Coverage with evidence development schemes for medical devices in Europe: characteristics and challenges

Carlo Federici (), Vivian Reckers-Droog, Oriana Ciani, Florian Dams, Bogdan Grigore, Zoltán Kaló, Sándor Kovács, Kosta Shatrov, Werner Brouwer and Michael Drummond
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Carlo Federici: Bocconi University
Vivian Reckers-Droog: Erasmus University Rotterdam
Oriana Ciani: Bocconi University
Florian Dams: University of Bern
Bogdan Grigore: University of Exeter
Zoltán Kaló: Syreon Research Institute
Sándor Kovács: Syreon Research Institute
Kosta Shatrov: University of Bern
Michael Drummond: University of York

The European Journal of Health Economics, 2021, vol. 22, issue 8, No 8, 1253-1273

Abstract: Abstract Objectives Medical devices are potentially good candidates for coverage with evidence development (CED) schemes, as clinical data at market entry are often sparse and (cost-)effectiveness depends on real-world use. The objective of this research was to explore the diffusion of CED schemes for devices in Europe, and the factors that favour or hamper their utilization. Methods We conducted structured interviews with 25 decision-makers from 22 European countries to explore the characteristics of existing CED programmes for devices, and how decision makers perceived 13 pre-identified challenges associated with initiating and operating CED schemes for devices. We also collected data on individual schemes that were either initiated or still ongoing in the last 5 years. Results We identified seven countries with CED programmes for devices and 78 ongoing schemes. The characteristics of CED programmes varied across countries, including eligibility criteria, roles and responsibilities of stakeholders, funding arrangements, and type of decisions being contemplated at the outset of each scheme. We observed a high variability in how decision makers perceived CED-related challenges possibly reflecting country-specific arrangements and different experiences with CED. One general finding across all countries was that relatively little attention was paid to the evaluation of schemes, both during and at their completion. Conclusions CED programmes for devices with different characteristics exist in Europe. Decision-makers’ perceptions differ on the challenges associated with these schemes. More exchange of knowledge and experience will help decision makers anticipate the likely challenges in CED schemes for devices, and to learn from good practices existing elsewhere.

Keywords: Coverage with evidence development; Medical devices; European HTA policies; Value of information; Adoption and reimbursement of medical devices (search for similar items in EconPapers)
JEL-codes: I18 (search for similar items in EconPapers)
Date: 2021
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Citations: View citations in EconPapers (4)

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DOI: 10.1007/s10198-021-01334-9

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