Recommendations about add-on reimbursement for medical devices in France in December 2024

The French National Authority for Health (HAS) released new recommendations about add-on reimbursement of medical devices and medical aids from the December 2024 meetings of the National Commission for Evaluation of Medical Devices and Health Technologies (CNEDiMTS). Three favorable opinions were published concerning the registration of new medical devices in the List of Reimbursable Products and Services (LPPR). 

The evaluation process begins with an assessment of clinical (actual) benefit (Service Attendu, SA), which is determined to be either sufficient or insufficient. A sufficient clinical benefit is required for inclusion in the LPPR. If deemed sufficient, the clinical added value (Amélioration du Service Attendu, ASA) is graded from I (major) to V (absent) for the claimed indications, supporting pricing decisions.

One of the medical devices recommended for inclusion in LPPR in December 2024 was POLYsmooth Sublime Line, a single round, smooth, pre-filled with silicone gel breast implant by Polytech Health & Aesthetics GMBH (sufficient actual benefit and level V of clinical added value compared to other similar breast implants registered in the LPPR).

Two other recommendations were made in relation to medical aids.

See the details in French here.

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