title: [Cost-effectiveness analysis of Belimumab in patients with systemic lupus erythematosus in Spain].
abstract: OBJECTIVE
  To estimate the cost-effectiveness of belimumab in patients with systemic lupus erythematosus (SLE) presenting positive biomarkers and active disease despite standard treatment (ST), from the Spanish social perspective.
  
  
  METHODS
  A microsimulation model was used to estimate the cost-effectiveness of belimumab plus ST versus ST alone. A treatment duration of two years with a life-time horizon were considered. Efficacy data were obtained from belimumab clinical trials and the evolution of the disease was simulated from John Hopkins ´ patient cohort data in the United States. Utility data were obtained from literature review. Direct and indirect costs were calculated based on Spanish published data (€, 2014), applying a discount rate (DR) of 3% to both costs and effects. Results were expressed as incremental cost-effectiveness ratio (ICER) in terms of gained life years (LY) and quality of life adjusted life years (QALYs). Probabilistic (PSA) and deterministic sensitivity analyses (DR of 0% and 5%, 5-years treatment duration and excluding indirect costs) were performed to determine the robustness of the model.
  
  
  RESULTS
  The incremental cost-effectiveness ratio (ICER) was 16,647€ per life year gained, with an incremental cost-utility ratio (ICUR) of 23,158€ per additional QALY gained. In 68% of the scenarios simulated in the PSA, belimumab was found to be a cost-effective alternative, considering a threshold of 30,000€/ QALY.
  
  
  CONCLUSIONS
  Belimumab can be regarded as a cost-effective alternative from the Spanish social perspective.
authors.affiliation: Departamento de Evaluación de Medicamentos, GSK España, Tres Cantos.. silvia.c.diaz@gsk.com.
authors.forename: Silvia
authors.initials: S
authors.lastname: Díaz-Cerezo
authors.affiliation: Hospital Virgen de la Salud, Toledo. España.. silvia.c.diaz@gsk.com.
authors.forename: Ángel María
authors.initials: ÁM
authors.lastname: García-Aparicio
authors.affiliation: Departamento de Evaluación de Medicamentos, GSK España, Tres Cantos.. silvia.c.diaz@gsk.com.
authors.forename: Javier
authors.initials: J
authors.lastname: Parrondo
authors.affiliation: Departamento de Evaluación de Medicamentos, GSK España, Tres Cantos.. silvia.c.diaz@gsk.com.
authors.forename: Laura Amanda
authors.initials: LA
authors.lastname: Vallejo-Aparicio
mesh_terms: D000368:Aged; D061067:Antibodies, Monoclonal, Humanized / Q000191:economics* / Q000627:therapeutic use*; D003362:Cost-Benefit Analysis; D016527:Drug Costs; D005260:Female; D006801:Humans; D007166:Immunosuppressive Agents / Q000191:economics* / Q000627:therapeutic use*; D008180:Lupus Erythematosus, Systemic / Q000188:drug therapy* / Q000191:economics*; D008297:Male; D008875:Middle Aged; D019057:Quality-Adjusted Life Years; D013030:Spain
chemical_list: D061067:Antibodies, Monoclonal, Humanized; D007166:Immunosuppressive Agents; C511911:belimumab