Recommendations about add-on reimbursement for medical devices in France in February 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 February 2023. Twenty-eight 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 cardiovascular and peripheral vascular, neurovascular, ophthalmological, spine, and orthopedic devices, surgical procedures, 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.

• Subcutaneous defibrillation lead EMBLEM MRI S-ICD (MODÈLE 3501) by BOSTON SCIENTIFIC (application for renewal of registration; sufficient actual benefit; level V or level III of Clinical Added Value (ASA), depending on the indications or comparator);
• Abdominal aortic stent graft ZENITH FLEX by COOK (application for renewal of registration; sufficient actual benefit; level V of clinical added value compared to other abdominal aortic stents listed on the LPPR);
• Peripheral sirolimus-eluting stent NITIDES by ALVIMEDICA (application for registration; sufficient actual benefit; level V of clinical added value compared to other drug-eluting peripheral stents listed on the LPPR);
• Paclitaxel-coated peripheral balloon RANGER by BOSTON SCIENTIFIC (application for renewal of registration; sufficient actual benefit; level IV of clinical added value compared to the bare balloon).
• Self-expanding intracranial stent CERENOVUS ENTERPRISE 2 by JOHNSON & JOHNSON (application for renewal of registration; sufficient actual benefit; level V of clinical added value compared to other intracranial stents listed on the LPPR and used in identical indications).
• Aqueous humor drainage system PRESERFLO MICROSHUNT by SANTEN (application for registration; sufficient actual benefit; level IV of clinical added value compared to other conventional filtering surgeries (trabeculectomy, sclerectomy)).
• Growth implant with self-expanding domino NEMOST by EUROS (application for registration; sufficient actual benefit; level II of clinical added value compared to growth rods with classic domino).

Also, recommendations were made in relation to orthopedic devices, surgical procedures, and a number of medical aids.

See the details in French here.

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