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

The French National Authority for Health (HAS) has released new recommendations about add-on reimbursement of medical devices and medical aids from the January 2025 meetings of the National Commission for Evaluation of Medical Devices and Health Technologies (CNEDiMTS). Seventeen favorable opinions were published concerning the registration or modification of registration conditions/extension of indications for the medical devices in the List of Reimbursable Products and Services (LPPR). 

The evaluation process begins with an assessment of 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 January 2025 include:

• Impella CP with SmartAssist – A percutaneous, short-term, left-ventricular, axillary flow, electromechanical assist device by Abiomed (application for registration; sufficient actual benefit; level II clinical added value compared to optimal medical treatment);
• AtriClip FLEX Left Atrial Appendage (LAA) Exclusion System with Preloaded Gillinov-Cosgrove Clip by AtriCure (application for registration; sufficient actual benefit; level V clinical added value compared to other available surgical approaches for LAA exclusion during concomitant cardiac surgery);
• SynchroMed III – A programmable implantable pump for intrathecal therapy (application for registration; sufficient actual benefit; level V clinical added value compared to the SynchroMed II system).

Recommendations were also made regarding other cardiovascular devices, endocrine, e-health, interventional radiology, orthopedic devices, and medical aids.

See the details in French here.

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