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 November 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, peripheral vascular, neurovascular, dermatological, and endocrine devices, as well as medical aids.
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:
- Percutaneous mitral valve repair systems MITRACLIP G4-XTW, MITRACLIP G4-XT, MITRACLIP G4-NTW, MITRACLIP G4-NT, MITRACLIP XTR, MITRACLIP NTR by Abbott (application for renewal of registration; sufficient actual benefit; level V of clinical added value);
- Balloon catheter for in-stent coronary restenosis SEQUENT PLEASE NEO by B.Braun (application for modification of registration conditions; sufficient actual benefit; level V of clinical added value).
Recommendations for devices in peripheral vascular area:
- Self-expanding stent WALLSTENT UNI by Boston Scientific (application for modification of registration conditions; sufficient actual benefit; level V of clinical added value).
Recommendations for devices used in neurovascular area:
- Self-expanding intracranial stent P64 by PHENOX (application for registration; sufficient actual benefit; level V of clinical added value).
Recommendations for devices used in dermatology:
- Negative pressure wound treatment system PICO7 by SMITH & NEPHEW (application for registration; sufficient actual benefit; level V of clinical added value).
Recommendations for devices used in endocrinology:
- Semi-closed loop system dedicated to the automated management of type I diabetes MINIMED 780G by Medtronic (application for registration; sufficient actual benefit; level III of clinical added value).
Recommendations for medical aids:
- Sterile solution for ophthalmic use OPTIVE ADVANCE by Allergan (application for registration; insufficient actual benefit);
- Hemostatic dressing Quikclot by Z-Medica (application for registration; insufficient actual benefit);
- External breast prostheses THUASNE (application for renewal of registration; sufficient actual benefit; level V of clinical added value);
- Mandibular advancement orthosis AMO by Somnomed (application for renewal of registration; insufficient actual benefit);
- Mandibular advancement orthosis SOMNODENT by Somnomed (application for renewal of registration; sufficient actual benefit; level V of clinical added value).
See the details in French here.
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