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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

Authors Ramos M, Haughney J, Henry N, Lindner L, Lamotte M

Received 24 February 2016

Accepted for publication 29 April 2016

Published 12 September 2016 Volume 2016:8 Pages 445—456


Checked for plagiarism Yes

Review by Single-blind

Peer reviewer comments 2

Editor who approved publication: Professor Giorgio Lorenzo Colombo

Mafalda Ramos,1 John Haughney,2 Nathaniel Henry,3 Leandro Lindner,4 Mark Lamotte1

1Real World Evidence, IMS Health, Zaventem, Belgium; 2Academic Primary Care Division of Applied Health Sciences, University of Aberdeen, Aberdeen, Scotland, 3Health Economics and Outcomes Research, Real World Evidence, IMS Health, London, UK; 4AstraZeneca, Barcelona, Spain

Purpose: Aclidinium–formoterol 400/12 µg is a long-acting muscarinic antagonist (LAMA) and a long-acting β2-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 (FEV1), risk of exacerbation, FEV1 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.

Keywords: cost-effectiveness, Scotland, Markov model, lung-function improvement, LABA, LAMA

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