Outcomes Following Initiation of Triple Therapy with Fluticasone Furoate/Umeclidinium/Vilanterol versus Multiple-Inhaler Triple Therapy Among Medicare Advantage with Part D Beneficiaries and Those Commercially Enrolled for Health Care Insurance in the United States

Abstract

Purpose

Patients with chronic obstructive pulmonary disease (COPD) have been shown to benefit from triple therapy commonly delivered by multiple-inhaler triple therapy (MITT); however, the complexity of MITT regimens may decrease patient adherence. Fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI), a once-daily single-inhaler triple therapy (SITT), became available in the United States (US) in 2017, but real-world data comparing outcomes for SITT versus MITT are currently limited. This study compared outcomes among patients with COPD initiating MITT versus SITT with FF/UMEC/VI who were either Medicare Advantage with Part D (MAPD) beneficiaries or commercial enrollees in the US.

Methods

Retrospective study using administrative claims data from the Optum Research Database for patients with COPD who initiated FF/UMEC/VI or MITT between September 1, 2017, and March 31, 2019 (index date: first pharmacy claim for FF/UMEC/VI cohort; earliest day of ≥30 consecutive days-long period of overlap in the day’s supply of all triple therapy components for MITT cohort). COPD exacerbations, adherence to triple therapy, and all-cause and COPD-related health care resource utilization (HCRU) and costs were compared between FF/UMEC/VI and MITT initiators.

Results

In total, 4659 FF/UMEC/VI initiators and 9845 MITT initiators for the MAPD population, and 821 FF/UMEC/VI initiators and 1893 MITT initiators for the commercial population were included in the study. MAPD beneficiaries initiating FF/UMEC/VI had a significantly lower annual rate of severe exacerbations compared to MITT initiators (0.26 vs 0.29; p=0.014). They also had a significantly higher mean adherence (proportion of days covered) (0.51 vs 0.37; p<0.001) and significantly lower all-cause and COPD-related inpatient stays compared to MITT initiators ([32.02% vs 34.27%; p=0.017], [16.09% vs 17.72%; p=0.037]). Trends were similar among the commercial population, but the results were not statistically significant.

Conclusion

FF/UMEC/VI initiators had significantly fewer severe exacerbations, higher triple therapy adherence, and lower HCRU costs compared to MITT initiators for MAPD beneficiaries.

Plain language summary

Triple therapy for chronic obstructive pulmonary disease (COPD) includes the use of several inhalers daily in a respiratory therapy combination known as multiple-inhaler triple therapy (MITT), which can be challenging for patients. However, treatment can be simplified by combining these therapies into just one inhaler, in a respiratory therapy combination known as single-inhaler triple therapy (SITT). As there is currently limited information comparing treatment outcomes in patients using SITT versus those using MITT in the real world, in this study we included Medicare Advantage with Part D (MAPD) beneficiaries and commercial enrollees with COPD who started using either an SITT combination of fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI) or MITT. More specifically, we looked at flare-ups in COPD symptoms (known as exacerbations), percentage of days that a patient had their medication on hand (known as treatment adherence), and health care utilization and costs. The study was conducted using administrative claims data between September 1, 2016, and March 31, 2020 from the Optum Research Database. For patients who had MAPD insurance, individuals who started FF/UMEC/VI experienced fewer severe exacerbations and increased treatment adherence, as compared to those who started MITT. They also had lower health care utilization and costs compared to those using MITT. Similar results were observed for patients who were commercially enrolled, albeit lacking statistical significance. Overall, the findings of this study indicate that triple therapy with FF/UMEC/VI can improve exacerbations and treatment adherence in patients with COPD and decrease health care utilization and associated costs.

Keywords:

• chronic obstructive pulmonary disease
• triple therapy
• multiple-inhaler triple therapy
• single-inhaler triple therapy
• adherence
• exacerbations

Abbreviations

COPD, chronic obstructive pulmonary disease; ER, emergency room; FF/UMEC/VI, fluticasone furoate/umeclidinium/vilanterol; HCRU, health care resource utilization; ICS, inhaled corticosteroid; IP, inpatient; LABA, long-acting beta-agonist; LAMA, long-acting muscarinic antagonist; MAPD, Medicare Advantage with Part D; MITT, multiple-inhaler triple therapy; OP, outpatient; ORD, Optum Research Database; PDC, proportion of days covered; SABA, short-acting beta-agonist; SAMA, short-acting muscarinic antagonist; SD, standard deviation; SITT, single-inhaler triple therapy; US, United States.

Data Sharing Statement

The datasets generated during and/or analyzed during the current study are contained in a database owned by Optum^® and are not publicly available and therefore cannot be broadly disclosed or made publicly available at this time. The disclosure of these data to third-party clients assumes certain data security and privacy protocols are in place, and that the third-party client has executed Optum’s standard license agreement which includes restrictive covenants governing the use of the data.

Ethics Approval and Informed Consent

As this was an analysis of claims data, institutional review board (IRB) approval was not required. Per Title 45 of CFR, Part 46 (https://www.hhs.gov/ohrp/regulations-and-policy/regulations/45-cfr-46/index.html), the administrative claims data analysis of our study was exempt from the IRB review as it was a retrospective analysis of existing data (hence no patient intervention or interaction), and no patient-identifiable information was included in the claims dataset.

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 Mirela Panea of Apollo, OPEN Health Communications, and was funded by GSK. The authors would like to thank Felix Cao, Scott Li, Yiyu Fang, Damon Van Voorhis, Lynn Wacha, and Andrea Steffens of Optum, for dataset programming support, as well as Stephanie Curran, of Optum, for project management.

These data have been previously presented in abstract/poster form at the American Thoracic Society International Conference, May 14–19, 2021: Bogart M, Bunner SH, Johnson MG, Bengtson LGS. Benefits of Initiating Single-Inhaler Triple Therapy (SITT) with Fluticasone Furoate/Umeclidinium/Vilanterol (FF/UMEC/VI) Versus Multiple-Inhaler Triple Therapy (MITT) Among Medicare Advantage with Part D Beneficiaries with Chronic Obstructive Pulmonary Disease (COPD). B39. COPD MANAGEMENT: FROM PHARMACOLOGIC TREATMENT TO NOVEL THERAPIES.

Author Contributions

All authors made a significant contribution to the work reported, whether that was in the conception, study design, execution, acquisition of data, analysis and interpretation, or in all of these areas; took part in drafting, revising, or critically reviewing the manuscript; 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 was an employee of GSK and held stock/shares in GSK at the time of the study conduct. KKD is an employee of GSK and holds stock/shares in GSK. LGSB, MGJ, NNG, and SHB are/were employees of Optum, which received research funds from GSK to conduct this study. Current affiliation details for MB: Gilead Sciences, Foster City, CA, USA. Current affiliation details for LGSB: Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, CT, USA (Boehringer Ingelheim has no connection to this study). Current affiliation details for SHB: Genesis Research, Hoboken, NJ, USA.

Additional information

Funding

This study was funded by GSK (study numbers 214316 and 214318) The sponsor was involved in study conception and design, and the decision to submit the article for publication. The sponsor was also given the opportunity to review the manuscript for medical and scientific accuracy as well as intellectual property considerations.