DePuy Spine, Inc., a Johnson & Johnson company, announced that CIGNA, one of the nation's largest health insurers, will now cover artificial disc replacement for single-level degenerative disc disease.
DePuy Spine is the world leader in spine arthroplasty and the manufacturer of the CHARITE® Artificial Disc, the first artificial disc approved by the U.S. Food and Drug Administration (FDA) in 2004.
CIGNA, which provides health insurance to about 47 million people, joins Aetna, Kaiser Permanente, Horizon Blue Cross Blue Shield and dozens of regional insurers, in covering the surgical implantation of the CHARITE Disc for low back pain and disability from degenerative disc disease.
"Initially, some insurers were reluctant to cover artificial disc replacement until more clinical evidence became available," said Gary Fischetti, President, DePuy Spine. "CIGNA's decision, at this time, signals the body of evidence continues to grow to make more informed coverage decisions that benefit patients, and we continue to gather more clinical data about the product."
According to CIGNA's new policy published on its website, evidence in peer-reviewed scientific literature shows artificial disc replacement is safe and effective in the treatment of degenerative disc disease in a select group of individuals. The policy states that while the long-term safety and efficacy of artificial discs continue to be monitored, the short-term results have shown that these devices can improve the maintenance of range of motion within the lumbar spine and provide stabilization to the intervertebral disc space.
The CHARITE Disc has been implanted in several thousand patients in the U.S. and more than 15,000 throughout the world. Artificial disc replacement is an alternative to spinal fusion surgery, the most common surgical treatment for lower back pain, performed on more than 200,000 people each year. The goals of artificial disc replacement include maintaining segmental spinal motion, reducing pain, increasing patient activity, restoring disc height and lordosis, and eliminating post-operative fusion problems, such as donor site pain and pseudoarthrosis.
Since its FDA approval, several studies about the safety and effectiveness of the CHARITÉ Disc have appeared in the peer-reviewed journal Spine, recognized around the world as the pre-eminent journal in the field. Five-year CHARITE Disc data is expected to be published later this year. This will be the first 5-year data available on an artificial disc in the U.S.
Last year, DePuy Spine formed the Centers for Arthroplasty Research in Spine (CARES) to document clinical outcomes, further education and research, and help to improve insurance coverage. CARES includes the first national patient registry for artificial disc replacement.
In clinical trial results, when comparing artificial disc replacement patients to spinal fusion surgery patients, the CHARITE Disc patient group maintained more motion, avoided pain at the donor site, had a shorter hospital stay and were more satisfied with the procedure. There were no significant differences in complications.
The CHARITE Artificial Disc, made of two metallic endplates and a polyethylene sliding core, is designed to replace a worn out or damaged spinal disc. Spinal discs maintain the position of the spine and allow for bending.
The CHARITE Artificial Disc is indicated for spinal arthroplasty in skeletally mature patients with degenerative disc disease at one level from L4 to S1. Degenerative disc disease is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These patients should have no more than 3mm of spondylolisthesis at the involved level. Patients receiving the CHARITE Artificial Disc should have failed at least six months of conservative treatment prior to implantation.
As with any surgical procedure, artificial disc replacement surgery has risks. Individual patient results may vary and are not indicative of all outcomes. Patients should consult a trained spine surgeon to determine whether this procedure is appropriate.
About DePuy Spine
DePuy Spine, Inc., a Johnson & Johnson company, has worked and partnered with leading clinicians, researchers, and thought leaders to develop products to treat spine disorders for more than 20 years. The company is committed to advancing the knowledge of all health care professionals and their patients in addressing spinal pathologies.
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