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

The French National Authority for Health (HAS) has released new recommendations regarding add-on reimbursement for medical devices and medical aids following the March 2025 meetings of the National Commission for the Evaluation of Medical Devices and Health Technologies (CNEDiMTS). Six favorable opinions were published concerning the registration of new devices or modifying conditions/indications for existing ones 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 March 2025 include:

• Retrieval/aspiration FLOWTRIEVER SYSTEM for pulmonary embolism treatment by Inari Medical (application for registration; sufficient actual benefit; level III or IV clinical added value depending on the patient’s condition (high risk or intermediate-high risk of premature death accordingly) compared to anticoagulant therapy alone);
• Implantable cardiac monitor LUX-DX by Boston Scientific (application for registration; sufficient actual benefit; level V clinical added value compared to other implantable cardiac monitors registered on the LPPR).

Recommendations were also made regarding endocrine and neuromodulation devices and medical aids.

See the details in French here.

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