Health Technology Assessment of Medical Devices in Europe Department of Healthcare Management (MiG), Technical University Berlin (TU Berlin) Sabine Fuchs, MScPH Britta Olberg Dimitra Panteli Prof. Dr. Reinhard Busse 18 June 2014 HTAi, Washington DC 1 Project ADVANCE_HTA Overall objective • to complement and address areas of intense methodological debate in the application, use and implementation of HTA • to make improvements in HTA methods, which can be taken further by competent authorities Objective WP 5 (TU Berlin leading partner) • to map different assessment approaches towards the assessment of medical devices • to identify areas where knowledge and tools are lacking • to offer insight on how current HTA assessment tools can be modified or adapted 18 June 2014 HTAi, Washington DC 2 Methods and approach • Systematic review to identify and compare current HTA methodologies, processes and practices across EU Member States and synthesis report (task 2) • Includes a systematic search for and analysis of: (1) HTA guidelines/ regulations available on websites of HTA bodies, international networks and decision-makers and in the published literature (2) a representative pool of published HTA reports across EU Member States (in progress) 18 June 2014 HTAi, Washington DC 3 Methods and approach • Data generation – Identification of agencies – Information on included agencies and selection of relevant methodological documents – Systematic literature search for publications • Data analysis (in progress) – Method extraction tool • Participatory approach (Oct. 2014) 18 June 2014 HTAi, Washington DC 4 Identification of agencies INHATA members n=34 EUnetHTA partner organizations n=44 HTAi nonprofit members n=26 HTAi Vortal Europe n=46 IJTAHC 2011-2012 n=34 Dublicate organizations n=98 EU28 member states + EFTA Agency pool n=86 Based on: Panteli, Kreis & Busse, 2012 18 June 2014 HTAi, Washington DC 5 Information on included agencies and selection of methodological documents • Captured domains/elements (20 items): Role (e.g. agencies place in the countries HTA system), Structure (e.g. annual funding), Scope (e.g. types of technologies that the agency address), HTA report production (e.g. does the agency produce its own), – Methodology (e.g. available methodological guides/ regulations on methods on website) – – – – 18 June 2014 HTAi, Washington DC 6 Systematic literature search for publications • Search strategy: Pool of included agencies AND Type of technology AND Type/ content of publication • Databases: – Medline, EMBASE, Cochrane Library • Inclusion criteria: – Publication refers to the methodology or process of health technology assessment for medical devices by an institution/agency – Publication refers to an institution/agency included in the predetermined agency pool – Publication time January, 1st 2008 – September 29th, 2013 – Full text document available 18 June 2014 HTAi, Washington DC 7 Extraction of information • Development of method extraction tool which covers a broad range of aspects: – – – – – – – – 18 June 2014 Assessment elements (e.g. clinical effectiveness, safety) General approach (e.g. different application depending on type) Evidence procurement and selection (e.g. submissions; sources) Evidence appraisal (e.g. tools for appraisal) Review process & transparency (e.g. stakeholder involvement) Reassessment (e.g. specific interval) Knowledge exchange & transferability (e.g. reports from HTA agencies) Costs and economic evaluation (e.g. types of analyses) HTAi, Washington DC 8 Results • Overview of information availability on included agencies • Identified methodological documents on included agencies • Systematic literature search 18 June 2014 HTAi, Washington DC 9 Overview of information availibility 18 June 2014 HTAi, Washington DC Methodology 10 Identified methodological documents 39 methodological documents from 20 agencies in 16 countries were identified Source: www.johann-klein.com 18 June 2014 HTAi, Washington DC 11 Identified methodological documents 4 agencies with separate documents for the assessment of medical devices Source: www.johann-klein.com 18 June 2014 HTAi, Washington DC 12 Separate documents for the assessment of medical devices Nice (UK) HAS (FR) CVZ (NL) DACEHTA (DK) • The Diagnostics Assessment Programme manual, 2011: describes the principles and methods used to assess diagnostics • Methodological Choices for the Clinical Development of Medical Devices – Methodology guide, 2013: focus on aspects of clinical efficacy assessment • Medical tests: assessment of established medical science and medical practice, 2011: details of the CVZ assessment framework for medical tests, also for other parties • Mini-HTA for hospital services when introducing medical technology, 2005: tool for hospitals with form and guide, new medical devices • The Medical Technologies Evaluation Programme Methods guide, 2011: looks at new devices and diagnostics 18 June 2014 • Rapid Assessment Method for Assessing Medical and Surgical Procedures, 2007 (short document) HTAi, Washington DC 13 Identified methodological documents 4 agencies with separate provisions in their general methods Source: www.johann-klein.com 18 June 2014 HTAi, Washington DC 14 Identification Included Eligibility Screening Systematic literature search for publications 18 June 2014 Search in Databases (n= 4393) • PubMed (n= 1988) • Embase (n= 1548) • Cochrane Library (n= 857) Records after duplicates removed n= 4113 Records screened (Title/Abstract) n= 4113 Records excluded n= 4041 Full-text articles assessed for eligibility n= 72 Records excluded n= 49 Records included in qualitative synthesis n= 23 HTAi, Washington DC Source: Adapted from the PRISMA Group (2009) 15 Summary and further approach • Specific tools for the assessment of medical devices are rarely developed and implemented • Information on processes, practices and methodology of agencies/ institutions: – no or partially sufficient information – often in official language • participatory approach (forthcoming): – clarify and supplement earlier findings – capture challenges and trends 18 June 2014 HTAi, Washington DC 16 Thank you for your attention! 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