OBJECTIVES: To evaluate the cost-effectiveness of once-daily fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI) 92/55/22µg compared with twice-daily budesonide/formoterol (BUD/FOR) 320/9µg among patients with symptomatic COPD at risk of exacerbations from the Spanish National Healthcare System (NHS) perspective.

METHODS: The validated GALAXY COPD disease progression model used linked risk equations to predict healthcare costs, quality adjusted life years (QALYs) and incremental cost-effectiveness ratios (ICER), over a three-year time horizon. Baseline characteristics for the Spanish population were extracted from the literature and FULFIL study (NCT02345161), which compared FF/UMEC/VI with BUD/FOR, in patients with COPD. Treatment effects were based on the FULFIL intent-to-treat 24-week data at incremental FEV of 171mL. For the base case, the duration of treatment effect was set to 3 years. Direct healthcare costs (€, 2018) of treatments, exacerbations and COPD management were informed by Spanish public sources and published literature. A 3% discount rate for costs and benefits was applied. One-way and probabilistic (PSA) sensitivity analyses were performed.

RESULTS: Compared with BUD/FOR, FF/UMEC/VI treatment resulted in fewer moderate and severe exacerbations (2.206 and 0.322 vs 1.794 and 0.191) and a mean (95% CI) incremental cost and health benefit of €739 (€348, €1,091) and 0.1 (0.08, 0.12) QALYs, resulting in an ICER of €7,387 per QALY gained. The ICER was most sensitive to size of exacerbation treatment effect, duration of treatment effect, varying value (±20%) of resource use/event cost inputs, and time horizon. In the PSA, in 95% of 1000 simulations, the ICER fell between €3,336 and €12,176 for FF/UMEC/VI versus BUD/FOR, confirming robustness of the results. The probability of FF/UMEC/VI being cost-effective against BUD/FOR was 100% above a willingness-to-pay threshold of €14,000 per QALY gained.

CONCLUSIONS: According to the accepted ICER threshold of €30,000 in Spain, FF/UMEC/VI was a cost-effective treatment option when compared with BUD/FOR, across all scenarios and sensitivity analyses.