Huang Hui-Yao, Liu Cheng-Cheng, Yu Yue, Wang Le, Wu Da-Wei, Guo Lan-Wei, Wang Shu-Hang, Fang Hong, Bai Ying, Fang Yuan, Fan Qi, Sun Chao, Wu Ying, Shi Ju-Fang, Ma Fei, Tang Yu, Dai Min, Li Ning
Clinical Trials Center, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.
Office of Cancer Screening, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.
Front Pharmacol. 2020 Nov 12;11:572569. doi: 10.3389/fphar.2020.572569. eCollection 2020.
The availability of oncology biosimilars is deemed as a fundamental strategy to achieve sustainable health care. However, there is scarce systematic evidence on economic effectiveness of cancer biosimilars. We aimed to synthesize evidence from pharmacoeconomic evaluation of oncology biosimilars globally, provide essential data and methodological reference for involved stakeholders. This systematic review was conducted in PubMed, embase, the Cochrane library, CRD, ISPOR and NICE utill December 31, 2019. Information on basic characteristics, evaluation methodology and results were extracted. Quality of included studies was assessed using the Consolidated Health Economic Evaluation Reporting Standards Checklist. For 17 studies identified (13 from Europe and four from United States), the overall quality was generally acceptable. A total of seven biological molecules involved with filgrastim, EPOETIN , and trastuzumab leading the three. The mostly common evaluation perspective was payer, but the time horizon varied greatly. There were ten studies which adopted cost minimization analysis to evaluate efficiency while seven studies adopted budget impact analysis to address affordability, with cost ratio and cost saving being its corresponding primary endpoint. Although the comparability of included studies was limited and specific results were largely affected by uptake and price discount rates of the oncology biosimilar, the comprehensive results consistently favored its promotion. Globally, the economic evaluation of cancer biosimilars is in its initial phase. However, limited evidence from developed countries consistently supported both cost-effectiveness of efficiency and affordability of oncology biosimilars, while they were largely affected by uptake and price discount rate.
肿瘤生物类似药的可及性被视为实现可持续医疗保健的一项基本策略。然而,关于癌症生物类似药经济有效性的系统性证据却很匮乏。我们旨在综合全球肿瘤生物类似药药物经济学评估的证据,为相关利益攸关方提供关键数据和方法参考。本系统评价于2019年12月31日前在PubMed、Embase、Cochrane图书馆、CRD、ISPOR和NICE中进行。提取了有关基本特征、评估方法和结果的信息。使用《卫生经济评估报告标准合并清单》评估纳入研究的质量。对于纳入的17项研究(13项来自欧洲,4项来自美国),总体质量普遍可以接受。共有7种生物分子涉及非格司亭、促红细胞生成素和曲妥珠单抗,这三种生物分子占主导地位。最常见的评估视角是支付方,但时间跨度差异很大。有10项研究采用成本最小化分析来评估效率,7项研究采用预算影响分析来解决可负担性问题,成本比和成本节约是其相应的主要终点。尽管纳入研究的可比性有限,具体结果在很大程度上受到肿瘤生物类似药的采用率和价格折扣率的影响,但综合结果始终支持其推广。在全球范围内,癌症生物类似药的经济评估尚处于初始阶段。然而,来自发达国家的有限证据一致支持肿瘤生物类似药在效率方面的成本效益和可负担性,不过它们在很大程度上受到采用率和价格折扣率的影响。