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 May 2021. Recommendations concern orthopedic devices, cardiovascular, peripheral vascular, and neurovascular devices, medical aids, and pulmonary artery pressure sensor.
The first step in the assessment is the clinical (actual) 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 released for orthopedic devices:
- Viro-inactivated bone allograft DIZG (application for modification of registration conditions; sufficient actual benefit; level V of clinical added value);
- Total ankle prosthesis SALTO (application for radiation of code);
- Sacroiliac joint arthrodesis implant IFUSE-3DTM IMPLANT SYSTEM (application for registration; sufficient actual benefit, level V of clinical added value);
- Viro-inactivated bone allograft ALLOGREFFE OSSEUSE ALLOTEC C+TBA (application for modification of registration conditions; sufficient actual benefit; level V of clinical added value).
Three decisions were released for cardiovascular and peripheral vascular devices:
- Coronary endoprosthesis (stent) coated with titanium oxynitride (product without pharmacological action) TITAN OPTIMAX (application for modification of registration conditions; sufficient actual benefit; level V of clinical added value);
- Hybrid vascular prosthesis E-VITA OPEN NEO (application for registration; sufficient actual benefit, level V of clinical added value);
- Edge-to-edge mitral repair clip MITRACLIP G4-NTW (application for registration; sufficient actual benefit; level V of clinical added value).
Two decisions were published for neurovascular devices:
- Self-expanding intracranial stent with controlled release (known as flow diverter stent) FRED X (application for registration; insufficient actual benefit);
- Distal access catheter used in a thrombo-aspiration system AXS VECTA (application for registration; sufficient actual benefit; level V of clinical added value).
Pulmonary artery pressure sensor Cardiomems received insufficient actual benefit due to the lack of clinical data and thus, is not recommended for registration in the LPPR.
Several decisions were released for medical aids:
- Test strips for the determination of glucose and ketone bodies in urine KETO-DIASTIX (application for renewal of registration, sufficient actual benefit, level V of clinical added value);
- Class II energy return foot DYNASTAR 1A500 (application for renewal of registration, sufficient actual benefit, level V of clinical added value);
- Class I energy return foot DYNASTEP 1A101 (application for renewal of registration, sufficient actual benefit, level V of clinical added value);
- Round breast implant, smooth, pre-filled with silicone gel PEARL (application for registration; sufficient actual benefit, level V of clinical added value);
- Silicone external prostheses of the nipple-areola PINK PERFECT (application for registration; insufficient actual benefit);
- Class III energy return foot TERION (application for radiation of code);
- Class III energy return foot SILHOUETTE (application for radiation of code);
- Class II energy return foot SENATOR (application for radiation of code);
- Class II energy return foot PROMENADE (application for renewal of registration, sufficient actual benefit, level V of clinical added value);
- Lubricating eye drops SYSTANE COMPLETE (application for registration; insufficient actual benefit);
- Short-stretch cohesive compression band GAMME COMPRILAN:JOBST COMPRIHAFT (application for registration; sufficient actual benefit, level V of clinical added value);
- Short stretch compression band GAMME COMPRILAN:COMPRILAN (application for registration; sufficient actual benefit, level V of clinical added value);
- Ointment ONYSTER (application for renewal of registration, sufficient actual benefit, level V of clinical added value).
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).