Abstract

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. 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 FEV1 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. 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. 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.

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