Author(s)
Paly V1, Vallejo-Aparicio LA2, Schroeder M3, Martin A4, Izquierdo Alonso JL5, Riesco Miranda JA6, Soler Cataluña JJ7, Risebrough N8, Abreu C9, Biswas C10, Ismaila AS11
1ICON plc., Philadelphia, PA, USA, 2GlaxoSmithKline S.A., Madrid, Spain, 3GlaxoSmithKline plc., Brentford, UK, 4GlaxoSmithKline plc., Uxbridge, UK, 5Hospital Universitario de Guadalajara, Guadalajara, Spain, 6Hospital San Pedro de Alcántara, Cáceres, Spain, 7Hospital Arnau de Vilanova, Valencia, Spain, 8ICON plc., Toronto, ON, Canada, 9ICON plc., New York, NY, USA, 10ICON plc., Bangalore, India, 11GlaxoSmithKline plc., Collegeville, PA, USA
OBJECTIVES : To evaluate the cost-effectiveness of once-daily fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI) 100/62.5/25µg compared with once-daily FF/VI 100/25μg for patients with symptomatic chronic obstructive pulmonary disease (COPD) and a history of exacerbations from the Spanish National Healthcare System (NHS) perspective. METHODS : A validated COPD disease progression model (GALAXY, Briggs, 2017 Med Decis Making 37:4) used linked risk equations to predict healthcare costs, quality-adjusted life years (QALYs) and incremental cost-effectiveness ratios (ICER). Baseline characteristics for the Spanish population were extracted from the IMPACT study (NCT02164513) and published literature and were validated by clinical experts. Treatment effects and medication use were based on the IMPACT intent-to-treat population. For the base case, the time horizon and duration of treatment effect were 3 years. Direct healthcare costs (€, 2019) 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. Scenario, one-way and probabilistic sensitivity analyses (PSA) were performed. RESULTS : Treatment with FF/UMEC/VI, compared with FF/VI, resulted in fewer moderate and severe exacerbations (3.061 and 0.587 versus 3.481 and 0.650, respectively). FF/UMEC/VI was estimated to have incremental costs of €444 and incremental QALYs of 0.064, resulting in an ICER of €6,887 per QALY. The results were most sensitive to changes in the relative risk of exacerbation, duration of treatment effect, and time horizon; however, in all scenarios and sensitivity analyses ICERs remained below €30,000 per QALY. In PSA, the probability of FF/UMEC/VI being cost-effective vs FF/VI was 100% at a cost-effectiveness threshold of €30,000 per QALY. CONCLUSIONS : Within the Spanish NHS setting, treatment with FF/UMEC/VI was predicted to improve health outcomes and be highly cost-effective versus FF/VI, at the accepted willingness to pay threshold of €30,000, for the treatment of patients with symptomatic COPD and a history of exacerbations.