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

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

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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 (Original Article)

Division/Institute:

04 Faculty of Medicine > Faculty Institutions > sitem Center for Translational Medicine and Biomedical Entrepreneurship
11 Centers of Competence > KPM Center for Public Management

UniBE Contributor:

Dams, Florian, Shatrov, Kosta Donislavov

Subjects:

300 Social sciences, sociology & anthropology > 350 Public administration & military science
300 Social sciences, sociology & anthropology > 330 Economics
600 Technology > 610 Medicine & health
600 Technology > 650 Management & public relations

ISSN:

1618-7598

Publisher:

Springer

Funders:

Organisations 779306 not found.; [UNSPECIFIED] Open access funding by Università Commerciale Luigi Bocconi within the CRUI-CARE Agreement

Projects:

[UNSPECIFIED] COMED (www.comedh2020.eu)

Language:

English

Submitter:

Kosta Donislavov Shatrov

Date Deposited:

09 Mar 2022 12:32

Last Modified:

05 Dec 2022 16:07

Publisher DOI:

10.1007/s10198-021-01334-9

PubMed ID:

34117987

Uncontrolled Keywords:

Coverage with evidence development Medical devices European HTA policies Value of information Adoption and reimbursement of medical devices

BORIS DOI:

10.48350/165238

URI:

https://boris.unibe.ch/id/eprint/165238

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