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

Melanie Schroeder, Nicole Benjamin, Laura Atienza, Chandroday Biswas, Alan Martin, John D Whalen, José Luis Izquierdo Alonso, Juan Antonio Riesco Miranda, Juan José Soler-Cataluña, Alicia Huerta, Afisi S Ismaila, Melanie Schroeder, Nicole Benjamin, Laura Atienza, Chandroday Biswas, Alan Martin, John D Whalen, José Luis Izquierdo Alonso, Juan Antonio Riesco Miranda, Juan José Soler-Cataluña, Alicia Huerta, Afisi S Ismaila

Abstract

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.

Keywords: cost-utility analysis; fluticasone furoate; health-related quality of life; incremental cost-effectiveness ratio; umeclidinium; vilanterol.

Conflict of interest statement

MS, LA, AM, and ASI are employed by GlaxoSmithKline plc.; MS, AM, and ASI hold shares in GlaxoSmithKline plc. ASI is also an unpaid part-time professor at McMaster University, Canada. AH was employed by GlaxoSmithKline plc. and held shares in GlaxoSmithKline plc. at the time of the study. CB, NB and JDW were employees of ICON plc. at the time of the study. ICON is a consulting company that received research funds from GlaxoSmithKline plc. to conduct this study, but they were not paid for development of this manuscript. JLIA reports speaker fees, travel grants, and advisory board fees from AstraZeneca, Bayer, Boehringer Ingelheim, Chiesi, GlaxoSmithKline plc., Menarini, Novartis, Pfizer, Sandoz, and Teva. JARM has received speaker fees, travel grants, and consulting fees from AstraZeneca, Boehringer Ingelheim, Chiesi, Esteve, Ferrer, GlaxoSmithKline plc., Menarini, Novartis, and Pfizer. JJS-C has received speaker fees from AstraZeneca, Boehringer Ingelheim, Chiesi, Esteve, Ferrer, GlaxoSmithKline plc., Merck, Menarini, and Novartis, and consulting fees from Boehringer Ingelheim, GlaxoSmithKline plc., AstraZeneca, Ferrer, and Novartis. Trademarks are the property of their respective owners. The authors report no other conflicts of interest in this work.

© 2020 Schroeder et al.

Figures

Figure 1
Figure 1
Linked-risk equation model. Blue lines indicate the relationship between central attributes in different time periods and orange lines indicate the relationship between intermediate outcomes and exacerbations. Black lines indicate the relationship between the central attributes and the final health outcomes. Notes: *Calculated (in mL) using the risk equation at 1 year and converted to FEV1% predicted based on the cohort profile. Adapted with permission from Briggs AH, Baker T, Risebrough NA, et al, Med Decis Making, 37(4) 469–480. Copyright © 2017, Sage Publishing. Abbreviations: 6MWD, 6-minute walk distance; FEV1, forced expiratory volume in 1 second; LY, life year; QALY, quality-adjusted life year; RU, resource utilization; SGRQ, St. George’s Respiratory Questionnaire.
Figure 2
Figure 2
Deterministic sensitivity analyses for FF/UMEC/VI vs BUD/FOR (Spanish population). Abbreviations: BUD/FOR, budesonide/formoterol; CI, confidence interval; FEV1, forced expiratory volume in 1 second; FF/UMEC/VI, fluticasone furoate/umeclidinium/vilanterol; ICER, incremental cost-effectiveness ratio; QALY, quality-adjusted life year; SGRQ, St. George’s Respiratory Questionnaire.
Figure 3
Figure 3
Probabilistic sensitivity analysis results for FF/UMEC/VI vs BUD/FOR on the incremental cost-effectiveness plane. Abbreviations: BUD/FOR, budesonide/formoterol; FF/UMEC/VI, fluticasone furoate/umeclidinium/vilanterol; QALY, quality-adjusted life year.

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