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The Role of Health Technology Assessment in the European Union European on Health Systems and Policies ENSURING VALUE FOR MONEY IN HEALTH CARE The role of health technology assessment in the European Union Corinna Sorenson, Michael Drummond, Panos Kanavos Observatory Studies Series No 11 Ensuring value for money in health care The European Observatory on Health Systems and Policies supports and promotes evidence- based health policy-making through comprehensive and rigorous analysis of health systems in Europe. It brings together a wide range of policy-makers, academics and practitioners to analyse trends in health reform, drawing on experience from across Europe to illuminate policy issues. The European Observatory on Health Systems and Policies is a partnership between the World Health Organization Regional Office for Europe, the Governments of Belgium, Finland, Greece, Norway, Slovenia, Spain and Sweden, the Veneto Region of Italy, the European Investment Bank, the Open Society Institute, the World Bank, the London School of Economics and Political Science and the London School of Hygiene & Tropical Medicine. Ensuring value for money in health care The role of health technology assessment in the European Union Corinna Sorenson Michael Drummond Panos Kanavos Keywords: TECHNOLOGY ASSESSMENT, BIOMEDICAL – organization and administration OUTCOME AND PROCESS ASSESSMENT (HEALTH CARE) EVIDENCE-BASED MEDICINE DECISION MAKING COST-BENEFIT ANALYSIS EUROPEAN UNION © World Health Organization 2008, on behalf of the European Observatory on Health Systems and Policies All rights reserved. The European Observatory on Health Systems and Policies welcomes requests for permission to reproduce or translate its publications, in part or in full. Address requests about publications to: Publications, WHO Regional Office for Europe, Scherfigsvej 8 DK-2100 Copenhagen Ø, Denmark Alternatively, complete an online request form for documentation, health information, or for permission to quote or translate, on the Regional Office web site (http://www.euro.who.int/pubrequest). The designations employed and the presentation of the material in this publication do not imply the expression of any opinion whatsoever on the part of the European Observatory on Health Systems and Policies concerning the legal status of any country, territory, city or area or of its authorities, or concerning the delimitation of its frontiers or boundaries. Dotted lines on maps represent approximate border lines for which there may not yet be full agreement. The mention of specific companies or of certain manufacturers’ products does not imply that they are endorsed or recommended by the European Observatory on Health Systems and Policies in preference to others of a similar nature that are not mentioned. Errors and omissions excepted, the names of proprietary products are distinguished by initial capital letters. All reasonable precautions have been taken by the European Observatory on Health Systems and Policies to verify the information contained in this publication. However, the published material is being distributed without warranty of any kind, either express or implied. The responsibility for the interpretation and use of the material lies with the reader. In no event shall the European Observatory on Health Systems and Policies be liable for damages arising from its use. The views expressed by authors, editors, or expert groups do not necessarily represent the decisions or the stated policy of the European Observatory on Health Systems and Policies. ISBN 978 92 890 7183 3 Printed in the United Kingdom by MPG Books Ltd, Bodmin, Cornwall. Contents List of abbreviations vi List of tables, figures and boxes x About the authors xi Acknowledgements xii Executive summary xiii 1 Project overview, objectives and methods 1 2 Background on innovation and HTA 3 3 HTA and decision-making in Europe 9 4 Conclusions 33 Appendices: Select country case studies Appendix 1: Sweden 39 Appendix 2: The Netherlands 55 Appendix 3: Finland 72 Appendix 4: France 85 Appendix 5: Germany 100 Appendix 6: United Kingdom 114 References 145 List of abbreviations ACD Appraisal consultation document. Afssa Agence Française de Sécurité Sanitaire des Aliments. Afssaps Agence Française de Sécurité Sanitaire des Produits de Santé. Afsset Agence Française de Sécurité Sanitaire de l’Environnement et du Travail. ANAES Agence Nationale d’Accréditation et d’Evaluation en Santé National. ANDEM Agence Nationale pour le Déement de l’Evaluation Médicale. ASMR Amélioration du Service Médical Rendu. ATC Anatomical therapeutic chemical. BfArM Bundesinstitut für Arzneimittel und Medizinprodukte. BMG Bundesministerium für Gesundheit. BZgA Bundeszentrale für gesundheitliche Aufklärung. CAMTO Centre for Assessment of Medical Technology. CBA Cost benefit analysis. CBO Dutch Institute for Healthcare Improvement. CDC Centers for Disease Control and Prevention. CE Cost-effectiveness. CEA Cost-effectiveness analysis. CEDIT Comite d’Évaluation et de Diffusion des Innovations Technologiques. CEMTV Center for Evaluering og Medicinsk Teknologivurdering (DACEHTA). CEPP Commission d’Évaluation des Produits et Prestations. CEPS Comité Économique des Produits de Santé. CES College des Économistes de la Santé. CFH Commissie Farmaceutische Hulp (Pharmaceutical Care Committee). CMA Cost minimization analysis. CUA Cost-utility analysis. - vi - List of abbreviations vii CVZ College voor Zorgverzekeringen (Health Care Insurance Board). DAHTA Deutsche Agentur für Health Technology Assessment. DIMDI Deutschen Institut für Medizinische Dokumentation und Information. ERNIE Evaluation and review of NICE implementation evidence database. EUnetHTA European network for Health Technology Assessment. FinOHTA Terveydenhuollon menetelmien arviointiyksikkö (Finnish Office for Health Technology Assessment). HTA Health technology assessment. HTAi Health Technology Assessment International. IHE Institutet för hälso-och sjukvårdsekonomi (Swedish Institute for Health Economics. IMOR Institute for Medical Outcome Research. INAHTA International Network of Agencies for Health Technology Assessment. Inserm Institut National de la Santé et de la Recherche Médicale. IOM Institute of Medicine. IQWiG Gemeinsamen Bundesausschuss/Institut für Qualitat und Wirtschaftlichkeit im Gesundheitswesen. ISPOR International Society for Pharmacoeconomics and Outcomes Research. ITAS Institut für Technik-folgen-abschätzung und Systemanalyse. LFN Läkemedelsförmånsnämnden (Pharmaceutical Benefits Board). MPA Läkemedelsverket (Medical Products Agency). NAM Lääkelaitos (National Agency for Medicines). NCC National Collaborating Centre. NCCHTA National Coordinating Centre for Health Technology Assessment. NHG Nederlands Huisartsen Genootschap (Dutch College of General Practitioners). NHI National health insurance. NHS National Health Service (United Kingdom). viii Ensuring value for money in health care NICE National Institute for Health and Clinical Excellence. NoMA Statens legemiddelverk (Norwegian Medicines Agency). NSF National service framework. NWO Nederlandse Organisatie voor Wetenschappelijk Onderzoek (Netherlands Organisation for Scientific Research). OECD Organisation for Economic Co-operation and Development. PPB Lääkkeiden hintalautakunta (Pharmaceuticals Pricing Board). PCT Primary care trust. QALY Quality-adjusted life year. QIS NHS Quality Improvement Scotland. QUORUM Improving the quality of reporting of meta-analyses of randomized controlled trials. R&D Research and development. RCT Randomized controlled trial. RFV Riksforsakringsverket (National Social Insurance Board). ROHTO Lääkehoidon kehittämiskeskus (Centre for Pharmacotherapy Development). RVZ Raad voor Volksgezondeid & Zorg (Council for Public Health and Health Care). SBU Statens beredning för medicinsk utvärdering (Swedish Council on Technology Assessment in Health Care). ScHARR School of Health and Related Research, University of Sheffield. SHA Strategic health authority. SHI Statutory health insurance. SHTAC Southampton Health Technology Assessments Centre. SMC Scottish Medicines Consortium. SMR Therapeutic value. STA Single technology appraisal. STAKES National Research and Development Centre for Welfare and Health. TAB Büro für Technikfolgen-Abschätzung beim Deutschen Bundestag. TAG Technical appraisal guidance. TAR Technology assessment report. TNO Kennis voor zaken (Netherlands Organisation for Applied Scientific Research). List of abbreviations ix UNCAM Union Nationale des Caisses d’Assurance Maladie. UNOC Union Nationale des Organismes d’Assurance Maladie Complémentaire. WHO World Health Organization. WTP Willingness to pay. ZonMw Nederlandse organisatie voor gezondheidsonderzoek en zorginnovatie (Netherlands Organisation for Health Research and Development). List of tables, figures and boxes Tables Table 3.1 Institutions and advisory bodies responsible for HTA 10 activities. Table 3.2 Criteria for assessment. 17 Table A1.1 Overview of HTA governance, processes and role in 50 decision-making in Sweden. Table A2.1 Overview of HTA governance, processes and role in 67 decision-making in the Netherlands. Table A3.1 Overview of HTA governance, processes and role in 81 decision-making in Finland. Table A4.1 Overview of HTA governance, processes and role in 96 decision-making in France. Table A5.1 Overview of HTA governance, processes and role in 110 decision-making in Germany. Table A6.1 Examples of published and planned NICE guidance. 135 Table A6.2 Overview of HTA governance, processes and role in 139 decision-making in the United Kingdom. Figures Fig. A1.1 Principal
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