Sarah Kleijnen1, Wil Toenders2, Folkert de Groot2, Mirjana Huic3, Elisabeth George4, Beate Wieseler5, Mira Pavlovic6, Anna Bucsics7, Paolo D Siviero8, Martin van der Graaff9, Rafał Rdzany10, Finn Børlum Kristensen11, Wim Goettsch12. 1. National Health Care Institute (Zorginstituut Nederland), PO Box 320, 110 XH Diemen, The Netherlands; University of Utrecht, PO Box 80082, 3508 TB Utrecht, The Netherlands. Electronic address: skleijnen@zinl.nl. 2. ToendersdeGroot Consultants, Boomstede 281, 3608 AN Maarssen, The Netherlands. 3. Agency for Quality and Accreditation in Health Care and Social Welfare (Agencija za kvalitetu i akreditaciju u zdravstvu i socijalnoj skrbi), Planinska 13, HR-10000 Zagreb, Croatia. 4. National Institute for Health and Care Excellence, 10 Spring Gardens, London SW1A 2BU, England, United Kingdom. 5. The Institute for Quality and Efficiency in Healthcare (Institut für Qualität und Wirtschaftlichkeit im Gesundheidswesen), Im Mediapark 8, D-50670 Köln, Germany. 6. French National Authority for Health (Haute Autorité de Santé), 2, avenue du Stade de France, 93218 Saint-Denis La Plaine Cedex, France. 7. Association of Austrian Social Insurance Institutions (Hauptverband der Österreichischen Sozialversicherungsträger), Postfach 600, 1031 Vienna, Austria; University of Vienna, Brünner Straße 72, 1210 Vienna, Austria. 8. Italian Medicines Agency (Agenzia Italiana del Farmaco), Via del Tritone, 181, 00187 Rome, Italy. 9. National Health Care Institute (Zorginstituut Nederland), PO Box 320, 110 XH Diemen, The Netherlands. 10. Agency for Health Technology Assessment and Tariff System in Poland (Agencja Oceny Technologii Medycznych i Taryfikacji), ul. I. Krasickiego 26, 02-611 Warsaw, Poland. 11. Danish Health and Medicines Authority (Sundhedsstyrelsen), Axel Heides Gade 1, 2300 Copenhagen S, Denmark; University of Southern Denmark, Campusvej 55, DK 5230 Odense M, Denmark. 12. National Health Care Institute (Zorginstituut Nederland), PO Box 320, 110 XH Diemen, The Netherlands; University of Utrecht, PO Box 80082, 3508 TB Utrecht, The Netherlands.
Abstract
OBJECTIVE: The objective of this study is to identify the possible barriers and critical success factors for the implementation of European collaboration in the field of relative effectiveness assessment (REA) of drugs. METHODS: Data were gathered through semi-structured interviews with representatives from eight European health technology assessment (HTA) organisations involved in assessment of drugs for coverage decision-making (AAZ, AIFA, AHTAPol, HAS, HVB, IQWIG, NICE and ZiN). RESULTS: Potential barriers identified mainly relate to methodology, resources and challenges with implementation in the respective national processes (e.g. legal restrictions). The most critical success factors for production of cross-border assessments were the continuous cooperation of competent partners, and the quality and timely availability of the assessment. CONCLUSION: Further adaptation of the process and methods is required for optimal collaboration. In the near future it can be expected that cross-border assessments will meet in particular the needs of smaller/middle-sized European countries and also European countries with less developed HTA systems as the potential efficiency/quality gains are the highest for these countries. Therefore, national implementation of cross-border assessments is especially likely in these countries in the coming years. Once more experience is gained with cross-border assessments, and successes become more evident, efficiency/quality gains may also be likely for some larger countries with well established processes.
OBJECTIVE: The objective of this study is to identify the possible barriers and critical success factors for the implementation of European collaboration in the field of relative effectiveness assessment (REA) of drugs. METHODS: Data were gathered through semi-structured interviews with representatives from eight European health technology assessment (HTA) organisations involved in assessment of drugs for coverage decision-making (AAZ, AIFA, AHTAPol, HAS, HVB, IQWIG, NICE and ZiN). RESULTS: Potential barriers identified mainly relate to methodology, resources and challenges with implementation in the respective national processes (e.g. legal restrictions). The most critical success factors for production of cross-border assessments were the continuous cooperation of competent partners, and the quality and timely availability of the assessment. CONCLUSION: Further adaptation of the process and methods is required for optimal collaboration. In the near future it can be expected that cross-border assessments will meet in particular the needs of smaller/middle-sized European countries and also European countries with less developed HTA systems as the potential efficiency/quality gains are the highest for these countries. Therefore, national implementation of cross-border assessments is especially likely in these countries in the coming years. Once more experience is gained with cross-border assessments, and successes become more evident, efficiency/quality gains may also be likely for some larger countries with well established processes.