Real-World Cost-Effectiveness Analysis of Spinal Cord Stimulation vs Conventional Therapy in the Management of Failed Back Surgery Syndrome.

Purpose Failed back surgery syndrome (FBSS) causes disability and lowers health-related quality of life (HRQoL) for patients. Many patients become refractory to conventional medical management (CMM) and spinal cord stimulation (SCS) is advised. However, comparative cost-effectiveness research of both clinical approaches still lacks further evidence. This probabilistic cost-effectiveness analysis compares CMM versus SCS plus CMM in FBSS patients for a 5-year period in Spain. Patients and Methods Patient-level data was obtained from a 2-year real-world study (SEFUDOCE) of adults diagnosed with FBSS who were treated with CMM or SCS. Incremental cost-effectiveness ratios (ICER) were estimated in terms of direct clinical cost and quality-adjusted life years (QALYs). Costs (€ for 2019) were estimated from the Spanish National Health Service (NHS) perspective. We applied a yearly discount rate of 3% to both costs and outcomes and performed a probabilistic sensitivity analysis using bootstrapping. Results After 2 years, the health-related quality of life measured by the EQ-5D displayed greater improvements for SCS patients (00.39) than for improved CMM patients (0.01). The proportion of SCS patients using medication fell substantially, particularly for opioids (-49%). In the statistical model projection, compared with the CMM group at year 5, the SCS group showed an incremental cost of € 15,406 for an incremental gain of 0.56 0.56 QALYs, for an ICER of € 27,330, below the €30,000 willingness-to-pay threshold for Spain. SCS had a 79% of probability of being cost-effective. Conclusion SCS is a cost-effective treatment for FBSS compared to CMM alone based on real-world evidence.