Recommendations about add-on reimbursement for medical devices in France in May 2024

The French National Authority for Health (HAS) released new recommendations about add-on reimbursement of medical devices and medical aids from the meetings of the National Commission for Evaluation of Medical Devices and Health Technologies (CNEDiMTS) in May 2024. Seven recommendations were published concerning the registration of medical devices or modification of registration conditions/extension of indications for the medical devices in the List of Reimbursable Products and Services (LPPR). Opinions concern neurovascular, neuromodulation, endocrine, ophthalmology, and orthopedic devices, as well as medical aids.

The first step in the assessment is the clinical (actual) benefit (SA), which can be either sufficient or insufficient. This step determines the insertion into the LPPR list. If sufficient, the clinical added value (ASA) is graded on a scale from I (major) to V (absent) for claimed indications, which supports the pricing decisions.

Some examples of the recommendations are provided below:

• Self-expanding intracranial stent with controlled release DERIVO 2 by Acandis GmbH (application for registration; sufficient actual benefit; level V of clinical added value compared to the flow-diverters of the previous DERIVO and DERIVO MINI ranges);
• Implantable and rechargeable spinal cord stimulation system INCEPTIV by Medtronic (application for registration; sufficient actual benefit; level V of clinical added value compared to INTELLIS, a previous-generation implantable and rechargeable spinal cord stimulation system);
• Dual mobility acetabulum consisting of a cement-free cup, a metal alloy insert, and a highly cross-linked polyethylene insert enriched with vitamin E, TRINITY DUAL MOBILITY SYSTEM, by Corin (application for registration; sufficient actual benefit; level V of clinical added value compared to single mobility cups with a conventional polyethylene insert).

Recommendations were also made regarding endocrine, ophthalmology devices, and medical aids.

See the details in French here.

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