Recommendations about add-on reimbursement for medical devices in France in November 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 November 2023. Seven recommendations were published in relation to the registration of medical devices in the List of reimbursable products and services (LPPR). Opinions concern cardiovascular, nephrology and urology, 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 regarding applications for registration are provided below:

• Rate-controlled dual-chamber implantable cardiac pacemaker AMVIA SKY DR-T by BIOTRONIK (sufficient actual benefit; level V of clinical added value compared to EDORA 8 DR-T);
• Synthetic bone substitute AKTIBONE GRANULES by NORAKER (sufficient actual benefit; level V of clinical added value compared to other synthetic bone substitutes and bone substitutes containing derivatives of animal origin already listed on the LPPR);
• Adjustable hydraulic sub-urethral support implant for men ATOMS by AMI (insufficient actual benefit).

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

See the details in French here.

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