1 HealthCore, Wilmington, Delaware.
2 Boehringer Ingelheim Pharmaceuticals, Ridgefield, Connecticut.
J Manag Care Spec Pharm. 2019 Feb;25(2):205-217. doi: 10.18553/jmcp.2019.25.2.205.
Chronic obstructive pulmonary disease (COPD) is a major cause of morbidity and mortality and is associated with substantial economic burden. There is a lack of data regarding COPD outcomes and costs in a real-world setting, particularly by Global Initiative for Chronic Obstructive Lung Disease (GOLD) severity.
To (a) characterize a commercially insured U.S. population with COPD and (b) assess prevalence of exacerbations, health care resource utilization (HCRU), costs, and treatment patterns in a cohort of patients with confirmed COPD, overall and stratified by GOLD stage.
This retrospective observational cohort study used administrative claims data from the HealthCore Integrated Research Database to identify patients with ≥ 1 inpatient, emergency room (ER), or office visit claim for COPD between January 1, 2012, and November 30, 2013, and continuous enrollment for 1 year before and 2 years after the first COPD diagnosis date. Patients with a spirometry claim within 12 months were eligible for medical record abstraction to confirm COPD diagnosis (forced expiratory volume in 1 second [FEV]/forced vital capacity ratio < 0.7) and GOLD 1-4 classification (based on postbronchodilator FEV percent predicted). HCRU, costs, treatment patterns, and rate of moderate/severe exacerbation were identified from diagnosis up to 24 months. Outcomes were analyzed by univariate analysis stratified by GOLD classification. Multivariable analysis was conducted to assess associations between GOLD classification and outcomes of interest.
53,484 patients newly diagnosed with COPD were identified who met initial inclusion criteria: 14,293 (27%) had a qualifying spirometry claim, and 1,505 had confirmed COPD (GOLD 1, 333 [22%]; GOLD 2, 823 [55%]; GOLD 3, 317 [21%]; GOLD 4, 32 [2%]). Patients with greater disease severity had higher rates of moderate/severe COPD exacerbations (GOLD 1 and 2, 40.4 and 48.9 per 100 person-years, respectively; GOLD 3 and 4, 83.6 and 89.1 per 100 person-years, respectively). All-cause and COPD-related inpatient admissions, COPD-related office visits, and COPD-related ER visits were more prevalent with more severe GOLD classification. Mean annual COPD-related medical costs increased with GOLD classification ($5,945 for GOLD 1 patients, $18,070 for GOLD 4). COPD maintenance medication was filled by 42%, 56%, 73%, and 75% of patients in GOLD 1-4 (57% overall), respectively; combination corticosteroid/long-acting beta2-agonist inhalers were the most commonly used medication, regardless of GOLD classification. Patients with more severe disease had greater adherence (range 44%-68% of days covered for GOLD 1-4) and persistence (range 107-209 days for GOLD 1-4).
Trends toward increases in exacerbations, HCRU, and costs were observed as airflow limitation worsened. Adherence and persistence with COPD maintenance therapy was suboptimal even with severe disease.
This study was supported by Boehringer Ingelheim Pharmaceuticals (Ridgefield, CT), which was given the opportunity to review the manuscript for medical and scientific accuracy, as well as intellectual property considerations. Willey and Singer are employees of HealthCore (parent company Anthem), which received funding from Boehringer Ingelheim to complete this study. Wallace and Shinde were employed by HealthCore at the time of this study. Wallace and Singer report stock ownership in Anthem. Napier is an employee of Anthem. Kaila, Bayer, and Shaikh are employees of Boehringer Ingelheim Pharmaceuticsls. Portions of this research were presented at the following conferences: (a) A. Wallace, S. Kaila, V. Zubek, A. Shaikh, M. Shinde, V. Willey, M. Napier, and J. Singer, Healthcare resource utilization, costs, and exacerbation rates in patients with COPD stratified by GOLD airflow limitation classification in a US commercially insured population, presented at AMCP Nexus 2017; October 16-19, 2017; Dallas, TX; and (b) A.E. Wallace, V. Zubek, S. Kaila, A. Shaikh, M. Shinde, V. Willey, M.B. Napier, and J.R. Singer, Real-world treatment patterns among newly diagnosed COPD patients according to GOLD airflow limitation severity classification in a U.S. commercially insured/Medicare Advantage population, presented at CHEST 2017 Annual Meeting; October 28-November 1, 2017; Toronto, Ontario, Canada.
慢性阻塞性肺疾病(COPD)是发病率和死亡率的主要原因,并与大量的经济负担相关。在真实世界环境中,缺乏关于 COPD 结果和成本的数据,特别是按照全球倡议慢性阻塞性肺疾病(GOLD)严重程度划分的数据。
(a)描述美国商业保险人群中患有 COPD 的患者情况,(b)评估在确诊 COPD 患者队列中,总体及按照 GOLD 分期分层,评估加重频率、卫生保健资源利用(HCRU)、成本和治疗模式。
这项回顾性观察性队列研究使用了来自健康核心综合研究数据库的行政索赔数据,以确定在 2012 年 1 月 1 日至 2013 年 11 月 30 日期间至少有一次住院、急诊室(ER)或门诊就诊记录的患者,且在首次 COPD 诊断日期前 1 年和后 2 年内有连续参保记录。在 12 个月内有肺活量计索赔的患者,有资格进行病历摘录以确认 COPD 诊断(第一秒用力呼气量/用力肺活量比<0.7)和 GOLD 1-4 分类(基于支气管扩张剂后 FEV 预测百分比)。从诊断到 24 个月,确定了 HCRU、成本、治疗模式和中度/重度加重的频率。按 GOLD 分类进行单变量分析,对结果进行分层分析。进行多变量分析以评估 GOLD 分类与感兴趣结果之间的关联。
共确定了 53484 名新诊断为 COPD 的患者,符合初始纳入标准:14293 名(27%)有合格的肺活量计索赔,1505 名有确诊的 COPD(GOLD 1,333 名[22%];GOLD 2,823 名[55%];GOLD 3,317 名[21%];GOLD 4,32 名[2%])。疾病严重程度较高的患者有较高的中度/重度 COPD 加重频率(GOLD 1 和 2 分别为 40.4 和 48.9 人年,GOLD 3 和 4 分别为 83.6 和 89.1 人年)。所有原因和 COPD 相关的住院治疗、COPD 相关的门诊就诊和 COPD 相关的 ER 就诊都随着 GOLD 分类的严重程度而增加。按 GOLD 分类,COPD 相关的年度医疗费用也在增加(GOLD 1 患者为 5945 美元,GOLD 4 患者为 18070 美元)。在 GOLD 1-4 中,分别有 42%、56%、73%和 75%的患者(总体为 57%)使用了 COPD 维持药物;无论 GOLD 分类如何,联合皮质激素/长效β2-激动剂吸入剂是最常用的药物。疾病严重程度较高的患者具有更高的依从性(GOLD 1-4 的覆盖率为 44%-68%)和持久性(GOLD 1-4 为 107-209 天)。
随着气流受限的恶化,加重、HCRU 和成本的趋势都在增加。即使病情严重,COPD 维持治疗的依从性和持久性仍然不理想。
这项研究得到了勃林格殷格翰制药公司(康涅狄格州里奇菲尔德)的支持,该公司有机会审查手稿以确保医学和科学准确性以及知识产权考虑。Willey 和 Singer 是健康核心公司(Anthem 的母公司)的员工,该公司获得了勃林格殷格翰制药公司的资助来完成这项研究。Wallace 和 Shinde 在进行这项研究时受雇于 HealthCore。Wallace 和 Singer 报告在 Anthem 拥有股票。Napier 是 Anthem 的员工。Kaila、Bayer 和 Shaikh 是勃林格殷格翰制药公司的员工。该研究的部分内容在以下会议上进行了介绍:(a)A. Wallace、S. Kaila、V. Zubek、A. Shaikh、M. Shinde、V. Willey、M. Napier 和 J. Singer,COPD 患者气流受限分类与美国商业保险人群中的 COPD 患者资源利用、成本和加重率相关,在 AMCP Nexus 2017 上发表;2017 年 10 月 16-19 日;达拉斯,TX;和(b)A.E. Wallace、V. Zubek、S. Kaila、A. Shaikh、M. Shinde、V. Willey、M.B. Napier 和 J.R. Singer,根据 GOLD 气流受限严重程度分类,在新诊断为 COPD 的美国商业保险/医疗保险优势人群中,治疗模式的实际情况,在 CHEST 2017 年年度会议上发表;2017 年 10 月 28-11 月 1 日;多伦多,安大略省,加拿大。