Cost versus utility of aclidinium bromide 400 µg plus formoterol fumarate dihydrate 12 µg compared to aclidinium bromide 400 µg alone in the management of moderate-to-severe COPD

PURPOSE: Aclidinium–formoterol 400/12 µg is a long-acting muscarinic antagonist (LAMA) and a long-acting β(2)-agonist in a fixed-dose combination used in the management of patients with COPD. This study aimed to assess the cost-effectiveness of aclidinium–formoterol 400/12 µg against the long-acting muscarinic antagonist aclidinium bromide 400 µg. MATERIALS AND METHODS: A five-health-state Markov transition model with monthly cycles was developed using MS Excel to simulate patients with moderate-to-severe COPD and their initial lung-function improvement following treatment with aclidinium–formoterol 400/12 µg or aclidinium 400 µg. Health states were based on severity levels defined by Global Initiative for Chronic Obstructive Lung Disease 2010 criteria. The analysis was a head-to-head comparison without step-up therapy, from the NHS Scotland perspective, over a 5-year time horizon. Clinical data on initial lung-function improvement were provided by a pooled analysis of the ACLIFORM and AUGMENT trials. Management, event costs, and utilities were health state-specific. Costs and effects were discounted at an annual rate of 3.5%. The outcome of the analysis was expressed as cost (UK£) per quality-adjusted life-year (QALY) gained. The analysis included one way and probabilistic sensitivity analyses to investigate the impact of parameter uncertainty on model outputs. RESULTS: Aclidinium–formoterol 400/12 µg provided marginally higher costs (£41) and more QALYs (0.014), resulting in an incremental cost-effectiveness ratio of £2,976/QALY. Sensitivity analyses indicated that results were robust to key parameter variations, and the main drivers were: mean baseline forced expiratory volume in 1 second (FEV(1)), risk of exacerbation, FEV(1) improvement from aclidinium–formoterol 400/12 µg, and lung-function decline. The probability of aclidinium–formoterol 400/12 µg being cost-effective (using a willingness-to-pay threshold of £20,000/QALY) versus aclidinium 400 µg was 79%. CONCLUSION: In Scotland, aclidinium–formoterol 400/12 µg can be considered a cost-effective treatment option compared to aclidinium 400 µg alone in patients with moderate-to-severe COPD.