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基于中国 EVER-132-002 试验的戈沙妥珠单抗治疗激素受体阳性、人表皮生长因子受体 2 阴性转移性乳腺癌的成本效益

Cost-effectiveness of sacituzumab govitecan for hormone receptor-positive human epidermal growth factor receptor 2-negative metastatic breast cancer based on the EVER-132-002 trial in China.

作者信息

Liu Shixian, Wang Kaixuan, Chen Hao, Wan Ziming, Dou Lei, Li Shunping

机构信息

Centre for Health Management and Policy Research, School of Public Health, Cheeloo College of Medicine, Shandong University, Jinan, 250012, China.

NHC Key Laboratory of Health Economics and Policy Research (Shandong University), Jinan, 250012, China.

出版信息

Cost Eff Resour Alloc. 2025 Mar 19;23(1):8. doi: 10.1186/s12962-025-00613-z.

Abstract

BACKGROUND

The EVER-132-002 trial demonstrated the significant efficacy and manageable safety of sacituzumab govitecan in hormone receptor-positive human epidermal growth factor receptor 2-negative (HR + HER2-) metastatic breast cancer. This study evaluated the cost-effectiveness of sacituzumab govitecan compared with chemotherapy from the Chinese healthcare system perspective.

METHODS

A partitioned survival model at 21-day intervals over a 10-year time horizon was developed to evaluate the total cost, quality-adjusted life-years (QALYs), and incremental cost-effectiveness ratio (ICER) at willingness-to-pay (WTP) threshold of 3 times gross domestic product per capita ($38,042.49 per QALY). Clinical data were extracted from the EVER-132-002 trial; direct medical costs and utility values were obtained from public bid-winning databases, local charges or published literature. To determine the model's robustness, scenario, one-way, two-way and probabilistic sensitivity analyses were performed.

RESULTS

Compared with chemotherapy, sacituzumab govitecan generated an additional cost of $91,273.72, with an additional QALY of 0.43, resulted in an ICER of $211,948.62 per QALY. Patient weight was the most influential parameter on base-case results, and variations in each parameter did not substantially alter the conclusion. Probabilistic sensitivity analysis demonstrated that the probability of sacituzumab govitecan to be cost-effective was zero at the WTP threshold of $38,042.49 per QALY. Scenario analysis indicated that sacituzumab govitecan would be cost-effective versus chemotherapy only if its cost was reduced by 83% ($202.65 per unit) or more.

CONCLUSIONS

Sacituzumab govitecan might not be cost-effective compared with chemotherapy in the treatment for HR + HER2- metastatic breast cancer in China.

摘要

背景

EVER-132-002试验证明了戈沙妥珠单抗在激素受体阳性、人表皮生长因子受体2阴性(HR+HER2-)转移性乳腺癌中的显著疗效和可控安全性。本研究从中国医疗保健系统的角度评估了戈沙妥珠单抗与化疗相比的成本效益。

方法

建立了一个在10年时间范围内以21天为间隔的分段生存模型,以评估总成本、质量调整生命年(QALY)以及在支付意愿(WTP)阈值为人均国内生产总值的3倍(每QALY 38,042.49美元)时的增量成本效益比(ICER)。临床数据从EVER-132-002试验中提取;直接医疗成本和效用值从公开中标数据库、当地收费标准或已发表的文献中获得。为了确定模型的稳健性,进行了情景分析、单因素分析、双因素分析和概率敏感性分析。

结果

与化疗相比,戈沙妥珠单抗产生了91,273.72美元的额外成本,额外的QALY为0.43,导致ICER为每QALY 211,948.62美元。患者体重是对基础病例结果影响最大的参数,每个参数的变化并没有实质性改变结论。概率敏感性分析表明,在每QALY 38,042.49美元的WTP阈值下,戈沙妥珠单抗具有成本效益的概率为零。情景分析表明,只有当戈沙妥珠单抗的成本降低83%(每单位202.65美元)或更多时,它与化疗相比才具有成本效益。

结论

在中国,戈沙妥珠单抗与化疗相比治疗HR+HER2-转移性乳腺癌可能不具有成本效益。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ec89/11924825/d404efc6a289/12962_2025_613_Fig1_HTML.jpg

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