There are several key trends in cervical disc replacement for spine surgeons to know going forward, based on studies, analysis and outcomes.
"There has not been a single product in the history of orthopedics that has been studied as much as disc replacement or has more scientific data, cost analysis, radiographic outcomes and is still questioned by some in healthcare," says Neel Anand, MD, clinical professor of surgery and director of spine trauma at Cedars-Sinai Spine Center in Los Angeles. "At the end of the day, it's up to the regulators and insurance companies who are holding the purse strings to decide whether this technology should be available or not."
Dr. Anand, discusses the clinical, operational and reimbursement trends to expect going forward.
1. Data shows cervical disc replacement procedures are effective. Spine surgeon researchers are looking into less invasive technology and clinical research that shows there are better outcomes for patients who undergo less invasive procedures at five and 10 years. "Normally three-year results are sufficient, but in this case we needed five and 10-year results," says Dr. Anand. "We're also seeing evidence from randomized trials for FDA clearance showing these procedures do work, especially in the cervical spine."
Five-year data with the ProDisc-C shows total disc replacement had a 97.1 percent probability of no second procedures, compared with 85.5 percent of anterior cervical discectomy and fusion patients.
2. Reimbursement is still difficult for disc replacement. Artificial disc replacement technology and techniques were refined over the past decade and new data shows the cervical prosthesis can have benefits when compared to fusion procedures. However, lack of reimbursement is prohibitive for adoption. "The biggest problem now is insurance companies are not paying for it," says Dr. Anand. "Many of them deem cervical disc replacement experimental despite all the years of data we have to support its efficacy. In the right patient, cervical disc replacement has done extremely well."
3. Disc replacement is cheaper in the long run. Studies comparing the long term outcomes and expenses for cervical disc replacement with fusion show disc replacements are cheaper because there is a lower reoperation rate. Initially, the implants are expensive, but eliminating the cost of second surgeries and treatment for adjacent segment disease — more common among fusion patients — shows cost savings.
A study published in the Journal of Neurosurgery: Spine in June shows LDR's Mobi-C for one-level artificial disc replacements had a higher success rate after 48 months—69.5 percent—than anterior cervical discectomy and fusion—58.7 percent. The cost per quality-adjusted life year was $3,042 for disc replacement, significantly lower than $8,760 for ACDF.
4. Multi-level disc replacements are now feasible. Data also exists on multi-level artificial disc replacements, showing they can be effective. LDR's Mobi-C artificial disc became the first disc FDA-approved for two-level procedures and other companies may seek additional clearance as well. Two-level disc replacements will also have a Category III CPT code in 2015. "The technology is here and two-level procedures are getting better and better," says Dr. Anand.
5. More spine surgeons will perform disc replacement in the future. As disc replacement technology advances to provide better outcomes and lower costs, more surgeons will adopt the procedure. A Millennium Research Group report shows the spinal nonfusion market is expected to triple in size through 2022, exceeding $1.6 billion. Payers willing to reimbursement for them will accelerate the process.
"As long as we are reimbursed for the disc replacement, and the surgeries are approved, I think almost any spine surgeon would perform the procedure," says Dr. Anand. "It will become part of training and as our experience with the procedure improves, our indications will improve. I've found the procedure does extremely well, especially for younger patients in the 30 years old to 60 years old age group."