Abstract

Objetive To assess the cost-effectiveness of fixed-dose combinations of long-acting muscarinic antagonist and β2-agonist therapies for chronic obstructive pulmonary disease (COPD) treatment, in Spain. Methods: A Markov model with 5-health states based on severity levels defined by GOLD 2010 criteria was used to simulate in monthly cycles the evolution along a 5-year period of a cohort of moderate-to-severe COPD patients, treated with aclidinium–formoterol (ACL/FF) 400/12µg or tiotropium–olodaterol (TIO/OLO) 5/5µg. Clinical data on lung-function improvements were obtained from a network meta-analysis and applied to mean baseline forced expiratory volume in 1 second (FEV1) for the first 24-weeks period. Natural history for lung-function decline (41ml/year) was applied until the end of simulation. Risk of exacerbation and pneumonia occurrence were considered. Pharmaceutical costs were calculated with authorized dosages and public ex-factory prices. The Spanish national health system perspective was used. The health state-specific disease management and event costs, and utilities were obtained from literature. Total costs (€,2016) and benefits (life year gained [LYG] and quality adjusted life year [QALY]) were discounted (3.0% yearly). Sensitivity analyses (SA) were performed to assess the model uncertainty. Results: Both therapies provided the same health benefits (4,073 LYG and 2,928 QALY) at 5-year period. ACL/FF 400/12µg provided marginally lower costs (€-332) compared to TIO/OLO 5/5µg. SA confirmed the robustness of the results. Conclusion: In this model, ACL/FF was a cost-effective option for treatment of moderate-to-severe COPD patients in Spain, providing equivalent effects and showing a cost-saving compared to TIO/OLO.

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