Zimmer Biomet acquired LDR Spine for $1 billion earlier this year, adding LDR's Mobi-C to its spine portfolio. Mobi-C is the first cervical disc approved by the FDA for both one- and two-level spine procedures. Blue Cross Blue Shield in Illinois, Montana, New Mexico, Oklahoma and Texas all cover two-level disc replacement.
"We were very pleased to see the updated Anthem coverage policy for cTDR effective Aug. 18, now allowing for coverage of two-level contiguous cervical disc replacement procedures with the Mobi-C Cervical Disc," says Zimmer Biomet's Senior Director for Market Access, Health Economics and Reimbursement Jeffrey Zigler. "This is a huge leap forward for the therapy, putting the procedure in reach of over 40 million patients in the U.S. This is the latest and also one of the more momentous decisions by a third party on coverage rationale for the Mobi-C Cervical Disc."
Anthem conducts one of the most thorough health technology assessments in the United States to develop coverage policy and makes annual updates. The process includes a team of more than 25 physicians, pharmacists and clinical staff examining and updating policies. There is a committee of internal and external physicians associated with academic medical centers, journal editors and thought leaders from around the industry that determine the policy as part of the company's Medical Policy and Technology Assessment Committee.
In most cases, payers will conduct research into the evidence for FDA-approved devices and issue a policy for all manufacturers, which also allows for new devices to be covered when they enter the market. However, Anthem conducts research into individual FDA-approved discs. Anthem's policy specifically establishes coverage for five FDA-approved cervical discs for the one-level procedure:
• Bryan Cervical Disc
• PCM Cervical Disc
• Prestige Cervical Disc approved in 2007
The Mobi-C is the only disc approved for two levels by Anthem.
"As one of the larger payers in the nation, other regional plans will look to Anthem," says Mr. Zigler. "Anthem is an influential payer in numerous markets, and this news may prompt smaller plans and health technology assessment teams to follow suit. We anticipate that additional payers will find similar rationale in the published, peer-reviewed literature on this topic to also change their negative policies to allow coverage."
BlueCross and BlueShield Association also updated its 7.01.108 evidence review for one- and two-level cervical disc replacement, finding the procedure "sufficient to determine qualitatively that the technology results in a meaningful improvement in the net health outcome." Nearly all BCBS
A plans cover one-level disc replacement, and the BCBSA now considers two-level procedures to have the same level of evidence.
"With this announcement by Anthem, we estimate that over 200 million commercially insured Americans have access to one-level cervical disc replacement procedures and almost 150 million have access to two-level procedures," says Mr. Zigler. "We communicated regularly with the Anthem Medical Policy review team, who was extremely responsive and accepted our materials and key updates on the publication of peer-reviewed evidence, based on randomized, controlled clinical trials. We did not do this alone; patients, providers and even professional societies communicated the need for this policy change."
Both the North American Spine Society and International Society for the Advancement of Spine Surgery have coverage recommendations for cervical disc replacement. The recommendations are based on literature published showing as good or better outcomes for cervical disc replacement when compared to fusion. Anthem connects with the societies for policy updates as well.
There are several published articles in the literature on one- and two-level disc replacements comparing Mobi-C to anterior cervical discectomy and fusion. Results from the Mobi-C investigational device exemption trial found two-level disc replacement was superior to fusion at two and five years based on overall trial success. Additionally, disc replacement reported superior scores and success rate for NDI, as well as adjacent segment degeneration. The two-level disc replacement was also associated with lower reoperation rates.
The Journal of Neurosurgery: Spine published these results from the two-level study:
1. There was significant improvement in outcome scores relative to baseline during all study time points.
2. Mobi-C patients reported significantly more improvement than fusion patients in the Neck Disability Index score and SF-12 Physical Component Summary at 60 months.
3. Disc replacement patients reported more improved overall patient satisfaction rates 60 months after surgery compared to fusion patients.
4. The reoperation rate at 60 months was 4 percent for the Mobi-C patients and 16 percent for the ACDF patients.
5. There wasn’t a significant difference in adverse event rates between the two groups.
BCBSA stated, "Overall the evidence at five years shows outcomes that are superior to ACDF for two-level degenerative disc disease. The evidence is sufficient to determine qualitatively that the technology results in a meaningful improvement in the net health outcome."
In early September, Aetna also posted a clinical policy bulletin covering two-level total disc replacement procedures.
Finally, Tricare also announced two-level disc replacement coverage. Tricare provides health benefits for the armed forces and military personnel, military retirees and some reservists and dependents, with around 9.4 million beneficiaries around the world.
"The procedure can help troops suffering from certain spinal injuries enjoy a quicker recovery," says Mr. Zigler.
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