Recommendations about add-on reimbursement for medical devices in France in January 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 January 2024. Twelve recommendations were published concerning the registration of medical devices or modification of registration conditions with the extension of indications for the medical devices in the List of Reimbursable Products and Services (LPPR). Opinions concern cardiovascular, peripheral vascular, interventional radiology, neurovascular, ophthalmology, men’s health, and endoscopy 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:

• Implantable cardiac monitor LINQ II by Medtronic (sufficient actual benefit; level IV of clinical added value compared to other implantable cardiac monitors registered in the LPPR);
• Renal denervation catheter PARADISE by ReCor Medical (sufficient actual benefit; level III of clinical added value compared to the absence of a therapeutic alternative);
• Intracranial aneurysm intrasaccular embolization system Contour Neurovascular System by STRYKER received an insufficient actual benefit for the registration in the LPPR.

Also, recommendations were made in relation to ophthalmological, men’s health, and endoscopic devices and medical aids.

See the details in French here.

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