title: Cost effectiveness of adding budesonide/formoterol to tiotropium in COPD in four Nordic countries.
abstract: OBJECTIVE
  Assess the cost effectiveness of budesonide/formoterol (BUD/FORM) Turbuhaler(®)+tiotropium (TIO) HandiHaler(®) vs. placebo (PBO)+TIO in patients with chronic obstructive pulmonary disease (COPD) eligible for inhaled corticosteroids/long-acting β2-agonists (ICS/LABA).
  
  
  METHODS
  The cost-effectiveness analysis was based on the 12-week, randomised, double-blind CLIMB trial. The study included 659 patients with pre-bronchodilator forced expiratory volume in 1 s ≤ 50% and ≥1 exacerbation requiring systemic glucocorticosteroids or antibiotics the preceding year. Patients received BUD/FORM 320/9 μg bid + TIO 18 μg qd or PBO bid + TIO 18 μg qd. Effectiveness was defined as the number of severe exacerbations (hospitalisation/emergency room visit/systemic glucocorticosteroids) avoided. A sub-analysis included antibiotics in the definition of an exacerbation. Resource use from CLIMB was combined with Danish (DKK), Finnish (€), Norwegian (NOK) and Swedish (SEK) unit costs (2010). The incremental cost-effectiveness ratios (ICERs) for BUD/FORM + TIO vs. PBO + TIO were estimated using descriptive statistics and uncertainty around estimates using bootstrapping. Analyses were conducted from the societal and healthcare perspectives in Denmark, Finland, Norway and Sweden.
  
  
  RESULTS
  From a societal perspective, the ICER was estimated at €174/severe exacerbation avoided in Finland while BUD/FORM + TIO was dominant in the other countries. From the healthcare perspective, ICERs were DKK 1580 (€212), €307 and SEK 1573 (€165) per severe exacerbation avoided for Denmark, Finland and Sweden, respectively, while BUD/FORM + TIO was dominant in Norway. Including antibiotics decreased ICERs by 8-15%. Sensitivity analyses showed that results were overall robust.
  
  
  CONCLUSIONS
  BUD/FORM + TIO represents a clinical and economic benefit to health systems and society for the treatment of COPD in the Nordic countries. (ClinicalTrials.gov Identifier: NCT00496470).
authors.affiliation: Institute of Medicine, University of Bergen, Jonas Lies vei 65, N-5021 Bergen, Norway; Department of Thoracic Medicine, Haukeland University Hospital, Jonas Lies vei 65, N-5021 Bergen, Norway. Electronic address: rune.nielsen@med.uib.no.
authors.forename: Rune
authors.initials: R
authors.lastname: Nielsen
authors.forename: Hannu
authors.initials: H
authors.lastname: Kankaanranta
authors.forename: Leif
authors.initials: L
authors.lastname: Bjermer
authors.forename: Peter
authors.initials: P
authors.lastname: Lange
authors.forename: Sofie
authors.initials: S
authors.lastname: Arnetorp
authors.forename: Morten
authors.initials: M
authors.lastname: Hedegaard
authors.forename: Anna
authors.initials: A
authors.lastname: Stenling
authors.forename: Nicole
authors.initials: N
authors.lastname: Mittmann
mesh_terms: D058666:Adrenergic beta-2 Receptor Agonists / Q000191:economics / Q000627:therapeutic use; D000328:Adult; D000368:Aged; D001993:Bronchodilator Agents / Q000191:economics / Q000627:therapeutic use*; D019819:Budesonide / Q000191:economics / Q000627:therapeutic use*; D017281:Cost of Illness; D003362:Cost-Benefit Analysis; D004311:Double-Blind Method; D004338:Drug Combinations; D016527:Drug Costs / Q000706:statistics & numerical data; D004359:Drug Therapy, Combination; D004983:Ethanolamines / Q000191:economics / Q000627:therapeutic use*; D000068759:Formoterol Fumarate; D005938:Glucocorticoids / Q000191:economics / Q000627:therapeutic use; D017048:Health Care Costs / Q000706:statistics & numerical data*; D006295:Health Resources / Q000706:statistics & numerical data; D006801:Humans; D008875:Middle Aged; D029424:Pulmonary Disease, Chronic Obstructive / Q000188:drug therapy* / Q000191:economics; D012537:Scandinavian and Nordic Countries; D012602:Scopolamine Derivatives / Q000191:economics / Q000627:therapeutic use*; D018582:Sick Leave / Q000706:statistics & numerical data; D000069447:Tiotropium Bromide; D016896:Treatment Outcome
chemical_list: D058666:Adrenergic beta-2 Receptor Agonists; D001993:Bronchodilator Agents; D004338:Drug Combinations; D004983:Ethanolamines; D005938:Glucocorticoids; D012602:Scopolamine Derivatives; D019819:Budesonide; D000068759:Formoterol Fumarate; D000069447:Tiotropium Bromide
keywords: Budesonide/formoterol; COPD; Cost effectiveness; Nordic; Tiotropium