The French National Authority for Health (HAS) released new decisions about add-on and medical aid reimbursement of many medical devices from the meetings of the National Commission for Evaluation of Medical Devices and Health Technologies (CNEDiMTS) in May 2020.
The first step in the assessment is the clinical benefit, which can be either sufficient or insufficient. This step determines the insertion into the LPPR list. If sufficient, the clinical added value is graded on a scale from I (major) to V (absent), which supports the pricing decisions.
Four (4) decision was released for cardiovascular devices:
- DERIVO, a self-expanding intracranial stent with controlled release (called stent flow diverter) (application for registration; insufficient clinical benefit)
- SAPWARD EDWARDS 3 SYSTEM MODEL 9600 TFX IMPLANTABLE BY TRANSFEMORAL WAY (COMMANDER PLACEMENT SYSTEM), aortic valve bioprosthesis implanted via the transfemoral route (COMMANDER system) (application for modification of registration conditions; sufficient clinical benefit; level III clinical added value compared to aortic valve replacement surgery)
- LVIS EVO, a self-expanding intracranial stent (application for registration; sufficient clinical benefit; level V clinical added value)
- DERIVO MINI, a self-expanding intracranial stent with controlled release (called stent flow diverter) (application for registration; insufficient clinical benefit)
No decisions were released for orthopaedic devices.
Four (4) decisions were released for other devices:
- NAVIGATION-NAVIKIT KIT (application for registration; sufficient clinical benefit; level IV clinical added value when compared to CT scan guidance alone, without assisted navigation for interventions with a therapeutic aim; level V clinical added value when compared to CT scan guidance alone, without assisted navigation for invasive diagnostic procedures)
- SUPRASORB P SENSITIVE SACRUM, hydrocellular dressing (application for registration; sufficient clinical benefit; level V clinical added value)
- MEPITEL FILM, dressing (application for registration; insufficient clinical benefit)
- SUPRASORB P SENSITIVE HEEL (application for registration; sufficient clinical benefit; level V clinical added value)
See the news in French here.
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