Recommendations about add-on reimbursement for medical devices in France in July 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 July 2024. Nine recommendations were published concerning the registration of medical devices in the List of Reimbursable Products and Services (LPPR). Opinions concern cardiovascular, neurovascular, interventional radiology, nephrology and urology, orthopedic, endocrine devices, and in-vitro diagnostic tests, 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:

• Implantable heart monitor BIOMONITOR IV by Biotronik (application for registration; sufficient actual benefit; level V of clinical added value compared to BIOMONITOR IIIm);
• Device for automatic reading of blood sugar and ketonemia FORA 6 DUO and FORA 6 by SAS ALPHADIAB (application for registration; sufficient actual benefit; level V of clinical added value compared to other blood glucose and ketone meters and associated electrodes/strips listed on the LPPR);
• Radiofrequency needle electrodes COOL-TIP E SERIES by Medtronic (application for registration; sufficient actual benefit; level V of clinical added value compared to other radiofrequency ablation devices listed on the LPPR).

Recommendations were also made regarding other cardiovascular devices, orthopedic devices and medical aids.

See the details in French here.

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