July 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 July 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:

• Partially demineralized bone allograft BIOBank Synergy by Biobank (application for registration; sufficient actual benefit; level V clinical added value compared to other virus-inactivated bone allografts listed on the LPPR);
• Active transcutaneous bone conduction hearing implant Sentio System by Prodition (application for registration; sufficient actual benefit; level V clinical added value compared to other active transcutaneous bone conduction hearing implant systems).

Recommendations were also made regarding the registration of medical aids in the LPPR. The example of favorable opinion includes:

• Semi-closed loop system for the automated management of type 1 diabetes CONTROL-IQ (T:slim X2 control-IQ insulin pump + Dexcom G7 interstitial glucose sensor) by Tandem Diabetes Care (application for registration; sufficient actual benefit; level V clinical added value compared to those devices retained in the CNEDiMTS's opinion of 23.07.2024 on semi-closed loop systems: Other semi-closed loop systems included in the LPPR).

See the details in French here.

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