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

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<

SUBMITTER: Federici C 

PROVIDER: S-EPMC8526454 | biostudies-literature | 2021 Nov

REPOSITORIES: biostudies-literature