ZimVie Gains Coverage for Anterior Vertebral Body Tethering

Anthem Blue Cross Blue Shield (BCBS), a subsidiary/operating company of Elevance Health, has issued a positive medical policy decision for ZimVie Inc. applicable to anterior vertebral body tethering (AVBT), effective July 6. The decision expands potential treatment eligibility to patients indicated for AVBT within the 30+ million members covered under Anthem BCBS, and outlines the medical necessity criteria that must be met for coverage of AVBT.
 
“This decision marks a significant win for Anthem BCBS patients and the broader pediatric scoliosis community,” said Rebecca Whitney, senior vice president and president of ZimVie Spine. “Before the development of anterior vertebral body tethering, the primary surgical option for children with scoliosis was a spinal fusion with rigid rods that could limit mobility. The coverage decision from Anthem will provide children with greater access to AVBT as a motion preserving alternative that may allow them to return to their active daily lives. We hope that this decision also paves the way for policy updates from additional payers to positively impact the lives of children with scoliosis.”
 
ZimVie’s Tether device, a first-of-its-kind non-fusion scoliosis treatment, is the first and only U.S. Food and Drug Administration-approved device for AVBT. Its humanitarian device exemption (HDE) was granted based on over seven years of clinical data validating the safety and effectiveness of The Tether in scoliosis correction. More than 1,200 children have received The Tether since HDE approval in August 2019, with approximately 50 U.S. surgeons performing the procedure today.

The Tether is a Humanitarian Device. Authorized by Federal law for use in the treatment of skeletally immature patients that require surgical treatment to obtain and maintain correction of progressive idiopathic scoliosis, with a major Cobb angle of 30 to 65 degrees whose osseous structure is dimensionally adequate to accommodate screw fixation, as determined by radiographic imaging. Patients should have failed bracing and/or be intolerant to brace wear. The effectiveness of this device for this use has not been demonstrated.

“This policy change is a victory for families with scoliosis who need surgery, have researched their options, and have chosen a surgery that has the potential to maintain motion and decrease future complications,” said Jaren Riley, M.D., a board-certified, fellowship-trained pediatric orthopedic surgeon and the first in the Rocky Mountain Region to perform vertebral body tethering. “I am also grateful to Anthem BCBS for taking the time to meet with me personally and examine the promising data I presented.”
 
ZimVie is a global life sciences firm that develops, manufactures, and delivers a portfolio of dental and spine products and solutions designed to treat a wide range of spine pathologies and support dental tooth replacement and restoration procedures. The company was founded in March 2022 as an independent, publicly traded spin-off of the Dental and Spine business units of Zimmer Biomet. From its headquarters in Westminster, Colo., and additional facilities around the globe, the company serves customers in more than 70 countries worldwide.