Recommendations about add-on reimbursement for medical devices in France in August 2024

The French National Authority for Health (HAS) released new recommendations about add-on reimbursement of medical devices from the meetings of the National Commission for Evaluation of Medical Devices and Health Technologies (CNEDiMTS) in August 2024. Five recommendations were published concerning the registration of medical devices or modification of registration conditions/extension of indications for the medical devices in the List of Reimbursable Products and Services (LPPR). Opinions concern cardiovascular, peripheral vascular, neuromodulation, orthopedic, and spine devices.

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 heart monitor LUX-DX by Boston Scientific (application for registration; insufficient actual benefit);
• Iliac bifurcation vascular endoprosthesis E-LIAC by CryoLife (application for registration; sufficient actual benefit; level V of clinical added value compared to other iliac bifurcation stents listed on the LPPR);
• Rechargeable dual channel deep brain stimulation system PERCEPT RC by Medtronic (application for registration; sufficient actual benefit; level V of clinical added value compared to the ACTIVA RC dual channel rechargeable system).

Recommendations were also made regarding spine and orthopedic devices.

See the details in French here.

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