Challenges with coverage with evidence development schemes for medical devices: A systematic review

https://doi.org/10.1016/j.hlpt.2020.02.006Get rights and content
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Highlights

  • Payers increasingly use CED schemes to reduce decision uncertainty.

  • CED schemes are particularly relevant for medical devices.

  • Payers face many challenges when applying CED schemes for medical devices.

  • Challenges often relate to the unique characteristics of medical devices.

  • These challenges have to be addressed to improve a CED scheme's chance of success.

Abstract

Objectives

Coverage with evidence development (CED) schemes are particularly relevant for medical devices (MDs), since clinical evidence is often limited at the time of launch and their long-term (cost-) effectiveness heavily depends on how they are adopted into routine clinical practice. The objective of this study was to identify and describe the challenges that payers and manufacturers might face when assessing the desirability of, choosing the research design for, implementing, and evaluating CED schemes for MDs.

Methods

A systematic literature review was performed on six databases following PRISMA guidelines. Two independent reviewers assessed the eligibility of studies based on predefined criteria and extracted data from the included articles by using a pre-defined extraction template. The data were synthesised in a narrative review.

Results

The systematic search yielded 4293 articles of which 27 were eligible for inclusion. We identified 20 challenges that are associated with CED schemes for MDs. Five of these challenges relate directly to the characteristics of MDs, and hence are specific to MDs. These challenges concern deciding on whether a CED scheme is required, understanding the relevant uncertainties and risks, identifying meaningful outcomes, defining an adequate duration for a scheme, and market entry of new technologies.

Conclusions

Payers and manufacturers of MDs have to address the identified challenges to improve a CED scheme's chance of success. This can be further improved by public sharing of information about the outcome of applied schemes and way in which stakeholders have addressed the challenges they faced when applying a CED scheme.

Keywords

Coverage with evidence development
Performance based risk sharing agreements
Health technology assessment
Decision uncertainty
Medical devices

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