Misr International University, Cairo, Egypt

CONSORTIA

ASIA CONSORtIUM EXECUtIVE COMMIttEE CHAIRIsao Kamae, MD, DrPH (2016-2018), Professor of Health technology Assessment and Public Policy, graduate School of Public Policy, the University of tokyo, tokyo, Japan

LAtIN AMERICA CONSORtIUM EXECUtIVE COMMIttEE CHAIRManuel Espinoza, MD, MSc, PhD, (2016-2018), Professor, department of Public Health & Chief, HtA Unit, Catholic University of Chile, Santiago, Chile and Honorary Visiting Fellow, Centre for Health Economics University of York, York, Uk

ISPOR STUDENT COUNCIL

StUdENt NEtwORk CHAIR (2016-2017)Eman Biltaji, University of Utah Salt Lake City, Utah, USA

StUdENt NEtwORk AdVISOR (2016-2017)Zeba M. Khan, RPh, PhD, Vice President, Celgene Corporation, Summit, NJ, USA

ISPOR PAST PRESIDENTS

2015-2016 Daniel C. Malone, RPh, PhD

2014-2015 Adrian Towse, MA, MPhil

2013-2014 William H. Crown, PhD

2012-2013 Deborah Marshall, PhD, MSHA

2011-2012 Mark J. Sculpher, MSc, PhD

2010-2011 Scott D. Ramsey, MD, PhD

2009-2010 Michael Barry, MD, PhD, FRCPI

2008-2009 Chris L. Pashos, PhD

2007-2008 Diana Brixner, RPh, PhD

2006-2007 Michael Drummond, MCom, DPhil

2005-2006 Peter J. Neumann, ScD

2004-2005 Lieven Annemans, PhD, MSc, Mman

2003-2004 Sean Sullivan, MS, PhD

2002-2003 Peter Davey, MD, FRCP

2001-2002 Eva Lydick, PhD

2000-2001 Jon Montague-Clouse, RPh, MS

1999-2000 Bryan R. Luce, PhD, MBA

1998-1999 Robert S. Epstein, MD, MS

1997-1998 James Smeeding, RPh, MBA

1996-1997 Jean Paul Gagnon, PhD

1995-1996 William McGhan, PharmD, PhD

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KEY INFORMATION pages 110-113

FLOOR PLAN page 114

KEY INFORMATION AND FLOOR PLAN

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KEY INFORMATION

CONGRESS OBJECTIVES

Participants will be able to:

• Learn new health economics and outcomes research methods and techniques;

• Improve the quality of decision making through better utilization of health economics and outcomes research studies; and

• Learn how to assess and select the appropriate quality-of-life measurement instruments.

LANGUAGE INFORMATION

All sessions at the ISPOR 19th Annual European Congress are presented in English. ISPOR regrets that due to the

disruption to other delegates, whisper translation (chuchotage) is not permitted in any session, including short courses. To discuss options to meet educational needs in multiple languages, please contact [email protected].

NAME BAdGES & REGISTRATION MATERIALS

ISPOR now offers self-serve check-in and name badge printing. Printing stations will be set up in the Entrance to the Congress Center (Level 0), where delegates can scan the bar code from their email confirmation, or enter their email address or member ID to print their name badge.

The following tickets will also print with your name badge:

• Short Course ticket for each Short Course for which you registered (you MUST bring your Short Course ticket to the room to collect your materials and be admitted);

• One complimentary drink ticket to the Exhibitors’ Open House Reception: Monday, 31 October from 18:00-19:45;

• One complimentary drink ticket to the Exhibitors’ Wine & Cheese Reception: Tuesday, 1 November from 17:30-19:15;

• Social Event ticket (if pre-registered); and

• Continuing Education ticket (if pre-registered).

Registration bags, lanyards, Program & Schedule of Events, and Value in health Volume 19, Issue 7 are available for pick-up near ISPOR registration.

For security purposes all individuals must be registered and wear the official ISPOR Event Name Badge to gain access to the event, the sessions, the exhibit poster hall and any other ISPOR activity. Onsite staff and security will monitor for name badges and will deny access if individual does not have an official ISPOR Event Name Badge. Individuals not wearing a name badge will be directed to the registration help desk. Please note that if you lose your name badge and need to have it re-printed you cannot print that at the self-serve station, you will need to visit the registration help desk.

Because of the professional nature of the program, safety and liability reasons; guests and anyone under the age of 18 are not permitted access or to register for the event. This includes access to the event in general, to scientific presentations, and to the exhibit poster hall.

For any ISPOR sponsored social event, guests over the age of 21 are permitted to attend but must have a paid event ticket. Due to insurance and liability no one under 21 will be permitted to attend a social event.

CONGRESS REGISTRATION/SESSIONS

General event registration is inclusive of symposia, all general conference sessions, poster presentations, and the exhibit hall.

Separate registration is required for all Short Courses (Saturday, 29 October and Sunday, 30 October) and for the Social Event (Tuesday, 1 November). Please see ISPOR Registration for details. A schedule of ISPOR Group meetings, which are by invitation only, is provided on pages 75-76 of the Program & Schedule of Events, as well as in the congress mobile app and on the ISPOR website.

Congress registration is inclusive of symposia on Saturday, 29 October and Sunday 30 October and all congress sessions Monday-Wednesday, no pre-registration is required.

ISPOR REGISTRATION & HELP dESK HOURSISPOR Registration is located in the Entrance to the Congress Center (Level 0).

• Saturday, 29 October: 8:00-18:00 • Sunday, 30 October: 7:00-18:00 • Monday, 31 October: 7:00-18:00 • Tuesday, 1 November: 7:00-18:00 • Wednesday, 2 November: 7:00-16:00

SPECIAL SERVICES FOR dELEGATES

• Coat, Poster, Luggage Check: is available for a small fee and is located off the main entrance in Room 0.15-0.16 (L0).

• Dining: Café Motto will be available in the Entrance to the Congress Center (Level 0) for grab-and-go food/beverage purchases starting on Saturday. The Cantine (remote café) will be available in the Exhibit-Poster Hall (Hall X2 and X3 on Level -2) starting on Monday.

• Housing/Hotel: A representative of K.I.T. Group, the official ISPOR housing service, is onsite at the Entrance to the Congress Center (Level 0) to help delegates with any hotel questions they may have. This service is only valid for those who booked their hotels through the ISPOR/K.I.T. Group and not for any arrangements made outside of the official ISPOR rooming block. Saturday, 29 October: 9:00-18:00 Sunday, 30 October: 9:00-18:00 Monday, 31 October: 9:00-18:00 Tuesday, 1 November: 9:00-14:00

• First Aid Station: Behind Hall E2 on Level 0.

• Nursing Mothers’ Room: Room 0.41 (L0)

• Prayer Room: Hall L8 (L1)

EXHIBIT HALL HOURS

Exhibits are located in Hall X2 and X3 on Level -2.

Exhibitor Set-Up – Sunday, 30 October: 11:00-18:00

Exhibitor Dismantle – Wednesday, 2 November: 15:00

Exhibits Viewing Hours:

• Sunday, 30 October: 11:00-18:00 – Exhibitor Set-Up • Monday, 31 October: 8:30-19:45 – Exhibits Viewing • Tuesday, 1 November: 8:30-19:15 – Exhibits Viewing • Wednesday, 2 November: 8:30-15:00 – Exhibits Viewing

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Key information continued


ISPOR CONGRESS APP

Access the mobile app on your smartphone or use the myISPORVienna website (https://myisporvienna.zerista.com/) on your computer or tablet. Both options allow users to:

• Update your “electronic business card” (personal profile);

• Create a personalized Congress schedule;

• Search the congress program by scientific topic, keyword, or speaker;

• Connect with other attendees by sending messages (while keeping your email address private); and

• Find exhibitors and sponsors to connect with by viewing their virtual booths.

Search for “ISPOR 2016 Meetings” in the App Store or on Google Play!

The ISPOR 2016 Meetings app is compatible with Apple and Android devices and is available for download on the App Store and Google Play.

See page 8 for more information.

WIFI & INTERNET ACCESS

Internet stations are provided in the Exhibit-Poster Hall located in Hall X2 and X3 on Level -2.

For the convenience of Congress attendees, Wi-Fi is available in the convention center.

NETWORK: ISPOR2016

PASSWORD: vienna16

Wi-Fi is only intended for checking email and using the Congress mobile app, not for downloading files. Connection speeds will vary depending on the volume of users.

RESEARCH POdIUM & POSTER ABSTRACTS

Abstracts for all podium and poster research presentations given at the ISPOR 19th Annual European Congress will be published in the November 2016 issue of Value in health (Volume 19, Issue 7). We encourage ISPOR members and 19th Annual European Congress registrants to view this issue of Value in health online at: http://www.ispor.org/valueinhealth_index.asp. Congress registrants may also pick up a hard copy of this issue of Value in health near ISPOR Registration while copies are available.

FINANCIAL dISCLOSURE INFORMATION

Research podium and poster presentation financial disclosure information is available online at: http://www.ispor.org/valueinhealth_index.asp and in the November 2016 issue of Value in health. Faculty and staff involved in the planning or presentation of this Congress are required to disclose all real or apparent commercial financial affiliations related to Congress content. This information is available on request at the ISPOR Registration desk.

PRESENTATION SLIdES/POSTERS

Congress plenary session, issue panel, workshop, ISPOR forum, and symposia slides will be available via the Congress App and at the ISPOR 19th Annual European Congress Released Presentations page at www.ispor.org during/after the Congress, subject to speaker approval.

Podium and poster presentation abstracts and released slides or poster PDFs are available at the ISPOR Scientific Presentations Database (a searchable database of over 37,000 research papers presented at ISPOR meetings) at http://www.ispor.org/research_study_digest/index.asp.

HANdOUTS

• Plenary Sessions: Handouts for the plenary sessions are available in the session room at the time of the presentations.

• Research Presentations, Workshops & Issue Panels: Handouts for research presentations (podiums and posters), workshops, and issue panels are the sole responsibility of the presenting author(s).

• ISPOR Forums: Handouts for ISPOR Forums are available in the session room at the time of the presentations.

• Educational Symposia: Handouts for symposia are the sole responsibility of the host organization.

• All Remaining handouts will be made available at the handout table near ISPOR Registration

The Released Presentations page will feature many of the Congress’ slide presentations as PDFs. In 2015, more than 80% of the presentations were available to the public during/after the Congress. The Released Presentations page is accessible via the Congress mobile app and at www.ispor.org » 19th Annual European Congress.

ABSTRACT SUBMISSION HISTORICAL INFORMATION

During the ISPOR 19th Annual European Congress, 2206 posters, 51 research podiums, 32 workshops, and 21 issue panels will be presented.

SPEAKER INFORMATION

Upload the final version of your slide presentation in the Speaker Ready Room on the same day of your session!

All speakers are encouraged to use the Speaker Ready Room to preview their slide presentation and/or upload an updated version. Presentations submitted to ISPOR Speaker’s Corner by the specified advance deadline and all presentations uploaded/updated in the Speaker Ready Room 30 minutes prior to the session will be pre-loaded to the computer in the session room. All speakers are requested to arrive at their presentation room 15 minutes prior to the session start time. ISPOR staff will be available in the session room to assist the presenter.

Year Research Workshop Issue Total Not Panel Accepted (%)2012 1705 90 47 1842 11.7%2013 1888 103 55 2046 10.6%2014 2168 117 60 2345 9.3%2015 2592 97 78 2767 10.5%2016 2549 93 83 2725 13.8%

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A speaker ready room is provided in Room 0.90 on Level 0 with the following opening hours:

• Sunday, 30 October: 12:00-18:00 • Monday, 31 October: 8:00-18:00 • Tuesday, 1 November: 8:00-18:00 • Wednesday, 2 November: 8:00-15:00

RESEARCH POSTER PRESENTATIONS

Poster presentations will be on view in Hall X3 on Level -2.

The poster hall is organized in rows (A-L) and each poster board is numbered accordingly (e.g. A1, J10). Poster presentation titles and authors, as well as the numbered board location, are available on the https://myisporvienna.zerista.com/ web platform and ISPOR Vienna mobile app. This information is also available as a PDF on the ISPOR website and as a handout at the Poster Help Desk (please note quantities are limited).

Each poster presentation has been assigned a specific numbered board location, which is shown next to the presentation title. Please note this is different than the poster code (based on the abstract’s scientific topic), which was assigned to each poster presentation upon acceptance. Poster board numbering is shown on the floor plan on page 81 in the Program & Schedule of Events, as well as on the website and mobile app.

*Presenters are required to be at their posters during the Poster Author Discussion hour.

**Posters that are not removed at the scheduled dismantle times will be discarded.

ISPOR RESEARCH PRESENTATION AWARdS

Awards are given for the best research presentations for podiums and posters in the categories of GENERAL, NEW INVESTIGATOR, and STUDENT (up to 3 in each category).

All research podium presentations are considered for an award. The top 100 research poster presentations, based on abstract review score, are considered for a poster presentation award. These are identified with a rosette and will be judged during the Congress.

ISPOR 19th Annual European Congress Research Presentation Awards will be presented during the Third Plenary Session on Wednesday, 2 November at 11:15.

CONTINUING MEdICAL & CONTINUING PHARMACEUTICAL EdUCATION ACCREdITATION

NOTE: Continuing Education Accreditation is offered in conjunction with the ISPOR Short Course Program

only. Other Congress sessions and presentations are not accredited.

The ISPOr 19th Annual european congress Short course Program is co-sponsored by Purdue University College of Pharmacy, Continuing Education Division and ISPOR.

For pharmacists (CPE):

Attendees may earn up to 4 CPE credits per each accredited half-day short course session attendance, and up to 7.5 CPE credits per each accredited full day short course session attendance at the ISPOR 19th Annual European Congress.

Purdue University College of Pharmacy is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education. This is a knowledge-based, continuing education activity of Purdue University, an equal access/equal opportunity institution. Complete UAN, CPE/CME and disclosure information is listed within the continuing education Attendance and evaluation Booklet. To receive the maximum number of credits for each continuing education activity, participant must attend entire session and complete all registration and evaluation requirements.

For physicians (CME):

This activity has been planned and implemented in accordance with the Essential Areas and Policies of the Accreditation Council for Continuing Medical Education through the joint sponsorship of Purdue University College of Pharmacy and ISPOR. Purdue University College of Pharmacy, an equal access/equal opportunity institution, is accredited by the ACCME to provide continuing medical education for physicians. Purdue University College of Pharmacy designates this live activity for a maximum of up to 4 AMA PRA Category 1 Credit(s) TM per each accredited half-day short course attendance, and up to 7.5 AMA PRA Category 1 Credit(s) TM per each accredited full day short course attendance, towards the AMA Physician›s Recognition Award. Physicians should claim only the credit commensurate with the extent of their participation in the activity.

***Please note: Short courses are accredited based on presenters’ compliance with ACPE regulations. All presenters who comply with ACPE regulations will have their session accredited for Continuing Education credit. Accredited sessions will be designated in the CE Booklet.

INSTRUCTIONS

If you pre-registered: A Continuing Education materials ticket will be printed with your name badge. Registrants can redeem this ticket for the ISPOR 19th Annual European Congress continuing education Attendance and evaluation Booklet at the registration desk.

To register on-site: Please visit the registration desk. The fee for this service is l91 ($100).

To receive continuing education credits: Complete the ISPOR 19th Annual European Congress continuing education Attendance and evaluation Booklet and return the entire Evaluation Booklet to the ISPOR Help Desk at the end of the congress, OR send to the ISPOR office within two weeks of the close of the congress.

For CPE: Pharmacist’s ACPE credits will be directly reported to CPE Monitor within 60 days. No paper certificate will be sent to registrants. This requires that the participant provide their NABP e-profile ID and MMDD of birth. If you have any questions regarding the NABP ID please visit http://www.nabp.net/programs/cpe-monitor/cpe-monitor-service/

For CME: Certificates of participation will be sent 6 - 10 weeks after the receipt of the Evaluation Booklet to those who register and complete the program evaluation.

Please Note: Failure to return a completed CE Attendance & Evaluation Booklet to ISPOR within 30 days of the meeting end date will result in denial of credit.

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ISPOR SOCIAL EVENT

TUESDAY, 1 NOVEMBER 20:00-23:30

Grand Festival Hall (Festsaal) of Vienna’s City Hall, Rathaus Wien

Join us at the historic Grand Festival Hall of Vienna’s City Hall

for dinner, dancing and fun! This Gothic building is one of the most splendid in the city, with a tower reaching almost 98 meters high. Lighted by magnificent chandeliers, you will take a trip back in time with your ISPOR colleagues.

Separate registration required: j95 per person. Price includes buffet dinner, entertainment, and transportation from the Austria Center Vienna. registration subject to availability, see the ISPOr registration desk for details.

For Social Event Registrants:

• If you have pre-registered for the Social Event, your ticket will print out with your name badge. You will need this ticket for entry to the bus/event.

• Buses will depart from the Austria Center between 19:30 and 20:00 for the 15 minute journey to the Rathaus Wien.

• Return buses will start at 21:00, last bus at 23:15. Buses will depart every 30 minutes and different routes will serve various Congress hotels. Please see drivers for additional information.

SOCIAL MEdIA

Communicating by way of social media is encouraged if it falls within embargo and communications rules.

Be part of the live discussion!

• Tweet your comments to @ISPORorg during the Congress using #ISPORVienna

• Access expert insights and share your views on Congress sessions at the ISPOR LinkedIn Discussion Group: http://bit.ly/ISPOR-LIn

• Network with your peers on the ISPOR Facebook page: http://bit.ly/ISPOR-FB

RECORdING & PRESS INFORMATION

ISPOR supports the promotion of research presented at ISPOR Congresses, while safeguarding sensitive information, data, and research findings that are not yet available to the public. Due to the sensitive nature of data and the particularly preliminary, unpublished research findings, all filming and recording of scientific sessions and the poster hall is prohibited during the Congress, without the express written consent of ISPOR.

Portions of the ISPOR 19th Annual European Congress may be recorded by the International Society for Pharmacoeconomics and Outcomes Research (ISPOR). By participating in the discussions, Congress registrants agree that ISPOR may electronically copy, videotape, or audiotape their attendance at and involvement in any program. Registration and attendance at the ISPOR 19th Annual European Congress constitutes an

agreement by the registrant to ISPOR’s use and distribution (both now and in the future) of their image or voice in photographs, videotapes, electronic reproductions, and audiotapes of such events and activities. ISPOR will strictly enforce its rights as the exclusive licensee of all publication and reproduction rights to each presentation, and no presentation, in whole or in part, may be reproduced without approval from ISPOR.

Congress attendees must gain approval from a speaker or poster presenter prior to quoting or publishing that individual’s scientific results. Members of the press must identify themselves as such before questioning speakers and Congress attendees if using the information in a professional capacity.

More detailed information on ISPOR’s Press Pass, Legal, and Embargo Policies are available on ISPOR’s News & Press page at the ISPOR website (www.ispor.org).

For further questions on these policies, please contact: Betsy Lane ([email protected]), Director and Chief Marketing & Communications Officer.

CONGRESS PROGRAM dISCLAIMER

Please be advised that while the Congress program is designed to provide accurate information regarding the subject matter covered, the views, opinions, and recommendations expressed are those of the authors and speakers, not the International Society for Pharmacoeconomics and Outcomes Research (ISPOR), and thus ISPOR does not guarantee the accuracy of the information disseminated. If professional advice is desired, please consult a competent professional.

ANTITRUST COMPLIANCE

It is the undeviating policy of ISPOR to comply strictly with the letter and spirit of all local and U.S. Federal, State, and applicable international trade regulations and antitrust laws. Any activities of ISPOR or ISPOR-related actions of its officers, Executive Committee Members, or members that violate these regulations and laws are detrimental to the interests of ISPOR and are unequivocally contrary to ISPOR policy.

QUESTIONS & INFORMATION

Please ask ISPOR staff members for any additional information about the Congress or about ISPOR. ISPOR staff can be identified by their ISPOR name badge.

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CONGRESS FLOOR PLANS

Plenary and Breakout

Room

Green Level 1

iSPOR Registration

Press Roomi

Cloakroom

i

MainEntrance

i ii

Yellow Level 0

Brown Level -2

Red Level 2 –––––––Green Level 1 –––

Yellow Level 0 (ground) ––––Brown Level -2 –––

Nursing Mothers’

Room

i

First Aidi

Prayer Room

i

i Speaker Ready Room

Exhibit HallPoster Hall

Red Level 2

i

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The International Society for Pharmacoeconomics and Outcomes Research (ISPOR) provides

knowledge products and online tools to serve key health care stakeholders in the global health

economics and outcomes research (HEOR) community, including decision makers and payers,

researchers and academicians, regulators and assessors, industry, and patient representatives. These

knowledge products demonstrate ISPOR’s strong commitment to its mission to promote excellence

in HEOR to improve decision making for health globally. ISPOR also serves the HEOR community

by convening diverse constituencies to facilitate dialogue through initiatives such as its Health

Technology Assessment (HTA) Roundtables and Patient Representatives Roundtables.

Knowledge Products and Online ToolsDeveloped by ISPOR Scientific and Health Policy Working Groups

• Good Practices for Outcomes Research Reports

• Pharmacoeconomic Guidelines Around the World

• Global Health Care Systems Road Maps

• Scientific Presentations Database

• International Digest of Databases

• Assessing the Evidence for Health Care Decision Makers

• Guidelines Index for Outcomes Research

• ISPOR Books

– Book of Terms

– Therapeutic and Diagnostic Device Outcomes Research

– Reliability and Validity of Data Sources

– Taxonomy of Patient Registries

Additional information about ISPOR knowledge products is available at www.ispor.org.

ISPOR Knowledge Products and Online Tools


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International Society for Pharmacoeconomics and Outcomes Research 505 Lawrence Square Blvd. South, Lawrenceville, NJ 08648, USA tel: +1-609-586-4981 toll Free: 1-800-992-0643 Fax: +1-609-586-4982 Email: [email protected]

www.ispor.org

ISPOR Upcoming Events


UPCOMING ISPOR MEETINGS:ISPOR 22nd Annual International MeetingMay 20-24, 2017Boston, MA, USAAbstract Submission Opens: October 19, 2016Abstract Submission Deadline: January 19, 2017Early Registration Deadline: April 11, 2017 ISPOR 6th Latin America Conference15-17 September 2017São Paulo, BrazilAbstract Submission Opens: 23 January 2017Abstract Submission Deadline: 23 March 2017Early Registration Deadline: 18 July 2017 ISPOR 20th Annual European Congress4-8 November 2017glasgow, ScotlandAbstract Submission Opens: 27 March 2017Abstract Submission Deadline: 27 June 2017Early Registration Deadline: 19 September 2017

UPCOMING EDUCATIONAL TRAINING:Building a Budget Impact Model: Budget Impact Analysis TrainingNovember 16-17, 2016 durham, NC, USA

2017 EDUCATIONAL TRAININGS:Featuring the following topics—look for details to come:

Budget Impact Analysis

Elements of Pricing

Health Technology Assessment

Introduction to Health Economics and Outcomes Research

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