| Summary: | Melanie Schroeder,1 Nicole Benjamin,2 Laura Atienza,3 Chandroday Biswas,4 Alan Martin,5 John D Whalen,6 José Luis Izquierdo Alonso,7 Juan Antonio Riesco Miranda,8 Juan José Soler-Cataluña,9 Alicia Huerta,3 Afisi S Ismaila10,11 1Value Evidence and Outcomes, GlaxoSmithKline plc., Brentford, UK; 2Global Health Economics, ICON plc., Boston, MA, USA; 3Market Access, GlaxoSmithKline SA, Madrid, Spain; 4Global Health Economics, ICON plc., Bengaluru, Karnataka, India; 5Value Evidence and Outcomes, GlaxoSmithKline plc., Uxbridge, UK; 6Global Health Economics, ICON plc., Abingdon, UK; 7Pneumology, Hospital Universitario de Guadalajara, Guadalajara, Spain; 8Centro de Investigación Biomédica en Red de Enfermedades Respiratorias (CIBERES), Servicio de Neumología, Hospital San Pedro de Alcántara, Cáceres, Spain; 9Pneumology Department, Hospital Arnau de Vilanova-Lliria (Valencia), Valencia, Spain; 10Value Evidence and Outcomes, GlaxoSmithKline plc., Collegeville, PA, USA; 11Department of Health Research Methods, Evidence and Impact, McMaster University, Hamilton, ON, CanadaCorrespondence: Afisi S IsmailaGlaxoSmithKline Plc., 1250 South Collegeville Road, Collegeville, PA 19426-0989, USATel +1 (919) 315 8229Email afisi.s.ismaila@gsk.comPurpose: 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.Keywords: cost-utility analysis, health-related quality of life, incremental cost-effectiveness ratio, fluticasone furoate, vilanterol, umeclidinium
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