The Economic Impact of Biosimilars in Oncology and Hematology: The Case of Trastuzumab and Rituximab
The Economic Impact of Biosimilars in Oncology and Hematology: The Case of Trastuzumab and Rituximab
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DOI：
10.21873/anticanres.13552
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发表时间：
2019-07-01
影响因子：
2
通讯作者：
Bonetti, Andrea
中科院分区：
文献类型：
--
作者：
Giuliani, Jacopo;Bonetti, Andrea
背景/目的：生物仿制药是指在质量、疗效、安全性和免疫原性方面与已获批准的参考生物制品相比没有临床意义差异的生物制品，具有降低生物制品成本的潜力。考虑到肿瘤学生物类似药的数量不断增加，计算生物类似药在肿瘤学和血液学领域的经济影响是很重要的，以曲妥珠单抗和利妥昔单抗为例，它们分别对肿瘤学和血液学部门的预算影响最大。本分析旨在评估曲妥珠单抗和利妥昔单抗原产药与相应批准的生物仿制药的药理学成本。材料和方法：关键III期随机对照试验（rct）被认为是新辅助乳腺癌（BC）和晚期滤泡性淋巴瘤一线治疗的批准适应症。在癌症结果中获得益处所需的药理学成本：i)治疗失败时间（TTF）和ii)生物仿制药和原药的病理完全缓解（pCR）被计算。药费在我院药房支付，以欧元表示（原文如此）。结果：我们的分析评估了5项III期随机对照试验，包括2362例患者。生物仿制药与原研药相比，TTF的经济优势为每月274 (sic)（利妥昔单抗），从3283 （sic）到6310（曲妥珠单抗）（比原研药少约40%）。结论：结合药物药效学成本和以TTF和pCR为代表的疗效指标，利妥昔单抗和曲妥珠单抗的生物仿制药治疗晚期滤泡性淋巴瘤和乳腺癌具有成本效益
Background/Aim: Biosimilar agents are biologic products that have no clinically meaningful differences in terms of quality, efficacy, safety and immunogenicity compared to an already approved reference biological product, with the potential to reduce the costs of biologics. Considering the increasing numbers of oncology biosimilars, it is important to calculate the economic impact of biosimilars in oncology and hemathology, considering trastuzumab and rituximab as examples, with their greatest budgetary impact in Oncology and Hematology Units, respectively. The present analysis was conducted to assess the pharmacological costs of trastuzumab and rituximab originator versus the corresponding approved biosimilars. Materials and Methods: Pivotal phase III randomized controlled trials (RCTs) were considered for the approved indications in neoadiuvant breast cancer (BC) and in first-line treatment for advanced follicular lymphoma. Pharmacological costs necessary to get the benefit in the cancer outcomes: i) time to treatment failure (TTF) and ii) pathological complete response (pCR) in biosimilars and originators were calculated. The costs of drugs are at the Pharmacy of our Hospital and are expressed in euros ((sic)). Results: Our analysis evaluated 5 phase III RCTs, including 2,362 patients. The economic advantage of biosimilars versus (vs.) originator is 274 (sic) (rituximab) and from 3,283 (sic) to 6,310 (sic) (trastuzumab) per month for TTF (about 40% less than the originator). Conclusion: Combining pharmacological costs of drugs with the measure of efficacy represented by TTF and pCR, biosimilars of rituximab and trastuzumab are cost-effective treatments for advanced follicular lymphoma and breast cancer