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采用抗纤维化药物吡非尼酮和尼达尼布治疗特发性肺纤维化患者。

Adoption of the Antifibrotic Medications Pirfenidone and Nintedanib for Patients with Idiopathic Pulmonary Fibrosis.

机构信息

Department of Pulmonary and Critical Care Medicine.

Robert D. and Patricia E. Kern Center for the Science of Health Care Delivery.

出版信息

Ann Am Thorac Soc. 2021 Jul;18(7):1121-1128. doi: 10.1513/AnnalsATS.202007-901OC.

Abstract

In October 2014, the antifibrotic medications pirfenidone and nintedanib became the first medications approved by the U.S. Food and Drug Administration for use in patients with idiopathic pulmonary fibrosis (IPF). Since approval, there has been no nonregistry analysis of the real-world adoption of these medications in everyday clinical practice. To evaluate the adoption, persistence, and out-of-pocket (OOP) costs of pirfenidone and nintedanib since their approval in the United States in 2014. A retrospective cohort analysis was performed by identifying privately insured and Medicare Advantage beneficiaries with IPF. We then split the patients into three cohorts: those who were untreated and those who filled a prescription for either pirfenidone or nintedanib between October 1, 2014, and July 31, 2019. The primary outcome was adoption of the medications. Secondary outcomes included medication persistence and prescription drug costs. A total of 10,996 patients with IPF were identified in the data set. A minority of patients (26.4%) with IPF identified in the cohort had started either medication since approval in 2014, with the adoption of both medications being comparable at around 13.2%. Those receiving the medications were younger (72 vs. 73.9 yr;  < 0.0001) and healthier (3.9 vs. 4.9 comorbidities;  < 0.0001) than those not receiving treatment. Men were significantly more likely to receive treatment than woman (30.0% vs. 21.9%;  < 0.0001). Among treated patients, 42.8% discontinued the medications during the study period. Patients' OOP expenses per month were high for both drugs (mean, $397.51 for nintedanib; mean, $394.49 for pirfenidone). The adoption of both the antifibrotic medications in the United States in everyday practice has been low since approval and may be associated with the high OOP cost.

摘要

2014 年 10 月,抗纤维化药物吡非尼酮和尼达尼布成为美国食品和药物管理局批准用于特发性肺纤维化(IPF)患者的首批药物。自批准以来,尚未有非注册分析评估这两种药物在日常临床实践中的实际应用情况。本研究旨在评估自 2014 年在美国批准以来,吡非尼酮和尼达尼布的采用、持续使用和自付费用(OOP)。通过确定患有 IPF 的私人保险和医疗保险优势受益人群,进行了回顾性队列分析。然后,我们将患者分为三组:未治疗组和在 2014 年 10 月 1 日至 2019 年 7 月 31 日期间开处方使用吡非尼酮或尼达尼布的患者。主要结局是药物的采用情况。次要结局包括药物的持续使用情况和处方药费用。在数据集中共确定了 10996 例 IPF 患者。自 2014 年批准以来,少数(26.4%)患者开始使用任何一种药物,两种药物的采用率相似,约为 13.2%。接受治疗的患者比未接受治疗的患者更年轻(72 岁比 73.9 岁;<0.0001)和健康状况更好(3.9 种共病比 4.9 种共病;<0.0001)。男性接受治疗的可能性明显高于女性(30.0%比 21.9%;<0.0001)。在接受治疗的患者中,42.8%在研究期间停止了用药。两种药物的患者每月 OOP 费用都很高(尼达尼布的平均值为 397.51 美元,吡非尼酮的平均值为 394.49 美元)。自批准以来,这两种抗纤维化药物在美国日常实践中的采用率一直很低,这可能与高 OOP 成本有关。

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