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 June 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.
No decisions were released for cardiovascular devices.
Six (6) decisions were released for orthopaedic devices:
- PRODISC O, total lumbar disc prosthesis (registration for renewal; insufficient clinical benefit)
- OSTEOPURE, viro-inactivated bone allograft (application for modification of registration conditions and renewal of registration; sufficient clinical benefit; level V clinical added value compared to other virally inactivated bone allografts)
- PRODISC L, total lumbar disc prosthesis (application for renewal; sufficient clinical benefit; level V clinical added value)
- MOBIDISC, total lumbar disc prosthesis (application for renewal; sufficient clinical benefit; level V clinical added value compared to arthrodesis). Soon after, the request was canceled by the manufacturer
- MEDPOR CRANIAL HEMISPHERE, standard anatomically shaped bone substitute for cranial reconstruction (application for registration; sufficient clinical benefit; level V clinical added value compared to similar already registered items)
- AIR +, arthroscopic meniscal repair system (application for registration; sufficient clinical benefit; level V clinical added value compared to other meniscal repair devices)
Four (4) decisions were released for other devices:
- DOMUS 4 AUTO, alternating pressure motorized air mattress with associated compressor (application for modification of registration conditions; sufficient clinical benefit; level V clinical added value compared to similar mattresses)
- XPRESS, sinus dilation balloon device (application for registration; sufficient clinical benefit; level V clinical added value compared to functional endoscopic sinus surgery)
- ASPIRESR, left vagus nerve stimulation system (application for modification of registration conditions and renewal of registration; sufficient clinical benefit; level V clinical added value compared to DEMIPULSE generators (models 103 and 104))
- IALUSET, cream and impregnated compress (application for renewal; sufficient clinical benefit; level V clinical added value compared to DUODERM E hydrocolloid dressing)
See the latest decisions in French here.
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