Recommendations about add-on reimbursement for medical devices in France in February 2025

The French National Authority for Health (HAS) has released new recommendations about add-on reimbursement of medical devices and medical aids from the February 2025 meetings of the National Commission for Evaluation of Medical Devices and Health Technologies (CNEDiMTS). Sixteen favorable opinions were published concerning the registration or modification of registration conditions/extension of indications for the medical devices in the List of Reimbursable Products and Services (LPPR). 

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 medical devices recommended for LPPR inclusion in January 2025 include:

• Self-expanding intracranial stent with controlled release FRED X by Microvention Europe (application for registration; sufficient actual benefit; level V clinical added value compared to other self-expanding intracranial stents with the controlled release (flow diverters) listed on the LPPR);
• TREO Custom-Made Device (custom-made thoracic aortic leg combined with the RELAY (PRO or PLUS) custom-made aortic stent graft) by Vascutek (application for registration; sufficient actual benefit; level V clinical added value compared to ZENITH ARCH Device);
• Amplatzer Amulet LAAO, transcutaneous left atrial appendage closure device, by Abbott (application for modification of registration conditions; sufficient actual benefit; level V clinical added value compared to other transcutaneous LAA closure devices listed on the LPPR).

Recommendations were also made regarding other neurovascular and peripheral vascular devices, endocrinology, interventional radiology, nephrology and urology, orthopedic devices, and medical aids.

See the details in French here.

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