MANAGED ENTRY SCHEMES FOR MEDICAL DEVICES- GREAT OPPORTUNITY OR MAJOR CHALLENGE?

Author(s)

Richard Charter, MSc, Becton Dickinson, Allschwil, Switzerland; Michael F. Drummond, MCom, DPhil, University of York, Heslington, York, UK; Aleksandra Torbica, PhD, Bocconi University, Milano, Italy

ISSUE: Funding decisions are often difficult because of numerous uncertainties around the efficacy, effectiveness, safety or cost-effectiveness of new technologies. In this context, several countries have implemented novel market access schemes, with the aim of allowing market access, closely managed through agreements set up with health technology companies. These policies are labelled as “managed entry agreements” (MEA) and they include all types of “arrangements between a manufacturer and payer/provider that enable coverage or reimbursement of a health technology subject to specific conditions’’. These schemes have been developed mainly for pharmaceuticals to date, but there is a growing interest in expanding the scope of MEAs to medical devices, given the uncertainties concerning their effectiveness and use at the time of market approval. However, do the challenges of agreeing and operating these schemes outweigh the opportunities they provide? OVERVIEW: MEAs are generally regarded as an attractive policy option since they facilitate market access for new technologies, to the benefit of patients and technology manufacturers, while limiting the financial risk to the payer. These schemes also enable us to gather a stronger evidence base on the costs and outcomes of new health technologies than would otherwise be possible. Although MEA schemes are widely regarded as a promising policy, they require critical decisions to be made concerning the technologies to which they should be applied, the nature of the study to be undertaken, the funding of the research and the ways in which research findings should influence the final reimbursement and coverage determination. This suggests that manufacturers and other stakeholders need more advice on the design and conduct of these schemes before widely applying them on medical devices. This issue panel explores the perspectives of different stakeholders (manufacturers, policy makers and researchers) on the pros and cons of these schemes.

Conference/Value in Health Info

2017-11, ISPOR Europe 2017, Glasgow, Scotland

Code

IP16

Topic

Health Policy & Regulatory, Medical Technologies

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