Cost-Effectiveness and Cost-Utility Analysis of Spinal Cord Stimulation in Patients With Failed Back Surgery Syndrome: Results From the PRECISE Study

Abstract

ObjectiveTo assess the cost‐effectiveness and cost‐utility of Spinal Cord Stimulation (SCS) in patients with failed back surgery syndrome (FBSS) refractory to conventional medical management (CMM).Materials and MethodsWe conducted an observational, multicenter, longitudinal ambispective study, where patients with predominant leg pain refractory to CMM expecting to receive SCS+CMM were recruited in 9 Italian centers and followed up to 24 months after SCS. We collected data on clinical status (pain intensity, disability), Health‐Related Quality‐of‐Life (HRQoL) and on direct and indirect costs before (pre‐SCS) and after (post‐SCS) the SCS intervention. Costs were quantified in € 2009, adopting the National Health Service's (NHS), patient and societal perspectives. Benefits and costs pre‐SCS versus post‐SCS were compared to estimate the incremental cost‐effectiveness and cost utility ratios.Results80 patients (40% male, mean age 58 years) were recruited. Between baseline and 24 months post‐SCS, clinical outcomes and HRQoL significantly improved. The EQ‐5D utility index increased from 0.421 to 0.630 (p < 0.0001). Statistically significant improvement was first observed six months post‐SCS. Societal costs increased from €6600 (pre‐SCS) to €13,200 (post‐SCS) per patient per year. Accordingly, the cost‐utility acceptability curve suggested that if decision makers' willingness to pay per Quality‐Adjusted‐Life‐Years (QALYs) was €60,000, SCS implantation would be cost‐effective in 80% and 85% of cases, according to the NHS's and societal point of views, respectively.ConclusionsOur results suggest that in clinical practice, SCS+CMM treatment of FBSS patients refractory to CMM provides good value for money. Further research is encouraged in the form of larger, long‐term studies.

Failed back surgery syndrome: current perspectives

“…Although total societal costs increased after SCS placement, the authors concluded that SCS implantation would be cost-effective in 80%–85% when adjusting for quality-adjusted life years. This study underscores the continued costs of untreated FBSS on society as a whole, including loss of productivity, costs associated with disability, emergency room visits, imaging costs, and costs of medications and hospitalizations 64. Future studies include the Prospective, randomized study of multicolumn implantable lead stimulation for predominant low back pain (PROMISE) Study, which is a multicenter, prospective, randomized trial comparing SCS + CMM with CMM alone in patients with FBSS and predominantly lower back pain.…”

“…Metric measures included pain scores, quality of life, functional capacity, and patient satisfaction 63. More recently in the PRECISE Study, Zucco et al64 performed an observational, multicenter, longitudinal ambispective study on 80 patients with FBSS with predominant leg pain refractory to CMM and followed them for up to 24 months after SCS. Although total societal costs increased after SCS placement, the authors concluded that SCS implantation would be cost-effective in 80%–85% when adjusting for quality-adjusted life years.…”

Spinal Cord Stimulation 50 Years Later

“…78 Annemans et al 79 similarly found the ICER/QALY for FBSS to be £3153 with respect to HF-10 therapy. Correspondingly, finding that the EQ-5D utility index increased a mean 0.209 following implementation of SCS in FBSS patients refractory to conventional medical management, Zucco et al 80 quantified the cost of care increased by €7200 per patient-year, suggesting that SCS would be a cost-effective option from a public health perspective.…”

Spinal Cord Stimulation: Clinical Efficacy and Potential Mechanisms

“…7 The condition is believed to be caused by neuropathic back and leg pain, and is associated with high levels of suffering, decreased function, high unemployment rates, and escalating medical costs. [35][36][37] This poorly understood clinical entity lacks good treatment options, and a number of published reports have described studies of SCS in this population (Table 1). 38,39 Numerous early case series and prospective studies showed SCS to be beneficial in this patient population.…”