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戈沙妥珠单抗对比单药化疗后线治疗HR+/HER2－晚期转移性乳腺癌的成本-效用分析
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| 篇名： | 戈沙妥珠单抗对比单药化疗后线治疗HR+/HER2－晚期转移性乳腺癌的成本-效用分析 |
| TITLE： | Cost-utility analysis of sacituzumab govitecan versus single-agent chemotherapy in the treatment of HR+/HER2－ advanced metastatic breast cancer |
| 摘要： | 目的 评估戈沙妥珠单抗对比单药化疗用于激素受体阳性（HR+）/人表皮生长因子受体2阴性（HER2－）晚期转移性乳腺癌后线治疗的经济性。方法从中国医疗体系角度，基于TROPiCS-02研究构建分区生存模型评估戈沙妥珠单抗和单药化疗的成本和效用。以1个月为循环周期，研究时限设为10年，年贴现率设为5%，模型产出包括总成本和质量调整生命月（QALM），支付意愿阈值设为2023年我国人均国内生产总值的3倍（22340元/QALM），通过计算增量成本-效果比（ICER）进行成本-效用分析。运用单因素敏感性分析、概率敏感性分析和情境分析分别评估结果的稳健性，并测算戈沙妥珠单抗具备经济性优势时的价格阈值。结果与单药化疗相比，戈沙妥珠单抗可使HR+/HER2－晚期转移性乳腺癌患者获得增量效用4.25QALMs，但需要多花费561570元，ICER为132102元/QALM，高于支付意愿阈值。单因素敏感性分析结果显示，戈沙妥珠单抗月均费用对结果影响最大；概率敏感性分析结果显示，戈沙妥珠单抗在支付意愿阈值下具有经济性的概率为0。情境分析结果显示，不同研究时限（5、10、15年）下，本研究结论稳健。戈沙妥珠单抗具备经济性优势时的价格阈值为每180mg1344元。结论基于中国医疗体系角度，戈沙妥珠单抗在目前价格（每180mg8400元）下，相比单药化疗用于HR+/HER2－晚期转移性乳腺癌患者后线治疗不具有经济性，价格需要大幅下调才能具备经济性优势。 |
| ABSTRACT： | OBJECTIVE To estimate the cost-utility of sacituzumab govitecan （SG） versus single-agent chemotherapy in the treatment of hormone receptor-positive （HR+）/human epidermal growth factor receptor 2-negative （HER2－） advanced metastatic breast cancer. METHODS From the perspective of the Chinese medical system， a three-state partitioned survival model was constructed to examine the cost-utility of SG versus single-agent chemotherapy based on TROPiCS-02 trial. The cycle length was set to 1 month， and the time horizon was 10 years. The annual discount was 5%. The model output included total costs and quality adjusted life month （QALM）， and incremental cost-effectiveness ratio （ICER） was calculated for cost-utility analysis， by setting willingness-to-pay （WTP） threshold at 3 times gross domestic product （GDP） per capita of China in 2023 （22 340 yuan/QALM）. Univariate sensitivity analyses， probability sensitivity analyses， and scenario analyses were performed to evaluate the robustness of the results and calculate the price threshold when SG had economic advantages. RESULTS SG group gained incremental 4.25 QALM and 561 570 yuan compared with single-agent chemotherapy， which resulted in an ICER of 132 102/QALM that was higher than WTP. The results of the univariate sensitivity analysis showed that the monthly average cost of SG had the greatest impact on the results； the results of probability sensitivity analysis showed that the probability of SG scheme being cost-effective at the WTP threshold was 0. The results of scenario analysis showed that the conclusions of this study were robust under different time horizons （5， 10， 15 years）. The price threshold for SG being cost-effective was 1 344 yuan per 180 mg. CONCLUSIONS Based on the perspective of Chinese medical system， SG appears to be not cost-effective compared with single-agent chemotherapy for HR+/ HER2－ advanced metastatic breast cancer at the price of 8 400 yuan per 180 mg. A substantial price cut should be taken to be cost- effective. |
| 期刊： | 2024年第35卷第20期 |
| 作者： | 何银梅；李晓；刘晓丽；李龙舟；高彦；余建国；栾家杰；吴义来 |
| AUTHORS： | HE Yinmei，LI Xiao，LIU Xiaoli，LI Longzhou，GAO Yan，YU Jianguo，LUAN Jiajie，WU Yilai |
| 关键字： | 戈沙妥珠单抗；成本-效用分析；HR+/HER2－晚期转移性乳腺癌；分区生存模型；药物经济学 |
| KEYWORDS： | sacituzumab govitecan； cost-utility analysis； |
| 阅读数： | 2 次 |
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