LDR Device Fares Well in JAMA Study on Cervical TDR

Move over, standard of care…Mobi-C is coming through. LDR Holding Corporation has announced a new study showing that its Mobi-C Cervical Disc is more cost-effective than two-level anterior cervical discectomy and fusion (ACDF). The study, which appears in JAMA Surgery, states that cervical total disc replacement is cost-effective for two-level cervical disc disease, and that over a four year period it imparts a greater quality of life at less cost. The Mobi-C Cervical Disc is the only cervical disc that is FDA-approved for one and two-level use.

Working with the University of California Davis Health System Neurosurgery Department, the study’s lead author, Jared Ament, M.D., M.P.H., used clinical data from the two-level Mobi-C vs. ACDF randomized controlled trial in order to assign health states for the patient population. As indicated in the October 29, 2014 news release, the research team “generated Quality-Adjusted Life-Years (QALY) and Incremental Cost-Effectiveness Ratios (ICER) for both treatment groups. An intervention with a lower cost to QALY saved ratio (ICER) would be preferred over an intervention with a higher ratio. The ICER of CTDR [cervical total disc replacement] over ACDF is $24, 594 per QALY, lower than the commonly used U.S. ICER threshold of $50, 000 per QALY, suggesting that CTDR is a ‘highly cost-effective option.’”

In the news release Christophe Lavigne, president and CEO of LDR, stated, “The statistical superiority of Mobi-C compared to ACDF for two-level indications has been demonstrated through the IDE [investigational device exemption] for the overall composite primary effectiveness endpoint at 24 months, and the PMA [pre-market approval] for two-level indications was approved by the FDA in 2013. In today’s U.S. healthcare environment we knew it would be important to determine the cost-effectiveness of Mobi-C as compared to ACDF, the historical standard of care. We are excited to have this very important economic analysis of Mobi-C published, especially in such a prestigious journal as JAMA Surgery. The principal finding of this study, that Mobi-C appears to offer improved cost-effectiveness for two-level replacement (based on the 24 month outcomes), is an important factor for consideration by healthcare providers.”