Clinical and economic outcomes associated with the use of fluticasone propionate 250 mcg and salmeterol 50 mcg combination versus tiotropium bromide 18 mcg as initial maintenance treatment for chronic obstructive pulmonary disease in managed care

Abstract

Aims: To examine the clinical and economic outcomes associated with the use of long-acting bronchodilators for initial maintenance treatment of chronic obstructive pulmonary disease (COPD) by analyzing health insurance claims data in the US.

Methods: A retrospective, observational, matched cohort study used health insurance claims data (January 2008 to June 2013) to assess COPD-related outcomes for subjects aged ≥40 years. Subjects were assigned to a study cohort according to the first observed prescription fill for a long-acting bronchodilator (fluticasone propionate 250 mcg/salmeterol 50 mcg [FSC] or tiotropium bromide 18 mcg [TIO]). The analysis period for each subject comprised a 1-year pre-index date and 1-year post-index date. Primary outcome measure was total COPD-related costs per-patient per-year (PPPY) during the follow-up period. Secondary outcome measures included COPD-related exacerbations and the components of COPD-related costs.

Results: Overall, 24,040 subjects were identified; the analysis sample consisted of 19,090 subjects (9,545 per cohort) with no significant differences between cohorts. Mean COPD-related total costs PPPY were numerically lower among the FSC cohort; however, the difference was not statistically significant ($2,224 [±4,108] vs $2,352 [±3,721], p = .057). There was no difference between cohorts for COPD-related medical costs (p = .894). COPD-related pharmacy costs were significantly, yet modestly, lower in the FSC cohort compared with the TIO cohort ($1,160 [±1,106] vs 1,275 [±1,110], p < .001). There were no statistically significant differences in the rate or number of exacerbations between the matched cohorts.

Limitations: While propensity scoring achieved balance in baseline characteristics, some residual confounding unobserved in the database may be present.

Conclusions: Few clinical and economic differences between subjects initiating maintenance therapy with FSC or TIO were observed.

Keywords:

• Chronic obstructive pulmonary disease (COPD)
• fluticasone propionate
• salmeterol tiotropium bromide
• maintenance treatment naïve COPD
• healthcare claims
• economic burden
• clinical outcomes

JEL classification codes:

• I11
• I12

Transparency

Declaration of funding

This manuscript was funded by GlaxoSmithKline (GSK) (HO-14-14965/201512).

Declaration of financial/other relationships

CFB is an employee of GSK receiving salary, stock, and benefits. ADC, EF, TL, and PL-B are employed by Xcenda LLC, a consulting company that has received a research grant from GSK to conduct this study. A JME peer reviewer on this manuscript declares that they have received research support from GSK for a COPD project not related to any particular medication. A JME peer reviewer on this manuscript declares that they have participated in consulting, advisory boards, speaker panels, and received travel reimbursement from Amphastar, Astra Zeneca, Mylan, Novartis, Oriel, Pearl, Sunovion, Teva, and Theravance. This reviewer has also conducted multi-center clinical research trials for ∼40 pharmaceutical companies. The remaining JME peer reviewers on this manuscript have no relevant financial or other relationships to disclose.

Acknowledgments

Editorial assistance was provided by Katy Tucker at Fishawack Indicia Ltd, UK, and this service was supported by GSK.