title: Budget impact analysis of a fixed-dose combination of fluticasone propionate and formoterol fumarate (FP/FORM) in a pressurized metered-dose inhaler (pMDI) for asthma.
abstract: BACKGROUND
  The economic burden of asthma on the UK National Health Service (NHS) is the largest among allergic diseases. Current asthma guidelines recommend adding a long acting β2-agonist (LABA) to a low-dose inhaled corticosteroid (ICS) in patients who are on ICS monotherapy and have uncontrolled asthma. The fixed-dose combination of fluticasone propionate and salmeterol xinafoate (FP/SAL), available in a pressurized metered-dose inhaler (pMDI) device, is the most commonly prescribed ICS/LABA combination. An additional fixed-dose combination of fluticasone propionate and formoterol fumarate (FP/FORM) in pMDI is now available. In a 12-week non-inferiority study, FP/FORM demonstrated comparable efficacy to FP/SAL. The present analysis estimates the annual budget impact for the UK NHS using FP/FORM as an alternative to FP/SAL.
  
  
  METHODS
  Current pMDI prescribing data were from a real-world UK patient database (Cegedim Strategic Data). Annual costs to the NHS for drug acquisition, administration, and monitoring were estimated for FP/FORM and FP/SAL and used to assess the potential budget impact for the NHS for the use of FP/FORM instead of FP/SAL. Varying rates of uptake, adherence, adverse event-related costs, and resource use associated with switching treatment were assessed in scenario analyses.
  
  
  RESULTS
  Assuming similar levels of ICS use with both regimens, annual drug acquisition costs per person were lower with FP/FORM (£412) than with FP/SAL (£509). The difference in acquisition costs and otherwise comparable input costs between the treatments, results in potential annual savings of £15,110,279 to the NHS, assuming uptake of FP/FORM over FP/SAL in 50% of existing patients. The introduction of FP/FORM results in cost savings for the NHS in all of the assessed scenario analyses.
  
  
  CONCLUSIONS
  The comparable efficacy and lower acquisition costs of FP/FORM compared with FP/SAL make it a cost-saving option for the UK NHS for the treatment of asthma patients requiring combination maintenance therapy using a pMDI.
authors.affiliation: Mundipharma International Limited, Unit 194 Cambridge Science Park, Milton Road, Cambridge, CB4 0GW, UK, will.dunlop@mundipharma.co.uk.
authors.forename: William
authors.initials: W
authors.lastname: Dunlop
authors.forename: Louise
authors.initials: L
authors.lastname: Heron
authors.forename: Georgia
authors.initials: G
authors.lastname: Fox
authors.forename: Maire
authors.initials: M
authors.lastname: Greaney
mesh_terms: D000730:Androstadienes / Q000191:economics* / Q000627:therapeutic use; D018927:Anti-Asthmatic Agents / Q000191:economics* / Q000627:therapeutic use; D001249:Asthma / Q000188:drug therapy / Q000191:economics*; D003362:Cost-Benefit Analysis; D004338:Drug Combinations; D016527:Drug Costs; D057915:Drug Substitution / Q000191:economics; D004983:Ethanolamines / Q000191:economics* / Q000627:therapeutic use; D000068298:Fluticasone; D000068759:Formoterol Fumarate; D006801:Humans; D036501:Metered Dose Inhalers / Q000191:economics; D013222:State Medicine / Q000191:economics*; D006113:United Kingdom
chemical_list: D000730:Androstadienes; D018927:Anti-Asthmatic Agents; D004338:Drug Combinations; D004983:Ethanolamines; C586520:fluticasone-formoterol; D000068298:Fluticasone; D000068759:Formoterol Fumarate