Recommendations about add-on reimbursement for medical devices in France in October 2023

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 October 2023. Twelve recommendations were published in relation to the registration of medical devices in the List of reimbursable products and services (LPPR). Opinions concern cardiovascular, e-health, endocrine, gastrointestinal, neurology and neurosurgery, 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 regarding applications for registration are provided below:

• Implantable cardiac pacemaker with atrio-biventricular stimulation for “triple chamber” resynchronization AMVIA SKY HF-T by Biotronik (sufficient actual benefit; level V of clinical added value compared to EDORA 8 HF-T);
• MYLIFE CAMAPS FX (MYLIFE YPSOPUMP insulin pump with CAMAPS FX app with FREESTYLE LIBRE 3 sensor) by Ypsomed (sufficient actual benefit; level III of clinical added value compared to other systems (called open loop) composed of an external insulin pump and a sensor for measuring the interstitial glucose level, operating independently);
• Non-rechargeable neuromodulator of the sacral root neuromodulation system INTERSTIM X by Medtronic (sufficient actual benefit; level IV of clinical added value compared to INTERSTIM II, a non-rechargeable sacral root system);
• Chitosan tube intended to protect direct suturing of severed peripheral nerves REAXON DIRECT by KeriMedical (insufficient actual benefit);
• Microwave soft tissue ablation probe NEUWAVE by Johnson & Johnson (sufficient actual benefit; level V of clinical added value compared to radiofrequency ablation).

Also, recommendations were made in relation to other cardiovascular devices, orthopedic devices, and medical aids.

See the details in French here.

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