The French National Authority for Health (HAS) released new recommendations about add-on reimbursement of medical devices and medical aids from the meetings of the National Commission for Evaluation of Medical Devices and Health Technologies (CNEDiMTS) in December 2021. More than 15 recommendations were published in relation to the registration, modification of registration conditions, renewal of registration of devices in the List of reimbursable products and services (LPPR). Opinions concern cardiovascular, orthopedic, ENT devices, as well as medical aids. Except for this, CNEDiMTS published an opinion about transitional coverage (a newly established pathway for reimbursement) for a cardiovascular device.
The first step in the assessment is the clinical (actual) benefit (SA), which can be either sufficient or insufficient. This step determines the insertion into the LPPR list. If sufficient, the clinical added value (ASA) is graded on a scale from I (major) to V (absent) for claimed indications, which supports the pricing decisions.
Recommendations for cardiovascular devices:
- Implant for patent foramen ovale closure GORE CARDIOFORM by WL GORE (application for registration; sufficient actual benefit; level V of clinical added value);
- Transcatheter aortic valve implantation system NAVITOR by Abbott (application for registration; sufficient actual benefit; level V of clinical added value);
- Remote monitoring system associated with implantable heart monitors HOME MONITORING by Biotronik (application for registration; sufficient actual benefit; level IV of clinical added value).
Recommendations for orthopedic devices:
- Intramedullary limb-lengthening system FITBONE by Orthofix (application for registration; sufficient actual benefit; level II of clinical added value);
- Highly cross-linked polyethylene insert TRIANON by FH ORTHOPEDICS (application for renewal of registration; sufficient actual benefit; level V of clinical added value).
Recommendations for ENT devices:
- Absorbable nasal implant LATERA by STRYKER (application for registration; insufficient actual benefit).
Recommendations for medical aids:
- Continuous glucose measurement system GLUCOMEN DAY CGM by A.MENARINI Diagnostics (application for registration; sufficient actual benefit; level V of clinical added value);
- Anatomical hydrocellular dressings ECLYPSE ADHERENT SACRAL, ECLYPSE CONTOUR, ECLYPSE FOOT and ECLYPSE BOOT by BRIGHTWAKE LTD t/a ADVANCIS MEDICAL (application for registration; sufficient actual benefit; level V of clinical added value);
- Medical venous compression kits VENOTRAIN ULCERTEC 39 and VENOTRAIN ULCERTEC 46 by BAUERFEIND FRANCE (application for renewal of registration; sufficient actual benefit; level V of clinical added value);
- Class III energy return foot PROTEOR SIERRA by PROTEOR (application for renewal of registration; sufficient actual benefit; level V of clinical added value);
- Transanal irrigation system PERISTEEN PLUS IRRIGATION TRANSANALE by COLOPLAST LABORATORIES (application for registration; sufficient actual benefit; level V of clinical added value);
- Therapeutic shoes PODIABETES PALMYRE and PODIABETES PARADIS by NEUT (application for registration; sufficient actual benefit; level V of clinical added value);
- Sterile solution for ophthalmic use OPTIVE FUSION by ALLERGAN (application for modification and renewal of registration; sufficient actual benefit; level V of clinical added value).
Except for these opinions related to the LPPR, CNEDiMTS also published an opinion for the request for transitional coverage of Neovasc Reducer System by Neovasc intended to treat refractory stable angina pectoris class 3 or 4 according to the Canadian Cardiovascular Society (CCS), despite well-conducted pharmacological treatment, in patients who are contraindicated or at high risk of revascularization by coronary artery bypass grafting or by percutaneous coronary intervention. The CNEDiMTS has concluded that NEOVASC REDUCER SYSTEM was eligible for transitional coverage in the selected indications.
See the details in French here.
This news is just one of about 300 market access news collected by our team in the subscription services "HTA Alerts" and "Reimbursement Alerts" every two weeks from more than 80 organizations. Access our paid subscription services to stay on top of all developments specifically for your products in Europe (reimbursement news) and globally (HTA news). First EU issues of both newsletters are available for download free-of-charge.
Not ready for a subscription service? Subscribe to our free-of-charge newsletter delivered every second week to get updates about key reimbursement developments in Europe (10-12 news every two weeks).