1. Health Technology Assessment Methodology, an EUnetHTA View Basics for the Assessment in EU Countries PharmDr. Martin Visnansky, MBA, PhD., MSc. (HTA) HTA Methodology Development Presentation of Outcomes Ministry of Health, Czech republic June, the 21st, 2013

2. HTA Overview in CEE Countries Source: Tomek et al., ISPOR 2012

3. EUnetHTA History Source: EUnetHTA

4. EUnetHTA EUnetHTA was established to create an effective and sustainable network for HTA across Europe – we work together to help developing reliable, timely, transparent and transferable information to contribute to HTAs in European countries. EUnetHTA supports collaboration between European HTA organisations that brings added value at the European, national and regional level through: FACILITATING EFFICIENT USE OF RESOURCES AVAILABLE FOR HTA, CREATING A SUSTAINABLE SYSTEM OF HTA KNOWLEDGE SHARING, PROMOTING GOOD PRACTICE IN HTA METHODS AND PROCESSES. Source: EUnetHTA

5. EUnetHTA Vision EUnetHTA is a preferred facilitator of high-quality HTA collaboration in Europe. HTA agencies consider EUnetHTA an efficient way of collaborating. Source: EUnetHTA

6. EUnetHTA Mission is to support the collaboration between European HTA organisations that brings added value to healthcare systems at the European, national and regional level. supports efficient production and use of HTA in countries across Europe provides an independent and science-based platform for HTA agencies in countries across Europe to exchange and develop HTA information and methodology provides an access point for communication with stakeholders to promote transparency, objectivity, independence of expertise, fairness of procedure and appropriate stakeholder consultations develops alliances with contributing fields of research to support a stronger and broader evidence base for HTA while using the best available scientific competence. Source: EUnetHTA

7. EUnetHTA Values European Union values for health systems (universality, access to good quality care, equity and solidarity) Efficiency in HTA production Sustainability of the healthcare systems The principle of subsidiarity of the European Union The use of best evidence, common methodological standards, trust and transparency EUnetHTA finds it important to recognise and facilitate solutions to overcome barriers caused by language, variations in terminology, and culture. Source: EUnetHTA

8. EUnetHTA Objectives 2012 and beyond Increase collaborative production of timely and fit for purpose HTA information that is applicable in national or regional HTA production and decision making Increase reliability, quality and relevance of HTA thus expanding its applicability for policy making Build capacities in HTA Source: EUnetHTA

9. EUnetHTA JA2 List of Partners Lead partners: HVB (Austria) KCE (Belgium) DHMA (Denmark) Agenas (Executive Committee)Agenas (Executive Committee) CVZ (Executive Committee) DHMA (Executive Committee)DHMA (Executive Committee) HAS (Executive Committee) KCE (Executive Committee) THL (Executive Committee) THL (Finland) Associated Partners: BIQG/GÖG (Austria) HVB (Austria) LBI-HTA (Austria) KCE (Belgium) NCPHP (Bulgaria) AAZ (Croatia) MoH Cyprus (Cyprus) MoH Cz Rep (Czech Republic) DHMA (Denmark) UTA (Estonia) Source: EUnetHTA

10. EUnetHTA JA2 2012-2015 Strategies Strategies to increase collaborative production of HTA core information and to facilitate its use in national reporting Strategies to increase the reliability and relevance of HTA Source: EUnetHTA

11. EUnetHTA Strategy 2012 and beyond THE POP DATABASE –The EUnetHTA Planned and Ongoing Projects (POP) database allows HTA agencies to share information with each other on planned and ongoing projects conducted at the individual agency. –The aim of the database is to reduce duplication and facilitate collaboration among HTA agencies. HTA CORE MODEL –The HTA Core Model® is a methodological framework for shared production and sharing of HTA information. EVIDENT DATABASE –The Evidence database on new technologies (EVIDENT Database) allows sharing and storage of information on: reimbursement/coverage and assessment status of promising technologies and on additional studies requested or recommended further to a HTA. Source: EUnetHTA

12. EUnetHTA Core Model Source: EUnetHTA

13. EUnetHTA Joint Action 2 (2012-2015) The strategic objectives of the JA2 are: To strengthen the practical application of tools and approaches to cross-border HTA collaboration To aim at bringing collaboration to a higher level resulting in better understanding for the Commission and Member States (MS) of the ways to establish a sustainable structure for HTA in the EU To develop a general strategy, principles and an implementation proposal for a sustainable European HTA collaboration according to the requirements of Article 15 of the Directive for cross-border healthcare. Source: EUnetHTA

14. EUnetHTA JA2 Work Packages JA2 WP1 - COORDINATION JA2 WP2 - DISSEMINATION OF THE PROJECT JA2 WP3 - EVALUATION OF THE PROJECT JA2 WP4 - TESTING COLLABORATIVE PRODUCTION OF HTA INFORMATION FOR NATIONAL ADAPTATION AND REPORTINGJA2 WP4 - TESTING COLLABORATIVE PRODUCTION OF HTA INFORMATION FOR NATIONAL ADAPTATION AND REPORTING JA2 WP5 - APPLYING THE HTA CORE MODEL FOR RAPID ASSESSMENT FOR NATIONAL ADAPTATION AND REPORTING JA2 WP5 - APPLYING THE HTA CORE MODEL FOR RAPID ASSESSMENT FOR NATIONAL ADAPTATION AND REPORTING JA2 WP5 - APPLYING THE HTA CORE MODEL FOR RAPID ASSESSMENT FOR NATIONAL ADAPTATION AND REPORTING JA2 WP5 - APPLYING THE HTA CORE MODEL FOR RAPID ASSESSMENT FOR NATIONAL ADAPTATION AND REPORTING JA2 WP6 - INFORMATION MANAGEMENT INFRASTRUCTURE AND SERVICES (IMIS) JA2 WP7 - METHODOLOGY DEVELOPMENT AND EVIDENCE GENERATION: GUIDELINES AND PILOTS PRODUCTION JA2 WP7 - METHODOLOGY DEVELOPMENT AND EVIDENCE GENERATION: GUIDELINES AND PILOTS PRODUCTION JA2 WP7 - METHODOLOGY DEVELOPMENT AND EVIDENCE GENERATION: GUIDELINES AND PILOTS PRODUCTION JA2 WP7 - METHODOLOGY DEVELOPMENT AND EVIDENCE GENERATION: GUIDELINES AND PILOTS PRODUCTION JA2 WP8 - MAINTENANCE OF HTA CORE MODEL INFRASTRUCTURE TO SUPPORT SHARED PRODUCTION AND SHARING OF HTA INFORMATION JA2 WP8 - MAINTENANCE OF HTA CORE MODEL INFRASTRUCTURE TO SUPPORT SHARED PRODUCTION AND SHARING OF HTA INFORMATION JA2 WP8 - MAINTENANCE OF HTA CORE MODEL INFRASTRUCTURE TO SUPPORT SHARED PRODUCTION AND SHARING OF HTA INFORMATION JA2 WP8 - MAINTENANCE OF HTA CORE MODEL INFRASTRUCTURE TO SUPPORT SHARED PRODUCTION AND SHARING OF HTA INFORMATION Source: EUnetHTA

15. Information Asymmetry the Power of Media (especially Social Media) the Power of Legal Impact (CZ jackpot of 1 mil. €) the Power of Politics (Access, Quality, Costs) the Power of Purchasing Power / Co-Payment How about the Patient?

16. EUnetHTA Join Action Organigram Source: EUnetHTA

17. Are we ready for the new Challenge? EU Cross-border Healthcare Directive … October, 25 th, 2013 Role of Patients and Representative Patient Organizations Society Acknowledgement (Ethics, Transparency, Reliability, Trust) Products and Services Innovations, Centers of Excellence, Reference Centers in EU (an official status, defined by the MoH) New Forms of Communication, Social Media, Mobile Applications E-Health, E-Rx, Electronic Health Records, E-Cards Internal Capacities and Capabilities, Know-How, Effectivity, Stakeholder Involvement