COPD exacerbation costs in the IMPACT study: a within-trial analysis.

OBJECTIVES: Exacerbations account for the greatest proportion of costs associated with chronic obstructive pulmonary disease (COPD). Here we aimed to evaluate, from the US payer perspective, the costs associated with moderate and severe COPD exacerbation events for patients treated with fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI) compared with FF/VI or UMEC/VI. STUDY DESIGN: This post hoc, within-trial economic analysis used data derived from the InforMing the PAthway of COPD Treatment (IMPACT) study (NCT02164513). METHODS: Treatment groups within the IMPACT trial received either triple therapy with FF/UMEC/VI (100/62.5/25 mcg) or dual therapy (FF/VI [100/25 mcg] or UMEC/VI [62.5/25 mcg]). The primary end point for this IMPACT post hoc analysis was cost differences between the treatment arms related to 1-year on-treatment combined moderate and severe COPD exacerbation events. RESULTS: The final study sample for this within-trial analysis consisted of 10,355 patients, 49% of whom experienced an on-treatment moderate or severe exacerbation during the study. The mean 1-year on-treatment cost estimate associated with combined moderate and severe exacerbations was highest with UMEC/VI and lowest with FF/UMEC/VI ($6205 vs $4913, respectively). Mean cost differences were statistically significant for all pairwise comparisons of FF/UMEC/VI with FF/VI or UMEC/VI (-$549 [95% CI, -$565 to -$533] and -$1292 [95% CI, -$1313 to -$1272], respectively; both P <.0001). CONCLUSIONS: Treatment with FF/UMEC/VI compared with FF/VI or UMEC/VI in the US healthcare system resulted in lower exacerbation-related costs for combined moderate/severe exacerbation events, as well as moderate and severe exacerbations separately.

Predictors of Appropriate Pharmacotherapy Management of COPD Exacerbations and Impact on 6-Month Readmission.

BACKGROUND: Suboptimal treatment of exacerbations is a major concern in management of chronic obstructive pulmonary disease (COPD). The Pharmacotherapy Management of COPD Exacerbation (PCE) Healthcare Effectiveness Data and Information Set (HEDIS) measure is a quality measure included by the National Committee for Quality Assurance that focuses on appropriate use of steroids and bronchodilators during an acute COPD exacerbation. There is limited evidence evaluating predictors of this quality measure, as well as its association with hospital readmission and cost outcomes. OBJECTIVES: To (a) describe characteristics of patients hospitalized for COPD, (b) evaluate factors associated with appropriate receipt of pharmacotherapy upon discharge, and (c) evaluate factors associated with the rate of readmission. METHODS: In this retrospective, observational, event-based study of COPD-related hospital and ED visits, events were identified between 2007 and 2013 from a Central Texas health plan using administrative claims data. The index date was defined as the date of admission. Subjects were included if they were aged ≥ 40 years and had a medical claim with a primary diagnosis for COPD or a pharmacy claim for a COPD maintenance medication during the 1-year pre-index period. Study groups were identified based on the receipt of PCE within the time frame specified by HEDIS: (a) a systemic corticosteroid within 14 days of discharge (PCE-C) or (b) a bronchodilator within 30 days of discharge (PCE-D). Bivariate analyses of potential factors associated with the receipt of PCE were performed using t-tests for continuous data and chi-square tests for categorical data. Generalized estimating equations, including significant predictors from the bivariate analyses, were used to determine factors associated with receipt of PCE-C and/or PCE-D, as well association with COPD-related and all-cause readmission within 6 months of discharge. RESULTS: Of 375 identified index admissions, 254 (68%) patients received PCE-C; 299 (80%) received PCE-D; and 229 (61%) received both. Patients were more likely to receive PCE with an index inpatient visit as compared with an ED visit (PCE-C: RR = 2.25, 95% CI = 1.21-4.17, P = 0.010; PCE-D: RR = 1.90, 95% CI = 1.01-3.58, P = 0.048). Those with previous use of rescue medication were also more likely to receive PCE (PCE-C: RR = 1.88, 95% CI = 1.12-3.17, P = 0.018; PCE-D: RR = 2.11, 95% CI = 1.16-3.83, P = 0.014). Patients with greater adherence (proportion of days covered [PDC] ≥ 75%) to COPD maintenance medication before admission (RR = 8.67, 95% CI = 1.60-46.78, P = 0.012) were also more likely to receive PCE-D. Older patients were more likely to have a COPD-related readmission (RR = 1.07, 95% CI = 1.01-1.13, P = 0.028), while use of maintenance medication before admission was associated with lower risk of an all-cause readmission (RR = 0.49, 95% CI = 0.30-0.79, P = 0.004). In addition, patients with higher medical and pharmacy costs before the index event were more likely to have all-cause readmission (RR = 1.01, 95% CI = 1.00-1.02, P = 0.013). Receipt of PCE was not shown to be a significant predictor of all-cause or COPD-related readmission. CONCLUSIONS: The use of bronchodilators and systemic corticosteroids after a COPD-related inpatient or ED visit may be related to the severity of the index COPD exacerbation or patients' previous pattern of bronchodilator use. However, the use of maintenance medication before the index event was associated with a significant reduction in all-cause readmission, so proper treatment of the underlying disease may be an effective strategy in reducing readmission. DISCLOSURES: Funding for this study was provided by GlaxoSmithKline (HO-14-15081). Tran was a Fellow at Scott & White Health Plan (SWHP) during year 1 of this study and a Fellow at Novartis during year 2 of this study. Novartis did not have any input in this study nor did it contribute any funding or support for this research. Tran, Xiang, Godley, and Stock were employed by SWHP at the time of this study. Rascati is employed by the University of Texas at Austin and also by the Journal of Managed Care & Specialty Pharmacy and has received consulting fees from GlaxoSmithKline. Coleman, Bogart, and Stanford are GlaxoSmithKline employees and shareholders. Study design was created by Rascati, Tran, and Godley, with assistance from Stock, Coleman, Bogart, and Stanford. Tran and Xiang collected the data, with data analysis and interpretation performed by Stock and Rascati. The manuscript was written by Tran, Rascati, and Xiang and revised by Godley, Stock, Coleman, Bogart, and Stanford.