Recommendations about add-on reimbursement for medical devices in France in June 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 June 2023. Twenty-eight recommendations were published in relation to the registration, modification of registration conditions, and renewal of registration for devices in the List of reimbursable products and services (LPPR). Opinions concern cardiovascular and peripheral vascular, endocrine, ENT, orthopedic, spinal, and surgical 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.

• Coronary stent coated with sirolimus Orsiro Mission by Biotronik (application for modification of registration conditions; sufficient actual benefit; level V of clinical added value compared to other active coronary stents listed on the LPPR in the selected indications);
• Implantable pacemaker with atrioventricular stimulation for resynchronization (triple-chamber) associated with the Carelink remote monitoring system, Percepta Quad CRT-P MRI SureScan by Medtronic (application for modification and renewal of registration; sufficient actual benefit; level V of clinical added value compared to other implantable pacemakers with atrio-biventricular stimulation for resynchronization, known as "triple-chamber" equipped with a remote monitoring system already registered in the LPPR);
• Paclitaxel-eluting peripheral balloon SeQuent Please OTW by B. Braun Medical (application for modification and renewal of registration; sufficient actual benefit; level IV of clinical added value compared to the bare balloon);
• Implantable non-rechargeable spinal ganglion stimulation system Proclaim DRG by Abbott (application for renewal of registration; sufficient actual benefit; level V of clinical added value compared to other spinal cord stimulation systems registered in the LPPR in the same indications);
• Peripheral embolization system, helical, electrically detachable, with hydrogel Azur/Azur CX by Terumo (application for modification of registration conditions; sufficient actual benefit; level V of clinical added value compared to the devices registered on the LPPR in the generic line described in chapter 1.4.1 (LPPR code 3194045));
• Balloon kyphoplasty system Kyphon by Medtronic (application for registration; sufficient actual benefit; level IV or level V of clinical added value depending on the comparators).

Also, recommendations were made in relation to other cardiovascular and spinal devices, endocrine, orthopedic, surgical, and ENT devices, and a number of medical aids.

See the details in French here.

This news is just one of about 300 market access news collected by our team in the subscription services "HTA Alerts" and "Reimbursement Alerts" every two weeks from more than 80 organizations. Access our paid subscription services to stay on top of all developments specifically for your products in Europe (reimbursement news) and globally (HTA news). Contact us to get a free, three-month, no-obligation trial.