European network for Health Technology Assessment EUnetHTA European network for Health Technology Assessment Name of author / presenter / organisation / title European network for Health Technology Assessment | JA2 2012-2015 | www.eunethta.eu

Outline The Making of EUnetHTA EUnetHTA and the HTA Network EUnetHTA Achievements and Tools General Information about HTA European network for Health Technology Assessment | JA2 2012-2015 | www.eunethta.eu

10 November, 2018 The Making of EUnetHTA Title slide grey

Historical Timeline of EUnetHTA 10 November, 2018 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 (2006-2008) 2009 EUnetHTA Collaboration (2009) 2010 EUnetHTA Joint Action 1 (2010-2012) 2012 EUnetHTA Joint Action 2 (2012-2015) Text slide 1 column European network for Health Technology Assessment | JA2 2012-2015 | www.eunethta.eu

10 November 2018 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 2014-2020 Financial support HTA Synergy 2006-2008 EUnetHTA Project 2009 EUnetHTA Collaboration 2010-2012 EUnetHTA JA1 2012-2015 EUnetHTA JA2 2016-2020 EUnetHTA Scientific and technical cooperation 2008-2011 Draft Cross Border Healthcare Directive. Article 15 on HTA network 2011-12 CBHC Directive now decided 2013 EU Cooperation on HTA Implementing Decision 2013+ HTA Network Legislation DG R&I 2011 FP7-Health 2012-Innovation-1 New methodologies for HTA Horizon 2020 Calls Health Care European network for Health Technology Assessment | JA2 2012-2015 | www.eunethta.eu

EUnetHTA Project (2006-2008) Objectives 10 November, 2018 EUnetHTA Project (2006-2008) 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 Text slide fact Total budget: € 3,233,858.10 European network for Health Technology Assessment | JA2 2012-2015 | www.eunethta.eu

EUnetHTA Project (2006-2008) 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 European network for Health Technology Assessment | JA2 2012-2015 | www.eunethta.eu

EUnetHTA Project (2006-2008) Deliverables 10 November, 2018 EUnetHTA 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 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” Text slide fact European network for Health Technology Assessment | JA2 2012-2015 | www.eunethta.eu

EUnetHTA Collaboration (2009) 10 November, 2018 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 2006-2008 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 Text slide fact European network for Health Technology Assessment | JA2 2012-2015 | www.eunethta.eu

EUnetHTA Joint Action 1 (2010-2012) Objectives 10 November, 2018 EUnetHTA 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 Text slide fact Total budget: € 5.959.525 European network for Health Technology Assessment | JA2 2012-2015 | www.eunethta.eu

EUnetHTA Joint Action 1 (2010-2012) Work Packages 10 November, 2018 EUnetHTA Joint Action 1 (2010-2012) 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 Text slide fact European network for Health Technology Assessment | JA2 2012-2015 | www.eunethta.eu

EUnetHTA Joint Action 1 (2010-2012) Deliverables 10 November, 2018 EUnetHTA 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 Text slide fact European network for Health Technology Assessment | JA2 2012-2015 | www.eunethta.eu

EUnetHTA Joint Action 2 (2012-2015) Objectives 10 November, 2018 EUnetHTA 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 Text slide fact Total budget: € 9,428,550 European network for Health Technology Assessment | JA2 2012-2015 | www.eunethta.eu

EUnetHTA Joint Action 2 (2012-2015) Work Packages 10 November, 2018 EUnetHTA Joint Action 2 (2012-2015) 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 cost- effectiveness Text slide fact European network for Health Technology Assessment | JA2 2012-2015 | www.eunethta.eu

EUnetHTA Joint Action 2 (2012-2015) Planned deliverables 10 November, 2018 EUnetHTA 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 EUnetHTA tools and methodology Report on evaluation of project completion including assessment of the impact on secondary users of HTA information Text slide fact European network for Health Technology Assessment | JA2 2012-2015 | www.eunethta.eu

Strengthening practical application Project JA1 JA2 Establishment Putting into practice Strengthening practical application European network for Health Technology Assessment | JA2 2012-2015 | www.eunethta.eu

Organisational and Governance Structure 10 November 2018 Organisational and Governance Structure EU Institutions Plenary Assembly Executive Committee Stakeholder Forum The Secretariat SAGs WP1 WP2 WP3 WP4 WP5 WP6 WP7 WP8 EUnetHTA Organigram European network for Health Technology Assessment | JA2 2012-2015 | www.eunethta.eu

Composition of the Stakeholder Forum Payers Patients/ Consumers Industry Providers European network for Health Technology Assessment | JA2 2012-2015 | www.eunethta.eu

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 European network for Health Technology Assessment | JA2 2012-2015 | www.eunethta.eu

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 European network for Health Technology Assessment | JA2 2012-2015 | www.eunethta.eu

Participants JA2 EUnetHTA Partners and Associates in JA2. 10 November, 2018 Participants JA2 EUnetHTA Partners and Associates in JA2. Large number of regional agencies and non-for-profit organisations that produce or contribute to HTA Map slide European network for Health Technology Assessment | JA2 2012-2015 | www.eunethta.eu

EUnetHTA and the HTA Network European network for Health Technology Assessment | JA2 2012-2015 | www.eunethta.eu

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 | JA2 2012-2015 | www.eunethta.eu

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 European network for Health Technology Assessment | JA2 2012-2015 | www.eunethta.eu

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” European network for Health Technology Assessment | JA2 2012-2015 | www.eunethta.eu

EUnetHTA Output European network for Health Technology Assessment | JA2 2012-2015 | www.eunethta.eu

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 European network for Health Technology Assessment | JA2 2012-2015 | www.eunethta.eu

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 European network for Health Technology Assessment | JA2 2012-2015 | www.eunethta.eu

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. European network for Health Technology Assessment | JA2 2012-2015 | www.eunethta.eu

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 HTAs. Results are presented as collections of result cards. The theme of each result card is outlined by the assessment element cards. REPORTING STRUCTURE How to present the answers

The Domains of the HTA Core Model® 10 November, 2018 The Domains of the HTA Core Model® Change colour on table Click on table to activate Table Tools Click on menu ‘Design’ Choose colour from Tables Styles / Medium Style 2 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 Rapid Full Table slide European network for Health Technology Assessment | JA2 2012-2015 | www.eunethta.eu

Core HTA Structure Pool of structured HTA Information 10 November, 2018 Core HTA Structure Primarily EUnetHTA Primarily national INFORMATION Pool of structured HTA Information Collections Serve also as project platforms Local products L HTA L RHTA Official EUnetHTA RC Core HTA L HTA RC RC RC RC RC Rapid HTA RC RC RC RC RC AUTOMATIC VOLUNTARY L RHTA RC RC RC RC RC L RHTA Other Full domain RC RC RC RC RC Free set (≥ 1) L HTA RC RC RC RC RC Graphics slides L HTA TAILORED My collection TOOLS HTA Core Model Online Tool & Service Local Tools Primarily EUnetHTA Primarily local European network for Health Technology Assessment | JA2 2012-2015 | www.eunethta.eu

The HTA Core Model Online® Access to the HTA Core Model®: www.htacoremodel.info European network for Health Technology Assessment | JA2 2012-2015 | www.eunethta.eu

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. European network for Health Technology Assessment | JA2 2012-2015 | www.eunethta.eu

The POP Database Online 10 November, 2018 The POP Database Online Picture and text Access to the POP Database : http://eunethta.dimdi.de/PopDB/ European network for Health Technology Assessment | JA2 2012-2015 | www.eunethta.eu

POP Statistics: Quarterly Updates In the second quarter of 2015, the POP Database contained: 1,068 planned, ongoing and recently published projects from 43 EUnetHTA JA partners and 26 countries 2015 Q1 POP Request Out of 69 EUnetHTA JA partners: Response rate: 65 % Total number of projects: 1,314 Alert (SAME) topics: 103 (8 %) Similar projects (within alert topics): 251 Access-right: 47 partners 2015 Q1 POP Request Out of 69 EUnetHTA JA partners: Response rate: 57 % Total number of projects: 1,068 Alert (SAME) topics: 100 (9 %) Similar projects (within alert topics): 244 Access-right: 43 partners

The EVIDENT Database Description 10 November, 2018 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. Text and picture European network for Health Technology Assessment | JA2 2012-2015 | www.eunethta.eu

The EVIDENT Database Online Access to the EVIDENT Database: https://evident.has-sante.fr/has/login.xhtml European network for Health Technology Assessment | JA2 2012-2015 | www.eunethta.eu

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 effective- ness 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. European network for Health Technology Assessment | JA2 2012-2015 | www.eunethta.eu

9 Methodological Guidelines for Rapid REA Endpoints used for REA of pharmaceuticals Levels of evidence Internal validity Clinical endpoints Applicability of evidence in the context of a relative effectiveness assessment Composite endpoints Surrogate endpoints Safety Link to the guidelines Health-related quality of life http://www.eunethta.eu/eunethta- guidelines Comparators and comparisons Criteria for the choice of the most appropriate comparator(s) Direct and indirect comparison European network for Health Technology Assessment | JA2 2012-2015 | www.eunethta.eu

External Collaboration European network for Health Technology Assessment | JA2 2012-2015 | www.eunethta.eu

EUnetHTA-EMA Collaboration 10 November, 2018 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. Text and picture European network for Health Technology Assessment | JA2 2012-2015 | www.eunethta.eu

EUnetHTA-EMA Collaboration 10 November, 2018 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 Text and picture European network for Health Technology Assessment | JA2 2012-2015 | www.eunethta.eu

EUnetHTA-FP7 Projects Collaboration 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) European network for Health Technology Assessment | JA2 2012-2015 | www.eunethta.eu

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 European network for Health Technology Assessment | JA2 2012-2015 | www.eunethta.eu

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 European network for Health Technology Assessment | JA2 2012-2015 | www.eunethta.eu

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 European network for Health Technology Assessment | JA2 2012-2015 | www.eunethta.eu

General Information about HTA European network for Health Technology Assessment | JA2 2012-2015 | www.eunethta.eu

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 | JA2 2012-2015 | www.eunethta.eu

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 | JA2 2012-2015 | www.eunethta.eu

Health Technology Life-cycle 10 November, 2018 Health Technology Life-cycle HTA / REA Use of technology in health care Early scientific advice Rapid REA Additional data collection Graphics slides Time line of innovation European network for Health Technology Assessment | JA2 2012-2015 | www.eunethta.eu

Abbreviations HTA Health Technology Assessment JA Joint Action DG R&I Directorate-General for Research and Innovation CBHC Cross-border Healthcare FP7 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 EUnetHTA Planned and Ongoing Projects database EVIDENT The Evidence database on new technologies HTAi Health Technology Assessment International November 10, 2018 European network for Health Technology Assessment | JA2 2012-2015 | www.eunethta.eu

Thank you Any questions? 10 November, 2018 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 European network for Health Technology Assessment | JA2 2012-2015 | www.eunethta.eu