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

The French National Authority for Health (HAS) released new recommendations on the registration of medical devices and medical aids in the List of Reimbursable Products and Services (LPPR) following the June 2025 meetings of the National Commission for the Evaluation of Medical Devices and Health Technologies (CNEDiMTS). Seven favourable opinions were issued concerning add-on reimbursement for medical devices in the cardiovascular, peripheral vascular, and ophthalmology fields. 

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.

Examples of the CNEDiMTS recommendations regarding the registration of the new devices in the LPPR List in June 2025:

• Triclip G4, edge-to-edge tricuspid valve repair system by Abbott Medical (application for registration; sufficient actual benefit; level III clinical added value compared to optimal medical treatment alone);
• Ridaforolimus eluting coronary stent EluNIR PERL by Medinol (application for registration; sufficient actual benefit; level V clinical added value compared to other active coronary stents listed on the LPPR in the selected indications);
• Aqueous humor drainage valve AHMED AGV-FP8 by France Chirurgie Instrumentation (FCI) (application for registration; sufficient actual benefit; level V clinical added value compared to other drainage implants available in the selected indications (MOLTENO implant and BAERVELDT valve, mainly)).

See the details in French here.

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