title: Cost-effectiveness of budesonide/formoterol for maintenance and reliever asthma therapy.
abstract: BACKGROUND
  Budesonide/formoterol (Symbicort) Maintenance and Reliever Therapy (SMART) is an effective asthma-management approach that treats symptoms with rapid increases in budesonide/formoterol. The cost-effectiveness of SMART vs higher fixed-dose budesonide/formoterol or salmeterol/fluticasone is unknown.
  
  
  METHODS
  This 6-month, double-blind study randomized patients with asthma uncontrolled by inhaled corticosteroids alone (n = 3335; age > or =12 years) to budesonide/formoterol 160/4.5 microg b.i.d. plus additional doses as needed (SMART), budesonide/formoterol 320/9 microg b.i.d. plus as-needed terbutaline, or salmeterol/fluticasone 50/250 microg b.i.d. plus as-needed terbutaline. Economic analysis, assuming health care and societal perspectives, applied 2004 UK and Australian unit costs to pooled resource-use data. The effectiveness variable was the rate of severe exacerbations/patient/6 months.
  
  
  RESULTS
  Patients treated using the SMART approach experienced fewer severe exacerbations than fixed-dose budesonide/formoterol and salmeterol/fluticasone patients (0.12 vs 0.16 and 0.19 events/patient/6 months, respectively; P < or = 0.0048). Budesonide/formoterol (Symbicort) Maintenance and Reliever Therapy provided similar improvements in other markers of asthma control at a lower overall daily inhaled corticosteroid dose compared with fixed-dose treatment. Study drug costs accounted for a majority of both direct costs (DC; 78-87%) and total costs (TC; 50-63%) for all treatments, and were significantly lower in the SMART group compared with the fixed-dose groups (P < or = 0.0014). Direct and TC per patient/6 months were lower for SMART vs salmeterol/fluticasone (DC:-AUS$154, P < 0.0001; TC:-AUS$163, P = 0.0036;-87 pound sterling, P = 0.0026) and vs budesonide/formoterol using UK costs (DC:-73 pounds sterling, P < 0.0001; TC:- 91 pounds sterling, P = 0.0014). Costs tended to be lower for SMART vs budesonide/formoterol using Australian costs (DC:-AUS$35, P = 0.16; TC:-AUS$70, P = 0.20). Results were stable under sensitivity testing. Indirect resource use and cost were not significantly different between groups.
  
  
  CONCLUSIONS
  Compared with higher fixed-dose budesonide/formoterol and salmeterol/fluticasone, SMART reduces the incidence of severe exacerbations at a lower or similar overall cost and can be considered a cost-effective treatment regimen.
authors.affiliation: Department of General Practice and Primary Care, University of Aberdeen, Aberdeen AB25 2AY, UK.
authors.forename: D
authors.initials: D
authors.lastname: Price
authors.forename: A
authors.initials: A
authors.lastname: Wirén
authors.forename: P
authors.initials: P
authors.lastname: Kuna
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001249:Asthma / Q000188:drug therapy* / Q000191:economics*; D001315:Australia; D001993:Bronchodilator Agents / Q000191:economics* / Q000627:therapeutic use; D019819:Budesonide / Q000008:administration & dosage / Q000191:economics*; D002648:Child; D017281:Cost of Illness; D003362:Cost-Benefit Analysis; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D004338:Drug Combinations; D016527:Drug Costs; D004359:Drug Therapy, Combination; D017850:Economics, Pharmaceutical; D004983:Ethanolamines / Q000008:administration & dosage / Q000191:economics*; D005260:Female; D000068759:Formoterol Fumarate; D006801:Humans; D008297:Male; D008875:Middle Aged; D006113:United Kingdom
chemical_list: D001993:Bronchodilator Agents; D004338:Drug Combinations; D004983:Ethanolamines; D019819:Budesonide; D000068759:Formoterol Fumarate