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在中国,赛托珠单抗戈沙妥珠单抗对比化疗治疗转移性三阴性乳腺癌患者的成本效益分析

Cost-effectiveness of sacituzumab tirumotecan versus chemotherapy for patients with metastatic triple-negative breast cancer in China.

作者信息

Shu Yamin, Tang Ying, Ding Yiling, Xu Pingping, Zhang Qilin

机构信息

Department of Pharmacy, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, 430030, China.

Department of Colorectal Surgery, Zhongshan Hospital, Fudan University, Shanghai, 200032, China.

出版信息

Breast. 2025 Aug 5;83:104550. doi: 10.1016/j.breast.2025.104550.

Abstract

PURPOSE

Sacituzumab tirumotecan (sac-TMT), a trop-2-targeted antibody-drug conjugate, has demonstrated significant clinical benefit in the OptiTROP-Breast01 trial for patients with advanced or metastatic triple-negative breast cancer (TNBC). This study evaluated the cost-effectiveness of sac-TMT compared with chemotherapy from the perspective of the Chinese healthcare system.

METHODS

A partitioned survival model incorporating multiple survival extrapolation approaches was developed to estimate long-term clinical and economic outcomes. Survival data were reconstructed from the OptiTROP-Breast01 trial, while cost and utility inputs were derived from publicly databases and literature. Outcomes included life-years, quality-adjusted life-years (QALYs), total costs, and key economic endpoints: incremental cost-effectiveness ratio (ICER), incremental net health benefit (INHB), incremental net monetary benefit (INMB), and expected value of perfect information (EVPI). Sensitivity, scenario, and subgroup analyses were conducted to assess uncertainty.

RESULTS

In the base-case analysis, sac-TMT yielded an additional 0.32 QALYs and 0.35 life-years compared with chemotherapy, with an incremental cost of $31815.17, resulting in an ICER of $98796.02 per QALY, exceeding the $40763.34 threshold in China. One-way sensitivity analysis identified the dose intensity, utility for PFS, patient weight, and price of sac-TMT as key drivers of ICER. Scenario analysis showed that reducing the drug price to 20 % of the current level would lower the ICER to $13319.46/QALY, with a 99.82 % probability of cost-effectiveness. EVPI was estimated at $33.69 per person.

CONCLUSION

While sac-TMT offers survival benefits in metastatic TNBC, it is unlikely to be cost-effective at current pricing. Substantial price reductions and optimized use may improve its economic value and support reimbursement.

摘要

目的

赛托珠单抗戈沙妥珠单抗(sac-TMT)是一种靶向滋养层细胞表面抗原2(trop-2)的抗体药物偶联物,在OptiTROP-Breast01试验中已证明对晚期或转移性三阴性乳腺癌(TNBC)患者具有显著的临床益处。本研究从中国医疗保健系统的角度评估了sac-TMT与化疗相比的成本效益。

方法

开发了一个包含多种生存外推方法的分段生存模型,以估计长期临床和经济结果。生存数据从OptiTROP-Breast01试验中重建,而成本和效用输入则来自公开数据库和文献。结果包括生命年、质量调整生命年(QALY)、总成本以及关键经济终点:增量成本效益比(ICER)、增量净健康效益(INHB)、增量净货币效益(INMB)和完美信息期望值(EVPI)。进行了敏感性、情景和亚组分析以评估不确定性。

结果

在基础案例分析中,与化疗相比,sac-TMT产生了额外的0.32个QALY和0.35个生命年,增量成本为31815.17美元,导致ICER为每QALY 98796.02美元,超过了中国40763.34美元的阈值。单向敏感性分析确定剂量强度、无进展生存期(PFS)的效用、患者体重和sac-TMT的价格是ICER的关键驱动因素。情景分析表明,将药物价格降至当前水平的20%将使ICER降至13319.46美元/QALY,成本效益概率为99.82%。估计EVPI为每人33.69美元。

结论

虽然sac-TMT在转移性TNBC中提供了生存益处,但按当前定价不太可能具有成本效益。大幅降价和优化使用可能会提高其经济价值并支持报销。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/912f/12351129/88ef7ebf5486/gr1.jpg

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