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CADTH_2014_E4_French_Perspective_on_the_European_collaboration_on_HTA__François Meyer
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CADTH_2014_E4_French_Perspective_on_the_European_collaboration_on_HTA__François Meyer

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Is HTA More similar Than Different Across the Atlantic? Comparison of Canada and Europe

Is HTA More similar Than Different Across the Atlantic? Comparison of Canada and Europe

Published in Health & Medicine
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  • 1. French perspective on the European collaboration on HTA Dr François Meyer, MD CADTH SYMPOSIUM APRIL 2014
  • 2. European network for Health Technology Assessment | JA2 2012-2015 | www.eunethta.eu 2
  • 3. 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. 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
  • 5. 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
  • 6. 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
  • 7. 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. 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)
  • 9. 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.
  • 10. 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
  • 11. 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. 12 European network for Health Technology Assessment | JA2 2012-2015 | www.eunethta.eu 13 WP4 Testing collaborative production of HTA information WP5 Applying the HTA Core Model for Rapid Assessment WP6 Information Management Infrastructure and Services (IMIS) WP7 Methodology development and evidence generation WP8 Maintenance of HTA Core Model infrastructure WP1 Coordination & Sustainable network Implementation WP2 Dissemination & Capacity Building WP3 Evaluation & Data Collection on cost- effectiveness
  • 13. 13 European network for Health Technology Assessment | JA2 2012-2015 | www.eunethta.eu 13 WP4 Testing collaborative production of HTA information WP5 Applying the HTA Core Model for Rapid Assessment WP6 Information Management Infrastructure and Services (IMIS) WP7 Methodology development and evidence generation WP8 Maintenance of HTA Core Model infrastructure WP1 Coordination & Sustainable network Implementation WP2 Dissemination & Capacity Building WP3 Evaluation & Data Collection on cost- effectiveness Early Dialogues Disease specific guideline Additional Evidence Generation Methodo- logical guidelines Template for industry HTA core model
  • 14. 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