Date post: | 13-Apr-2017 |
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GPC is a major initiative of the Center for Medical Technology Policy
REAL WORLD EVIDENCEINITIATIVE REPORT
February 2017
GREEN PARK COLLABORATIVE
• A multi-stakeholder forum to clarify the evidence expectations of payers– Public and private payer requirements for evidence of effectiveness and
value for specific conditions and technologies• Key participant-stakeholders in initiatives
– Public and private payers, FDA, NIH, AHRQ, guideline developers, professional societies, life sciences companies
• Output/Activities (depending on initiative)– Effectiveness guidance documents (EGDs)– High priority topic-specific workshops and webinars
• Benefits of participation– Greater transparency of decision-maker expectations (payers, HTA,
guideline developers, health systems, etc.); substantive interaction with key stakeholders; input into methods guidance and recommendations
RWE INITIATIVE: PURPOSE
ProblemMany frameworks and checklists exist to assess the quality of observational and other real-world studies• Frameworks complex, lengthy,
difficult to use• Relatively little input from users• How users make decisions on
single studies and bodies of evidence remains unclear
SolutionDevelop easy-to-use tool for transparent assessment of RWE• User-vetted• “Informed judgment” and visual
summary of methodological rigor and relevance of RW studies
• Detailed assessment can follow, if merited
• Aims: consistency, improved understanding, transparency
APPROACH TO FRAMEWORK DEVELOPMENT
FOUR-PHASED APPROACH
Incorporation of Key Findings and Final RWE Framework
Vetting of Draft Framework and In-Person Meetings
Background Research
Stakeholder and Expert Engagement
TIMELINE
QUARTER 1
QUARTER 2 JUNE 2016 QUARTER
3 – 4FEBRUARY
2017
Identify target users in health plans, health systems, other contexts; assess decision needs of users through interviews
Convene expert workgroups Advisory Committee Methods WG Dissemination WG
Hold in-person workshop with decision-makers to road test tool
Incorporate feedback from workshop and additional user vetting
Produce final framework and interactive tool with user’s guide
ADVISORY COMMITTEE
MEMBERSJoseph Chin, CMS Sally Okun, PatientsLikeMeGregory Daniel, Duke University Tom Oliver, ASCONancy Dryer, Quintiles Eleanor Perfetto, UMD School of PharmacyScott Flanders, Astellas Edmund Pezalla, AetnaJohn Fox, Priority Health Catherine Piech, Janssen PharmaceuticalsJohnathan Jarow, FDA Megan Maguire Priolo, GBMCSachin Kamal-Bahl, Pfizer Alan Rosenberg, AnthemJulie Locklear, EMD Serono Lucy Savitz, Intermountain HealthcareJoan McClure, NCCN Marcus Wilson, HealthcoreElizabeth McGlynn, Kaiser Permanente Brande Ellis Yaist, Eli Lilly and CompanyPeter Neumann, Tufts Medical Center
METHODS WORKGROUP
MEMBERSKristen Bibeau, Teva Pharmaceuticals George Browman, University of British
ColumbiaScott Flanders, Astellas Jennifer Graff, NPC
Craig Henderson, UCSF David Henry, University of Toronto
Brad Hirsch, Flatiron Health Sachin Kamal-Bahl, Pfizer
Mark Levenson, CDER Office of Biostatistics Gary Lyman, ASCO
Jim Murray, Eli Lilly and Company Sally Morton, Virginia Tech
Josée Poirier, MeYou Health, LLC Beverly Shea, University of Ottowa
Mike Stoto (Chair), Georgetown University Timothy Vaughan, PatientsLikeMe
Mingliang Zang, Janssen
DISSEMINATION WORKGROUP
MEMBERSAylin Altan, Optum Labs Rabia Kahveci, HTA Consultant
Megan Klopchin, Eli Lilly and Company Karen Lencoski, Astellas
Julie Locklear, EMD Serono Joan McClure, NCCN
Troy Sarich, Janssen Marcus Wilson, HealthCore
Julie Simmons (Co-Chair), CMTP John Beilenson (Co-Chair), Strategic Communications & Planning
SPONSORS
SUMMARY OF CONTENT
MODULES
MODULE 1: Articulating Question
• What is the decision to be made?
• What information is required?
MODULE 2A: Assessing Relevance
• Population• Intervention• Comparators• Outcome(s)• Timing• Setting
MODULE 2B: Assessing
Rigor• Quality of
Research Question
• Potential for Bias
• Precision• Data Integrity
MODULE 2C:Effect Size
• What is the magnitude and direction of the effect?
BASIC QUESTIONS RATED WITH SCORING SYSTEM THAT CAN BE PLOTTED AND VISUALIZED
MODULE 2A (EXAMPLE)
DIRECTIONS1. Check each box as you consider the
domains within the Relevance dimension
2. Rate Relevance for each study along a continuum (1 – minimally relevant to 4 – maximally relevant)
3. Enter “0” only if there is a necessary piece of information the study fails to provide
DOMAINS If "0"PopulationInterventionComparatorPrimary OutcomeTimingSettingPopulationInterventionComparator ComparatorPrimary OutcomeTiming
ComparatorPrimary Outcome
ComparatorPrimary Outcome
STUDY 1
STUDY 2
Smith, 2005
Johnson, 2003
MODULE 3 (EXAMPLE OF OUTPUT)
• Each sphere is the data point for one study and represents the Likert-type assessments for Relevance (x-axis) and Rigor (y-axis) (Modules 2A and 2B).
• The size of the sphere indicates the magnitude of an effect (Module 2C).
• The color of the sphere indicates the direction of an effect (green=positive; white=negative or no difference) (Module 2C).
• Note: “0” scores for Relevance and Rigor are not plotted
NEXT STEPS
Testing and Demonstration• Current iteration: a free and downloadable Excel Tool (Version 1.0)
– Will continue to vet and test Tool for usefulness, relevance, reliability, and interpretation
• Focus groups and early adopter survey to inform the next iteration of the Excel Tool (Version 2.0), as well as the development of a desktop software solution
Additional Tools• Growing a library of use cases, video demonstrations for users,
webinars, and additional training tools based on feedback from early adopters
ACKNOWLEDGEMENTS
INITIATIVE TEAM
CENTER FOR MEDICAL TECHNOLOGY POLICYRachael Moloney, Research Manager Initiative Lead
Donna Messner, Sr. Vice President GPC Program Director
Sean Tunis, President & CEO Advisor
Jennifer Al Naber, GPC Program Manager Initiative Manager
Julie Simmons, Manager, Marketing & Communications
Co-chair, Dissemination Workgroup
EXTERNAL COLLABORATORSMichael Stoto, Georgetown University Chair, Methods Workgroup
John Beilenson, Strategic Communications & Planning (SCP)
Co-chair, Dissemination Workgroup