The effect of delaying initiation with umeclidinium/vilanterol in patients with COPD: an observational administrative claims database analysis using marginal structural models.
| Title: | The effect of delaying initiation with umeclidinium/vilanterol in patients with COPD: an observational administrative claims database analysis using marginal structural models. |
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| Authors: | Buikema AR; 1Health Economics and Outcomes Research, Optum, 11000 Optum Circle, Eden Prairie, MN 55344 USA.; Brekke L; 1Health Economics and Outcomes Research, Optum, 11000 Optum Circle, Eden Prairie, MN 55344 USA.; Anderson A; 1Health Economics and Outcomes Research, Optum, 11000 Optum Circle, Eden Prairie, MN 55344 USA.; Koep E; 1Health Economics and Outcomes Research, Optum, 11000 Optum Circle, Eden Prairie, MN 55344 USA.; Van Voorhis D; 1Health Economics and Outcomes Research, Optum, 11000 Optum Circle, Eden Prairie, MN 55344 USA.; Sharpsten L; 1Health Economics and Outcomes Research, Optum, 11000 Optum Circle, Eden Prairie, MN 55344 USA.; Hahn B; 2US Value Evidence and Outcomes, GSK, 5 Moore Drive, Research Triangle Park, NC 27709-3398 USA.; Ray R; 3US Medical Affairs, GSK, 5 Moore Drive, Research Triangle Park, NC 27709-3398 USA.; Stanford RH; 2US Value Evidence and Outcomes, GSK, 5 Moore Drive, Research Triangle Park, NC 27709-3398 USA. |
| Source: | Multidisciplinary respiratory medicine [Multidiscip Respir Med] 2018 Oct 11; Vol. 13, pp. 38. Date of Electronic Publication: 2018 Oct 11 (Print Publication: 2018). |
| Publication Type: | Journal Article |
| Language: | English |
| Journal Info: | Publisher: Mattioli1885 Country of Publication: Italy NLM ID: 101477642 Publication Model: eCollection Cited Medium: Print ISSN: 1828-695X (Print) Linking ISSN: 1828695X NLM ISO Abbreviation: Multidiscip Respir Med Subsets: PubMed not MEDLINE |
| Imprint Name(s): | Publication: 2024- : Fidenza, Italy : Mattioli1885; Original Publication: Borgomanero : Novamedia |
| 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 |
| Competing Interests: | This study utilized de-identified retrospective claims data, and as such, this study does not require institutional review board (IRB) review and approval or informed consent procedures. This study is in scope for GlaxoSmithKline (GSK)‘s policy 408 for reporting and disclosure.Not applicable.BH, RR, and RHS are employees of GSK and hold stocks/shares in GSK. ARB, LB, AA, EK, DVV, and LS are employees of Optum, which was contracted by GSK to conduct the study. Employees of Optum were not paid for manuscript development.Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations. |
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| Contributed Indexing: | Keywords: COPD; Costs; Exacerbation; Marginal structural model; Time-varying confounding; Umeclidinium/vilanterol |
| Entry Date(s): | Date Created: 20181020 Latest Revision: 20240402 |
| Update Code: | 20260130 |
| PubMed Central ID: | PMC6180385 |
| DOI: | 10.1186/s40248-018-0151-6 |
| PMID: | 30338068 |
| Database: | MEDLINE |
Journal Article