LDR Announces Publication of Five-Year Results of Cost Utility Analysis of Mobi-C Cervical Disc
Study Finds Mobi-C Appears to be Highly Cost-Effective Compared With ACDF for Treating Two-Level Cervical Disc Disease Out to Five Years
AUSTIN, Texas, Feb. 09, 2016 (GLOBE NEWSWIRE) -- LDR Holding Corporation (Nasdaq:LDRH), a global medical device company focused on designing and commercializing novel and proprietary surgical technologies for the treatment of patients suffering from spine disorders, today announced that NEUROSURGERY® has published a peer-reviewed article that evaluated the cost-effectiveness of two-level cervical Total Disc Replacement (cTDR) with the Mobi-C® Cervical Disc as compared to anterior cervical discectomy and fusion (ACDF) based on five-year outcomes data. The paper, Cost Utility Analysis of The Cervical Artificial Disc versus Fusion for The Treatment of 2-Level Symptomatic Degenerative Disc Disease: 5-Year Follow-Up, was published online by NEUROSURGERY on February 5, 2016, with print publication to follow. The full article is available online at The study, authored by Jared Ament, M.D., MPH with the UC Davis Health System Neurosurgery Department, utilized the clinical data from the two-level Mobi-C vs. ACDF randomized controlled trial in order to assign health states for the patient population. The objective of the paper was to determine the cost-effectiveness of cTDR compared to ACDF for two-level cervical disc disease. The study concludes that for patients with 2-level degenerative disc disease, cTDR appears to be a “highly cost-effective surgical modality compared with ACDF” and that, “from a societal perspective, cTDR imparts greater quality of life at less cost than ACDF.” “The clinical superiority of Mobi-C compared to ACDF for two-level indications has been demonstrated through the Investigational Device Exemption (IDE) trial for the overall composite primary effectiveness endpoint at 60 months,” said Christophe Lavigne, President and CEO of LDR. “We are excited to have this very important, long-term economic analysis of Mobi-C published, especially in such a prestigious journal as NEUROSURGERY. The principal finding of this study, that two-level Mobi-C appears to offer improved cost-effectiveness compared to ACDF (based on the 60-month outcomes), represents further evidence to support broader payer coverage for two-level cervical disc replacement, and greater surgeon adoption of Mobi-C.” As part of the research, costs were derived from institutional billing data at the IDE trial sites. The research team used decision analytical modeling to generate Quality-Adjusted Life-Years (QALY) and Incremental Cost-Effectiveness Ratios (ICER) for both treatment groups on which to base their conclusions. QALY is a measure of disease burden and assesses the value for the money associated with a medical intervention. ICER is the ratio of the change in costs to incremental benefits of a therapeutic intervention or treatment. An intervention with a lower cost to QALY gained ratio such as 2-level cTDR would be preferred over an intervention with a higher ratio like 2-level ACDF. The cost-effectiveness of 2-level Mobi-C over fusion was first studied, peer-reviewed and published by Dr. Ament, et al. in the December 2014 issue of the Journal of the American Medical Association (JAMA) Surgery. That study was based on analysis of IDE trial data through the first 24 months, and also concluded that cTDR with Mobi-C appears to be a highly cost-effective surgical modality compared with ACDF for the treatment of two-level cervical disc disease. One notable takeaway when comparing the two studies, is that the ICER for the five-year data far exceeded that of the two-year data, suggesting that cTDR with Mobi-C becomes more cost-effective over time. Mobi-C Cervical Disc About LDR Holding Corporation Forward-Looking Statements ©2016 LDR Holding Corporation, All Rights Reserved CONTACT: Media Contact: Stephen Karaolis SKaraolis@kwittken.com (631) 559-2879 |
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