title: BUDGET IMPACT ANALYSIS OF BELIMUMAB IN TREATING SYSTEMIC LUPUS ERYTHEMATOSUS.
abstract: OBJECTIVE
  The study evaluates the costs of systemic lupus erythematosus (SLE) and the budget impact due to the introduction of belimumab in the Italian setting.
  
  
  METHODS
  Adaptation to the Italian setting of a budget impact model with a time horizon of 4 years (year 0 without belimumab, years 1-3 with belimumab) to compare treatment, administration, and clinical monitoring costs of standard therapy and of the alternative scenario in which belimumab is administered in addition to the standard therapy to the subgroup of patients selected according to the label approved by the European Medicines Agency. The model takes also into account the costs of flares.
  
  
  RESULTS
  Over 3 years, belimumab is able to prevent cumulatively 1,111 severe flares and 3,631 nonsevere flares with a total saving for the Italian National Health System (NHS) of approximately €6.2 million. Budget impact ranges from €4.4 million in the first year to €20.3 million in the third year.
  
  
  CONCLUSIONS
  The decrease in the number of flare partially counterbalances the costs of the new technology (impact attenuation of approximately 16 percent). These data elucidate the importance to control and monitor the disease progression and to prevent exacerbations, which are the major causes of the increase in costs paid by the NHS and by the society. The financial impact could be replicate on a regional basis, to inform local decision makers. Further developments are possible as the model does not consider the additional clinical and economic benefits of reduced damage accrual and slowed disease progression.
authors.affiliation: Institute of Management,Scuola Superiore Sant'Anna.
authors.forename: Francesca
authors.initials: F
authors.lastname: Pierotti
authors.affiliation: Institute of Management,Scuola Superiore Sant'Anna.
authors.forename: Iaria
authors.initials: I
authors.lastname: Palla
authors.affiliation: GlaxoSmithKline.
authors.forename: Lara
authors.initials: L
authors.lastname: Pippo
authors.affiliation: Institute of Management,Scuola Superiore Sant'Anna.
authors.forename: Valentina
authors.initials: V
authors.lastname: Lorenzoni
authors.affiliation: Institute of Management,Scuola Superiore Sant'Annag.turchetti@sssup.it.
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Turchetti
mesh_terms: D061067:Antibodies, Monoclonal, Humanized / Q000191:economics* / Q000627:therapeutic use*; D002017:Budgets; D003362:Cost-Benefit Analysis; D018450:Disease Progression; D006801:Humans; D007166:Immunosuppressive Agents / Q000191:economics* / Q000627:therapeutic use*; D007558:Italy; D008180:Lupus Erythematosus, Systemic / Q000188:drug therapy*; D017059:Models, Econometric; D012720:Severity of Illness Index; D013222:State Medicine / Q000191:economics*
chemical_list: D061067:Antibodies, Monoclonal, Humanized; D007166:Immunosuppressive Agents; C511911:belimumab
keywords: Budget Impact Model (BIM); Systemic lupus erythematosus; flares