title: Tiotropium's cost-effectiveness for the treatment of COPD: a cost-utility analysis under real-world conditions.
abstract: BACKGROUND
  Tiotropium is reimbursed since March 2004 in Belgium for the treatment of Chronic Obstructive Pulmonary Disease (COPD). Questions however remain on this product's value for money. The purpose of this study is to calculate tiotropium's cost-effectiveness under real-world conditions.
  
  
  METHODS
  Strengths of both observational and RCT data were combined in a model. A large longitudinal (2002-2006) observational dataset of regular tiotropium users (56,321 patients) was analysed to retrieve the baseline risk for exacerbations and exacerbation-related hospitalisations the year before the first delivery of tiotropium. The relative treatment effect from the UPLIFT (Understanding Potential Long-term Impacts on Function with Tiotropium) trial was then applied to this baseline risk to reflect the effect of tiotropium treatment and calculate the intervention's incremental cost-effectiveness ratio (ICER).
  
  
  RESULTS
  After 1000 Latin Hypercube simulations, the incremental benefit expressed as quality-adjusted life years (QALY) gained is on average 0.00048 (95% confidence interval (CI) 0.00009-0.00092). In combination with a substantial mean incremental cost of €373 per patient (95% CI 279-475), this results in an unfavourable average ICER of €1,244,023 (95% CI 328,571-4,712,704) per QALY gained. Results were most sensitive to the treatment effect on hospitalisations. Based on our large observational database, up to 89% of the patients were not hospitalised for COPD in the year before the first tiotropium delivery.
  
  
  CONCLUSIONS
  The main cause for tiotropium's unfavourable cost-effectiveness ratio is a combination of a relative high price for tiotropium, a low number of hospitalisations without tiotropium treatment (on average 0.14/year) and a non-significant treatment effect (on average 0.94) with respect to avoiding exacerbation-related hospitalisations. From an economic point of view, a revision of reimbursement modalities (e.g. with a lower price) would be justified and would entail a more efficient use of resources.
authors.affiliation: Belgian Health Care Knowledge Centre (KCE), Brussels, Belgium. mattias.neyt@kce.fgov.be
authors.forename: Mattias
authors.initials: M
authors.lastname: Neyt
authors.forename: Stephan
authors.initials: S
authors.lastname: Devriese
authors.forename: Nancy
authors.initials: N
authors.lastname: Thiry
authors.forename: Ann
authors.initials: A
authors.lastname: Van den Bruel
mesh_terms: D000368:Aged; D001530:Belgium; D001993:Bronchodilator Agents / Q000191:economics* / Q000627:therapeutic use; D016001:Confidence Intervals; D003362:Cost-Benefit Analysis / Q000379:methods; D005260:Female; D006760:Hospitalization / Q000191:economics; D006801:Humans; D007349:Insurance, Health, Reimbursement / Q000191:economics; D008297:Male; D029424:Pulmonary Disease, Chronic Obstructive / Q000188:drug therapy / Q000191:economics*; D019057:Quality-Adjusted Life Years; D012602:Scopolamine Derivatives / Q000191:economics* / Q000627:therapeutic use; D000069447:Tiotropium Bromide
chemical_list: D001993:Bronchodilator Agents; D012602:Scopolamine Derivatives; D000069447:Tiotropium Bromide