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中国药科大学国际医药商学院,南京 211198
硕士研究生。研究方向:医药产业经济与政策。 E-mail:15253894826@163.com
副教授,硕士生导师,博士。研究方向:医药产业经济与政策。E-mail:1020092084@cpu.edu.cn
收稿日期:2023-07-29,
修回日期:2023-12-25,
录用日期:2023-12-29,
纸质出版日期:2024-01-30
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武亚楠,吴方,侯艳红.德曲妥珠单抗对比恩美曲妥珠单抗二线治疗HER2阳性转移性乳腺癌的成本-效用分析[J].中国药房,2024,35(02):204-209.
WU Yanan,WU Fang,HOU Yanhong.Cost-utility analysis of trastuzumab deruxtecan versus trastuzumab emtansine in the second-line treatment for HER2-positive metastatic breast cancer[J].ZHONGGUO YAOFANG,2024,35(02):204-209.
武亚楠,吴方,侯艳红.德曲妥珠单抗对比恩美曲妥珠单抗二线治疗HER2阳性转移性乳腺癌的成本-效用分析[J].中国药房,2024,35(02):204-209. DOI: 10.6039/j.issn.1001-0408.2024.02.14.
WU Yanan,WU Fang,HOU Yanhong.Cost-utility analysis of trastuzumab deruxtecan versus trastuzumab emtansine in the second-line treatment for HER2-positive metastatic breast cancer[J].ZHONGGUO YAOFANG,2024,35(02):204-209. DOI: 10.6039/j.issn.1001-0408.2024.02.14.
目的
2
评估德曲妥珠单抗(T-DXd)对比恩美曲妥珠单抗(T-DM1)二线治疗
HER2
阳性转移性乳腺癌的经济性,为临床用药方案的选择及医疗卫生决策提供依据。
方法
2
基于DESTINY-Breast03试验构建分区生存模型,以3周为循环周期,模拟至患者终身。以质量调整生命年(QALY)作为产出指标并计算增量成本-效果比(ICER),再利用敏感性分析验证基础分析结果的稳健性,以此来比较T-DXd与T-DM1二线治疗
HER2
阳性转移性乳腺癌的经济性。
结果
2
在以3倍我国2022年人均国内生产总值(GDP)为意愿支付阈值(257 094元/QALY)的前提下,使用T-DXd方案的患者在获得增量效用(0.69 QALYs)的同时也需要支付更多成本,ICER值为1 850 478.40元/QALY。单因素敏感性分析结果显示,对ICER影响较大的因素有无进展生存期状态效用值、T-DXd价格、成本贴现率等,但这些参数在合理范围内波动均不能使基础分析结果发生翻转。概率敏感性分析结果显示,当WTP的阈值上升为1 500 400元/QALY时,T-DXd方案具有经济性的概率为50%。情境分析结果也验证了基础分析结果的稳健性。
结论
2
在以3倍我国人均GDP为意愿支付阈值的前提下,与T-DM1方案相比,T-DXd二线治疗
HER2
阳性转移性乳腺癌不具有经济性。
OBJECTIVE
2
To evaluate the cost-effectiveness of trastuzumab deruxtecan(T-DXd) versus trastuzumab emtansine (T-DM1) in the second-line treatment of
HER2
-positive metastatic breast cancer, and to provide a basis for the selection of clinical medication regimen and medical and health decisions.
METHODS
2
Based on the clinical trial DESTINY-Breast03, a partitioned survival model was constructed, with a cycle of 3 weeks as the simulation of patients’ lifetime. The incremental cost-effectiveness ratio (ICER) was calculated by using quality-adjusted life years (QALY) as output indicators, and sensitivity analysis was used to verify the robustness of the basic analysis results; the cost-effectiveness of the second-line
treatment for
HER2
-positive metastatic breast cancer was compared between T-DXd and T-DM1.
RESULTS
2
Under the premise of taking 3 times China’s per capita gross domestic product (GDP) in 2022 as the willingness-to-pay threshold (257 094 yuan/QALY), the T-DXd group also needed to pay more cost compared with T-DM1 group while obtaining incremental utility (0.69 QALYs), and the ICER value was 1 850 478.40 yuan/QALY. The results of univariate sensitivity analysis showed that progression-free survival state utility value, T-DXd price, cost discount rate were factors that had a great influence on ICER value, but these parameters could not flip the basic analysis results within a reasonable range. In the probability sensitivity analysis, when the threshold of willingness-to-pay rose to 1 500 400 yuan/QALY, the probability of economic activity was 50% in the T-DXd regimen. The results of the scenario analysis also verified the robustness of the original research results.
CONCLUSIONS
2
Under the premise of 3 times China’s per capita GDP as the WTP threshold, compared with T-DM1, T-DXd is not cost-effective in the second-line treatment of
HER2
-positive metastatic breast cancer.
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