Rita Daubner-Bendes1, Sándor Kovács1,2, Maciej Niewada3, Mirjana Huic4, Michael Drummond5, Oriana Ciani6,7, Carl Rudolf Blankart8,9, Olena Mandrik10, Aleksandra Torbica6,11, John Yfantopoulos12, Guenka Petrova13, Malwina Holownia-Voloskova3,14, Rod S Taylor7,15, Maiwenn Al16, Oresta Piniazhko17, László Lorenzovici18,19, Rosanna Tarricone6,11, Antal Zemplényi1,20, Zoltán Kaló1,21. 1. Syreon Research Institute, Budapest, Hungary. 2. Centre for Health Technology Assessment, University of Pécs, Pécs, Hungary. 3. Department of Experimental and Clinical Pharmacology, Medical University of Warsaw, Warsaw, Poland. 4. HTA/EBM Consulting Centre, Zagreb, Croatia. 5. Centre for Health Economics, University of York, York, United Kingdom. 6. Centre for Research on Health and Social Care Management, SDA Bocconi School of Management, Milan, Italy. 7. Evidence Synthesis and Modelling for Health Improvement, College of Medicine and Health, Institute of Health Research, University of Exeter, Exeter, United Kingdom. 8. KPM Center for Public Management, University of Bern, Bern, Switzerland. 9. sitem-insel AG, Swiss Institute for Translational and Entrepreneurial Medicine, Bern, Switzerland. 10. School of Health and Related Research, Health Economics and Decision Science, The University of Sheffield, Sheffield, United Kingdom. 11. Department of Social and Political Science, Bocconi University, Milan, Italy. 12. School of Economics and Political Science, University of Athens, Athens, Greece. 13. Department of Social Pharmacy and Pharmacoeconomics, Faculty of Pharmacy, Medical University of Sofia, Sofia, Bulgaria. 14. Health Technology Assessment Department, State Budgetary Institution "Research Institute for Healthcare Organization and Medical Management of Moscow Healthcare Department", Moscow, Russia. 15. MRC/CSO Social and Public Health Sciences Unit and Robertson Centre for Biostatistics, Institute of Health and Well Being, University of Glasgow, Glasgow, United Kingdom. 16. Erasmus School of Health Policy and Management, Erasmus University Rotterdam, Rotterdam, Netherlands. 17. HTA Department of State Expert Centre of Ministry of Health of Ukraine, Kyiv, Ukraine. 18. G. E. Palade University of Medicine, Pharmacy, Science and Technology, Tirgu Mures, Romania. 19. Syreon Research Romania, Tirgu Mures, Romania. 20. Division of Pharmacoeconomics, Faculty of Pharmacy, University of Pécs, Pécs, Hungary. 21. Centre for Health Technology Assessment, Semmelweis University, Budapest, Hungary.
Abstract
Objectives: Methodological challenges in the evaluation of medical devices (MDs) may be different for early and late technology adopter countries, as well as the potential health technology assessment (HTA) solutions to tackle them. This study aims to provide guidance to Central and Eastern European (CEE) countries on how to address key challenges of HTA for MDs with special focus on the transferability of scientific evidence. Methods: As part of the COMED Horizon 2020 project, a comprehensive list of issues related to MD HTA were identified based on a targeted literature review. Health technology assessment issues which pose a greater challenge or require different solutions in late technology adopter countries were selected. Draught recommendations to address these issues were developed and discussed in a focus group. The recommendations were then validated with a wider group of experts, including HTA and reimbursement decision makers from CEE countries in May and June 2020. Results: A consolidated list of 11 recommendations were developed in 3 major areas: (1) clinical value assessment, focusing on the use of joint EU work, relying on real-world evidence, use of coverage with evidence development schemes, transferring evidence from foreign countries and addressing the challenges of learning curve and centre effect; (2) economic value assessment, covering cost calculation of complex medical devices and transferability of economic evaluations of MDs; (3) HTA processes, related to the frequent product modifications and various indications of MDs. Conclusions: Central and Eastern European countries with limited resources for conducting HTA, can benefit from HTA methods and evidence generated in early technology adopter countries. Considering the appropriate reuse of international HTA materials, late technology adopter countries can still implement HTA, even for MDs, which have a more limited evidence base compared with pharmaceuticals.
Objectives: Methodological challenges in the evaluation of medical devices (MDs) may be different for early and late technology adopter countries, as well as the potential health technology assessment (HTA) solutions to tackle them. This study aims to provide guidance to Central and Eastern European (CEE) countries on how to address key challenges of HTA for MDs with special focus on the transferability of scientific evidence. Methods: As part of the COMED Horizon 2020 project, a comprehensive list of issues related to MD HTA were identified based on a targeted literature review. Health technology assessment issues which pose a greater challenge or require different solutions in late technology adopter countries were selected. Draught recommendations to address these issues were developed and discussed in a focus group. The recommendations were then validated with a wider group of experts, including HTA and reimbursement decision makers from CEE countries in May and June 2020. Results: A consolidated list of 11 recommendations were developed in 3 major areas: (1) clinical value assessment, focusing on the use of joint EU work, relying on real-world evidence, use of coverage with evidence development schemes, transferring evidence from foreign countries and addressing the challenges of learning curve and centre effect; (2) economic value assessment, covering cost calculation of complex medical devices and transferability of economic evaluations of MDs; (3) HTA processes, related to the frequent product modifications and various indications of MDs. Conclusions: Central and Eastern European countries with limited resources for conducting HTA, can benefit from HTA methods and evidence generated in early technology adopter countries. Considering the appropriate reuse of international HTA materials, late technology adopter countries can still implement HTA, even for MDs, which have a more limited evidence base compared with pharmaceuticals.
Keywords:
Central-Eastern Europe (CEE); health technology assessement (HTA); medical device (MD); methodological challenge; real world evidence (RWE); transferability; value assessment
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