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

The French National Authority for Health (HAS) released new recommendations about add-on reimbursement of medical devices and medical aids from the November 2024 meetings of the National Commission for Evaluation of Medical Devices and Health Technologies (CNEDiMTS). Two recommendations were published concerning the registration of new medical devices in the List of Reimbursable Products and Services (LPPR). 

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.

One of the recommendations released in November 2024 was made for round or anatomical breast implant, micro-textured, pre-filled with silicone gel and associated templates, MESMO, by Polytech Health & Aesthetics GMBH (application for registration; sufficient actual benefit; level V of clinical added value compared to other round or anatomically shaped, micro-textured, pre-filled with silicone gel breast implants.

Another recommendation was made in relation to diabetes medical aids.

See the details in French here.

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