Recommendations about add-on reimbursement for medical devices in France in September 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 September 2023. Twenty recommendations were published in relation to the registration, modification of registration conditions, and renewal of registration for devices in the List of reimbursable products and services (LPPR). Opinions concern, peripheral vascular and neurovascular, neurology and neurosurgery, ENT, spine, ophthalmology, and orthopedic 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 are provided below.

• MRI-guided laser thermoablation system VISUALASE by Medtronic (application for registration; sufficient actual benefit; level II of clinical added value compared to craniotomy resection surgery);
• Liquid embolic agent SQUID by Balt Extrusion (application for registration; sufficient actual benefit; level V of clinical added value compared to ONYX);
• Paclitaxel-eluting peripheral balloon PASSEO 18 LUX by Biotronik (application for registration; sufficient actual benefit; level V of clinical added value compared to IN.PACT Admiral);
• Injectable synthetic bone substitute NANOSTIM by Medtronic (application for renewal of registration; sufficient actual benefit; level V of clinical added value compared to synthetic bone substitutes and bone substitutes containing derivatives of animal origin already listed on the LPPR);

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

See the details in French here.

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