The Mobi-C Cervical Disc is now available to more than 200 million insured patients with one-level disc disease and more than 150 million patients with two-level disc disease across more than 90 commercial insurance plans.
That makes Mobi-C the most widely covered intervertebral disc for cervical disc replacement in the industry.
This “solidifies Zimmer Biomet’s foothold as a market leader in cervical disc replacement, ” said David Dvorak, President and CEO of Zimmer Biomet Holdings, Inc.
The device was acquired by Zimmer Biomet when it acquired LDR Holding Corporation in July 2016.
In an October 25, 2016 press statement, the company said this milestone was reached when Anthem (formerly WellPoint), with nearly 40 million enrollees in its health plans, added Mobi-C to the list of covered devices for one-level disc replacement and as the sole cervical total disc prosthesis covered for two-level surgery.
First FDA Approved
Mobi-C was the first cervical disc approved by the FDA for reconstruction of the cervical disc at both one and two levels to treat arm pain and/or neurological deficit caused by various spine disorders or injuries. According to the company, the disc is a cobalt chromium alloy and polyethylene mobile-bearing prosthesis that is inserted in a single step, without requiring bone chiseling to accommodate vertebral anchorage such as screws or keels.
“Unlike cervical fusion, the current standard of care, which immobilizes the targeted vertebrae, Mobi-C features patented mobile-bearing technology designed to allow the prosthetic disc to self-adjust to facilitate motion similar to that of the natural cervical spine, ” said the company statement.
Payer Coverage
The company told OTW that the Anthem policy itself is unique, in that its research into individual FDA-approved discs directly informs the language of the policy. In most cases, a payer will have researched all the evidence for FDA-approved devices, and will issue a policy that is generic across all manufacturers. The wisdom being: if the treatment option is ready to be covered as a result of the overall evidence base that is usually good enough (and allows for new devices to enter the market which may not have been a part of the payer’s review).
But in this case, Anthem created a very specific policy that establishes coverage as it relates to seven individual, FDA-approved cervical disc replacement devices:
- For one-level procedures, use of the Mobi-C Cervical Disc, the Bryan Cervical Disc, the PCM Cervical Disc, the ProDisc-C Cervical Disc, and the Prestige Cervical Disc approved in 2007 (note: not the Prestige LP approved more recently in 2014) is covered by Anthem;
- For two-level procedures, only the Mobi-C Cervical Disc is covered by Anthem;
- Anthem does not intend to cover, for any procedure, use of the SECURE-C or the Prestige LP (the newer version of Prestige, approved by the FDA in 2014).
Anthem joins Aetna, which posted an updated Clinical Policy Bulletin (CPB) on cervical total disc replacement (cTDR) in early September 2016 to cover two-level procedures.
Also in early September, the BlueCross BlueShield Association (BCBSA) posted an update to its 7.01.108 evidence review of one- and two-level cTDR. BCBSA found that the evidence for two-level procedures was “sufficient to determine qualitatively that the technology results in a meaningful improvement in the net health outcome.” BCBSA considered the weight of evidence for two-level procedures to be the same as for that of one-level procedures.
Adam Johnson, Zimmer Biomet’s head of spine, dental, craniomaxillofacial and thoracic, said the payers relied on peer-reviewed clinical and real-world evidence from 40, 000 procedures. “As the most widely insured cervical intervertebral disc prosthesis, Mobi-C is poised to become the standard of care for total cervical disc replacement.”
