目的:MVASI(Amgen)和Zirabev(Pfizer)是两种最早被批准用于转移性结直肠癌(mCRC)一线治疗的贝伐单抗生物仿制药。我们旨在确认和量化MVASI和Zirabev相对于鼻祖贝伐单抗对mCRC患者的实际成本节约和成本效益。
方法:我们以人群为基础,安大略省的回顾性队列研究,加拿大,其中鼻祖和生物仿制药贝伐单抗是普遍公共资助的。所有在2008年1月至2019年8月期间接受鼻祖贝伐单抗或在2019年8月至2021年3月期间接受生物仿制药贝伐单抗的mCRC患者均进行倾向评分匹配(1:4)以调整基线差异。从公共卫生支付者的角度计算1年患者水平的总费用(CAD)和影响(生命年(LY)和质量调整生命年(QALY))。主要结果包括增量净货币收益(INMB)和增量净健康收益(INHB)。敏感性分析包括生物相似类型的亚组分析(MVASI/Zirabev)和2年分析。
结果:匹配的队列包括747个生物仿制药病例和2,945个比较者。贝伐单抗生物仿制药的增量成本为-6,379美元(95CI:-9,417,-3,537)(即,成本节约)和0.0(95%CI:-0.02,0.02)LY和-0.01(95CI:-0.03,0)QALY的增量效应。INMB和INHB估计为6,331美元(95%CI:6,245,6,417)和0.127LY(95%CI:0.125,0.128),分别,在50,000美元/LYG的支付意愿门槛下,所有估计都表明生物类似药贝伐单抗的成本效益。在生物仿制药品牌亚组和2年敏感性分析中,成本效益保持一致。
结论:贝伐单抗生物仿制药在现实世界中可以节省成本,同时提供与鼻祖贝伐单抗相似的生存益处,确认其实施和支持卫生系统可持续性的最初期望。
OBJECTIVE: MVASI (Amgen) and Zirabev (Pfizer) are two of the earliest bevacizumab biosimilars approved for the first-line treatment of metastatic colorectal cancer (mCRC). We aimed to confirm and quantify the real-world cost-savings and cost-effectiveness of MVASI and Zirabev relative to originator bevacizumab for patients with mCRC.
METHODS: We conducted a population-based, retrospective cohort study in Ontario, Canada, where originator and
biosimilar bevacizumab are universally publicly funded. All mCRC patients who received originator bevacizumab between January 2008 and August 2019 or
biosimilar bevacizumab between August 2019 and March 2021 were propensity score-matched (1:4) to adjust for baseline differences. Total 1-year patient-level costs (CAD) and effects (life years (LY) and quality-adjusted life years (QALY)) were calculated from the public health payer\'s perspective. Primary outcomes included incremental net monetary benefit (INMB) and incremental net health benefit (INHB). Sensitivity analyses included a subgroup analysis by
biosimilar type (MVASI/Zirabev) and a 2-year analysis.
RESULTS: The matched cohort included 747
biosimilar cases and 2,945 comparators. Bevacizumab biosimilars were associated with an incremental cost of -$6,379 (95%CI: -9,417, -3,537) (i.e., cost-saving) and incremental effect of 0.0 (95% CI: -0.02, 0.02) LY and -0.01 (95%CI: -0.03, 0) QALY gained. INMB and INHB estimates were $6,331 (95% CI: 6,245, 6,417) and 0.127 LY (95% CI: 0.125, 0.128), respectively, at a willingness-to-pay threshold of $50,000/LYG, with all estimates indicating the cost-effectiveness of biosimilar bevacizumab. Cost-effectiveness remained consistent across
biosimilar brand subgroups and 2-year sensitivity analyses.
CONCLUSIONS: Bevacizumab biosimilars demonstrated real-world cost-savings while providing similar survival benefit as originator bevacizumab, confirming the initial expectations of their implementation and supporting health system sustainability.