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基于全球哮喘倡议严重程度分级的短效支气管扩张剂使用情况和哮喘经济负担:来自美国大型商业和管理型医疗补助人群的见解。

The use of short-acting bronchodilators and cost burden of asthma across Global Initiative for Asthma-based severity levels: Insights from a large US commercial and managed Medicaid population.

机构信息

BioPharmaceuticals Medical - USA, AstraZeneca, Wilmington, DE.

Life Sciences, IBM Watson Health, Cambridge, MA, now with Inovalon, Bowie, MD.

出版信息

J Manag Care Spec Pharm. 2022 Aug;28(8):881-891. doi: 10.18553/jmcp.2022.21498. Epub 2022 Jun 16.

Abstract

Despite the availability of effective treatments, patients with asthma, regardless of severity, remain at risk of severe exacerbations resulting in significant burden to patients, the health care system, and insurance providers. To examine severe exacerbations, treatment patterns, health care resource utilization (HCRU), and costs across all asthma severities. In this retrospective study, patients aged 4 years and older filling 1 short-acting (β-agonist (SABA) and at least 1 maintenance fill or at least 2 SABAs with or without maintenance fills were identified from administrative claims data from the IBM MarketScan Commercial and IBM MarketScan Multistate Medicaid Research databases (January 2010 to December 2017). Patients were indexed on a random SABA fill (2011-2016) and had 12 months of continuous eligibility pre-index and post-index. Patients were classified into Global Initiative for Asthma (GINA) 2018 severity steps and by asthma control, as measured by SABA fill use in the 12 months pre-index: low (1 SABA fill per year), medium (2-3 SABA fills per year), and high (≥ 4 SABA fills per year); well controlled, not well controlled, and very poorly controlled, respectively. Severe asthma exacerbation events, health care costs, and asthma-related HCRU and costs were assessed relative to asthma severity and asthma control post-index. Of 1,005,522 patients, 50.3% filled GINA Step 1; 19.7% GINA Step 2; 10.9% GINA Step 3; and 19.1% GINA Steps 4-5 treatments. Overall, 953,337 severe exacerbation events occurred (approximately 0.95 events per patient), equating to 0.96, 0.67, 0.83, and 1.28 events per patient for patients filling GINA Step 1 through Steps 4-5, respectively. GINA Step 1 had the highest proportion of patients experiencing at least 1 event (57.0%), followed by GINA Steps 4-5 (55.2%), GINA Step 3 (45.0%), and GINA Step 2 (41.9%) treatments ( < 0.05). For GINA Step 1, 64.4% of well-controlled patients experienced at least 1 exacerbation event vs 50.4% of not well-controlled and 53.0% of very poorly controlled patients ( < 0.05). For patients filling GINA Step 2-5 treatments, a greater proportion of very poorly controlled patients experienced at least 1 exacerbation event vs well-controlled patients ( < 0.05). The average total annual health care cost per patient was $7,148 and total annual asthma-related costs were $1,741. Each additional SABA fill was associated with a 26.0%, 10.8%, and 34.6% increase in incidence of total exacerbations, all-cause costs, and asthma-related costs, respectively ( < 0.05). In this real-world database study, increased SABA fills and occurrence of exacerbations were correlated and associated with higher all-cause and asthma-related costs across all severities. New treatment paradigms, particularly for rescue therapies, are warranted to improve clinical and cost outcomes in these patients. This analysis was funded by AstraZeneca. Michael Pollack, Hitesh Gandhi, and Ileen Gilbert are employees and stockholders of AstraZeneca and contributed to the design and conduct of the study. AstraZeneca was given an opportunity to review the final version of the manuscript. At the time of the study, Joseph Tkacz was an employee of IBM Watson Health, which received funding from AstraZeneca to conduct this study. Miguel Lanz has received research funding from AstraZeneca, Optinose, and Regeneron and consulting fees and honoraria from ALK, Amgen, AstraZeneca, Novartis, Sanofi, and Regeneron. Njira Lugogo received consulting fees for advisory board participation from Amgen, AstraZeneca, Genentech, GlaxoSmith-Kline, Novartis, Regeneron, Sanofi, and Teva; honoraria for nonspeaker's bureau presentations from GlaxoSmithKline and AstraZeneca; and travel support from AstraZeneca. Her institution received research support from Amgen, AstraZeneca, Avillion, Gossamer Bio, Genentech, GlaxoSmithKline, Regeneron, Sanofi, and Teva.

摘要

尽管有有效的治疗方法,但哮喘患者无论严重程度如何,仍有发生严重加重的风险,这会给患者、医疗保健系统和保险公司带来重大负担。本研究旨在评估所有哮喘严重程度患者的严重加重、治疗模式、医疗保健资源利用(HCRU)和成本。

在这项回顾性研究中,从 IBM MarketScan 商业和 IBM MarketScan 多州医疗补助研究数据库(2010 年 1 月至 2017 年 12 月)的行政索赔数据中确定了年龄为 4 岁及以上的患者,这些患者在过去 12 个月内至少使用过 1 次短效(β-激动剂(SABA)和至少 1 次维持治疗,或至少 2 次 SABA 联合或不联合维持治疗。患者在随机 SABA 填充索引(2011-2016)上,并在索引前和索引后有 12 个月的连续资格。患者根据全球哮喘倡议(GINA)2018 严重程度步骤和 SABA 填充使用情况在索引前 12 个月内进行分类:低(每年 1 次 SABA 填充)、中(每年 2-3 次 SABA 填充)和高(每年≥4 次 SABA 填充);分别为控制良好、控制不佳和控制极差。评估了严重哮喘加重事件、医疗保健成本以及与哮喘严重程度和哮喘控制相关的 HCRU 和成本。

在 1005522 名患者中,50.3%的患者接受 GINA 第 1 步治疗;19.7%的患者接受 GINA 第 2 步治疗;10.9%的患者接受 GINA 第 3 步治疗;19.1%的患者接受 GINA 第 4-5 步治疗。总的来说,发生了 953337 次严重加重事件(约每例患者 0.95 次),分别相当于接受 GINA 第 1 步至第 4-5 步治疗的患者中,每年发生 0.96、0.67、0.83 和 1.28 次事件。GINA 第 1 步治疗的患者中至少有 1 次加重事件的比例最高(57.0%),其次是 GINA 第 4-5 步治疗(55.2%)、GINA 第 3 步治疗(45.0%)和 GINA 第 2 步治疗(41.9%)(<0.05)。在 GINA 第 1 步治疗的患者中,64.4%的控制良好患者发生了至少 1 次加重事件,而控制不佳患者为 50.4%,控制极差患者为 53.0%(<0.05)。在接受 GINA 第 2-5 步治疗的患者中,控制极差患者发生至少 1 次加重事件的比例明显高于控制良好患者(<0.05)。每位患者的平均年总医疗保健成本为 7148 美元,哮喘相关总成本为 1741 美元。每次额外的 SABA 填充与总加重事件、全因成本和哮喘相关成本的发生率分别增加 26.0%、10.8%和 34.6%(<0.05)。在这项真实世界的数据库研究中,SABA 填充量的增加和加重事件的发生与所有严重程度的全因和哮喘相关成本的增加相关。需要新的治疗模式,特别是对救援疗法的治疗模式,以改善这些患者的临床和成本结果。这项分析得到了阿斯利康的资助。Michael Pollack、Hitesh Gandhi 和 Ileen Gilbert 是阿斯利康的员工和股东,他们为研究的设计和实施做出了贡献。阿斯利康有机会审查手稿的最终版本。在研究期间,Joseph Tkacz 是 IBM Watson Health 的员工,该公司接受了阿斯利康的资助,进行了这项研究。Miguel Lanz 从阿斯利康、Optinose 和 Regeneron 获得了研究经费,并因咨询费和演讲费从 ALK、Amgen、阿斯利康、诺华、赛诺菲和再生元获得了报酬。Njira Lugogo 因参与顾问委员会获得了 Amgen、阿斯利康、Genentech、葛兰素史克、诺华、Regeneron、赛诺菲和梯瓦的咨询费;因非发言人局会议的演讲获得了葛兰素史克和阿斯利康的酬金;并因阿斯利康的旅行支持而获得了酬金。她的机构因 Amgen、阿斯利康、Avillion、Gossamer Bio、Genentech、葛兰素史克、Regeneron、赛诺菲和梯瓦的研究获得了研究经费。

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