May 2025 recommendations about add-on reimbursement for medical devices in France

The French National Authority for Health (HAS) has released new recommendations regarding the registration of medical devices and medical aids in the List of Reimbursable Products and Services (LPPR) following the May 2025 meetings of the National Commission for the Evaluation of Medical Devices and Health Technologies (CNEDiMTS). One favourable opinion was issued concerning add-on reimbursement for medical device in the men’s health field. 

The evaluation process begins with assessing the clinical (actual) benefit (Service Attendu, SA), which is classified as either sufficient or insufficient. Only devices with a sufficient clinical benefit are eligible for inclusion in the LPPR. If deemed sufficient, the clinical added value (Amélioration du Service Attendu, ASA) is then graded from I (major) to V (absent) for the claimed indications, influencing pricing decisions.

The CNEDiMTS recommendation regarding the registration of the new device in the LPPR List in May 2025 concerns biodegradable balloon spacer BioProtect Balloon by Bioprotect (application for registration; sufficient actual benefit; level IV clinical added value compared to the lack of an alternative).

See the details in French here.

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