Cost-Effectiveness Analysis of a Once-Daily Single-Inhaler Triple Therapy for Patients with Chronic Obstructive Pulmonary Disease (COPD) Using the FULFIL Trial: A Spanish Perspective

• Published in: International journal of chronic obstructive pulmonary disease Vol. 15; pp. 1621 - 1632
• Main Authors: Schroeder, Melanie, Benjamin, Nicole, Atienza, Laura, Biswas, Chandroday, Martin, Alan, Whalen, John D, Izquierdo Alonso, José Luis, Riesco Miranda, Juan Antonio, Soler-Cataluña, Juan José, Huerta, Alicia, Ismaila, Afisi S
• Format: Journal Article
• Language: English
• Published: London Dove Medical Press Limited 01.01.2020; Dove Medical Press Ltd; Dove; Dove Medical Press
• Subjects: Chronic obstructive lung disease; Chronic obstructive pulmonary disease; Clinical trials; Comorbidity; Cost analysis; Cost benefit analysis; cost-utility analysis; Dyspnea; fluticasone furoate; Health care; Health care costs; health-related quality of life; incremental cost-effectiveness ratio; Inhalers; Medical care quality; Medical prognosis; Medical research; Original Research; Patients; Pharmaceutical industry; Population; Quality of life; Questionnaires; Sensitivity analysis; umeclidinium; Vilanterol; United Kingdom; Switzerland; Ireland; Spain
• ISSN: 1178-2005; 1176-9106; 1178-2005
• DOI: 10.2147/COPD.S240556

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[euro]) 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 [euro]69 and gain of 0.107 QALYs, which resulted in an ICER of [euro]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 [euro]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 [euro]30,000 per QALY gained. Conclusion: At the accepted Spanish ICER threshold of [euro]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