Buikema Ami R, Brekke Lee, Anderson Amy, Koep Eleena, Van Voorhis Damon, Sharpsten Lucie, Hahn Beth, Ray Riju, Stanford Richard H
1Health Economics and Outcomes Research, Optum, 11000 Optum Circle, Eden Prairie, MN 55344 USA.
2US Value Evidence and Outcomes, GSK, 5 Moore Drive, Research Triangle Park, NC 27709-3398 USA.
Multidiscip Respir Med. 2018 Oct 11;13:38. doi: 10.1186/s40248-018-0151-6. eCollection 2018.
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.
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.
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%; = 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%; = 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; < 0.001).
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.
慢性阻塞性肺疾病（COPD）具有较高的临床和经济负担。COPD的最佳药物治疗旨在减轻症状以及降低急性加重的频率和严重程度。乌美溴铵/维兰特罗（UMEC/VI）是一种已获批准的联合疗法，用于COPD患者的每日一次维持治疗。本研究评估了延迟启动UMEC/VI对医疗费用和急性加重风险的影响。
利用Optum研究数据库对2014年4月28日至2016年7月31日期间开始使用UMEC/VI的COPD患者进行回顾性分析。索引日期为UMEC/VI在美国药品处方集上可用后的首次COPD就诊日期（商业保险：2014年4月28日；医疗保险优势计划：2015年1月1日）。患者在索引日期后随访12个月，并根据索引日期后启动UMEC/VI的月份（30天时间段）分为12个队列（即第1 - 12个月）。随访期间研究的结局包括COPD相关和全因医疗费用以及COPD急性加重风险。采用边际结构模型（MSM）来控制随访期间因治疗和病情严重程度变化导致的随时间变化的混杂因素。
2200例开始使用UMEC/VI的患者纳入研究样本。患者的平均年龄为69.3岁，49.9%为女性，69.7%有医疗保险。经过MSM分析，UMEC/VI启动每延迟一个月，12个月调整后的COPD相关医疗费用增加2.9%（95%置信区间[CI]：0.1 - 5.9%；P = 0.044），与第1个月开始使用UMEC/VI的患者相比，第12个月开始使用的患者调整后的费用高出37.4%（分别为13,087美元和9524美元）。UMEC/VI启动每延迟一个月，12个月调整后的全因医疗费用增加2.8%（95% CI：0.6 - 5.2%；P = 0.013），第12个月开始使用UMEC/VI的患者与第1个月开始使用的患者相比，调整后的费用高出36.1%（分别为22,766美元和16,727美元）。尚未开始使用UMEC/VI的患者每月发生严重急性加重的风险显著高于已开始使用的患者（风险比：1.74；95% CI：1.35 - 2.23；P < 0.001）。
在因COPD就诊后及时使用UMEC/VI似乎能带来经济和临床益处，可降低医疗费用和急性加重风险。有必要进行更多研究以评估与从单一疗法升级至UMEC/VI相比，将UMEC/VI作为一线疗法启动的益处。
