Coverage with Evidence Development Schemes for Medical Devices in Europe: Characteristics and Challenges

Carlo Baldassarre Federici, Vivian. Reckers-Droog, Oriana Ciani, Florian Dams, Bogdan Grigore, Z. Kalo, Sandor Kovacs, Kosta Shatrov, Werner Brouwer, Mike Drummond

Research output: Contribution to journalArticlepeer-review


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 7 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.
Original languageEnglish
Pages (from-to)1253-1273
JournalThe European Journal of Health Economics
Publication statusPublished - 12 Jun 2021

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