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聚乙二醇化重组人粒细胞刺激因子生物类似药在美国支持性肿瘤学中的应用:关于给药方案及经济考量以最大化患者获益的叙述性综述

Pegfilgrastim Biosimilars in US Supportive Oncology: A Narrative Review of Administration Options and Economic Considerations to Maximize Patient Benefit.

作者信息

Humphreys Sophia Z, Geller Robert B, Walden Paul

机构信息

Sutter Health, 2200 River Plaza Dr, Sacramento, CA, 95833, USA.

Coherus BioSciences, Redwood City, CA, USA.

出版信息

Oncol Ther. 2022 Dec;10(2):351-361. doi: 10.1007/s40487-022-00207-2. Epub 2022 Sep 16.

Abstract

Granulocyte colony-stimulating factor (G-CSF) biologics, such as pegfilgrastim, are a standard of care in supportive cancer treatment that are administered once per chemotherapy cycle to reduce the incidence of febrile neutropenia. The high cost of these biologics in the United States can be a limiting factor to accessing care; however, lower-cost pegfilgrastim biosimilars have been available for several years for patients requiring prophylaxis of febrile neutropenia. Different options for pegfilgrastim administration are also now available to accommodate specific patient preferences. As patients may want to minimize the risk of both neutropenia and SARS-CoV-2 infection, same-day administration is a pertinent option during the present COVID-19 pandemic. Therefore, individualized, patient-centered approaches and risk-management strategies should be considered when selecting the treatment and administration method for prophylaxis of febrile neutropenia. Three methods of administration would minimize hospital or clinic visits while also providing the prophylactic effect of G-CSF: same-day administration after chemotherapy, use of the US Food and Drug Administration-approved on-body injector delivering pegfilgrastim approximately 27 h after chemotherapy, or self-administration by the patient or caregiver > 24 h after chemotherapy. Choice of the specific administration option should be based on the patient's specific needs, while also considering mitigating factors, such as the economic burden associated with biologic medications and the risk of COVID-19. Pegfilgrastim biosimilars can minimize the additional financial burden on patients and the health care system during this pandemic and beyond.

摘要

粒细胞集落刺激因子(G-CSF)生物制剂,如培非格司亭,是支持性癌症治疗中的一种标准治疗方法,在每个化疗周期给药一次,以降低发热性中性粒细胞减少的发生率。这些生物制剂在美国的高昂成本可能是获得治疗的一个限制因素;然而,对于需要预防发热性中性粒细胞减少的患者,低成本的培非格司亭生物类似药已经上市数年。现在也有不同的培非格司亭给药选择,以适应特定患者的偏好。由于患者可能希望将中性粒细胞减少和感染SARS-CoV-2的风险降至最低,在当前的COVID-19大流行期间,同日给药是一个相关的选择。因此,在选择预防发热性中性粒细胞减少的治疗和给药方法时,应考虑个体化、以患者为中心的方法和风险管理策略。三种给药方法可以在尽量减少医院或诊所就诊次数的同时,也提供G-CSF的预防效果:化疗后同日给药、使用美国食品药品监督管理局批准的体内注射器在化疗后约27小时注射培非格司亭,或患者或护理人员在化疗后>24小时自行给药。具体给药选项的选择应基于患者的特定需求,同时也要考虑减轻因素,如生物药物相关的经济负担和COVID-19的风险。在本次大流行及之后,培非格司亭生物类似药可以将患者和医疗保健系统的额外经济负担降至最低。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/24a9/9681957/ce2cfabbcb24/40487_2022_207_Fig1_HTML.jpg

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