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·药物经济学·
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
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*
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武亚楠 ,吴 方,侯艳红(中国药科大学国际医药商学院,南京 211198)
中图分类号 R956;R979.1 文献标志码 A 文章编号 1001-0408(2024)02-0204-06
DOI 10.6039/j.issn.1001-0408.2024.02.14
摘 要 目的 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 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 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
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。
关键词 德曲妥珠单抗;恩美曲妥珠单抗;HER2阳性转移性乳腺癌;分区生存模型;成本-效用分析
Cost-utility analysis of trastuzumab deruxtecan versus trastuzumab emtansine in the second-line treatment
for HER22-positive metastatic breast cancer
WU Yanan,WU Fang,HOU Yanhong(School of International Pharmaceutical Business,China Pharmaceutical
University,Nanjing 211198,China)
ABSTRACT OBJECTIVE 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 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 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 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.
KEYWORDS trastuzumab deruxtecan; trastuzumab emtansine; HER2-positive metastatic breast cancer; partitioned survival
model; cost-utility analysis
Δ 基金项目 国家社会科学基金项目(No.22BGL252) 乳腺癌是女性最常见的恶性肿瘤。根据WHO国际
*第一作者 硕士研究生。研究方向:医药产业经济与政策。
癌 症 机 构(International Agency Research on Cancer,
E-mail:15253894826@163.com
# 通信作者 副教授,硕士生导师,博士。研究方向:医药产业经济 IARC)发布的2020年全球癌症负担数据显示,世界范围
与政策。E-mail:1020092084@cpu.edu.cn 内乳腺癌的发病例数高居第一,在因癌症死亡的原因中
· 204 · China Pharmacy 2024 Vol. 35 No. 2 中国药房 2024年第35卷第2期