186. Cost-effectiveness of the Coflex interlaminar stabilization device: evidence for increasing physician reimbursement

Abstract

BACKGROUND CONTEXT The growing prominence of motion preserving spine surgery necessitates the need for quality economic evaluations. Economic studies on the Coflex Interlaminar Stabilization (ILS) device that simultaneously compare decompression alone (DA) and decompression with pedicle screw fusion (D+PS) are lacking. Data are also limited when assessing surgeon reimbursement and its value proposition. PURPOSE To critically assess the cost-effectiveness and reimbursement for the Coflex ILS device compared to both DA and decompression with D+PS. STUDY DESIGN/SETTING A parameterized Markov model was designed to capture health outcomes and health care resource utilization following the initial surgery using either the Coflex ILS device, DA, or D+PS. PATIENT SAMPLE The study population consisted of patients from two randomized controlled trials (one European, n=230 and one US-based, n=322), all with moderate to severe lumbar stenosis. OUTCOME MEASURES The primary outcome measure is health-related utility expressed in quality-adjusted life years (QALYs). Secondary outcomes included complication rates and the percentage of time spent within health states. Cost-effectiveness was expressed as an Incremental cost-effectiveness ratio (ICER). METHODS The analysis was conducted in accord with the Second Panel on Cost-Effectiveness Health and Medicine. A 2-year follow-up period was used for the base case. Medicare and private payers were assumed to each comprise 50% of the patient population. A health system perspective evaluated direct medical resources while a societal perspective accounted for indirect costs. The ICER was benchmarked against the recommended US-based willingness-to-pay (WTP) threshold of $100,000 per QALY. All costs were inflation-adjusted to 2016 dollars. Both costs and QALYs were discounted at a yearly rate of 3% to reflect their present value. RESULTS At 2 years, Coflex ILS patients spent approximately 35% of the time in the minimal disability health state compared to 28% and 24% for the D+PS and DA cohorts, respectively (p $290,000 per QALY gain). From a payer perspective, total reimbursement for Coflex ILS can theoretically be increased 59% and remain cost-effective compared to DA. This equates to a potential increase in physician reimbursement of up to 3800%. CONCLUSIONS Coflex ILS is cost-effective compared to DA and economically dominant compared to D+PS at 2 years. Despite slightly higher revision rates with most ILS devices, cost-effectiveness actually improved in our analysis from 2-5 years suggesting that this technology warrants careful reconsideration. FDA DEVICE/DRUG STATUS Coflex (Approved for this indication).