Abstract

To assess the cost-effectiveness of once-daily fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI) 100/62.5/25μg compared with once-daily dual bronchodilator therapy of umeclidinium/vilanterol (UMEC/VI) 62.5/25μg for symptomatic COPD patients with a history of exacerbations, from a Spanish National Healthcare System (NHS) perspective. A published and externally validated linked risk-equation cohort model (GALAXY; Briggs, et al. Med Decis Making;37(4):469-80) was implemented to predict COPD progression, associated healthcare costs, quality-adjusted life-years (QALYs) and the ICER of FF/UMEC/VI vs UMEC/VI over a three-year time-horizon. The base-case analysis was performed with 52-week intent-to-treat efficacy results from the IMPACT trial (NCT02164513) applied for the entire time-horizon. Spanish COPD population baseline characteristics were taken from available literature and the IMPACT study data and validated by Spanish clinical experts. Utility values for calculating QALYs were estimated from patient baseline characteristics using a regression-equation obtained based on Spanish observational data. Direct healthcare costs (€, 2019) including treatment acquisition costs, exacerbation and COPD management costs, were informed by Spanish public sources. A 3% discount rate for costs and effects was applied. Scenario, one-way and probabilistic sensitivity analyses (PSA) were performed. Over a three-year time-horizon, patients receiving FF/UMEC/VI were predicted to gain +0.054 additional QALYs against cost-savings of €450 per patient compared with UMEC/VI, resulting in a dominant treatment strategy (less costly and more effective). Across scenario and sensitivity analyses, FF/UMEC/VI was also dominant in most cases, with all remaining being cost-effective with an ICER below the Spanish accepted threshold of €30,000 per QALY gained. Results were most sensitive to changes in the exacerbation treatment effect, duration of treatment effect and time-horizon. PSA showed FF/UMEC/VI being dominant vs UMEC/VI in 100% of simulations. FF/UMEC/VI was a less costly and more effective (dominant) treatment strategy compared with UMEC/VI for symptomatic COPD patients with a history of exacerbations within the Spanish NHS.

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