Purpose: To evaluate the cost-effectiveness of once-daily fluticasone furoate/umeclidinium/ vilanterol (FF/UMEC/VI) vs twice-daily budesonide/formoterol (BUD/FOR) in patients with symptomatic chronic obstructive pulmonary disease (COPD) at risk of exacerbations, from the Spanish National Healthcare System perspective. Patients and Methods: The validated GALAXY-COPD model was used to simulate disease progression and predict healthcare costs, quality-adjusted life years (QALYs), and incremental cost-effectiveness ratios (ICERs) over a 3-year time horizon for a Spanish population. Patient characteristics from published literature were supplemented by data from FULFIL (NCT02345161), which compared FF/UMEC/VI vs BUD/FOR in patients with symptomatic COPD at risk of exacerbations. Treatment effects, extrapolated to 3 years, were based on Week 24 results in the FULFIL intent-to-treat population, including change in forced expiratory volume in 1 second, St. George's Respiratory Questionnaire score, and exacerbation rates. Treatment, exacerbations, and COPD management costs (2019€) were informed by Spanish public sources and published literature. A 3% discount rate for costs and benefits was applied. One-way sensitivity and scenario analyses, and probabilistic sensitivity analysis (PSA), were performed. Results: FF/UMEC/VI treatment led to fewer moderate and severe exacerbations (2.126 and 0.306, respectively) vs BUD/FOR (2.608 and 0.515, respectively), with a mean incremental cost of €69 and gain of 0.107 QALYs, which resulted in an ICER of €642 per QALY gained. In sensitivity analyses, the ICER was most sensitive to treatment effect variations in exacerbations and healthcare resource utilization/event costs. Overall, 95% of 1000 PSA simulations resulted in an ICER less than €11,000 per QALY gained for FF/UMEC/VI vs BUD/FOR, confirming robustness of the results. The probability of FF/UMEC/VI being cost-effective vs BUD/FOR was 100% at a willingness-to-pay threshold of €30,000 per QALY gained. Conclusion: At the accepted Spanish ICER threshold of €30,000, FF/UMEC/VI represents a cost-effective treatment option vs BUD/FOR in patients with symptomatic COPD at risk of exacerbations.

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Purpose Given between-country differences in healthcare systems, treatment costs, and disease management guidelines, country-specific cost-effectiveness analyses are important. This study evaluated the cost-effectiveness of once-daily fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI) versus FF/VI and UMEC/VI among patients with symptomatic chronic obstructive pulmonary disease (COPD) at risk of exacerbations from a Spanish healthcare system perspective. Patients and Methods Baseline data and treatment effects from the IMPACT trial were populated into the validated GALAXY COPD progression model. Utilities were estimated using Spanish observational data. Direct healthcare costs (2019 €) were informed by Spanish public sources. A 3% discount rate for costs and benefits was applied. The time horizon and treatment duration were 3 years (base case). One-way sensitivity, scenario, and probabilistic sensitivity analyses were performed. Results FF/UMEC/VI treatment resulted in fewer exacerbations over 3 years (4.130 vs 3.648) versus FF/VI, with a mean (95% confidence interval [CI]) incremental cost of €444 (€149, €713) per patient and benefit of 0.064 (0.053, 0.076) quality-adjusted life years (QALYs), resulting in an incremental cost-effectiveness ratio (ICER) of €6887 per QALY gained. FF/UMEC/VI was a dominant treatment strategy versus UMEC/VI, resulting in fewer exacerbations (4.130 vs 3.360), with a mean (95% CI) incremental cost of –€450 (–€844, –€149) and benefit of 0.054 (0.043, 0.064) QALYs. FF/UMEC/VI was cost-effective versus FF/VI and UMEC/VI across all analyses. Conclusion FF/UMEC/VI was predicted to be a cost-effective treatment option versus FF/VI or UMEC/VI in symptomatic COPD patients at risk of exacerbations in Spain, across all scenarios and sensitivity analyses.

Objectives: Clinical studies of mechanical ventilation (MV) are often small with large uncertainty in outcomes. Meta-analysis provides a method to combine data into a single estimate of efficacy. Meta-analysis of proportional assist ventilation+ (PAV+) versus pressure support ventilation (PSV) was recently undertaken but did not report outcomes relevant to our cost-effectiveness model. A pragmatic meta-analysis was undertaken to provide estimates of efficacy and explore how data sources used impact on outcomes. Methods: A Markov-model of patient care from MV in the intensive care unit (ICU) through to discharge home or death was developed for the Canadian setting. Structured searches identified studies of PAV+ versus PSV that were then subject to meta-analysis. Outcomes of interest were MV/ICU/hospital time, tracheostomy, and ICU/hospital mortality. The model was populated with efficacy inputs from either Canadian trials or meta-analysis estimates. Outcomes were over 20 years, with costs in 2017 CAD with quality-adjusted life years (QALYs) using EQ-5D. Performed sensitivity analyses (n=2,000) used a willingness-to-pay (WTP) threshold of CAD 50,000 per QALY gained. Results: Seven studies comparing PAV+ with PSV were identified, totalling 271 PAV+ patients and 253 PSV patients and meta-analysis included at least 4 studies for each outcome. The cost of care with PSV was CAD 141,003 and 6.07 QALYs were accrued. Using Canadian data, the cost of care with PAV+ was CAD 129,333 and 6.29 QALYs were accrued, making PAV+ dominant. With meta-analysis data, PAV+ cost CAD 147,276 and accrued 6.98 QALYs over the 20 years, meaning it was cost effective at CAD 6,875 per QALY gained. In the Canadian scenario 80% of simulations were under the WTP threshold, compared with 100% when using meta-analysis. Conclusions: In our test, efficacy data from individual trials or meta-analysis substantially changed the numerical results but the interpretation remained largely intact. PAV+ is expected to be cost-effective for MV in Canada.