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 January 2023. Twenty-four 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, neurovascular, and orthopedic devices, in-vitro diagnostics, 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.
Recommendations for cardiovascular and peripheral vascular devices:
- Coronary stent coated with sirolimus VIVO ISAR by TRANSLUMINA (application for registration; sufficient actual benefit; level V of clinical added value compared to other active coronary stents listed on the LPPR and already covered in the selected indications);
- Fenestrated aortic stent graft ANACONDA CUSTOM FENESTRATED by VASCUTEK (application for modification and renewal of registration; sufficient actual benefit; level V of clinical added value compared to ZENITH FENESTRATED).
Recommendations for orthopedic devices:
- Magnetic intramedullary lengthening nail PRECICE IMLL by NuVasive (application for registration; sufficient actual benefit; level II of clinical added value compared to external fixators).
Recommendations for neurovascular devices:
- Self-expanding intracranial stent with controlled release p48 MW by PHENOX (application for registration; sufficient actual benefit; level V of clinical added value compared to the flow diverter of the previous range, p64).
Also, recommendations were made in relation to in-vitro diagnostics and a number of medical aids.
See the details in French here.
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