Changing clinical landscape
For years, spinal fusion has been the dominant procedure for cervical spine surgery. While spinal fusion continues to hold the largest market share, tides are changing as non-fusion options are more widely available and accepted in spine practices today. Companies focused on disc replacement, like LDR with its Mobi-C® Cervical Disc, are poised to become leaders in the changing spinal instrumentation market.
The Millennium Research Group reported that the global spinal non-fusion market would surpass $1.6 billion by 2022, nearly tripling in size from just a few years ago. By 2020, cervical disc replacement is expected to have 10 percent of the global spine surgery market, according to a MedMarket Diligence report.
Patients are demanding alternatives to fusion, which limits mobility and could lead to adjacent segment disease. Payers are also more willing to reimburse for disc replacement devices, giving more patients access to the procedure.
There are around 31 million Americans with back pain at any given time and low back pain is the leading cause of disability worldwide, according to the Global Burden of Disease 2010. An estimated 80 percent of the population will experience back pain at some point in their lives. According to an American Chiropractic Association report, Americans spend at least $50 billion each year on back pain. Healthcare providers are looking for the best solutions to treat each patient cost-effectively and return them to normal life.
Cervical disc replacement could fill those needs for the appropriately indicated patients.
Level 1, long-term, five-year safety and efficacy data on both the one and two- level Mobi-C versus traditional cervical fusion
This data was first presented at the North American Spine Society (NASS) annual meeting in November 2014, and was the subject of six recent podium presentations at the International Society for the Advancement of Spine Surgery (ISASS) annual meeting in April 2015 in San Diego. Conclusions highlighted during the presentations included:
• Two-level Mobi-C patients, as compared to Anterior Cervical Discectomy and Fusion, or ACDF, demonstrated statistically significantly better long-term sustainability of success and clinical outcomes.
• Comparing two-level Cervical Total Disc Replacement, or CTDR, and ACDF in the prospective, randomized study with long-term follow-up, Mobi-C showed statistically significantly greater clinical improvement in general and disease specific outcome measures compared to ACDF.
• In addition, there were statistically significantly fewer primary and adjacent level reoperations with cervical artificial disc treatment as compared to fusion.
"We've been very pleased with our early experience in the U.S. cervical disc market as it builds on our existing strong presence in anterior cervical fusion with the ROI-C® Cervical Cage," says Christophe Lavigne, President and Chief Executive Officer of LDR. "In contrast to many spine procedures performed today, cervical disc replacement is supported by an exceptional library of Level 1 clinical evidence, now including data from the one and two-level Mobi-C IDE trials. In this era of evidence-based medicine, surgeons look to cervical disc replacement as a procedure behind which they can stand."
LDR has gone further with its technology than any other company in the marketplace today by obtaining FDA approval for both one and two-level disc replacement. Mobi-C is currently the only FDA-approved device for two-level disc replacement.
"We feel that the clinical data demonstrates clear areas of patient benefits over fusion, especially for two-level indications," says Mr. Lavigne. "The data has also been well received and appreciated by spine surgeons."
Economic impact
The clinical benefits may lead to economic benefits. Last year a study was published in JAMA Surgery examining the cost-effectiveness of two-level disc replacement with Mobi-C. Healthcare providers are focused on both clinical quality and cost-effectiveness today, and proving cost-savings to the healthcare system is a valuable tool.
The study showed the incremental cost-effectiveness ratio of cervical total disc replacement was $24,594 per quality-adjusted life year (QALY) over anterior cervical discectomy and fusion. This is lower than the commonly used threshold of $50,000 per QALY—the baseline for effectiveness. Cervical disc replacement, as a result, is a highly cost-effective option.
From a societal perspective, the study also found two-level cervical disc replacement offered a greater quality of life at a lower cost over a two-year period.
"This makes a strong argument for using disc replacement on appropriately indicated patients," says Mr. Lavigne.
Reimbursement
Two-level cervical disc replacement received a Category I CPT code on January 1, 2015, following establishment of a Category 1 CPT code for one-level on January 1, 2009.The Category I codes provide surgeons with greater certainty as to what they will be paid for performing cervical disc replacement and is a big step forward to consistent spinal arthroplasty reimbursement.
"While it is difficult to quantify coding changes as they relate to our business, it's fair to say the impact can only be positive," commented Mr. Lavigne.
Training and support for the future
Beyond the technology, LDR is continuing to invest in expanding medical education and training programs for surgeons. The company provides training courses and cadaveric labs for surgeons to learn disc replacement technique with the Mobi-C Cervical Disc.
"Relative to disc replacement we have an extraordinary opportunity to expand the market and increase our presence," says Mr. Lavigne. "We believe that the coverage environment for cervical disc replacement will continue to improve. Additional long term evidence will support increased surgeon adoption and patient demand."
LDR's business model focuses on a small number of highly differentiated technologies with the core being VerteBRIDGE® Plating Technology for spinal fusion and Mobi-C for cervical disc replacement. Mr. Lavigne says, "The company will continue to focus on novel technologies and plans to introduce new products in the next 18 to 24 months."
"We are enthusiastic about the products in our pipeline, including the InterBRIDGE® Interspinous Fusion Device that is undergoing evaluation," says Mr. Lavigne. "We foresee continued, exceptional opportunities for LDR in both the lumbar and cervical segments."
This article is sponsored by LDR.