Next year is looking pretty good to spine device company LDR, known for their cervical disc replacement technology. The Mobi-C cervical disc is the only artificial disc approved by the Food and Drug Administration for two-level procedures, a trait that will come in handy next year when a new Category 1 CPT code that supports two-level cervical arthroplasty procedures becomes effective.
Surgeons can perform artificial disc replacement on-label for both one- and two-level procedures. Many cervical procedures occur at two levels, which means surgeons don't need to switch from disc replacement at one level to fusions at two. A summary of changes for next year include:
• Category 1 CPT codes for both one and two level cervical disc replacement will be in place
• 2015 will be the first full year with a new DRG code for cervical disc with higher payment to hospital over fusion
• More clinical data is expected reinforcing the quality of clinical outcomes with cervical disc
"Things are falling into place for cervical disc replacement, making this an exciting time," says LDR Executive Vice President, Global Marketing Joe Ross. "There are surgeons who had not previously adopted cervical discs who are now beginning to do so. They are seeing how well it works for existing users and they are experiencing strong interest from their patients."
LDR was founded in 2000 and went public last year on the NASDAQ. North America, and the United States specifically, remains the dominant global market for cervical disc replacements, according to a Persistence Market Research report, and there is increasing awareness of cervical disc replacement procedure successes. Consequently, the U.S. is a primary focus for LDR with their exclusive technologies, including Mobi-C Cervical Disc device.
"We know that in the United States there is a large number of surgeons who still have the opportunity to adopt procedures like cervical disc replacement as proper coding is put in place and coverage becomes broader," says Mr. Ross. "With regard to patients suffering from cervical disc disease, we talk with surgeons who remind us that the primary goal of anterior cervical surgery has never been to fuse; it has been to relieve pain and, if possible, maintain mobility. Historically, surgeons fused the spine as a consequence of the surgery to relieve pain, but now they have another option for some patients. We believe that surgeons, when seeing a patient where anterior cervical surgery is indicated, might think of them as a candidate for disc replacement first, unless a contra-indication is apparent. This would represent a changing mindset to the gold standard being disc replacement and fusion being the alternative if another option is needed."
Changing surgeon mindset requires time and energy. LDR invested significantly in robust clinical research in the form of the prospective, randomized IDE trial. In the two-level arm of this trial, Mobi-C demonstrated overall superiority to two-level cervical fusion based on the primary, composite endpoint at two years follow up. There is also a possible economic advantage for disc replacement patients, as described in the scientific paper published in JAMA Surgery in October 2014. The report showed:
1. The incremental cost-effectiveness ratio of cervical two-level disc replacement over ACDF is $24,594 per quality-adjusted life year. The common threshold for ICER is $50,000 per QALY with anything lower seen as cost-effective.
2. Cervical two-level disc replacement also has an impact from a societal perspective. The procedure allowed patients to have a greater quality of life at a lower cost than ACDF over the four-year period studied.
"The most important investment we made was in the clinical trial so that we now have clinical data to share with the surgeon community," says Mr. Ross. "We have access to an enormous dataset which will be important for years to come. We've also made investments in cost-effectiveness and cost-utility studies. We believe that this research is also important as it demonstrates which treatment may be better from an overall societal perspective. "
At the North American Spine Society annual meeting in 2014, there were five podium presentations focused on the Mobi-C cervical disc replacement outcomes including some reported advantages over fusion.
But the company doesn't stop at surgeon education. LDR also built a website for patient education designed to inform patients, in a fair and balanced manner, on their treatment options including cervical disc replacement with Mobi-C. "We feel that it is fair for patients to be knowledgeable about and to inquire regarding their treatment options," says Mr. Ross. "They can discuss with their physician the information that they found on our site, or similar sites with equally credible content, and that conversation might help to confirm the best treatment option in a particular instance." More information is available at cervicaldisc.com.
The company has heard stories, directly from patients, regarding their search for physicians offering cervical disc replacement as an option. In one instance, a patient whose pathology fell under the indications for cervical disc replacement, based on our understanding, consulted with multiple surgeons in his community who all said he needed surgery and offered only fusion. None mentioned disc replacement as an approved and available treatment. Finally, the fourth surgeon he visited, who happened to be one of the Mobi-C IDE investigators, offered a disc replacement and that's where he had his surgery.
"Offering state-of-the-art surgical options is one way that surgeon practices can position themselves as the spine specialist in their area," says Mr. Ross. "Not only will it help them to attract more patients but it will also reinforce their credibility as cervical spine specialists and help to draw in greater practice volume. Of course only some percentage of those patients will be indicated for any particular procedure, however it is the overall patient traffic that can help them to increase their presence in their community. The medical history demonstrates that surgeons will not ignore a superior treatment, and we expect to see more and more adoption of cervical disc in the next five to 10 years."
More articles on spine surgery:
North American spine surgery market in 5 years: 8 things to know
Technology paves the way: What are spine practices adding to improve operations?
7 key points on post-cervical disc replacement heterotopic ossification
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