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 August 2020. Decisions concern cartilage implant, energy return prosthetic feet, and Yttrium-90 microspheres.
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 decisions were published by HAS in August:
- CAPTIVA, synthetic cartilage implant (application for registration, sufficient clinical benefit, level V clinical added value compared to arthrodesis)
- DYNAMIQUE 1D10, energy return prosthetic foot of class I (application for renewal, sufficient clinical benefit, level V clinical added value compared to other class I energy return prosthetic feet)
- TRITON, energy return prosthetic foot of class III (application for renewal, sufficient clinical benefit, level V clinical added value compared to other class III energy return prosthetic feet)
- THERASPHERE, Yttrium-90 microspheres (request for modification of registration conditions):
- sufficient clinical benefit as a first-line of palliative treatment of naive intrahepatic cholangiocarcinoma, unresectable at diagnosis or during recurrence after resection, with or without combination with chemotherapy, level IV clinical added value compared to chemotherapy or the appropriate symptomatic treatment; sufficient clinical benefit for the treatment of hepatic metastases from colorectal cancer, level V clinical added value compared to the appropriate symptomatic treatment;
- insufficient clinical benefit as a second-line palliative treatment for intrahepatic cholangiocarcinomas, refractory to chemotherapy, unresectable at diagnosis or during recurrence after resection
See the latest decisions in French here.
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