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Objective  To assess the cost‐effectiveness and cost‐utility of  S pinal  C ord  S timulation ( SCS ) in patients with failed back surgery syndrome ( FBSS ) refractory to conventional medical management ( CMM ).    Materials and Methods  We 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),  H ealth‐ R elated  Q uality‐of‐ L ife ( HRQoL ) and on direct and indirect costs before (pre‐ SCS ) and after (post‐ SCS ) the  SCS  intervention. Costs were quantified in € 2009, adopting the  N ational  H ealth  S ervice'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.    Results  80 patients (40% male, mean age 58 years) were recruited. Between baseline and 24 months post‐ SCS , clinical outcomes and  HRQoL  significantly improved. The  EQ ‐5 D  utility index increased from 0.421 to 0.630 ( p  &lt; 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  Q uality‐ A djusted‐ L ife‐ Y ears ( 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.    Conclusions  Our 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.

neuromodulation: technology at the neural interface

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