Recommendations about add-on reimbursement for medical devices in France in February 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 February 2024. Fourteen 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, neurovascular, neuromodulation, endocrine, 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 are provided below:

• Aortic valve bioprosthesis implanted via transcutaneous arterial route EVOLUT FX by Medtronic (application for registration; sufficient actual benefit; level IV and level V of clinical added value depending on the comparator);
• Stent retriever SOLITAIRE X by Medtronic (application for modification and renewal of registration; sufficient actual benefit; level V of clinical added value compared to other stent retrievers registered with the LPPR in the selected indications);
• Semi-closed loop system dedicated to automated management of type 1 diabetes OMNIPOD 5 (OMNIPOD 5 insulin pump and controller + DEXCOM G6 interstitial glucose measurement system) by INSULET (application for registration; sufficient actual benefit; level III of clinical added value compared to systems (called open loop) composed of an external insulin pump and a sensor for measuring the interstitial glucose level, operating independently);
• Implantable gastric neurostimulator ENTERRA II by ENTERRA MEDICAL (application for registration; sufficient actual benefit; level IV of clinical added value compared to the combination of hygienic and dietary measures and taking reference medications for three months).

Also, recommendations were made in relation to other cardiovascular, neurovascular, and endocrine devices, endoscopic devices, and medical aids.

See the details in French here.

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