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

The French National Authority for Health (HAS) has released new recommendations regarding add-on reimbursement for medical devices and medical aids following the April 2025 meetings of the National Commission for the Evaluation of Medical Devices and Health Technologies (CNEDiMTS). Eleven 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.

Some examples of medical devices recommended in April 2025 for inclusion in LPPR are provided below:

• Paclitaxel-coated balloon IN.PACT 018 by Medtronic (application for registration; sufficient actual benefit; level V clinical added value compared to IN.PACT ADMIRAL);
• Rechargeable deep brain stimulation system VERCISE GENUS R16 by Boston Scientific (application for modification of conditions and renewal of registration; sufficient actual benefit; level V clinical added value compared to rechargeable deep brain stimulation systems listed on the LPPR for the selected indication);
• MINIMED 780G SYSTEM combined with the SIMPLERA SYNC continuous interstitial glucose sensor by Medtronic (application for registration; sufficient actual benefit; level V clinical added value compared to other systems specified in the CNEDiMTS opinion of 23.07.2024 on semi-closed loop systems).

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

See the details in French here.

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