The key findings from the study were:
1. The incremental cost-effectiveness ratios 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 primary effectiveness endpoint for the study was 24 months. Two-level disc replacement PMA was granted in 2013 by the FDA.
“In today’s U.S. healthcare environment we knew it would be important to determine the cost-effectiveness of Mobi-C as compared with ACDF, the historical standard of care,” said Christophe Lavigne, president and CEO of LDR.
The company has grown in 2014 after going public and then issuing a follow-on offering. Earlier this year, the AMA CPT Coding Panel announced a new Category I Code approval for two-level cervical arthroplasty, which goes into effect next year. LDR’s Mobi-C is the only device approved for two-level disc replacements and the company could have a big 2015 as a result.
LDR plans to release their third quarter financial report on Nov. 5.
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