The French National Authority for Health (HAS) published new set of decisions regarding add-on reimbursement of medical devices and medical aids in September

Oct 2017

The French National Authority for Health (HAS) published a new set of decisions in relation to add-on reimbursement of medical devices and reimbursement of medical aids that had been released by National Commission for Evaluation of Medical Devices and Health Technologies (CNEDiMTS) in September:

Two decisions for knee and hip prostheses were approved by CNEDiMTS:
- NEXGEN LPS, total knee prosthesis (application for registration, approved)
- Insert LONGEVITY, highly crosslinked polyethylene hip implants (request for amendment + renewal of registration, approved)
Five applications for registrations for therapeutic shoes were approved:
- PROPHYLAXE (ref. : 96519 - 96522), adult therapeutic shoes (application for registration, approved)
- PROPHYLAXE (ref. : 97307 - 97308), adult therapeutic shoes (application for registration, approved)
- PROPHYLAXE (ref. : 96524 - 96525) , adult therapeutic shoes (application for registration, approved)
- PROPHYLAXE (ref. 96100 - 96101 - 96102 - 96103) , adult therapeutic shoes (application for registration, approved)
- FinnOrtho, adult therapeutic shoes (application for registration, approved)
Seventeen decisions for devices of treatment of cardio-vascular diseases were published:
Two decisions for coronary stents
- TITAN OPTIMAX, coronary stent with titanium oxynitride coating (renewal of registration, approved)
- XPOSITION S, coronary stent coated with sirolimus (application for registration, rejected due to insufficient expected benefit (AS))
Ten decisions were prepared for heart valve replacement procedures
- Devices for aortic valve replacement
  - EPIC SUPRA, bioprosthetic aortic heart valve (application for registration on the list of health products that are financed for hospitalization in accordance to Article L.165-11 and R.165-49 of the Social Security Code, approved)
  - CROWN PRT, bioprosthetic aortic heart valve (application for registration on the list of health products that are financed for hospitalization in accordance to Article L.165-11 and R.165-49 of the Social Security Code, approved)
  - SOLO SMART, bioprosthetic aortic heart valve (application for registration on the list of health products that are financed for hospitalization in accordance to Article L.165-11 and R.165-49 of the Social Security Code, approved)
  - EPIC, bioprosthetic aortic heart valve (application for registration on the list of health products that are financed for hospitalization in accordance to Article L.165-11 and R.165-49 of the Social Security Code, approved)
  - TRIFECTA, bioprosthetic aortic heart valve (application for registration on the list of health products that are financed for hospitalization in accordance to Article L.165-11 and R.165-49 of the Social Security Code, approved)
  - TRIFECTA GT, bioprosthetic aortic heart valve (application for registration on the list of health products that are financed for hospitalization in accordance to Article L.165-11 and R.165-49 of the Social Security Code, approved)
- Devices for mitral valve replacement:
  - EPIC Mitral, bioprosthetic mitral heart valve (application for registration on the list of health products that are financed for hospitalization in accordance to Article L.165-11 and R.165-49 of the Social Security Code, approved)
  - PERICARBON MORE MITRAL, bioprosthetic mitral heart valve (application for registration on the list of health products that are financed for hospitalization in accordance to Article L.165-11 and R.165-49 of the Social Security Code, approved)
- Devices for pulmonary valve replacement
  - MELODY with percutaneous implant system ENSSEMBLE, transcatheter pulmonary valve with delivery system (renewal of registration, approved)
  - MELODY with percutaneous implant system ENSEMBLE II , transcatheter pulmonary valve with delivery system (renewal of registration, approved)
Three decisions for peripheral vascular technologies were obtained from CNEDiMTS:
- GORE TIGRIS, peripheral vascular auto-expansible bioprosthesis covered with heparin (request for amendment, approved)
- RANGER, drug-coated balloon (application for registration, rejected due to insufficient expected benefit (AS))
- ZILVER PTX, drug-eluting peripheral stent (request for amendment, approved)

See full list of decisions here.

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