OBJECTIVES

Given the increased attention to functional improvement in spine surgery as it relates to activities of daily living and cost, it is critical to fully understand the numerous bone graft options available. The purpose of this analysis was to comprehensively evaluate the cost-effectiveness of i-FACTOR Bone Graft compared to local autograft in anterior cervical discectomy and fusion (ACDF).

METHODS

The study patient population was extracted from a multi-center randomized controlled trial (RCT). Analysis was conducted in accordance with the Second Panel on Cost-Effectiveness Health and Medicine. Health-related utility was expressed in quality-adjusted life years (QALYs). The base case analysis utilized SF-36 data from the RCT. Both cost and QALY outcomes were discounted at a yearly rate of 3% to reflect their present value. A cohort Markov model was constructed to analyze peri- and post-operative costs and QALYs for both i-FACTOR and control groups. Cost-effectiveness was calculated as the incremental cost-effectiveness ratio (ICER). Scenario, probabilistic, and threshold sensitivity analyses were conducted to determine model discrimination and calibration.

RESULTS

The primary time horizon used to estimate cost and health utility was 2-years following index surgery. From a health system perspective, assuming a 50:50 split between Medicare and Private payers, the i-FACTOR cohort is cost-effective at 1-year post-operatively (21,983 $/QALY) compared to control. At 2-years and beyond, i-FACTOR becomes dominant, irrespective of payer mix and surgical setting. At willingness-to-pay (WTP) thresholds of $50,000-100,000/QALY, ~66% to ~75% of all 5,000 input parameter simulations favor P-15. While testing thresholds, the most conservative estimate limits the P-15 cost to $1,877, representing a 278% increase from its current rate.

CONCLUSIONS

The novel bone enhancing biologic i-FACTOR is not only cost-effective but may represent a dominant economic strategy, affording greater benefit at lower cost compared to the current standard of care.