ZimVie Gains Reimbursement for Mobi-C Cervical Disc in France

ZimVie announced the French Republic published approval for reimbursement of its Mobi-C cervical disc in France’s private and public sectors.
 
Further, clinical data for Mobi-C was awarded the highest quality rating of 10A* by the Orthopaedic Data Evaluation Panel in the U.K. Physicians have used Mobi-C for cervical disc replacement at one level or two contiguous levels to treat patients in France and the U.K. since 2004.
 
“This reimbursement of the Mobi-C prosthesis is really excellent news. After almost twenty years of communicating the results of a French multi-center study, reimbursement for Mobi-C for both one- and two-level applications has been obtained,” Dr. Thierry Dufour, spine neurosurgeon at Clinique Geoffroy Saint Hilaire in Paris told the press. “This decision was eagerly awaited by the French surgical community, as the Mobi-C prosthesis was invented, designed, and manufactured in France. With the economic obstacle of reimbursement addressed, cervical disc arthroplasty will now be more broadly available.”
 
On March 19, 2023, the French Republic’s Ministry of Health and Prevention issued in JORF N° 0067, a new version of the List of Products and Services (Liste des Produits et Prestations, or LPP) reimbursable by health insurance and covered by the Health Insurance Fund (otherwise known as standard coverage). The LPP (Text No. 24) now includes the newly introduced medical device code 3174999 for “Cervical Disc Prostheses – Mobi-C Plug & Fit.” Implants included on the LPP must be CE-marked devices with therapeutic, diagnostic, or assistive added value, supported by clinical studies showing the solution’s benefits.
 
Another validation of the Mobi-C came through the recent 10A* rating from the Orthopaedic Data Evaluation Panel (ODEP) in the U.K. ODEP provides the objective, systematic review and rating of strength of evidence supporting medical device performance. Its rating consists of several components:
 

• The numerical portion of the rating indicates the number of years of clinical evidence, with ten years representing full compliance with the benchmark from the National Institute for Health and Care Excellence (NICE), which provides national guidance and advice to improve health and social care in the United Kingdom.
• The “A” designates “Strong Evidence” based on a generally higher number of patients (giving greater confidence in the results presented), with all patients being subject to follow-up (their outcomes recorded).
• ddition of the star denotes a benchmark replacement rate of less than 1 in 20 (5%) at 10 years. There is no higher quality rating than A*.

 
“We applaud the French reimbursement decision for Mobi-C and welcome the exemplary 10A* rating from ODEP,” said Rebecca Whitney, global president of ZimVie Spine. “We believe that these wins further validate the confidence that surgeons worldwide have demonstrated for Mobi-C since its first use in France in 2004 and FDA approval for one- and two-level use in the United States in 2013. Products like Mobi-C fuel our mission to preserve motion and restore daily life for patients.”