A longitudinal, retrospective cohort study on the impact of roflumilast on exacerbations and economic burden among chronic obstructive pulmonary disease patients in the real world

Yin Wan,¹ Shawn X Sun,² Shelby Corman,¹ Xingyue Huang,² Xin Gao,¹ Andrew F Shorr<sup>3

1</sup>Health Economics and Modeling, Outcomes Research, Pharmerit International, Bethesda, MD, USA; ²Health Economics and Outcomes Research, Forest Laboratories, LLC, an affiliate of Actavis, Inc., Jersey City, NJ, USA; ³Pulmonary Critical Care, Washington Hospital Center and Georgetown University, Washington, DC, USA

Background: Roflumilast is approved in the United States to reduce the risk of COPD exacerbations in patients with severe COPD. Exacerbation rates, health care resource utilization (HCRU), and costs were compared between roflumilast patients and those receiving other COPD maintenance drugs.
Methods: LifeLink™ Health Plan Claims Database was used to identify patients diagnosed with COPD who initiated roflumilast (roflumilast group) or ≥3 other COPD maintenance drugs (non-roflumilast group) from May 1, 2011 to December 31, 2012. Patients must have been enrolled for 12 months before (baseline) and 3 months after (postindex) the initiation date, ≥40 years old, not systemic corticosteroid dependent, and without asthma diagnosis at baseline. Difference-in-difference models compared change from baseline in exacerbations, HCRU (office, emergency visits, and hospitalizations), and total costs between groups, adjusting for baseline differences.
Results: A total of 14,211 patients (roflumilast, n=710; non-roflumilast, n=13,501) were included. During follow-up, the rate of overall exacerbations per patient per month decreased by 11.1% in the roflumilast group and increased by 15.9% in the non-roflumilast group (P<0.001). After controlling for baseline differences, roflumilast-treated patients experienced a greater reduction in exacerbations (0.0160 fewer exacerbations per month, P=0.01), numerically greater reductions in hospital admissions (0.003 fewer per month, P=0.57), office visits (0.46 fewer per month, P=0.26), and total costs from baseline compared with non-roflumilast patients ($116 less per month, P=0.62).
Conclusion: In a real-world setting, patients initiating roflumilast experienced reductions in exacerbations versus patients treated with other COPD medications.

Keywords: PDE-4 inhibitor, COPD, outcomes, health care resource utilization