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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 400/12µg 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

Linda Kemp1, John Haughney2, Neil Barnes3, Erika Sims1, Julie von Ziegenweidt1, Elizabeth V Hillyer1, Amanda J Lee4, Alison Chisholm1, David Price1,21Research in Real Life Ltd, Old Winery Business Park, Cawston, Norwich, UK; 2Centre of Academic Primary Care, University of Aberdeen, Foresterhill Health Centre, Westburn Road, Aberdeen, UK; 3Department of Respiratory Medicine, London Chest Hospital, Bonner Road, London, UK; 4Medical Statistics Team, Section of Population Health, University of Aberdeen, Foresterhill, Aberdeen, UKPurpose: To evaluate and compare real world cost-effectiveness of inhaled corticosteroids (ICS) administered by metered dose inhaler (MDI), breath-actuated MDI (BAI), or dry powder inhaler (DPI) in asthma.Patients and methods: This retrospective database study analyzed the direct health care costs and proportion of patients (aged 5–60 years) achieving asthma control over 1 year in two population groups: those starting ICS (initiation population) and those receiving a first increase in ICS dose (step-up population). Asthma control was defined as no unplanned asthma visits, oral corticosteroids, or antibiotics for lower respiratory infection; outcomes were adjusted for confounding variables. Cost-effectiveness of BAI and DPI were compared with MDI.Results: For the initiation population (n = 56,347), average annual health care costs per person (adjusted results), as compared with MDIs, were £9 higher (95% CI: -1.65 to 19.71) for BAIs and £32 higher (95% CI: 19.51 to 43.66) for DPIs. The probability of BAIs being the dominant strategy (more effective and less costly than MDIs) was 5% and of BAIs being more effective and more costly than MDIs was 94%. DPIs were consistently more effective and more costly than MDIs, with an incremental cost-effectiveness ratio of £1711 (95% CI: 760 to 3,576) per additional controlled patient per year. For the step-up population (n = 9169), mean total health care costs per person, (adjusted) as compared with MDIs, were £1 higher (95% CI: -27.28 to 31.55) for BAIs and £73 higher (95% CI: 44.48 to 103.29) for DPIs. The probability of BAIs being dominant was 48% and of BAIs being more effective but more costly than MDIs was 52%; the probability of DPIs being more effective but more costly than MDIs was 96%.Conclusion: The real world effectiveness of ICS inhalers may vary, and inhaler device selection for patients with asthma should take into consideration not only initial device cost but also the subsequent health care resource costs.Keywords: asthma control, breath-actuated inhaler, dry powder inhaler, metered dose inhaler, incremental cost-effectiveness ratio