Inpatient Admissions and Re-Admissions in Medicare Beneficiaries Initiating Umeclidinium/Vilanterol or Tiotropium Therapy

Abstract

Purpose

Patients with chronic obstructive pulmonary disease (COPD) who are hospitalized are more likely to die from their illness and have increased likelihood of re-admission than those who are not. Subsequent re-admissions further increase the burden on healthcare systems. This study compared inpatient admission rates and time-to-first COPD-related inpatient admission among Medicare beneficiaries with COPD indexed on umeclidinium/vilanterol (UMEC/VI) versus tiotropium (TIO).

Patients and Methods

This retrospective study used the All-Payer Claims Database to investigate hospital admission and re-admission outcomes in Medicare beneficiaries with COPD with an initial pharmacy claim for UMEC/VI or TIO from 1 January 2015 to 28 February 2020. Inpatient admissions, baseline, and follow-up variables were assessed in patients indexed on UMEC/VI and TIO after propensity score matching (PSM), with time-to-first on-treatment COPD-related inpatient admission as the primary endpoint. Re-admissions were assessed among patients with a COPD-related inpatient admission in the 30- and 90-days post-discharge.

Results

Post-PSM, 7152 patients indexed on UMEC/VI and 7069 on TIO were eligible for admissions analysis. The mean (standard deviation [SD]) time-to-first COPD-related inpatient admission was 46.71 (87.99) days for patients indexed on UMEC/VI and 44.96 (85.90) days for those on TIO (p=0.06). The mean (SD) number of inpatient admissions per patient was 1.24 (2.92) for patients indexed on UMEC/VI and 1.26 (3.05) for those on TIO (p=0.49). Proportion of patients undergoing re-admissions was similar between treatments over both 30 and 90 days, excluding a significantly lower proportion of patients indexed on UMEC/VI than those indexed on TIO for COPD-related re-admissions for hospital stays of 4–7 days and 7–14 days, and all-cause re-admissions for stays of 4–7 days.

Conclusion

Patients with COPD using Medicare in the US and receiving UMEC/VI or TIO reported similar time-to-first inpatient admission and similar proportion of re-admissions.

Plain Language Summary

Umeclidinium/vilanterol (UMEC/VI) is associated with improvements in patient outcomes for chronic obstructive pulmonary disease (COPD) versus tiotropium (TIO). Patients with COPD who have hospitalizations have higher healthcare costs and are more likely to be re-hospitalized and die from their illness than those who do not. This study compared hospital admission rates and time to admission among Medicare beneficiaries with COPD treated with UMEC/VI versus TIO.

This study used a medical record database to compare hospital admissions and re-admissions, baseline and follow-up variables were compared in patients prescribed with UMEC/VI and TIO from 1 January 2015 to 28 February 2020. Hospital re-admissions were assessed among patients with a COPD-related inpatient admission in the 30 or 90 days after discharge.

Patients had similar COPD-related hospitalizations and number of hospital admissions per patient regardless of medication. Proportion of patients undergoing re-admissions was similar between treatments, apart from a lower proportion of patients prescribed UMEC/VI than TIO for COPD-related re-admissions for hospital stays of 4–7 and 7–14 days, and all-cause re-admissions for 4–7 days.

Despite expectations that patients receiving UMEC/VI would demonstrate increased time-to-first admission and a lower proportion of re-admissions than those receiving TIO, patients reported similar data irrespective of their prescribed medication. Use of head-to-head comparison with claims data and inability to divide patients based on lung function or clinical symptoms may have decreased chances of detecting any significant difference between the treatments, although these results support current recommendations on use of dual therapy.

Keywords:

• COPD
• initial maintenance therapy
• umeclidinium/vilanterol dual therapy
• tiotropium monotherapy
• hospital admissions
• hospital re-admissions

Abbreviations

APCD, All-Payer Claims Database; ATS, American Thoracic Society; CAT, COPD Assessment test; CCI, Quan Charlson Comorbidity Index; COPD, chronic obstructive pulmonary disease; GOLD, Global Initiative for Chronic Obstructive Lung Disease; HCRU, healthcare resource utilization; ICD-CM, International Classification of Diseases Clinical Modification; ICS, inhaled corticosteroid; IP, inpatient; LABA, long-acting β₂-agonist; LAMA, long-acting muscarinic antagonist; mMRC, modified Medical Research Council dyspnea questionnaire; NAC, N-acetylcysteine; N/A, not applicable; PSM, Propensity Score Matching; SABA, short-acting β₂-agonist; SAMA, short-acting muscarinic antagonist; SD, standard deviation; TIO, tiotropium bromide; UMEC, umeclidinium; US, United States; VI, vilanterol.

Data Sharing Statement

The data analyzed in this publication are derived from the APCD. Authors had access to the study data for the purposes of this work only. Data were accessed through an existing GSK license to address pre-specified research questions only. Therefore, the data cannot be broadly disclosed or made publicly available at this time.

Ethics Approval and Informed Consent

Approval of this study was provided by the GSK Protocol Review Committee, which reviewed the protocol. No personal subject contact or primary collection of individual human data occurred, and anonymized patient-level data were used in this analysis; patient consent was therefore not required.

Acknowledgments

Editorial support (in the form of writing assistance including preparation of the draft manuscript under the direction and guidance of the authors, collating and incorporating authors’ comments for each draft, assembling tables and figures, grammatical editing and referencing) was provided by Christopher Heath, PhD, of Fishawack Indicia Ltd, UK, part of Avalere Health, and was funded by GSK. Michael Bogart was employed at Customer Engagement, Value, Evidence and Outcomes (CEVEO) US Medical Affairs, GSK, Research Triangle Park, NC, USA, at the time of the study; Gary Yat-Hung Leung and Anissa Cyhaniuk were employed at STATinMED Research, Dallas, TX, USA, at the time of the study.

Author Contributions

All authors made a significant contribution to the work reported, whether that is in the conception, study design, execution, acquisition of data, analysis and interpretation, or in all these areas; took part in drafting, revising or critically reviewing the article; gave final approval of the version to be published; have agreed on the journal to which the article has been submitted; and agree to be accountable for all aspects of the work.

Disclosure

MB and KD are employees of GSK and hold stock and shares at GSK or were employees and did hold stock and shares at the time of the study. GL and AC were employees of STATinMED Research at the time of the study, which received funding from GSK to conduct the study. STATinMED Research is a business that provides consulting and other research services to pharmaceutical, device, government, and non-government organizations. STATinMED Research employees work with a variety of companies and organizations and are expressly prohibited from receiving any payment or honoraria directly from these organizations for services rendered.

Additional information

Funding

This study was funded by GSK (GSK study 214310). GSK-affiliated authors had a role in study design, data analysis, data interpretation, and writing of the report and GSK funded the article processing charges and open access fee.