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Cost-effectiveness of roflumilast as an add-on to triple inhaled therapy versus triple inhaled therapy in patients with severe and very severe COPD associated with chronic bronchitis in the UK



Chris Kiff, Sandrine Ruiz, Nebibe Varol, et al.

Int J Chron Obstruct Pulmon Dis 2018;13:2707–2720
doi: 10.2147/COPD.S167730

Patients with chronic obstructive pulmonary disease (COPD) are prone to disease exacerbations, which can have significant impact on their health. Patients with COPD are commonly treated with triple inhaled therapy, which consists of inhaled corticosteroids (ICS), long-acting beta-2 agonists (LABAs) and long-acting muscarinic antagonists (LAMAs). However, exacerbations can persist despite treatment. Roflumilast is a phosphodiesterase type four inhibitor that can be added to triple inhaled therapy to further reduce the risk of exacerbation.

In this study, researchers assessed the lifetime costs, outcomes and cost-effectiveness of adding roflumilast to triple inhaled therapy (triple inhaled therapy + roflumilast) in patients with severe and very severe COPD (defined as forced expiratory volume in 1 second [FEV1] <50%). The primary endpoint was the reduction in the rate of moderate to severe COPD exacerbations. In addition to severe to very severe COPD, patients included had chronic bronchitis and were documented to have at least two moderate or severe exacerbations in the past year. Data were collected from previous roflumilast trials, REACT and RE2SPOND.

Results demonstrated a non-significant reduction in the rate of moderate or severe exacerbations in patients treated with the triple inhaled therapy + roflumilast compared with those treated with triple inhaled therapy alone. Based on the calculated costs, the triple inhaled therapy + roflumilast group demonstrated an additional 0.14 quality-adjusted life-years (QALYs) at an incremental cost of £3,508, generating a deterministic incremental cost-effectiveness ratio of £24,976.

Researchers concluded that, compared with triple inhaled therapy alone, roflumilast is a cost-effective add-on treatment in patients with severe to very severe COPD, chronic bronchitis and a history of exacerbations. Based on these findings, the National Institute for Health and Care Excellence (NICE) updated its guidance to now recommend the use of roflumilast as an add-on to triple inhaled therapy for patients with severe COPD and a history of ≥2 exacerbations in the previous year despite previous treatment.

This study was funded by AstraZeneca UK Ltd.




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