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·药物经济学·
德曲妥珠单抗对比化疗方案二线治疗HER-2低表达晚期乳腺癌
的经济学评价
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李 雪 ,贾才凤 ,郑 颖 ,张 森 ,王美祺 ,王明霞 (1.河北医科大学第四医院药学部,石家庄 050011;
2.河北医科大学第四医院临床药理研究部,石家庄 050011;3.河北医科大学第四医院乳腺中心,石家庄
050011)
中图分类号 R956;R737.9 文献标志码 A 文章编号 1001-0408(2024)19-2383-08
DOI 10.6039/j.issn.1001-0408.2024.19.11
摘 要 目的 从我国卫生体系角度出发,评价德曲妥珠单抗方案对比医生选择化疗(TPC)方案二线治疗人表皮生长因子受体2
(HER-2)低表达晚期乳腺癌的经济性。方法 基于DESTINY-Breast04临床试验数据构建动态Markov模型,模拟时限为10年,循
环周期为3周。以成本、质量调整生命年(QALY)、增量成本-效果比(ICER)作为模型产出指标,采用5%的贴现率,以3倍2023年
我国人均国内生产总值(GDP)作为意愿支付(WTP)阈值,采用成本-效用分析法分析激素受体阳性队列和所有患者队列中两种治
疗方案的经济性,再通过不确定性分析验证基础分析结果的稳健性。结果 基础分析结果显示,德曲妥珠单抗方案与TPC方案相
比,在激素受体阳性队列和所有患者队列中的 ICER 值分别为 1 045 655.76、906 404.99 元/QALY,均高于 WTP 阈值(268 074
元/QALY)。单因素敏感性分析结果显示,疾病无进展状态效用值、德曲妥珠单抗价格、疾病进展状态效用值等参数对模型结果影
响较大。概率敏感性分析结果显示,当WTP阈值为3倍2023年我国人均GDP时,德曲妥珠单抗方案具有经济性的概率为0。情
境分析结果显示,在考虑援助计划时,德曲妥珠单抗方案具有经济性的概率为0;当德曲妥珠单抗价格降低70%时,该方案具有经
济性的概率显著提高至82.80%。结论 在以3倍2023年我国人均GDP作为WTP阈值时,德曲妥珠单抗方案相对于TPC方案二线
治疗HER-2低表达晚期乳腺癌不具有经济性;按地区适当降低德曲妥珠单抗的价格,可以提高其经济性。
关键词 德曲妥珠单抗;晚期乳腺癌;HER-2低表达;二线治疗;Markov模型;药物经济学
Pharmacoeconomic evaluation of trastuzumab deruxtecan versus chemotherapy in the second-line
treatment of advanced breast cancer with HER-2 low expression
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LI Xue ,JIA Caifeng ,ZHENG Ying ,ZHANG Sen ,WANG Meiqi ,WANG Mingxia(1. Dept. of Pharmacy, the
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Fourth Hospital of Hebei Medical University, Shijiazhuang 050011, China;2. Dept. of Clinical Pharmacology,
the Fourth Hospital of Hebei Medical University, Shijiazhuang 050011, China;3. Breast Center, the Fourth
Hospital of Hebei Medical University, Shijiazhuang 050011, China)
ABSTRACT OBJECTIVE To evaluate the economics of trastuzumab deruxtecan versus the physician-selected chemotherapy
(TPC) regimen in the second-line treatment of advanced breast cancer with epidermal growth factor receptor 2 (HER-2) low
expression from the perspective of the Chinese healthcare system. METHODS Based on the data of DESTINY-Breast04 clinical
trial, the dynamic Markov model was constructed. The time frame of the model simulation was 10 years, and the cycle was 3
weeks. Taking cost, quality-adjusted life year (QALY) and incremental cost-effectiveness ratio (ICER) as the model output
indicators, the discount rate of 5% was applied, and 3 times China’s per capita gross domestic product (GDP) in 2023 was taken
as the willingness-to-pay (WTP) threshold value. Cost-utility analysis was used to evaluate the economics of the two treatment
regiments in the hormone receptor-positive cohort and all
Δ 基金项目 河北省自然科学基金项目(No.H2021206432) patient cohorts, and uncertainty analysis was used to verify the
*第一作者 主管药师,硕士研究生。研究方向:肿瘤药物的临床 robustness of the basic analysis result. RESULTS The results
研究与评价。E-mail:lx15633081136@163.com
of the basic analysis showed that compared with the TPC
# 通信作者 主任药师,博士生导师,博士。研究方向:肿瘤药物的
临床研究与评价。电话:0311-66696233。E-mail:46700792@hebmu. regimen, the ICER value of trastuzumab deruxtecan regimen
edu.cn were 1 045 655.76 and 906 404.99 yuan/QALY in the hormone
中国药房 2024年第35卷第19期 China Pharmacy 2024 Vol. 35 No. 19 · 2383 ·