Recommendations about add-on reimbursement for medical devices in France in May 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 May 2023. Twenty-one 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, gastrointestinal, 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.

• Dual-chamber frequency-controlled implantable pacemaker equipped with the Home Monitoring remote transmission system EDORA 8 DR-T by Biotronik (application for modification and renewal of registration; sufficient actual benefit; level V of clinical added value compared to other dual-chamber pacemakers equipped with a remote monitoring system listed on the LPPR for the same indications);
• Aortic conduit with mechanical valve Open Pivot by Medtronic (application for renewal of registration; sufficient actual benefit; level V of clinical added value compared to other aortic conduits with mechanical valves already registered on LPPR);
• Pulmonary valved conduit of bovine origin Contegra by Medtronic (application for renewal of registration; sufficient actual benefit; level IV of clinical added value compared to the absence of allograft);
• Dual-mobility acetabular cup consisting of a cemented cup and a conventional polyethylene insert EUROSCUP Mobile Cemented by EUROS (application for registration; sufficient actual benefit; level V of clinical added value compared to single mobility cups with a conventional polyethylene insert).

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

See the details in French here.

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