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

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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