A Cost Effectiveness Analysis of Spinal Cord Stimulation versus Conventional Medical Management for the Treatment of Low Back Pain Using Data from DISTINCT RCT and Medical Claims from a U.S. Commercial Payer Database.

Purpose: To compare the healthcare utilization (HCU) and costs for passive recharge burst Spinal Cord Stimulation (SCS) and conventional medical management (CMM) cohorts in patients with chronic low back pain (LBP) to a matched real-world cohort of similar indication. The null hypothesis is that SCS is equally or less cost-effective than CMM in treating LBP. Patients and Methods: DISTINCT is a prospective, multi-center, randomized study. Data was collected during in-clinic visits at baseline, one, three, and six months. The DISTINCT "completer cohort" included 79 DISTINCT SCS patients and 55 DISTINCT CMM patients who completed the six-month visit. An external real-world cohort (n = 71) with similar characteristics to DISTINCT CMM patients was identified from a claims database (Optum's de-identified Market Clarity Data). Accessed data included healthcare resource utilization (HCU), pain-related medication usage, pain scale, and quality of life. HCU data covered physical therapy, chiropractic therapy, massage therapy, occupational therapy, acupuncture, injection treatments, radiofrequency ablation procedures, and opioid and anticonvulsant usage. Results: The DISTINCT study demonstrated superior outcomes in pain relief, function, and other symptoms with SCS compared to CMM in the treatment of persistent (at least 6 months) low back pain. DISTINCT SCS patients utilized fewer healthcare resources and incurred lower costs than DISTINCT CMM patients. Real-world CMM patients exhibited higher utilization of certain therapies, suggesting potential pre-crossover bias. SCS resulted in significant cost savings and improved quality of life compared to CMM. Including device costs, cost-effectiveness could be achieved within 2.7 years based on DISTINCT data. The real-world CMM arm used more high-priced interventional therapies, suggesting a pre-crossover bias in the CMM cohort. Conclusion: This analysis supports the long-term benefits and cost-effectiveness of SCS in managing chronic LBP compared to CMM.