Recommendations about add-on reimbursement for medical devices in France in December 2023

The French National Authority for Health (HAS) released new recommendations about add-on reimbursement of medical devices and medical aids from the meetings of the National Commission for Evaluation of Medical Devices and Health Technologies (CNEDiMTS) in December 2023. Nine recommendations were published in relation to the registration of medical devices in the List of reimbursable products and services (LPPR). Opinions concern cardiovascular, peripheral vascular, and ophthalmological devices, as well as medical aids.

The first step in the assessment is the clinical (actual) benefit (SA), which can be either sufficient or insufficient. This step determines the insertion into the LPPR list. If sufficient, the clinical added value (ASA) is graded on a scale from I (major) to V (absent) for claimed indications, which supports the pricing decisions.

Some examples of the recommendations regarding applications for registration are provided below:

• Renal denervation catheter SYMPLICITY SPYRAL by Medtronic (sufficient actual benefit; level III of clinical added value compared to the absence of a therapeutic alternative);
• Paclitaxel releasing coronary balloon RESTORE DEB by CARDIONOVUM (insufficient actual benefit);
• Aqueous humor drainage system XEN by ABBVIE (insufficient actual benefit).

Also, recommendations were made in relation to other peripheral vascular devices and medical aids.

See the details in French here.

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