Finn Børlum Kristensen, MD, PhD Director, EUnetHTA Secretariat Danish Health and Medicines Authority (EUnetHTA Coordinator) Copenhagen, Denmark

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1 EUnetHTA European network for Health Technology Assessment DATABASES, REGISTRIES AND OTHER DATA CAPTURE TOOLS: HOW CAN WE AVOID MULTIPLICITY AND CREATE AN INTEGRATED DATA-CAPTURE APPROACH ALONG THE PRODUCT DEVELOPMENT CYCLE? The HTA perspective DIA, Vienna March 26, 2014 Finn Børlum Kristensen, MD, PhD Director, EUnetHTA Secretariat Danish Health and Medicines Authority (EUnetHTA Coordinator) Copenhagen, Denmark

2 Disclaimer The views and opinions expressed in the following PowerPoint slides are those of the individual presenter and should not be attributed to Drug Information Association, Inc. ( DIA ), its directors, officers, employees, volunteers, members, chapters, councils, Special Interest Area Communities or affiliates, or any organization with which the presenter is employed or affiliated These PowerPoint slides are copyright of the European network for Health Technology Assessment. Reproduction is permitted provided the source is acknowledged. 2

3 Participants in EUnetHTA JA National, regional agencies, universities, hospitals and nonfor-profit research organisations 38 Associated Partner organisations designated by Member States 30 Collaborating Partners contribute in kind 3

4 Some of the Partner Organisations in Joint Action 2 ( ), e.g. Germany, IQWIG,DIMDI France, HAS UK, NICE, NETSCC Italy, AGENAS, AIFA, ASSR Emilia Romagna, Veneto Region Spain, ISCIII, AETSA, OSTEBA, Avalia-T, AQuAS Croatia, AAZ Poland, AHTAPOL Austria, LBI, HVB, GÖG Netherlands, CVZ Belgium, KCE Portugal, INFARMED Sweden, SBU, TLV Norway, NOKC Finland, THL, FIMEA Denmark, DHMA (Coordinator), CFK Region Midt

5 This presentation EUnetHTA specific National registries and databases in national HTA Parent EMA and ENCePP Standardisation and harmonisation 5

6 Health Technology Life-cycle Use of technology in health care Early scientific advice Rapid REA HTA / REA Additional data collection Time line of innovation 6

7 Specific initiatives along the lifecycle taken up within European HTA cooperation Early scientific advice to technology sponsors (drugs, devices) Guidelines on assessing outcomes, diagnostics, and economic evaluation Additional data collection Moving to joint production through piloting Aligning HTA and regulatory needs Appropriate stakeholder involvement 7

8 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. 8

9 The EVIDENT Database Online Access to the EVIDENT Database: 9

10 The Domains of the HTA Core Model - assessing dimensions of value SCOPE HTA Core Model DOMAINS 1. Health problem and current use of technology Full Rapid 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 Reliable, timely, transparent, transferable HTA information Value???

11 Parent Joint Action Cross Border PAtient REgistries initiative (PARENT), is a Joint Action under the EU's Health Programme Overall objective: To support member states in developing comparable and coherent patient registries in fields of identified importance (e.g. chronic diseases, rare diseases, medical technology) Aim. To rationalize and harmonize the development and governance of patient registries, thus enabling analyses of secondary data for public health and research purposes EUnetHTA is a member of the JA s Associated Projects Group Read more at 11

12 12

13 EUnetHTA-EMA Collaboration Opportunities, specific steps to improve the efficiency of the process and conditions for patients timely access to an effective medicine A three-year Workplan is being implemented 13

14 HTA 2.0 Europe

15 Thank you for your attention This presentation arises from the EUnetHTA Joint Action 2 which has received funding from the European Union, in the framework of the Health Programme

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