OBJECTIVES: Chronic back and leg pain results in patients’ loss of function, reduced QoL and increased societal costs. The objective was to assess health-related QoL (HRQoL) and health resource utilization in failed back surgery syndrome patients. A comparison of spinal cord stimulation plus non-surgical conventional medical management (SCS group) versus non-surgical conventional medical management alone (CMM group) was made from the Spanish National Health System. METHODS: The PROCESS study has been used as data source (Kumar 2007, Manca 2008). 100 patients from 12 European, Canadian and Australian hospitals (1 Spanish: Sant Pau Hospital, Barcelona), were randomised to either the SCS or CMM group. Health care resource consumption data, the implantable generator use in SCS patients, hospital stay, and drug/non-drug pain-related treatment were collected prospectively. Resource consumption costs were obtained from local databases (eSalud and portalfarma databases) using Spanish 2007 figures. HRQoL was assessed using EuroQol-5D (EQ-5D) questionnaire and evaluated with Spanish Time Trade Off tariffs. Both costs and outcomes were assessed for each patient over the first 6-months of the PROCESS trial. RESULTS: The 6-month mean total health care cost in the SCS group (€17,291; SD €4.243) was significantly higher than in the CMM group (€1,433; SD€2,088), with a mean difference of €15,858 (95% CI: 14.548-17.173€). A reduction in drug costs for SCS group was observed. However, the gain in HRQoL with SCS was markedly greater in the SCS group, with a mean EQ-5D score difference of 0,26 (95% CI: 0,14-0,39) and 0,21 (95% CI: 0,08-0,34), respectively at 3- and 6-months. CONCLUSIONS: SCS added to CMM in patients with neuropathic leg and back pain results in higher costs to Spanish National Health System, but also generates important improvements in patients’ EQ-5D in 6-months period. Over time, savings in drug costs might compensate for some of the initial costs of SCS.