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June 2026 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 June 2026, 14 favorable opinions were published on add-on reimbursement for new medical devices in ENT, neuromodulation, orthopedics, peripheral vascular, and wounds treatment fields, and one related to the extension of indications for a cardiovascular device. Some examples are provided below:
- Cochlear implants Nucleus Nexa CI1032, Nucleus Nexa CI1012, and Nucleus Nexa CI1022 (application for registration; sufficient actual benefit; level V clinical added value compared to other cochlear implants listed on the LPPR);
- iFuse TORQ Implant System for sacroiliac joint arthrodesis (application for registration; sufficient actual benefit; level V clinical added value compared to other implants in the iFuse implant system range);
- ActiGraft, kit for preparation of autologous blood clot, used for treatment of chronic wounds (application for registration; sufficient actual benefit; level IV clinical added value compared to well-conducted standard care for four to six weeks, combining nursing care and first-line dressings according to the healing phase).
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