Post on 28-Nov-2014
description
transcript
French perspective on the
European collaboration on HTA
Dr François Meyer, MD CADTH SYMPOSIUM APRIL 2014
Maximum two
lines in header
Press ‘Caps locked’
for title in Caps
European network for Health Technology Assessment | JA2 2012-2015 | www.eunethta.eu
Change Country colour
Click twice on country,
choose between the five
highlighted colours
under Shape fill
2
3
From HTA to pricing and reimbursement
Chefs de projet HAS
Commission CNEDiMTS
CT
Review of
available data
ASSESSMENT APPRAISAL
Dossier
from
Company
Literature
Economic Committee
Ministry of Health
NHI funds
Decision
on P&R
Demande
d’étude
Avis HAS
H T A
4
Areas for cooperation / harmonisation
HAS internal assessors
HAS
Committee
Review of
available data
ASSESSMENT APPRAISAL
Dossier
from
Company
Literature
Decicion makers on reimburse-ment and
Price
Decision
on P&R
Request for
additional
data
collection
Early
Dialogue
Core HTA
information
Assessment
HAS Guidance
Additional
data
collection
Methodo-
logical
Guidelines
Template
for data
sub-
mission
Two types of collaborative actions
Cooperation on HTA production
Objectives Actions
• Avoid duplication of work
• Increase consistency
• Increase transparency
• Joint assessment reports / Core HTA
information
• Template for companies to submit
data
• Methodological guidelines
5
Improvement of quality of data produced in primary research
Objectives Actions
• Improvement of the developmet
plans of new technologies
• Improvement of the additional data
collection (to reduce uncertainty
ater initial assessment)
• Early Dialogues
• Disease specific guidelines
• Definition of common core protocols
for additionnal data collection
Cooperation on HTA production:
Common assessments
Drugs (published)
Zostavax®, Herpes zoster vaccine
Invokana®, canagliflozin, oral antidiabetic
6
Medical Devices – Procedures (published)
By-pass duodéno-jéjunal sans chirurgie (Endobarrier®)
Renal denervation systems for resistant hypertension
Medical Devices – Procedures (ongoing)
Balloon Eustachian tuboplasty for the treatment of Eustachian tube
obstruction
Biodegradable stents for benign gastrointestinal pathology
Cooperation on HTA production:
Methodological guidelines
7
9 Guidelines published: • Criteria for choice of most appropriate comparator(s)
• Methods of comparison: direct and indirect comparisons
• Endpoints used for REA of pharmaceuticals:
– Clinical endpoints
– Surrogate endpoints
– Composite endpoints
– Health-related quality of life
– Safety
• Levels of evidence:
– Internal validity
– Applicability
New Guidelines under development – Economic evaluation
– Personalised Medicine
– Medical Devices
8
Ex: Choice of endpoints for relative
effectiveness assessment (REA)
Primary endpoint: – Main symptom/sign of a disease
– Valid measure of clinical benefit
• Hard endpoint (mortality, MI, stroke)
• Surrogate (HbA1c, BP, HIV viral load)
– Relevant
– Responsive to change
Depends on: – Target population
– Characteristics of disease
– Core symptom/sign
– Intended claim
– Valid measure of clinical benefit
– “Hierarchy of endpoints in a trial (primary, co-primary, secondary, exploratory)
Choice of endpoints for relative
effectiveness assessment (REA)
• Trial still to be powered on primary endpoint
• Other endpoints (e.g. clinical events related to
the disease or its treatment, HRQoL)
– systematically assessed in comparison to an
adequate comparator(s) in parallel to the primary
endpoint ;
– Relevance and hierarchy of the different endpoints
will depend on the objective of REA, on the disease
itself and the aim of treatment investigated ;
Guidelines are tested through the production of
common assessment reports (core HTA) and early
dialogues.
9
Improvement of quality of data
produced in primary research (1)
1. Initial data production
Disease specific guidelines
• Ongoing: Osteoarthritis
• Public consultation: Q4 2014
• Includes pharmaceuticals, medical devices
Early dialogues
• Company presents its development plans and ask
questions to HTA bodies to check whether the choices
made are appropriate (choice of comparator, endpoint,
population…)
• Confidential
10
Improvement of quality of data
produced in primary research (2)
2. Additional data collection
– Request made by HTA bodies at the time of initial
evalution to reduce uncertainty for a new technology
• Already achieved :
IT system and database to communicate between
HTA bodies
Criteria to select technologies for which there is a
need for additional data collection
• Ongoing
Position papers on how to best define the research question
and how to chose the appropriate method for ADC
Common core protocols
11
12 European network for Health Technology Assessment | JA2 2012-2015 | www.eunethta.eu
13
WP4Testing
collaborative production
of HTA information
WP5Applying the HTA
Core Model for Rapid
Assessment
WP6Information
Management Infrastructure and Services
(IMIS)
WP7Methodology development and evidence
generation
WP8Maintenance of HTA Core Model
infrastructure
WP1Coordination &
Sustainablenetwork
Implementation
WP2Dissemination & Capacity Building
WP3Evaluation &
Data Collectionon cost-
effectiveness
13 European network for Health Technology Assessment | JA2 2012-2015 | www.eunethta.eu
13
WP4Testing
collaborative production
of HTA information
WP5Applying the HTA
Core Model for Rapid
Assessment
WP6Information
Management Infrastructure and Services
(IMIS)
WP7Methodology development and evidence
generation
WP8Maintenance of HTA Core Model
infrastructure
WP1Coordination &
Sustainablenetwork
Implementation
WP2Dissemination & Capacity Building
WP3Evaluation &
Data Collectionon cost-
effectiveness
EarlyDialogues
Diseasespecific
guideline
AdditionalEvidence
Generation
Methodo-logical
guidelines
Template for industry
HTA core model
14
Areas for cooperation / harmonisation
HAS internal assessors
HAS
Committee
Review of
available data
ASSESSMENT APPRAISAL
Dossier
from
Company
Literature
Decicion makers on reimburse-ment and
Price
Decision
on P&R
Request for
additional
data
collection
Early
Dialogue
Core HTA
information
Assessment
HAS Guidance
Additional
data
collection
Methodo-
logical
Guidelines
Template
for data
sub-
mission