OBJECTIVES: Umeclidinium/vilanterol (UMEC/VI) is a novel fixed dose combination of a long acting muscarinic (LAMA) and a long acting beta agonist (LABA) agents. The objective of this analysis was to evaluate the incremental cost-effectiveness ratio (ICER) of UMEC/VI compared with Tiotropium (TIO), from the Spanish National Health System (NHS) perspective. METHODS: A previously published linked equations cohort model based on the epidemiological longitudinal study ECLIPSE was used. Patients included were COPD patients with a post-bronchodilator forced expiratory volume in one second (FEV1) <70% and presence of respiratory symptoms measured with the mMRC dyspnoea scale (mMRC >2). Treatment effect, expressed as change FEV1 from baseline, was estimated from a 24 week-head-to-head phase III clinical trial comparing UMEC/VI with TIO and was assumed to last 52 weeks following treatment initiation (maximum duration of UMEC/VI clinical trials). Spanish utility values were derived from a published local observational study. Unitary healthcare costs (€2015) were obtained from local sources. A 3-year time horizon was selected and 3% discount was applied to effects and costs. Results were expressed as cost/quality adjusted life years (QALY). Univariate and probabilistic sensitivity analysis (PSA) were performed. RESULTS: UMEC/VI produced additional 0.03 QALY and 590€ versus TIO, leading to an ICER of 21,475€/QALY. According to PSA, the probability of UMEC/VI being cost-effective was 80.3% at a willingness-to-pay of 30,000€/QALY. CONCLUSIONS: UMEC/VI could be considered as a cost-effective treatment alternative compared with TIO in symptomatic COPD patients from the Spanish NHS perspective.