title: An economic evaluation of budesonide/formoterol for maintenance and reliever treatment in asthma in general practice.
abstract: BACKGROUND
  In budesonide/formoterol (Symbicort(R) Turbuhaler(R), AstraZeneca, Lund, Sweden) maintenance and reliever therapy (SMART), patients with asthma take a daily maintenance dose of budesonide/formoterol, with the option of taking additional doses for symptom relief instead of a short-acting beta(2)-agonist (SABA). This study assesses the cost-effectiveness of SMART compared with usual care in patients with mild-to-moderate persistent asthma treated by general practitioners in the Netherlands from a societal perspective.
  
  
  METHODS
  The study was linked to a randomized, active-controlled, open-label, multicenter, 12-month clinical trial, with a prospective collection of resource use. One hundred and two patients > or =18 years with mild-to-moderate persistent asthma and daily inhaled corticosteroids (ICS) prior to the trial were included. SMART was given as two inhalations of budesonide/formoterol (100/6 microg) once daily, plus additional doses as needed. The control group was treated according to guidelines, which prescribe medium daily doses of ICS plus an SABA if needed. A long-acting beta(2)-agonist (LABA) is added if necessary. Effectiveness was measured as the proportion of asthma-control days, Asthma Control Questionnaire (ACQ) scores, the net proportion of patients with relevant ACQ improvement, and the proportion of well-controlled patients. Costs included asthma medication, physician contacts, and absence from work.
  
  
  RESULTS
  Mean total costs for SMART were <euro>134.81 lower (95% CI: -<euro>439.48; <euro>44.85). Production losses were <euro>94.10 (95% CI: -<euro>300.60; <euro>0.29) lower for SMART (<euro>10.77 vs. <euro>104.87). No significant differences in health outcomes were seen, with 3.81 fewer asthma-control days per patient-year for SMART (95% CI: -36.8; 30.8), a 0.049 better ACQ score (95% CI: -0.21; 0.29), a 5.8% larger net proportion of improved patients (95% CI: t15.6%; 27.3%), and a 2.1% (95% CI: -25.5; 20.8%) smaller increase in the proportion of well-controlled patients.
  
  
  CONCLUSIONS
  Treating primary care patients with mild-to-moderate persistent asthma with SMART instead of ICS plus bronchodilators does not affect health outcomes and does not increase costs; therefore, is likely to be an alternative for guideline-directed treatment, from a health and economic perspective.
authors.affiliation: Institute for Medical Technology Assessment, Erasmus University Medical Center, DR Rotterdam, The Netherlands. goossens@bmg.eur.nl
authors.forename: Lucas M A
authors.initials: LM
authors.lastname: Goossens
authors.forename: Roland A
authors.initials: RA
authors.lastname: Riemersma
authors.forename: Dirkje S
authors.initials: DS
authors.lastname: Postma
authors.forename: Thys
authors.initials: T
authors.lastname: van der Molen
authors.forename: Maureen P M H
authors.initials: MP
authors.lastname: Rutten-van Mölken
mesh_terms: D000305:Adrenal Cortex Hormones / Q000008:administration & dosage / Q000191:economics*; D000328:Adult; D018927:Anti-Asthmatic Agents / Q000008:administration & dosage / Q000191:economics*; D001249:Asthma / Q000188:drug therapy* / Q000191:economics*; D019819:Budesonide / Q000008:administration & dosage / Q000191:economics*; D000069502:Budesonide, Formoterol Fumarate Drug Combination; D016022:Case-Control Studies; D017281:Cost of Illness; D003362:Cost-Benefit Analysis; D004338:Drug Combinations; D016527:Drug Costs; D004983:Ethanolamines / Q000008:administration & dosage / Q000191:economics*; D005260:Female; D017048:Health Care Costs; D006801:Humans; D008297:Male; D017059:Models, Econometric; D009426:Netherlands; D016032:Randomized Controlled Trials as Topic; D012044:Regression Analysis; D016896:Treatment Outcome
chemical_list: D000305:Adrenal Cortex Hormones; D018927:Anti-Asthmatic Agents; D000069502:Budesonide, Formoterol Fumarate Drug Combination; D004338:Drug Combinations; D004983:Ethanolamines; D019819:Budesonide