EUnet HTA European network for Health Technology Assessment

EUnet. HTA European network for Health Technology Assessment Name of author / presenter / organisation / title European network for Health Technology Assessment | JA 2 2015 | www. eunethta. eu

Outline • The Making of EUnet. HTA • EUnet. HTA and the HTA Network • EUnet. HTA Achievements and Tools • General Information about HTA European network for Health Technology Assessment | JA 2 2015 | www. eunethta. eu 2

The Making of EUnet. HTA European network for Health Technology Assessment | JA 2 2015 | www. eunethta. eu 3

Historical Timeline of EUnet. HTA 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 EUnet. HTA Project (2006 2008) 2009 EUnet. HTA Collaboration (2009) 2010 EUnet. HTA Joint Action 1 (2010 2012) 2012 EUnet. HTA Joint Action 2 (2012 2015) European network for Health Technology Assessment | JA 2 2015 | www. eunethta. eu 4

The timeline of reaching a sustainable and permanent HTA network in Europe Health Programme 2005 2009 Call for project proposals Call for joint action 2014 -2020 2011 Financial support Call for joint action HTA 2006 -2008 EUnet. HTA Project Legislation 2009 2010 -2012 -2015 2016 -2020 EUnet. HTA Collaboration EUnet. HTA JA 1 EUnet. HTA JA 2 EUnet. HTA Scientific and technical cooperation y rg e n 2008 -2011 -12 2013 Draft Cross Border Healthcare Directive. Article 15 on HTA network CBHC Directive now decided EU Cooperation on HTA Implementing Decision DG R&I 2011 FP 7 Health European network for Health Technology Assessment | JA 2 2015 | www. eunethta. eu Sy 2013+ HTA Network Horizon 2020 2012 Innovation 1 Calls New methodologies for HTA Health Care 5

EUnet. HTA Project (2006 -2008) Objectives • To establish an effective and sustainable European network for Health Technology Asessment – EUnet. HTA – 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, 858. 10 European network for Health Technology Assessment | JA 2 2015 | www. eunethta. eu 6

EUnet. HTA Project (2006 -2008) Work Packages WP 4 Common Core HTA WP 5 Adapting HTA WP 6 HTA and Health Policy WP 7 New Technologies WP 1 WP 2 WP 3 Coordination Communication Evaluation European network for Health Technology Assessment | JA 2 2015 | www. eunethta. eu WP 8 System to support HTA 7

EUnet. HTA Project (2006 -2008) 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 EUnet. HTA 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 • EUnet. HTA Conference “HTA’s Future in Europe” European network for Health Technology Assessment | JA 2 2015 | www. eunethta. eu 8

EUnet. HTA Collaboration (2009) • Since 2009, the EUnet. HTA Collaboration has been operating to implement the permanent collaboration on HTA in Europe building on the work initiated during the EUnet. HTA Project 2006 -2008 • The EUnet. HTA 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 EUnet. HTA Collaboration took an initiative in developing a proposal for the Joint Action on HTA European network for Health Technology Assessment | JA 2 2015 | www. eunethta. eu 9

EUnet. HTA Joint Action 1 (2010 -2012) 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: € 5. 959. 525 European network for Health Technology Assessment | JA 2 2015 | www. eunethta. eu 10

EUnet. HTA Joint Action 1 (2010 -2012) Work Packages WP 5 WP 4 Core HTA REA of Pharmaceuticals WP 6 IMS WP 8 WP 7 New Technologies WP 1 WP 2 WP 3 Coordination Dissemination Evaluation European network for Health Technology Assessment | JA 2 2015 | www. eunethta. eu Strategy and Business Model Development 11

EUnet. HTA Joint Action 1 (2010 -2012) 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 European network for Health Technology Assessment | JA 2 2015 | www. eunethta. eu 12

EUnet. HTA Joint Action 2 (2012 -2015) 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 European network for Health Technology Assessment | JA 2 2015 | www. eunethta. eu 13

EUnet. HTA Joint Action 2 (2012 -2015) Work Packages WP 4 WP 5 WP 6 Testing collaborative production of HTA information Applying the HTA Core Model for Rapid Assessment Information Management Infrastructure and Services (IMIS) WP 1 Coordination & Sustainable network Implementation WP 2 Dissemination & Capacity Building European network for Health Technology Assessment | JA 2 2015 | www. eunethta. eu WP 7 WP 8 Methodology development and evidence generation Maintenance of HTA Core Model infrastructure WP 3 Evaluation & Data Collection on costeffectiveness 14

EUnet. HTA Joint Action 2 (2012 -2015) 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 EUnet. HTA tools and methodology • Report on evaluation of project completion including assessment of the impact on secondary users of HTA information European network for Health Technology Assessment | JA 2 2015 | www. eunethta. eu 15

Project Establishment JA 1 Putting into practice European network for Health Technology Assessment | JA 2 2015 | www. eunethta. eu JA 2 Strengthening practical application 16

Organisational and Governance Structure EU Institutions Plenary Assembly Executive Committee Stakeholder Forum SAGs The Secretariat WP 1 WP 2 WP 3 WP 4 WP 5 WP 6 WP 7 WP 8 EUnet. HTA Organigram European network for Health Technology Assessment | JA 2 2015 | www. eunethta. eu 17

Composition of the Stakeholder Forum Payers Patients/ Consumers Industry European network for Health Technology Assessment | JA 2 2015 | www. eunethta. eu Providers 18

Purpose of the Stakeholder Forum To provide stakeholders with the opportunity • to participate as stakeholder representatives in the EUnet. HTA Joint Actions • to observe and comment on the EUnet. HTA 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 EUnet. HTA Joint Actions European network for Health Technology Assessment | JA 2 2015 | www. eunethta. eu 19

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 EUnet. HTA 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 European network for Health Technology Assessment | JA 2 2015 | www. eunethta. eu 20

Participants JA 2 EUnet. HTA Partners and Associates in JA 2. Large number of regional agencies and non for profit organisations that produce or contribute to HTA European network for Health Technology Assessment | JA 2 2015 | www. eunethta. eu 21

EUnet. HTA and the HTA Network European network for Health Technology Assessment | JA 2 2015 | www. eunethta. eu 22

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” European network for Health Technology Assessment | JA 2 2015 | www. eunethta. eu 23

EUnet. HTA’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 European network for Health Technology Assessment | JA 2 2015 | www. eunethta. eu 24

EUnet. HTA’s Role in the Implementation of Article 15 EUnet. HTA JA 2 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” European network for Health Technology Assessment | JA 2 2015 | www. eunethta. eu 25

EUnet. HTA Output European network for Health Technology Assessment | JA 2 2015 | www. eunethta. eu 26

EUnet. HTA 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 European network for Health Technology Assessment | JA 2 2015 | www. eunethta. eu 27

EUnet. HTA Tools EUnet. HTA Core Model Online EUnet. HTA Planned and Ongoing Projects Database (POP) EUnet. HTA Evidence database on new technologies (EVIDENT) EUnet. HTA Adaptation Glossary & Toolkit EUnet. HTA Contact Database EUnet. HTA Intranet Groups EUnet. HTA E-meeting facility EUnet. HTA News Aggregator European network for Health Technology Assessment | JA 2 2015 | www. eunethta. eu 28

The HTA Core Model® Description Purpose The HTA Core Model® is a methodological framework for shared production and sharing of HTA information. 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. European network for Health Technology Assessment | JA 2 2015 | www. eunethta. eu 29

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 of. REPORTING HTAs. Results are presented as collections STRUCTURE of result The theme Howcards. to present of each result card answers isthe outlined by the assessment element cards. European network for Health Technology Assessment | JA 2 2015 | www. eunethta. eu 30

The Domains of the HTA Core Model® DOMAINS SCOPE Rapid 1. Health problem and current use of technology 2. Description and technical characteristics 3. Safety Full 4. Clinical effectiveness 5. Costs and economic evaluation 6. Ethical analysis 7. Organisational aspects 8. Social aspects 9. Legal aspects European network for Health Technology Assessment | JA 2 2015 | www. eunethta. eu 31

Core HTA Structure Primarily EUnet. HTA Pool of structured HTA Information Primarily national Local products Collections Serve also as project platforms L HTA Official EUnet. HTA L RHTA INFORMATION RC RC RC Core HTA RC RC RC L HTA Rapid HTA AUTOMATIC VOLUNTARY Other L RHTA RC RC RC Full domain RC RC RC Free set (≥ 1) L HTA TOOLS My collection HTA Core Model Online Tool & Service Local Tools Primarily EUnet. HTA European network for Health Technology Assessment | JA 2 2015 | www. eunethta. eu L HTA TAILORED Primarily local 32

The HTA Core Model Online® Access to the HTA Core Model®: www. htacoremodel. info European network for Health Technology Assessment | JA 2 2015 | www. eunethta. eu 33

The POP Database Description Purpose The EUnet. HTA Planned and Ongoing Projects (POP) database allows EUnet. HTA 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. To facilitate collaboration among European HTA agencies and reduce duplication of work. European network for Health Technology Assessment | JA 2 2015 | www. eunethta. eu 34

The POP Database Online Access to the POP Database : http: //eunethta. dimdi. de/Pop. DB/ European network for Health Technology Assessment | JA 2 2015 | www. eunethta. eu 35

POP Statistics: Quarterly Updates In the second quarter of 2015, the POP Database contained: 1, 068 planned, ongoing and recently published projects from 43 EUnet. HTA JA partners and 26 countries 2015 Q 1 POP Request Out of 69 EUnet. HTA JA partners: • Response rate: 65 % • Response rate: 57 % • Total number of projects: 1, 314 • Total number of projects: 1, 068 • Alert (SAME) topics: 103 (8 %) • Alert (SAME) topics: 100 (9 %) • Similar projects (within alert topics): 251 • Similar projects (within alert topics): 244 • Access-right: 47 partners • Access-right: 43 partners 36 European network for Health Technology Assessment | JA 2 2015 | www. eunethta. eu

The EVIDENT Database Description Purpose 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. To reduce redundancy, promote generation of further evidence and facilitate European collaboration in the domain. It also contains information on reimbursement / coverage and assessment status of promising technologies in European network for Health Technology Assessment | JA 2 2015 | www. eunethta. eu 37

The EVIDENT Database Online Access to the EVIDENT Database: https: //evident. has sante. fr/has/login. xhtml European network for Health Technology Assessment | JA 2 2015 | www. eunethta. eu 38

Development 9 Methodological Guidelines for Rapid REA of Pharmaceuticals developed in European network for Health Technology Assessment | JA 2 2015 | www. eunethta. eu

9 Methodological Guidelines for Rapid REA Endpoints used for REA of pharmaceuticals 1. Clinical endpoints 2. Composite endpoints 3. Surrogate endpoints Levels of evidence 8. Internal validity 9. Applicability of evidence in the context of a relative effectiveness assessment 4. Safety 5. Health related quality of life Comparators and comparisons 6. Criteria for the choice of the most appropriate comparator(s) Link to the guidelines http: //www. eunethta. eu/eunethtaguidelines 7. Direct and indirect comparison European network for Health Technology Assessment | JA 2 2015 | www. eunethta. eu 40

External Collaboration European network for Health Technology Assessment | JA 2 2015 | www. eunethta. eu 41

EUnet. HTA-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. European network for Health Technology Assessment | JA 2 2015 | www. eunethta. eu 42

EUnet. HTA-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 EUnet. HTA JA 2 • Conferences, workshops and seminars/meetings European network for Health Technology Assessment | JA 2 2015 | www. eunethta. eu 43

EUnet. HTA-FP 7 Projects Collaboration FP 7 Projects • Ad. Hop. HTA (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) • Med. Tec. HTA (Methods for Health Technology Assessment of Medical Devices: a European Perspective) European network for Health Technology Assessment | JA 2 2015 | www. eunethta. eu 44

EUnet. HTA-FP 7 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 European network for Health Technology Assessment | JA 2 2015 | www. eunethta. eu 45

EU Joint Actions PARENT and EUCERD PARENT: The Cross Border PAtient REgistries i. Ni. Tiative EUCERD: The European Union Committee of Experts on Rare Diseases Objective: • To facilitate timely information flow and input between EUnet. HTA the current EU initiatives in the areas of patient registries and rare diseases European network for Health Technology Assessment | JA 2 2015 | www. eunethta. eu 46

EUnet. HTA-HTAi Collaboration Subjects of EUnet. HTA-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 European network for Health Technology Assessment | JA 2 2015 | www. eunethta. eu 47

General Information about HTA European network for Health Technology Assessment | JA 2 2015 | www. eunethta. eu 48

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 European network for Health Technology Assessment | JA 2 2015 | www. eunethta. eu 49

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. European network for Health Technology Assessment | JA 2 2015 | www. eunethta. eu 50

Use of technology in health care Health Technology Life-cycle HTA / REA Early scientific advice Rapid REA Additional data collection Time line of innovation European network for Health Technology Assessment | JA 2 2015 | www. eunethta. eu 51

Abbreviations HTA Health Technology Assessment JA Joint Action DG R&I Directorate General for Research and Innovation CBHC Cross border Healthcare FP 7 The Seventh Framework Programme REA Relative effectiveness assessment IMS Information Management and Services IMIS Information Management Infrastructure and Services SAG Stakeholder Advisory Group WP Work Package POP The EUnet. HTA Planned and Ongoing Projects database EVIDENT The Evidence database on new technologies HTAi Health Technology Assessment International European network for Health Technology Assessment | JA 2 2015 | www. eunethta. eu November 27, 2020 52

Thank you Any questions? This presentation arises from the EUnet. HTA Joint Action 2 which has received funding from the European Union, in the framework of the Health Programme European network for Health Technology Assessment | JA 2 2015 | www. eunethta. eu