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与短效重组粒细胞集落刺激因子(G-CSF)参比产品相比,其生物类似药的患者特征及使用模式

Patient Characteristics and Utilization Patterns of Short-Acting Recombinant Granulocyte Colony-Stimulating Factor (G-CSF) Biosimilars Compared to Their Reference Product.

作者信息

Mendelsohn Aaron B, Marshall James, McDermott Cara L, Pawloski Pamala A, Brown Jeffrey S, Lockhart Catherine M

机构信息

Harvard Pilgrim Health Care Institute, Harvard Medical School, Boston, MA, USA.

Biologics and Biosimilars Collective Intelligence Consortium (BBCIC), 675 North Washington Street, Suite 220, Alexandria, VA, USA.

出版信息

Drugs Real World Outcomes. 2021 Jun;8(2):125-130. doi: 10.1007/s40801-021-00228-9. Epub 2021 Jan 30.

DOI:10.1007/s40801-021-00228-9
PMID:33517548
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC7847294/
Abstract

BACKGROUND

Data on short-acting recombinant granulocyte colony-stimulating factor (G-CSF) biosimilar utilization from claims data in the USA are limited.

OBJECTIVE

To evaluate patient baseline characteristics and utilization patterns for short-acting G-CSF products with particular focus on the assessment of filgrastim biosimilar usage relative to the originator product.

PATIENTS AND METHODS

We examined filgrastim, filgrastim-sndz, and tbo-filgrastim use among adult patients between January 2012 and March 2019 across the five health-plan research partners in the BBCIC Distributed Research Network. The publicly available Sentinel System analytic toolkit was used to perform the distributed analyses.

RESULTS

We evaluated over 38 million eligible health-plan members representing more than 88 million person-years of data. We identified 45,204 incident treatment episodes, including 33,118 episodes with filgrastim, 6525 episodes with filgrastim-sndz, and 5,561 episodes with tbo-filgrastim. We observed that the demographic and clinical characteristics of users were comparable across products. While total use of all filgrastim products remained consistent, the proportion of incident episodes of the originator filgrastim steadily decreased since 2014, with filgrastim-sndz and tbo-filgrastim making up the difference. Utilization for the G-CSF biosimilar, filgrastim-sndz, increased from 40 (1%) of 6823 total filgrastim product episodes in 2015, to 2486 (44%) of a total 5668 episodes of filgrastim products in 2018 (partial data for 2018).

CONCLUSION

New episodes of short-acting biosimilar filgrastim products have increased over time while the overall number of new users remained flat. Although barriers to biosimilar use in oncology have been noted, uptake has begun and continues to grow.

摘要

背景

来自美国索赔数据的短效重组粒细胞集落刺激因子(G-CSF)生物类似药使用情况的数据有限。

目的

评估短效G-CSF产品的患者基线特征和使用模式,特别关注与原研产品相比,非格司亭生物类似药的使用情况评估。

患者与方法

我们在BBCIC分布式研究网络的五个健康计划研究合作伙伴中,研究了2012年1月至2019年3月期间成年患者使用非格司亭、聚乙二醇化非格司亭和替培非格司亭的情况。使用公开可用的哨兵系统分析工具包进行分布式分析。

结果

我们评估了超过3800万符合条件的健康计划成员,代表超过8800万人年的数据。我们确定了45204例新治疗 episodes,包括33118例使用非格司亭的 episodes、6525例使用聚乙二醇化非格司亭的 episodes和5561例使用替培非格司亭的 episodes。我们观察到,不同产品使用者的人口统计学和临床特征具有可比性。虽然所有非格司亭产品的总使用量保持一致,但自2014年以来,原研非格司亭新发病例的比例稳步下降,聚乙二醇化非格司亭和替培非格司亭填补了这一差距。G-CSF生物类似药聚乙二醇化非格司亭的使用量从2015年6823例非格司亭产品总 episodes中的40例(1%),增加到了2018年(2018年部分数据)5668例非格司亭产品总 episodes中的2486例(44%)。

结论

随着时间的推移,短效非格司亭生物类似药的新发病例有所增加,而新使用者的总数保持平稳。尽管肿瘤学中使用生物类似药存在障碍,但采用率已经开始并持续增长。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/6898/8128947/3b4311f89645/40801_2021_228_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/6898/8128947/3b4311f89645/40801_2021_228_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/6898/8128947/3b4311f89645/40801_2021_228_Fig1_HTML.jpg

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