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贝伐珠单抗生物类似药与原研贝伐珠单抗治疗转移性结直肠癌的成本-效果分析:基于真实世界数据的比较研究。

Cost-Effectiveness Analysis of Bevacizumab Biosimilars Versus Originator Bevacizumab for Metastatic Colorectal Cancer: A Comparative Study Using Real-World Data.

机构信息

Sunnybrook Health Sciences Centre, Toronto, ON, Canada.

ICES, Toronto, ON, Canada.

出版信息

Value Health. 2024 Dec;27(12):1689-1697. doi: 10.1016/j.jval.2024.07.018. Epub 2024 Aug 9.

DOI:10.1016/j.jval.2024.07.018
PMID:39127249
Abstract

OBJECTIVES

MVASI (Amgen) and Zirabev (Pfizer) are 2 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 LYs) were calculated from the public health payer's perspective. Primary outcomes included incremental net monetary benefit 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 2945 comparators. Bevacizumab biosimilars were associated with an incremental cost of -$6379 (95%CI: -9417, -3537) (ie, cost saving) and incremental effect of 0.0 (95% CI: -0.02, 0.02) LY and -0.01 (95% CI: -0.03, 0) quality-adjusted LYs gained. Incremental net monetary benefit and INHB estimates were $6331 (95% CI: 6245, 6417) and 0.127 LY (95% CI: 0.125, 0.128), respectively, at a willingness-to-pay threshold of $50 000/life year gained, with all estimates indicating the cost-effectiveness of biosimilar bevacizumab. Cost-effectiveness remained consistent across biosimilar brand subgroups and 2-year sensitivity analyses.

CONCLUSION

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.

摘要

目的

MVASI(安进)和 Zirabev(辉瑞)是最早获批用于转移性结直肠癌(mCRC)一线治疗的贝伐珠单抗生物类似药中的 2 种。我们旨在确认并量化 MVASI 和 Zirabev 相对于 mCRC 患者的原研贝伐珠单抗的真实世界成本节约和成本效益。

方法

我们在加拿大安大略省进行了一项基于人群的回顾性队列研究,在该省,原研和生物类似药贝伐珠单抗均由公共资金普遍资助。所有在 2008 年 1 月至 2019 年 8 月期间接受原研贝伐珠单抗或 2019 年 8 月至 2021 年 3 月期间接受生物类似药贝伐珠单抗治疗的 mCRC 患者均进行了倾向评分匹配(1:4),以调整基线差异。从公共卫生支付者的角度计算了患者在 1 年的总个人成本(CAD)和效果(寿命年[LY]和质量调整寿命年[QALY])。主要结局包括增量净货币收益和增量净健康收益(INHB)。敏感性分析包括按生物类似药类型(MVASI/Zirabev)的亚组分析和 2 年分析。

结果

匹配队列包括 747 例生物类似药病例和 2945 例对照。贝伐珠单抗生物类似药的增量成本为-6379 加元(95%CI:-9417,-3537)(即成本节约),增量效果为 0.0 (95%CI:-0.02,0.02)LY 和-0.01 (95%CI:-0.03,0)质量调整后的 LY 获益。在 50000 加元/生命年获益的意愿支付阈值下,增量净货币收益和 INHB 估计值分别为 6331 加元(95%CI:6245,6417)和 0.127 LY(95%CI:0.125,0.128),所有估计均表明生物类似药贝伐珠单抗具有成本效益。在生物类似药品牌亚组和 2 年敏感性分析中,成本效益保持一致。

结论

贝伐珠单抗生物类似药在提供与原研贝伐珠单抗相似的生存获益的同时,实现了真实世界的成本节约,证实了其实施的最初预期,并支持了卫生系统的可持续性。

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