Recommendations about add-on reimbursement for medical devices in France in March 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 March 2024. Twelve 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, neurovascular, ENT, and surgical devices, interventional radiology and endoscopy procedures, 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:

• Self-expanding intracranial stent with controlled release (flow-diverter stent) FRED X by MicroVention (application for registration; sufficient actual benefit; level V of clinical added value compared to the flow diverters of the previous FRED and FRED Jr ranges);
• EDWARDS SAPIEN 3 aortic valve bioprosthesis implanted transfemorally (COMMANDER system) by Edwards Lifesciences (application for modification of registration conditions; sufficient actual benefit; level IV and level V of clinical added value depending on the patient's condition and comparator);
• Magnetic marker MAGSEED by Endomagnetics (application for registration; sufficient actual benefit; level IV of clinical added value compared to guidewire tracking).

Also, recommendations were made in relation to ENT devices for endoscopic procedures and medical aids.

See the details in French here.

This news is just one of about 300 market access news collected by our team in the premium subscription service Market Access Monitor every week from more than 80 organizations. Access our paid service to stay on top of all developments specifically for your products in Europe (reimbursement news) and globally (HTA news). Access is organized as an online Database and email alert formats. Contact us to get a free, three-month, no-obligation trial.