Abstract

To assess the cost-effectiveness of once-daily umeclidinium bromide/vilanterol (UMEC/VI) 62.5/25 mcg versus once-daily tiotropium/olodaterol (TIO/OLO) 5/5 mcg in symptomatic patients with chronic obstructive pulmonary disease (COPD) from a Spanish National Health Service perspective. A linked-equation cohort model was implemented to estimate COPD progression, associated healthcare costs, exacerbation rates, survival, and quality-adjusted life-years (QALYs). Statistical risk equations for clinical endpoints were derived from the ECLIPSE study (Exuzides A, et al. Med Decis Making 2017;37:453-68), and a health state approach was used to calculate costs. Utilities needed for QALYs calculation were estimated from patient baseline characteristics, using a regression fit to Spanish observational data. St George’s Respiratory Questionnaire (SGRQ)-based utilities were tested in a sensitivity analysis. Change from baseline in forced expiratory volume in 1 second (FEV1) was obtained from an 8-week head-to-head crossover study and was included as the main treatment effect in the model: +52 mL (95% confidence interval: 28–77) (Feldman G, et al. Adv Ther. 2017;34:2518-33). Baseline characteristics were sourced from Spanish-specific literature or the head-to-head study if unavailable. Direct healthcare costs (2017 EUR) were obtained from Spanish sources, including exacerbation, COPD management, and pharmacological treatment costs. Costs and benefits were discounted at 3%. Step-up therapy was included for patients deemed to fail current treatment. Over a 3-year time horizon, patients receiving UMEC/VI were predicted to gain QALYs (+0.029) against cost savings of €393/patient. Probabilistic and scenario analyses showed that variation in the main parameters and assumptions did not alter the results; in one-way sensitivity analysis, the results were most sensitive to FEV1 treatment effect. All (100%) probabilistic simulations showed UMEC/VI to be less costly and more effective than TIO/OLO. Treatment with UMEC/VI dominated (less costly and more effective) treatment with TIO/OLO in patients with symptomatic moderate COPD in Spain. Funding: GlaxoSmithKline (study HO-17-17500).

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