Federici, Carlo, Reckers-Droog, Vivian, Ciani, Oriana, Dams, Florian, Grigore, Bogdan, Kaló, Zoltán, Kovács, Sándor, Shatrov, Kosta, Brouwer, Werner and Drummond, Michael (2021) Coverage with evidence development schemes for medical devices in Europe : characteristics and challenges. The European Journal of Health Economics, 22 (8). pp. 1253-1273. doi:10.1007/s10198-021-01334-9 ISSN 1618-7598.

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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.

Item Type:	Journal Article
Subjects:	R Medicine > R Medicine (General)
Divisions:	Faculty of Science, Engineering and Medicine > Engineering > Engineering
Library of Congress Subject Headings (LCSH):	Medical instruments and apparatus, Medical instruments and apparatus -- Cost effectiveness, Medical instruments and apparatus -- Procurement, Medical instruments and apparatus -- Europe
Journal or Publication Title:	The European Journal of Health Economics
Publisher:	Springer
ISSN:	1618-7598
Official Date:	November 2021
Dates:	Date Event November 2021 Published 12 June 2021 Available 2 June 2021 Accepted 29 November 2020 Submitted
Volume:	22
Number:	8
Page Range:	pp. 1253-1273
DOI:	10.1007/s10198-021-01334-9
Status:	Peer Reviewed
Publication Status:	Published
Access rights to Published version:	Open Access (Creative Commons)
Date of first compliant deposit:	9 August 2022
Date of first compliant Open Access:	15 August 2022
RIOXX Funder/Project Grant:	Project/Grant ID RIOXX Funder Name Funder ID 779306 [ERC] Horizon 2020 Framework Programme http://dx.doi.org/10.13039/100010661

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