EUnetHTA. European network for Health Technology Assessment. European network for Health Technology Assessment JA

Transcription

1 EUnetHTA European network for Health Technology Assessment

2 Outline The Making of EUnetHTA EUnetHTA and the HTA Network EUnetHTA Achievements and Tools General Information about HTA 2

3 The Making of EUnetHTA 3

4 Historical Timeline of EUnetHTA 2004 The European Commission and the Council of Ministers target Health Technology Assessment (HTA) as a political priority, recognising ( ) an urgent need for establishing a sustainable European network on HTA 2005 Call for project proposal answered by a group of 35 organisations throughout Europe 2006 EUnetHTA Project ( ) 2009 EUnetHTA Collaboration (2009) 2010 EUnetHTA Joint Action 1 ( ) 2012 EUnetHTA Joint Action 2 ( ) 4

5 The timeline of reaching a sustainable and permanent HTA network in Europe Health Programme 2005 Call for project proposals 2009 Call for joint action 2011 Call for joint action Financial support HTA EUnetHTA Project 2009 EUnetHTA Collaboration EUnetHTA JA EUnetHTA JA EUnetHTA Scientific and technical cooperation Legislation Draft Cross Border Healthcare Directive. Article 15 on HTA network CBHC Directive now decided 2013 EU Cooperation on HTA Implementing Decision HTA Network DG R&I 2011 FP7-Health 2012-Innovation-1 New methodologies for HTA Horizon 2020 Calls Health Care 5

6 EUnetHTA Project ( ) Objectives To establish an effective and sustainable European network for Health Technology Asessment EUnetHTA that informs policy decisions To reduce overlap and duplication of effort and hence promote more effective use of resources To increase HTA input to decision-making in Member States and the EU and hence to increase the impact of HTA To strengthen the link between HTA and health care policy making in the EU and its Member States To support countries with limited experience with HTA Total budget: 3,233,

7 EUnetHTA Project ( ) Work Packages WP4 Common Core HTA WP5 Adapting HTA WP6 HTA and Health Policy WP7 New Technologies WP8 System to support HTA WP1 Coordination WP2 Communication WP3 Evaluation 7

8 EUnetHTA Project ( ) Deliverables A generic methodological HTA framework based on current best practices (HTA Core Model ) Handbook on Core HTA development HTA Adaptation toolkit from existing HTAs into other contexts An open EUnetHTA Stakeholder Forum to exchange views, expectations/feedback on HTA with stakeholders Web-based toolkit to facilitate European collaboration on evidence generation on promising health technologies A handbook on HTA capacity building and institutionalising HTA EUnetHTA Conference HTA s Future in Europe 8

9 EUnetHTA Collaboration (2009) Since 2009, the EUnetHTA Collaboration has been operating to implement the permanent collaboration on HTA in Europe building on the work initiated during the EUnetHTA Project The EUnetHTA Collaboration was organised into several teams of partners around specific functions Members of each function were assigned according to the individual Founding Partner organisation's preferences of participation The EUnetHTA Collaboration took an initiative in developing a proposal for the Joint Action on HTA 9

10 EUnetHTA Joint Action 1 ( ) Objectives To put into practice an effective and sustainable HTA collaboration in Europe that brings added value at the European, national and regional level Development of a general strategy and business model for sustainable European collaboration on HTA Development of HTA tools and methods Application and field testing of developed tools and methods To facilitate efficient use of resources available for HTA Total budget:

11 EUnetHTA Joint Action 1 ( ) Work Packages WP4 Core HTA WP5 REA of Pharmaceuticals WP6 IMS WP7 New Technologies WP8 Strategy and Business Model Development WP1 Coordination WP2 Dissemination WP3 Evaluation 11

12 EUnetHTA Joint Action 1 ( ) Deliverables An online Tool for producing, publishing, storing and retrieving HTA information and a new application of the HTA Core Model A common methodology for the relative effectiveness assessment (REA) of pharmaceuticals An operational web-based toolkit including database containing information on evidence generation for new technologies An Information Management System (IMS) and the related documentation, processes and policies Further development of a stakeholder involvement policy Development of a collaborative business model for sustainability A relative effectiveness assessment of a pharmaceutical 12

13 EUnetHTA Joint Action 2 ( ) Objectives To strengthen the practical application of tools and approaches to cross-border HTA collaboration To achieve a better understanding for the European Commission and Member States of ways to establish a sustainable structure for the HTA work in the EU To produce recommendations regarding the design and management of the future EU HTA cooperation Total budget: 9,428,550 13

14 EUnetHTA Joint Action 2 ( ) Work Packages 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 costeffectiveness 14

15 EUnetHTA Joint Action 2 ( ) Planned deliverables Recommendations on the implementation of sustainable European network for HTA Full Core HTAs Pilot rapid assessments Methodological guidelines and templates to support production of core HTA information and rapid assessments Guidelines and pilots to improve quality and adequacy of initial and additional evidence generation Upgraded and updated application package of HTA Core Model Report on yearly training courses on EUnetHTA tools and methodology Report on evaluation of project completion including assessment of the impact on secondary users of HTA information 15

16 Project JA1 JA2 Establishment Putting into practice Strengthening practical application 16

17 EU Institutions Organisational and Governance Structure Plenary Assembly Executive Committee Stakeholder Forum The Secretariat SAGs WP1 WP2 WP3 WP4 WP5 WP6 WP7 WP8 EUnetHTA Organigram 17

18 Composition of the Stakeholder Forum Payers Patients/ Consumers Industry Providers 18

19 Purpose of the Stakeholder Forum To provide stakeholders with the opportunity to participate as stakeholder representatives in the EUnetHTA Joint Actions to observe and comment on the EUnetHTA Joint Action work to provide advice to overarching governance questions in the Joint Actions, and to bring forward specific themes and concerns considered relevant by the stakeholders' constituencies in line with the aims of the EUnetHTA Joint Actions 19

20 Purpose of the Stakeholder Advisory Groups (SAGs) Representatives from Stakeholder organisations participate in WP activities via SAGs to represent Stakeholder views provide perspectives and knowledge on the EUnetHTA work in progress Help WPs to improve the basis of their deliberations Examples of participation: - Commenting on the scope of the project / selected methodologies - Commenting on draft reports in preparation of final draft documents before public consultation 20

21 Participants JA2 EUnetHTA Partners and Associates in JA2. Large number of regional agencies and non-for-profit organisations that produce or contribute to HTA 21

22 EUnetHTA and the HTA Network 22

23 Article 15 of the Directive 2011/24/EU on cross-border health care The Union shall support and facilitate cooperation and the exchange of scientific information among Member States within a voluntary network connecting national authorities or bodies responsible for health technology assessment designated by the Member States That network shall be based on the principle of good governance including transparency, objectivity, independence of expertise, fairness of procedure and appropriate stakeholder consultations 23

24 EUnetHTA s Role in the Implementation of Article 15 To develop a general strategy, principles and recommendations for a sustainable European network for scientific and technical cooperation To ensure the scientific and technical cooperation for the HTA Network according to the requirements of the Directive for cross-border healthcare 24

25 EUnetHTA s Role in the Implementation of Article 15 EUnetHTA JA2 General Objective (Grant Agreement p. 35) to strengthen the practical application of tools and approaches to cross-border HTA collaboration bringing it to a higher level and resulting in a better understanding for the Commission and the EU Member States of ways to establish a sustainable structure for HTA work in the EU that avoids unnecessary duplication of assessment efforts 25

26 EUnetHTA Output 26

27 EUnetHTA has facilitated increased collaboration between European HTA organisations practical efforts in improving efficient use of resources available for HTA the creation of a sustainable system of HTA knowledge sharing the promotion of good practice in HTA methods and processes the basis for delivery of reliable, timely, transparent and transferable information contributing to HTAs in European countries 27

28 EUnetHTA Tools EUnetHTA HTA Core Model Online EUnetHTA Planned and Ongoing Projects Database (POP) EUnetHTA Evidence database on new technologies (EVIDENT) EUnetHTA Adaptation Glossary & Toolkit EUnetHTA Contact Database EUnetHTA Intranet Groups EUnetHTA E-meeting facility EUnetHTA News Aggregator 28

29 The HTA Core Model Description The HTA Core Model is a methodological framework for shared production and sharing of HTA information. Purpose To enable production of high quality HTA information in a structured format to support the production of local (national or regional) HTAs and reuse of existing information. 29

30 The Structure of the HTA Core Model ONTOLOGY Questions that an HTA should answer METHODOLOGICAL GUIDANCE How to answer the questions Common reporting structure that enables standardised reporting REPORTING STRUCTURE How to present of each result card the answers of HTAs. Results are presented as collections of result cards. The theme is outlined by the assessment element cards. 30

31 Full Rapid The Domains of the HTA Core Model SCOPE DOMAINS 1. Health problem and current use of technology 2. Description and technical characteristics 3. Safety 4. Clinical effectiveness 5. Costs and economic evaluation 6. Ethical analysis 7. Organisational aspects 8. Social aspects 9. Legal aspects 31

32 TOOLS INFORMATION Core HTA Structure Pool of structured HTA Information Primarily EUnetHTA Collections Serve also as project platforms Primarily national Local products RC RC RC RC RC RC RC RC RC RC RC Official EUnetHTA Core HTA Rapid HTA L HTA L HTA L RHTA RC RC RC RC RC RC RC RC RC RC AUTOMATIC Other Full domain VOLUNTARY L RHTA L RHTA RC RC RC RC RC Free set ( 1) My collection TAILORED L HTA L HTA HTA Core Model Online Tool & Service Local Tools Primarily EUnetHTA Primarily local 32

33 The HTA Core Model Online Access to the HTA Core Model : 33

34 The POP Database Description The EUnetHTA Planned and Ongoing Projects (POP) database allows EUnetHTA Partners and Associates to share information on planned, ongoing or recently published projects of participating agencies and identify similar projects through a matching system provided by the online database. Purpose To facilitate collaboration among European HTA agencies and reduce duplication of work. 34

35 The POP Database Online Access to the POP Database : 35

36 POP Statistics: Quarterly Updates In Spring 2014, POP Database contained: 1,230 planned, ongoing and recently published projects from 44 EUnetHTA JA partners and 24 countries (Oct/Dec 2013) POP Request Out of 63 EUnetHTA JA partners: 28 responded and entered/updated projects in the database 11 responded but DID NOT feed the database 24 did not respond at all (38%) Total number of projects: 1,219 Alert (SAME) topics: 101 (8%) Similar projects (within alert topics): 249 Access-rights: 41 partners (Jan/March 2013) POP Request Out of 68 EUnetHTA JA partners: 35 responded and entered/updated projects in the database 8 responded but DID NOT feed the database (no current changes in the projects) 25 did not respond at all (37 %) Total number of projects: 1,216 Alert (SAME) topics: 103 (8 %) Similar projects (within alert topics): 247 Access-rights: 46 partners 36

37 The EVIDENT Database Description The EVIDENT Database enables sharing early information on evidence gaps identified during the production of HTA reports and consequent recommendations / requests for additional data collection. It also contains information on reimbursement / coverage and assessment status of promising technologies in Europe. Purpose To reduce redundancy, promote generation of further evidence and facilitate European collaboration in the domain. 37

38 The EVIDENT Database Online Access to the EVIDENT Database: 38

39 9 Methodological Guidelines for Rapid REA Development 9 Methodological Guidelines for Rapid REA of Pharmaceuticals developed in JA1 by WP5. Content Guidelines on methodological challenges that are encountered by health technology assessors while performing a rapid relative effectiveness assessment of pharmaceuticals. Primary Aim To help the assessors of evidence interpret and process the data that are presented to them as part of a REA. 39

40 9 Methodological Guidelines for Rapid REA Endpoints used for REA of pharmaceuticals 1. Clinical endpoints 2. Composite endpoints 3. Surrogate endpoints 4. Safety 5. Health-related quality of life Comparators and comparisons 6. Criteria for the choice of the most appropriate comparator(s) 7. Direct and indirect comparison Levels of evidence 8. Internal validity 9. Applicability of evidence in the context of a relative effectiveness assessment Link to the guidelines 40

41 External Collaboration 41

42 EUnetHTA-EMA Collaboration To identify opportunities for and undertake specific steps to improve the efficiency of the process and conditions for patients timely access to an effective medicine. 42

43 EUnetHTA-EMA Collaboration Scientific advice/early dialogues involving regulators and HTAs Scientific and methodological guideline development Post-licensing (post-authorisation) data generation Availability of clinical study data Orphan medicinal products Cooperation in specific pilot projects of EUnetHTA JA2 Conferences, workshops and seminars/meetings 43

44 EUnetHTA-FP7 Projects Collaboration FP7 Projects AdHopHTA (Adopting Hospital Based Health Technology Assessment in EU) Advance-HTA (Advancing and strengthening the methodological tools and practices relating to the application and implementation of Health Technology Assessment) Integrate-HTA (Integrated health technology assessment for evaluating complex technologies) MedTecHTA (Methods for Health Technology Assessment of Medical Devices: a European Perspective) 44

45 EUnetHTA-FP7 Projects Collaboration Objective: To identify opportunities for developing alliances with contributing fields of research in order to support a stronger and broader evidence base for HTA 45

46 EU Joint Actions PARENT and EUCERD PARENT: The Cross Border PAtient REgistries initiative EUCERD: The European Union Committee of Experts on Rare Diseases Objective: To facilitate timely information flow and input between EUnetHTA the current EU initiatives in the areas of patient registries and rare diseases 46

47 EUnetHTA-HTAi Collaboration Subjects of EUnetHTA-HTAi Collaboration - HTAi Glossary - HTAi Vortal Objective: - To support the latest developments and new / regional HTA terminology are reflected in the global efforts to streamline HTA glossaries (through the HTAi Glossary). - To provide a structured access to information of interest about Health Technology Assessment 47

48 General Information about HTA 48

49 Definition of Health Technology Health technology is the application of scientific knowledge in health care and prevention Examples of Health Technology Diagnostic and treatment methods Medical equipment Pharmaceuticals Rehabilitation and prevention methods Organisational and support systems within which health care is provided 49

50 Definition of HTA Health technology assessment (HTA) is a multidisciplinary process that summarises information about the medical, social, economic and ethical issues related to the use of a health technology, in a systematic, transparent, unbiased, robust manner. Its aim is to inform the formulation of safe, effective health policies that are patient focused and seek to achieve best value. Despite its policy goals, HTA must always be firmly rooted in research and the scientific method. 50

51 Use of technology in health care Health Technology Life-cycle HTA / REA Early scientific advice Rapid REA Additional data collection Time line of innovation 51

52 Abbreviations HTA JA DG R&I CBHC FP7 REA IMS IMIS SAG WP POP EVIDENT HTAi Health Technology Assessment Joint Action Directorate-General for Research and Innovation Cross-border Healthcare The Seventh Framework Programme Relative effectiveness assessment Information Management and Services Information Management Infrastructure and Services Stakeholder Advisory Group Work Package The EUnetHTA Planned and Ongoing Projects database The Evidence database on new technologies Health Technology Assessment International May 26,

53 Conference, October 2014 Under the patronage of the Italian Ministry of Health Conference website: 53

54 Thank you Any questions? This presentation arises from the EUnetHTA Joint Action 2 which has received funding from the European Union, in the framework of the Health Programme