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

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 October 2024. Ten recommendations were published concerning the registration or modification of registration conditions/extension of indications for the medical devices in the List of Reimbursable Products and Services (LPPR). 

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 released in October 2024 are provided below:

• Self-expanding intracranial stents ACCLINO flex plus by Acandis (application for registration; sufficient actual benefit; level V of clinical added value compared to other intracranial stents listed on the LPPR with identical indications);
• Custom-made aortic endoprosthesis Zenith Arch Device by Cook (application for registration (update); sufficient actual benefit; level IV of clinical added value compared to other surgical procedures (enhanced elephant trunk procedure and hybrid repair (disconnection of supra-aortic trunks with stent placement));
• Coronary sinus reduction system Shockwave Reducer by Shockwave Medical (application for registration; insufficient actual benefit).

Other recommendations concerned cardiovascular devices, interventional radiology devices, and medical aids.

See the details in French here.

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