Recommendations about add-on reimbursement for medical devices in France in April 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 April 2024. Eighteen 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, gastrointestinal, interventional radiology, nephrology and urology, neuromodulation, and orthopedic 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:

• Implantable dual-chamber leadless cardiac pacemaker (type VDD) implanted by transcatheter route MICRA AV by Medtronic (application for registration; sufficient actual benefit; level IV of clinical added value compared to leadless single-chamber ventricular implantable pacemakers);
• Stent retriever CERENOVUS NIMBUS by Johnson & Johnson (application for registration; sufficient actual benefit; level V of clinical added value compared to other mechanical thrombectomy techniques (thrombo-aspiration catheter and/or stent retriever);
• Microwave soft tissue ablation probe Emprint by Medtronic (application for registration; sufficient actual benefit; level V of clinical added value compared to radiofrequency ablation);
• Cryoablation needles IceForce 2.1 CX 90° by Boston Scientific (application for registration; sufficient actual benefit; level II of clinical added value compared to the absence of a therapeutic alternative);
• Implantable and rechargeable spinal cord stimulation system ETERNA by Abbott (application for registration; sufficient actual benefit; level V of clinical added value compared to PRODIGY MRI, a previous-generation implantable and rechargeable spinal cord stimulation system).

Recommendations were also made regarding other neuromodulation and interventional radiology devices, nephrology and urology, orthopedic devices, and medical aids.

See the details in French here.

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