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比较 LAMA+LABA 固定剂量疗法治疗的 COPD 患者的医疗保健利用情况和相关成本。

Comparison of COPD health care utilization and associated costs across patients treated with LAMA+LABA fixed-dose therapies.

机构信息

Boehringer Ingelheim Pharmaceuticals, Ridgefield, CT.

Optum, Eden Prairie, MN.

出版信息

J Manag Care Spec Pharm. 2021 Jul;27(7):810-824. doi: 10.18553/jmcp.2021.20514. Epub 2021 Mar 25.

Abstract

There is limited clinical trial and/or real-world evidence comparing differences among currently approved fixed-dose combination (FDC) long-acting muscarinic antagonist (LAMA)/long-acting beta2-agonist (LABA) treatments. To compare chronic obstructive pulmonary disease (COPD)-related and all-cause health care resource utilization (HCRU) and costs between COPD patients initiating tiotropium (TIO) + olodaterol (OLO) versus (a) other LAMA + LABA FDCs and (b) umeclidinium (UMEC) + vilanterol (VI), specifically. In this retrospective observational study, patients initiating fixed-dose LAMA + LABA therapy (earliest fill date = index date) between January 1, 2014, and September 30, 2018, were identified using administrative claims data from the Optum Research Database. Patients were followed post-index for 1-12 months. Follow-up was censored at the earliest occurrence of index therapy discontinuation or switch, health plan disenrollment, study end date, or reaching the maximum 12-month allowed duration. Propensity score matching of 1:2 was used to balance differences in baseline characteristics between cohorts for each of the 2 comparisons. Annualized population averages of HCRU and costs were calculated for each cohort as [sum of visits (or costs) for all individuals during the follow-up period] ÷ [sum of follow-up on-treatment time for all individuals] × 365 days. After matching, compared with patients who initiated other LAMA + LABAs or UMEC + VI, patients who initiated TIO + OLO had 14.29% and 16.95% fewer mean annualized per-patient COPD-related emergency department (ED) visits (vs. other LAMA + LABAs: 0.49 vs. 0.59, = 0.005; vs. UMEC + VI: 0.48 vs. 0.56, = 0.026) and 3.07% and 3.14% fewer mean annualized per-patient pharmacy fills (vs. other LAMA + LABAs: 12.66 vs. 13.07, = 0.016; vs. UMEC + VI: 12.62 vs. 13.02, = 0.022), leading to 17.39% and 21.47% lower mean annualized per-patient COPD-related ED costs (vs. other LAMA + LABAs: $289 vs. $368, = 0.003; vs. UMEC + VI: $285 vs. $345, = 0.027) and 4.56% and 5.67% lower mean annualized per-patient pharmacy spending (vs. other LAMA + LABAs: $3,570 vs. $3,741, < 0.001; vs. UMEC + VI: $3,556 vs. $3,770, < 0.001) in the follow-up period. Similarly, patients in the TIO + OLO cohort had 15.63% and 21.17% fewer mean annualized per-patient all-cause ED visits (vs. other LAMA + LABAs: 1.08 vs. 1.37, < 0.001; vs. UMEC + VI: 1.08 vs. 1.28, = 0.001), 8.29% fewer mean annualized per-patient outpatient visits (vs. UMEC + VI: 13.28 vs. 14.48, = 0.031), 3.41% fewer mean annualized per-patient pharmacy fills (vs. other LAMA + LABAs: 56.92 vs. 58.93, = 0.028), 19.48% and 22.28% lower mean annualized per-patient all-cause ED costs (vs. other LAMA + LABAs: $755 vs. $971, < 0.001; vs. UMEC + VI: $749 vs. $930, < 0.001), and 10.86% lower mean annualized per-patient outpatient setting costs (vs. UMEC + VI: $3,348 vs. $3,756, = 0.050). There were no statistically significant differences for the other outcome measures. In a real-world setting, differences in HCRU and costs were observed between FDC LAMA + LABAs, with patients initiating TIO + OLO having lower ED visits/costs, COPD-related pharmacy fills/costs, and all-cause pharmacy use and outpatient visits/costs than those initiating other FDC LAMA + LABAs or UMEC + VI specifically. The remaining HCRU and cost measures were not significantly different. This study was sponsored by Boehringer Ingelheim Pharmaceuticals, Inc. (BIPI; Ridgefield, CT). BIPI was given the opportunity to review the manuscript for medical and scientific accuracy, as well as intellectual property considerations. Palli is an employee of BIPI. Xie, Chastek, Elliott, and Bengtson are employees of Optum, which was contracted by BIPI to conduct this study. The authors received no direct compensation related to the development of the manuscript. Part of the results of this study were accepted and presented at the 30th European Respiratory Society (ERS) International Congress (September 7-9, 2020; virtual).

摘要

目前获批的固定剂量复方长效毒蕈碱拮抗剂(LAMA)/长效β2-激动剂(LABA)治疗方案之间的差异,仅有有限的临床试验和/或真实世界证据进行比较。本研究旨在比较慢性阻塞性肺疾病(COPD)相关和全因医疗保健资源利用(HCRU)和成本,比较的对象是起始使用噻托溴铵(TIO)+奥达特罗(OLO)与(a)其他 LAMA+LABA FDC 和(b)乌美溴铵(UMEC)+维兰特罗(VI)的 COPD 患者。这项回顾性观察性研究,从 Optum Research Database 的行政索赔数据中,确定了在 2014 年 1 月 1 日至 2018 年 9 月 30 日期间起始使用固定剂量 LAMA+LABA 治疗的患者(最早用药日期=索引日期)。在索引日期后,对患者进行 1-12 个月的随访。如果出现索引治疗停药或换药、健康计划退保、研究结束日期或达到 12 个月的最大允许期限,即对随访进行截尾。对于每个比较,使用 1:2 的倾向评分匹配来平衡队列之间基线特征的差异。通过以下公式计算每个队列的 HCRU 和成本的年度平均值:[所有个体在随访期间的就诊次数(或费用)总和]÷[所有个体在治疗期间的时间总和]×365 天。匹配后,与起始其他 LAMA+LABA 或 UMEC+VI 的患者相比,起始 TIO+OLO 的患者 COPD 相关急诊就诊次数(vs. 其他 LAMA+LABA:0.49 与 0.59,P=0.005;vs.UMEC+VI:0.48 与 0.56,P=0.026)和药物处方使用次数(vs. 其他 LAMA+LABA:12.66 与 13.07,P=0.016;vs.UMEC+VI:12.62 与 13.02,P=0.022)分别减少了 14.29%和 16.95%,导致 COPD 相关急诊就诊成本(vs. 其他 LAMA+LABA:289 与 368,P=0.003;vs.UMEC+VI:285 与 345,P=0.027)和药物支出(vs. 其他 LAMA+LABA:3570 与 3741,P<0.001;vs.UMEC+VI:3556 与 3770,P<0.001)分别降低了 17.39%和 21.47%。同样,TIO+OLO 组的患者 COPD 相关全因急诊就诊次数(vs. 其他 LAMA+LABA:1.08 与 1.37,P<0.001;vs.UMEC+VI:1.08 与 1.28,P=0.001)、全因门诊就诊次数(vs.UMEC+VI:13.28 与 14.48,P=0.031)和药物处方使用次数(vs. 其他 LAMA+LABA:56.92 与 58.93,P=0.028)分别减少了 15.63%和 21.17%,全因急诊就诊成本(vs. 其他 LAMA+LABA:755 与 971,P<0.001;vs.UMEC+VI:749 与 930,P<0.001)和全因门诊就诊成本(vs.UMEC+VI:3348 与 3756,P=0.050)分别降低了 8.29%和 10.86%。其他结果指标无统计学差异。在真实世界环境中,与 FDC LAMA+LABA 相比,COPD 相关和全因医疗保健资源利用和成本存在差异,起始使用 TIO+OLO 的患者与起始使用其他 FDC LAMA+LABA 或 UMEC+VI 的患者相比,急诊就诊次数/成本、COPD 相关药物处方使用/成本以及全因药物使用和门诊就诊次数/成本更低。其他 HCRU 和成本指标无显著差异。这项研究由勃林格殷格翰公司(Boehringer Ingelheim Pharmaceuticals,Inc.,BIPI)赞助。BIPI 有机会审查手稿的医学和科学准确性以及知识产权考虑因素。Palli 是 BIPI 的员工。Xie、Chastek、Elliott 和 Bengtson 是 Optum 的员工,Optum 受 BIPI 委托开展此项研究。作者没有直接从开发手稿中获得任何直接补偿。该研究的部分结果被接受并在第 30 届欧洲呼吸学会(ERS)国际大会(2020 年 9 月 7 日至 9 日;虚拟会议)上发表。

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