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HEALTH TECHNOLOGY ASSESSMENT and HEALTH POLICY-MAKING in EUROPE Current Status, Challenges and Potential European on Health Systems and Policies HEALTH TECHNOLOGY ASSESSMENT AND HEALTH POLICY-MAKING IN EUROPE Current status, challenges and potential Marcial Velasco Garrido Finn Børlum Kristensen Camilla Palmhøj Nielsen Reinhard Busse Observatory Studies Series No 14 Health Technology Assessment and Health Policy-Making in Europe 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. Health Technology Assessment and Health Policy-Making in Europe Current status, challenges and potential 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 Marcial Velasco Garrido, Finn Børlum Kristensen, Europe. It brings together a wide range of policy-makers, academics and practitioners to analyse Camilla Palmhøj Nielsen, Reinhard Busse 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. Keywords: TECHNOLOGY ASSESSMENT, BIOMEDICAL OUTCOME ASSESSMENT (HEALTH CARE) POLICY MAKING HEALTH POLICY DELIVERY OF HEALTH CARE EUROPE © 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 4293 2 Printed in the United Kingdom Contents List of tables, figures and boxes vii Acknowledgements xi About the authors xiii Introduction 1 Marcial Velasco Garrido, Finn Børlum Kristensen, Camilla Palmhøj Nielsen, Reinhard Busse Chapter 1. Transnational collaboration on health technology 5 assessment – a political priority in Europe Finn Børlum Kristensen for the EUnetHTA partners Chapter 2. Policy processes and health technology assessment 19 Camilla Palmhøj Nielsen, Antonio Sarriá Santamera, Hindrik Vondeling Chapter 3. What is health technology assessment? 31 Finn Børlum Kristensen, Camilla Palmhøj Nielsen, Debbie Chase, Kristian Lampe, Sun Hae Lee-Robin, Marjukka Mäkelä Chapter 4. Health systems, health policy and health technology assessment 53 Marcial Velasco Garrido, Annette Zentner, Reinhard Busse Chapter 5. Health technology assessment in Europe – overview 79 of the producers Marcial Velasco Garrido, Juan Antonio Blasco Amaro, Americo Cichietti, Davide Integlia, Inger Natvig Norderhaug, Beatriz Valentin, Annette Zentner vi Health Technology Assessment and Health Policy-Making in Europe Chapter 6. What are the effects of HTA reports on the health system? 109 Evidence from the research literature Ansgar Gerhardus, Evelyn Dorendorf, John-Arne Røttingen, Antonio Sarriá Santamera Chapter 7. Needs and demands of policy-makers 137 Gerardo Atienza Merino, Leonor Varela Lema Chapter 8. Future challenges for HTA in Europe 161 John-Arne Røttingen, Ansgar Gerhardus, Marcial Velasco Garrido List of tables, figures and boxes Tables Table 2.1 Policy and research communities: different notions 25 of knowledge Table 3.1 How issues defined in the model may be translated into 44 research questions Table 4.1 Decisions related to health technologies 66 Table 4.2 Appraisal committees and corresponding assessment 70 units (selected examples) Table 4.3 Assessment, appraisal and decision-making institutions 72 in Switzerland Table 4.4 Criteria guiding coverage (funding + reimbursement + investing 74 + planning) decisions in selected European countries Table 5.1 HTA agencies and units in Europe 90 Table 5.2 Overview of institutions performing HTA and their activities in 94 selected European countries Table 6.1 Included studies – impact 126 Table 7.1 Included studies – needs and demands 156 Table 8.1 A quality framework for HTA 169 Table 8.2 Qualities of the HTA community and the Cochrane 177 Collaboration: a comparison viii Health Technology Assessment and Health Policy-Making in Europe Figures Fig. 2.1 Simple ideal model of a policy process 21 Fig. 2.2 Factors that influence policy-making 24 Fig. 3.1 From policy questions to HTA reports that inform policy 33 Fig. 3.2 HTA process 39 Fig. 4.1 Relationship between types of decisions and the definition 67 of benefit basket Fig. 4.2 General model of coverage decisions 69 Fig. 6.1 Hierarchical steps of the impact of HTA reports 111 Fig. 7.1 Decision-making process 139 Fig. 7.2 Selection of studies for systematic review 143 Fig. 8.1 Knowledge value chain in the health sector 162 Fig. 8.2 Different levels of health-care technologies/interventions 164 Fig. 8.3 Not too early, not too late: effective implementation 173 of innovations Fig. 8.4 Staircase of collaboration 174 Fig. 8.5 Role of HTA in the health system: a Norwegian example 179 Boxes Box 1.1 Cox Report: key statements on HTA 8 Box 1.2 Key messages in the WHO Health Evidence Network (HEN) 9 policy brief Box 1.3 Tallinn Charter: paragraph on innovations and HTA 10 Box 1.4 Article 17 of the Proposal for a Directive of the European 10 Parliament and of the Council on the application of patients’ rights in cross-border healthcare (presented by the Commission) Box 1.5 Explanatory memorandum of the Proposal for a Directive 11 of the European Parliament and of the Council on the application of patients’ rights in cross-border healthcare Box 1.6 Excerpt from: A Community framework on the application 12 of patients’ rights in cross-border healthcare which accompanied the Directive proposal Box 4.1 Areas of health technologies 56 List of tables, figures and boxes ix Box 4.2 Technologies in the health system: the example of 57 cardiovascular disease Box 4.3 Types of evidence in health-care system decisions 62 Box 4.4 Assessment and appraisal in Germany 71 Box 4.5 Coverage and pricing in France 71 Box 5.1 Establishment of the SBU 82 Box 5.2 HTA without an HTA agency: the Italian network 84 Box 5.3 Elucidating target audience’s perspective to determine 86 fields of work for an HTA agency Box 5.4 NCCHTA – research to inform NHS decision-making 91 Box 5.5 Belgian Health Care Knowledge Centre: HTA and 93 health services research Box 5.6 Expanding mandate of HTA institutions: the NOKC 96 Box 5.7 Hospital-based HTA: technology assessment unit in 100 the Agostino Gemelli University Hospital Box 5.8 Assessments for pharmaceutical reimbursement 102 policies – examples from Europe Box 6.1 Systematic review: method 113 Box 6.2 Impact of HTA reports on policy and practice: results 116 from a nine-country project Box 7.1 Knowledge-transfer strategy 140 Box 7.2 Methodology of systematic review 142 Box 7.3 Facilitators of the use of research evidence in policy-making 148 Box 7.4 Barriers to the use of research evidence in policy-making 149 Acknowledgements This book was made possible by cooperation between the European Network for Health Technology Assessment (EUnetHTA) Project and the European Observatory on Health Systems and Policies. The EUnetHTA Project ran from 2006 to 2008 and was supported by a grant from the European Commission. Sole responsibility for the content of this publication lies with the authors and the European Commission is not responsible for any use that may be made of the information contained therein. The Technische Universität Berlin hosted a workshop in March 2007.
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