New French Coverage with Evidence Development for Innovative Medical Devices: Improvements and Unresolved Issues

Value in Health : the Journal of the International Society for Pharmacoeconomics and Outcomes Research
Nicolas MartelliIsabelle Borget

Abstract

We describe here recent modifications to the French Coverage with Evidence Development (CED) scheme for innovative medical devices. CED can be defined as temporary coverage for a novel health product during collection of the additional evidence required to determine whether definitive coverage is possible. The principle refinements to the scheme include a more precise definition of what may be considered an innovative product, the possibility for device manufacturers to request CED either independently or in partnership with hospitals, and the establishment of processing deadlines for health authorities. In the long term, these modifications may increase the number of applications to the CED scheme, which could lead to unsustainable funding for future projects. It will also be necessary to ensure that the study conditions required by national health authorities are suitable for medical devices and that processing deadlines are met for the scheme to be fully operational. Overall, the modifications recently applied to the French CED scheme for innovative medical devices should increase the transparency of the process, and therefore be more appealing to medical device manufacturers.

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Citations

Dec 15, 2018·The International Journal of Health Planning and Management·Makoto TamuraTakuma Sugahara
Nov 14, 2020·International Journal of Environmental Research and Public Health·Rick A VremanWim G Goettsch
Sep 19, 2018·Value in Health : the Journal of the International Society for Pharmacoeconomics and Outcomes Research·Julia R TrosmanKathryn A Phillips
Apr 25, 2020·Value in Health : the Journal of the International Society for Pharmacoeconomics and Outcomes Research·Monique DabbousMondher Toumi
Dec 25, 2021·Journal of Managed Care & Specialty Pharmacy·Yilin Chen, Josh J Carlson

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