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 April 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:
- OPTIMIZER SMART, cardiac contractility modulation implantable device (application for registration; insufficient clinical benefit)
- CARPENTIER-EDWARDS PERIMOUNT RSR, MODEL 2800TFX, aortic valve bioprosthesis with frame (application for registration; sufficient clinical benefit)
- SYNERGY MEGATRON, coronary stent coated with everolimus (pharmacologically active product) (application for registration; sufficient clinical benefit; level V clinical added value)
- XIENCE PRIME BTK, a peripheral stent with the release of active ingredient (application for renewal; sufficient clinical benefit; level V clinical added value)
Two (2) decisions were released for orthopaedic devices:
- INFINITY, total ankle prosthesis (application for registration; sufficient clinical benefit; level V clinical added value)
- MEDPOR CCI, facial and cranial reconstruction (application for registration; sufficient clinical benefit; level V clinical added value)
Nine (9) decisions were released for other devices:
- ACTIVA RC PATIENT REMOTE CONTROL (application for registration; sufficient clinical benefit; level V clinical added value)
- AXTAIR AUTOMORPHO PLUS, support for pressure ulcer prevention: mattress topper (application for registration; sufficient clinical benefit; level V clinical added value)
- DIZG, human graft (application for registration; sufficient clinical benefit; level V clinical added value)
- SPYSCOPE DS, single-use cholangiopancreatoscope access and administration catheter (application for registration; sufficient clinical benefit; level II clinical added value in the treatment of complex gallstones and pancreatic stones when other endoscopic treatments have failed (compared to surgery); level III clinical added value in the diagnosis of undetermined bile stenosis after failure with ERCP with cytological brushing and / or endosonography (compared to the lack of an alternative))
- SPYSCOPE DS II single-use cholangiopancreatoscope access and administration catheter (application for registration; sufficient clinical benefit; level V clinical added value in two conditions)
- SPACEOAR, absorbable hydrogel (application for registration; sufficient clinical benefit; level IV clinical added value)
- WELLION GALILEO GLU / KET AND WELLION GALILEO KET, blood glucose meter (application for registration; sufficient clinical benefit; level V clinical added value)
- SURELIFT CPS, vaginal reinforcement implant (application for registration; insufficient clinical benefit)
- PHOENIX, human graft (application for registration; sufficient clinical benefit; level V clinical added value)
See the news in French here.
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