The effect of delaying initiation with umeclidinium/vilanterol in patients with COPD: an observational administrative claims database analysis using marginal structural models

Abstract Background Chronic obstructive pulmonary disease (COPD) is associated with high clinical and economic burden. Optimal pharmacological therapy for COPD aims to reduce symptoms and the frequency and severity of exacerbations. Umeclidinium/vilanterol (UMEC/VI) is an approved combination therap...

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Main Authors: Ami R. Buikema, Lee Brekke, Amy Anderson, Eleena Koep, Damon Van Voorhis, Lucie Sharpsten, Beth Hahn, Riju Ray, Richard H. Stanford
Format: Article
Language:English
Published: Mattioli 1885 2018-10-01
Series:Multidisciplinary Respiratory Medicine
Subjects:
Online Access:http://link.springer.com/article/10.1186/s40248-018-0151-6
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author Ami R. Buikema
Lee Brekke
Amy Anderson
Eleena Koep
Damon Van Voorhis
Lucie Sharpsten
Beth Hahn
Riju Ray
Richard H. Stanford
author_facet Ami R. Buikema
Lee Brekke
Amy Anderson
Eleena Koep
Damon Van Voorhis
Lucie Sharpsten
Beth Hahn
Riju Ray
Richard H. Stanford
author_sort Ami R. Buikema
collection DOAJ
description Abstract Background Chronic obstructive pulmonary disease (COPD) is associated with high clinical and economic burden. Optimal pharmacological therapy for COPD aims to reduce symptoms and the frequency and severity of exacerbations. Umeclidinium/vilanterol (UMEC/VI) is an approved combination therapy for once-daily maintenance treatment of patients with COPD. This study evaluated the impact of delaying UMEC/VI initiation on medical costs and exacerbation risk. Methods A retrospective analysis of patients with COPD who initiated UMEC/VI between 4/28/2014 and 7/31/2016 was conducted using the Optum Research Database. The index date was the first COPD visit after UMEC/VI available on US formulary (Commercial 4/28/2014; Medicare Advantage 1/1/2015). Patients were followed for 12 months post-index, and categorized into 12 cohorts corresponding to month (30-day period) of UMEC/VI initiation (i.e. Months 1–12) post-index. The outcomes studied during the follow up period included COPD-related and all-cause medical costs, and risk of COPD exacerbations. Marginal structural models (MSM) were used to control for time-varying confounding due to changes in treatment and severity during follow up. Results 2,200 patients initiating UMEC/VI were included in the study sample. Patients’ average age was 69.3 years, 49.9% were female and 69.7% were Medicare insured. Following MSM analysis, 12-month adjusted COPD-related medical costs increased by 2.9% (95% confidence interval [CI]: 0.1–5.9%; p = 0.044) for each monthly delay in UMEC/VI initiation, with a 37.4% higher adjusted cost for patients initiating UMEC/VI in Month 12 versus Month 1 ($13,087 vs. $9524). The 12-month adjusted all-cause medical costs increased by 2.8% (95% CI: 0.6–5.2%; p = 0.013) for each monthly delay, with a 36.1% higher adjusted cost for patients initiating UMEC/VI at Month 12 versus Month 1 ($22,766 vs. $16,727). The monthly risk of severe exacerbation was significantly higher in patients who had not yet initiated UMEC/VI than those who had (hazard ratio: 1.74; 95% CI: 1.35–2.23; p < 0.001). Conclusions Prompt use of UMEC/VI following a physician visit for COPD appears to result in economic and clinical benefits, with reductions in medical costs and exacerbation risk. Additional research is warranted to assess the benefits of initiating UMEC/VI as a first-line therapy compared with escalation to UMEC/VI from monotherapies.
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spelling doaj.art-897236101786485a904ae61d6fa152292024-04-28T09:58:40ZengMattioli 1885Multidisciplinary Respiratory Medicine2049-69582018-10-011311910.1186/s40248-018-0151-6The effect of delaying initiation with umeclidinium/vilanterol in patients with COPD: an observational administrative claims database analysis using marginal structural modelsAmi R. Buikema0Lee Brekke1Amy Anderson2Eleena Koep3Damon Van Voorhis4Lucie Sharpsten5Beth Hahn6Riju Ray7Richard H. Stanford8Health Economics and Outcomes Research, OptumHealth Economics and Outcomes Research, OptumHealth Economics and Outcomes Research, OptumHealth Economics and Outcomes Research, OptumHealth Economics and Outcomes Research, OptumHealth Economics and Outcomes Research, OptumUS Value Evidence and Outcomes, GSKUS Medical Affairs, GSKUS Value Evidence and Outcomes, GSKAbstract Background Chronic obstructive pulmonary disease (COPD) is associated with high clinical and economic burden. Optimal pharmacological therapy for COPD aims to reduce symptoms and the frequency and severity of exacerbations. Umeclidinium/vilanterol (UMEC/VI) is an approved combination therapy for once-daily maintenance treatment of patients with COPD. This study evaluated the impact of delaying UMEC/VI initiation on medical costs and exacerbation risk. Methods A retrospective analysis of patients with COPD who initiated UMEC/VI between 4/28/2014 and 7/31/2016 was conducted using the Optum Research Database. The index date was the first COPD visit after UMEC/VI available on US formulary (Commercial 4/28/2014; Medicare Advantage 1/1/2015). Patients were followed for 12 months post-index, and categorized into 12 cohorts corresponding to month (30-day period) of UMEC/VI initiation (i.e. Months 1–12) post-index. The outcomes studied during the follow up period included COPD-related and all-cause medical costs, and risk of COPD exacerbations. Marginal structural models (MSM) were used to control for time-varying confounding due to changes in treatment and severity during follow up. Results 2,200 patients initiating UMEC/VI were included in the study sample. Patients’ average age was 69.3 years, 49.9% were female and 69.7% were Medicare insured. Following MSM analysis, 12-month adjusted COPD-related medical costs increased by 2.9% (95% confidence interval [CI]: 0.1–5.9%; p = 0.044) for each monthly delay in UMEC/VI initiation, with a 37.4% higher adjusted cost for patients initiating UMEC/VI in Month 12 versus Month 1 ($13,087 vs. $9524). The 12-month adjusted all-cause medical costs increased by 2.8% (95% CI: 0.6–5.2%; p = 0.013) for each monthly delay, with a 36.1% higher adjusted cost for patients initiating UMEC/VI at Month 12 versus Month 1 ($22,766 vs. $16,727). The monthly risk of severe exacerbation was significantly higher in patients who had not yet initiated UMEC/VI than those who had (hazard ratio: 1.74; 95% CI: 1.35–2.23; p < 0.001). Conclusions Prompt use of UMEC/VI following a physician visit for COPD appears to result in economic and clinical benefits, with reductions in medical costs and exacerbation risk. Additional research is warranted to assess the benefits of initiating UMEC/VI as a first-line therapy compared with escalation to UMEC/VI from monotherapies.http://link.springer.com/article/10.1186/s40248-018-0151-6COPDUmeclidinium/vilanterolExacerbationCostsTime-varying confoundingMarginal structural model
spellingShingle Ami R. Buikema
Lee Brekke
Amy Anderson
Eleena Koep
Damon Van Voorhis
Lucie Sharpsten
Beth Hahn
Riju Ray
Richard H. Stanford
The effect of delaying initiation with umeclidinium/vilanterol in patients with COPD: an observational administrative claims database analysis using marginal structural models
Multidisciplinary Respiratory Medicine
COPD
Umeclidinium/vilanterol
Exacerbation
Costs
Time-varying confounding
Marginal structural model
title The effect of delaying initiation with umeclidinium/vilanterol in patients with COPD: an observational administrative claims database analysis using marginal structural models
title_full The effect of delaying initiation with umeclidinium/vilanterol in patients with COPD: an observational administrative claims database analysis using marginal structural models
title_fullStr The effect of delaying initiation with umeclidinium/vilanterol in patients with COPD: an observational administrative claims database analysis using marginal structural models
title_full_unstemmed The effect of delaying initiation with umeclidinium/vilanterol in patients with COPD: an observational administrative claims database analysis using marginal structural models
title_short The effect of delaying initiation with umeclidinium/vilanterol in patients with COPD: an observational administrative claims database analysis using marginal structural models
title_sort effect of delaying initiation with umeclidinium vilanterol in patients with copd an observational administrative claims database analysis using marginal structural models
topic COPD
Umeclidinium/vilanterol
Exacerbation
Costs
Time-varying confounding
Marginal structural model
url http://link.springer.com/article/10.1186/s40248-018-0151-6
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