Recommendations about add-on reimbursement for medical devices in France in August 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 August 2023. 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, peripheral vascular and neurovascular 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.

• Pulmonary valve bioprosthesis implanted by a transcutaneous venous route VenusP-Valve by Venus Medtech (application for registration; sufficient actual benefit; level II of clinical added value compared to surgical revision of the outflow tract of the right ventricle);
• Peripheral microcoils with controlled electrical detachment PRESTIGE SYSTEM by BALT Extrusion (application for registration; sufficient actual benefit; level V of clinical added value compared to devices listed on the LPPR in the generic line “Microcoils, platinum or MRI-compatible alloy or stainless steel, mechanical detachment, Microcoils (coils) fiber-reinforced or bare in platinum or in platinum and tungsten alloy or in MRI-compatible alloy or in stainless steel, with mechanical detachment, in multiple shapes” (LPPR code 3194045));
• Stent retrievers PRESET STANDARD, PRESET LUX, and PRESET LITE by Phenox (application for registration; sufficient actual benefit; level V of clinical added value compared to other stent retrievers listed on the LPPR in the selected indications).

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

See the details in French here.

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