ABSTRACT
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.
