The aim of this study was to perform a 1-year trial-based cost-effectiveness analysis (CEA) of tiotropium versus salmeterol followed by a 5-year model-based CEA. The within-trial CEA, including 7250 patients with moderate-to-very severe COPD, was performed alongside the 1-year international, randomized controlled POET-COPD trial comparing tiotropium with salmeterol regarding the effect on exacerbations. Main endpoints of the trial-based analysis were costs, number of exacerbations and exacerbation days. The model-based analysis was conducted to extrapolate results to 5 years and to calculate quality-adjusted life years (QALYs). One-year costs per patient from the German Statutory Health Insurance (SHI) perspective and the societal perspective were €126 (95% uncertainty interval (UI):55-195) and €170 (95% UI: 77-260) higher for tiotropium, respectively. The annual number of exacerbations was 0.064 (95% UI: 0.010-0.118) lower for tiotropium, leading to a reduction in exacerbationrelated costs of €87 (95% UI: 19-157). The incremental cost-effectiveness ratio (ICER) was €1961 per exacerbation avoided from the SHI perspective and €2647 from the societal perspective. In the model-based analyses, the 5-year costs per QALY for the two perspectives were €3488 and €8141, respectively. Tiotropium reduced exacerbations and exacerbation-related costs, but increased total costs. The resulting cost-effectiveness ratios were below commonly accepted willingness-to-pay thresholds.

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Keywords Chronic Obstructive Pulmonary Disease, Quality-adjusted life year, costs, exacerbations, model, trial
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Journal The European Respiratory Journal
Note Included here is the Author manuscript version, which is identical to the VOR offered on the Journal site since June 2012...
Hoogendoorn, M, Al, M.J, Beeh, K-M, Bowles, D.K, Graf von der Schulenburg, J.-M, Lungershausen, J, … Rutten-van Mölken, M.P.M.H. (2013). Cost-effectiveness of tiotropium versus salmeterol: the POET-COPD trial. The European Respiratory Journal, 41(3), 556–564. doi:10.1183/09031936.00027212