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

The French National Authority for Health (HAS) releases recommendations on the registration of medical devices and medical aids in the List of Reimbursable Products and Services (LPPR) based on assessments by the National Commission for the Evaluation of Medical Devices and Health Technologies (CNEDiMTS). 

The CNEDiMTS 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.

In August 2025, four favourable opinions were issued concerning the registration of the new devices in the LPPR List for add-on reimbursement. Some examples are provided below:

• Transcatheter pulmonary valve Harmony by Medtronic (application for registration; sufficient actual benefit; level II clinical added value compared to right ventricular outflow tract surgery);
• Upper airway (hypoglossal nerve) stimulation system Inspire IV by Inspire Medical Systems (application for registration; sufficient actual benefit; level V clinical added value compared to the previous model of Inspire IV system currently registered on the LPPR).

See the details in French here.

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