title: Cost-Effectiveness and Cost-Utility Analysis of Spinal Cord Stimulation in Patients With Failed Back Surgery Syndrome: Results From the PRECISE Study.
abstract: OBJECTIVE
  To 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).
  
  
  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), 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.
  
  
  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-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.
  
  
  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.
authors: Azienda Ospedaliera Salvini, Garbagnate Milanese, Italy.
authors: Furio
authors: F
authors: Zucco
authors: Centro di Studio e Ricerca sulla Sanità Pubblica (CESP), Università degli Studi di Milano Bicocca, Monza, Italy.
authors: Roberta
authors: R
authors: Ciampichini
authors: Università Magna Grecia, Catanzaro, Italy.
authors: Angelo
authors: A
authors: Lavano
authors: Ospedale Clinicizzato Ss.Annunziata, Chieti, Italy.
authors: Amedeo
authors: A
authors: Costantini
authors: Università Magna Grecia, Catanzaro, Italy.
authors: Marisa
authors: M
authors: De Rose
authors: Azienda Ospedaliera Universitaria Pisana, Pisa, Italy.
authors: Paolo
authors: P
authors: Poli
authors: Azienda Ospedaliero Universitaria Ospedale di Circolo e Fondazione Macchi, Varese, Italy.
authors: Gianpaolo
authors: G
authors: Fortini
authors: IRCCS Fondazione Salvatore Maugeri, Pavia, Italy.
authors: Laura
authors: L
authors: Demartini
authors: A.O.R.N. "S.G. Moscati,", Avellino, Italy.
authors: Enrico
authors: E
authors: De Simone
authors: Azienda Ospedaliera Santa Croce e Carle di Cuneo, Cuneo, Italy.
authors: Valentino
authors: V
authors: Menardo
authors: Ospedale "S. Maria di Cà Foncello,", Treviso, Italy.
authors: Piero
authors: P
authors: Cisotto
authors: Policlinico Universitario Agostino Gemelli, Roma, Italy.
authors: Mario
authors: M
authors: Meglio
authors: Centro di Studio e Ricerca sulla Sanità Pubblica (CESP), Università degli Studi di Milano Bicocca, Monza, Italy.
authors: Luciana
authors: L
authors: Scalone
authors: Centro di Studio e Ricerca sulla Sanità Pubblica (CESP), Università degli Studi di Milano Bicocca, Monza, Italy.
authors: Lorenzo G
authors: LG
authors: Mantovani
mesh_terms: D000368:Aged; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D003362:Cost-Benefit Analysis; D004185:Disability Evaluation; D055111:Failed Back Surgery Syndrome / Q000209:etiology / Q000523:psychology / Q000628:therapy; D008137:Longitudinal Studies; D011788:Quality of Life; D019057:Quality-Adjusted Life Years; D012189:Retrospective Studies; D012720:Severity of Illness Index; D062187:Spinal Cord Stimulation / Q000191:economics / Q000379:methods; D011795:Surveys and Questionnaires
keywords: Cost-effectiveness; Spinal Cord Stimulation; cost-utility; failed back surgery syndrome; quality adjusted life years