Recommendations about add-on reimbursement for medical devices in France in July 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 July 2023. Sixteen 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 neuromodulation and surgical 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.

• Implantable non-rechargeable spinal cord stimulation system PROCLAIM 5 by Abbott (application for modification of registration conditions; sufficient actual benefit; level V of clinical added value compared to other implantable non-rechargeable spinal cord stimulation systems listed on the LPPR);
• Non-rechargeable dual-channel system for deep brain stimulation INFINITY by Abbott (application for modification of registration conditions; sufficient actual benefit; level V of clinical added value compared to non-rechargeable dual-channel deep brain stimulation systems listed on the LPPR);
• Round breast implant, smooth, pre-filled with silicone gel and associated templates ROUND SILKSURFACE PLUS (without QID) by Motiva Implants (application for modification and renewal of registration; sufficient actual benefit; level IV of clinical added value compared to other round, smooth, pre-filled silicone gel breast implants registered in the LPPR).

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

See the details in French here.

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