title: Stepping down from high dose fluticasone/salmeterol to extrafine BDP/F in asthma is cost-effective.
abstract: BACKGROUND
  GINA guideline recommends stepping down treatment of asthma patients where control is achieved. The aim of this analysis was to estimate the costs and health outcomes associated with step down of controlled patients on high dose fluticasone/salmeterol (FP/S 1000/100 μg daily) to either medium dose FP/S (500/100 μg) dry powder or extrafine beclometasone/formoterol (BDP/F 400/24 μg) pMDI in three European countries.
  
  
  METHODS
  A patient-level simulation Markov model was constructed to enable the simulation of three comparative arms (FP/S 1000/100, FP/S 500/100, BDP/F 400/24). Transition probabilities and healthcare resources consumption were derived from a multinational clinical trial comparing BDP/F 400/24 μg vs. FP/S 500/100 μg as step down therapy in asthma. Direct costs and health state utilities were sourced from public source and published literature. The analysis was conducted from a health system perspective, based on six months horizon. Probabilistic sensitivity analyses were conducted.
  
  
  RESULTS
  The ICER (Incremental Cost-Effectiveness Ratio) associated with high dose dry powder FP/S 1000/100 μg vs. extrafine BDP/F 400/24 μg was above 70,000 GBP and 200,000 €/QALY (Quality Adjusted Life Years). An ICER of 29,000 GBP/QALY and above 30,000 €/QALY was associated with medium dose dry powder FP/S 500/100 μg vs. BDP/F 400/24 μg.
  
  
  CONCLUSIONS
  It was found that maintaining controlled patients on high dose FP/S is not cost-effective. Extrafine BDP/F 400/24 μg daily can be considered to be a cost-effective option in the countries analyzed to maintain control of asthmatic patients stepped down from high dose FP/S 1000/100 μg daily dry powder or suspension formulations.
authors.affiliation: University of Pisa, Via Paradisa 2, 56124 Pisa, Italy.
authors.forename: Pierluigi
authors.initials: P
authors.lastname: Paggiaro
authors.forename: Shishir
authors.initials: S
authors.lastname: Patel
authors.forename: Gabriele
authors.initials: G
authors.lastname: Nicolini
authors.forename: Lorenzo
authors.initials: L
authors.lastname: Pradelli
authors.forename: Orietta
authors.initials: O
authors.lastname: Zaniolo
authors.forename: Alberto
authors.initials: A
authors.lastname: Papi
mesh_terms: D000420:Albuterol / Q000008:administration & dosage / Q000031:analogs & derivatives* / Q000191:economics / Q000627:therapeutic use; D000730:Androstadienes / Q000008:administration & dosage* / Q000191:economics / Q000627:therapeutic use; D018927:Anti-Asthmatic Agents / Q000008:administration & dosage* / Q000191:economics / Q000627:therapeutic use; D001249:Asthma / Q000188:drug therapy* / Q000191:economics; D001507:Beclomethasone / Q000008:administration & dosage* / Q000191:economics / Q000627:therapeutic use; D003362:Cost-Benefit Analysis; D004305:Dose-Response Relationship, Drug; D004334:Drug Administration Schedule; D004338:Drug Combinations; D016527:Drug Costs / Q000706:statistics & numerical data; D004983:Ethanolamines / Q000008:administration & dosage* / Q000191:economics / Q000627:therapeutic use; D000068297:Fluticasone-Salmeterol Drug Combination; D000068759:Formoterol Fumarate; D017048:Health Care Costs / Q000706:statistics & numerical data; D006801:Humans; D008390:Markov Chains; D017059:Models, Econometric; D009426:Netherlands; D019057:Quality-Adjusted Life Years; D013030:Spain; D006113:United Kingdom
chemical_list: D000730:Androstadienes; D018927:Anti-Asthmatic Agents; D004338:Drug Combinations; D004983:Ethanolamines; D000068297:Fluticasone-Salmeterol Drug Combination; D001507:Beclomethasone; D000420:Albuterol; D000068759:Formoterol Fumarate
keywords: Asthma; Cost-effectiveness; Fixed dose combinations; Stepping down