Cost-utility analysis of datopotamab deruxtecan as first-line treatment for advanced triple-negative breast cancer in patients ineligible for immunotherapy

LIU Sisi; LIU Ran; GAO Shengnan; LIU Ziyi; WANG Yue; LIU Guoqiang

doi:10.6039/j.issn.1001-0408.2026.20.14

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Cost-utility analysis of datopotamab deruxtecan as first-line treatment for advanced triple-negative breast cancer in patients ineligible for immunotherapy

更新时间：2026-10-29

- Cost-utility analysis of datopotamab deruxtecan as first-line treatment for advanced triple-negative breast cancer in patients ineligible for immunotherapy
- ZHONGGUO YAOFANG Vol. 37, Issue 20, Pages: 2711-2717(2026)
- 作者机构：
  
  1.河北医科大学第三医院药学部，石家庄　050051
  2.河北医科大学研究生学院，石家庄　050017
  3.河北省药物与卫生技术综合评估学会，石家庄　050051
- 作者简介：
- 基金信息：
- DOI：10.6039/j.issn.1001-0408.2026.20.14
  CLC： R956
- Received：17 June 2026，
  
  Revised：2026-10-14，
  
  Accepted：14 October 2026，
  
  Published：30 October 2026
- 稿件说明：
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刘思思,刘冉,高胜男,等.德达博妥单抗一线治疗免疫疗法不适用的晚期三阴性乳腺癌的成本-效用分析 [J].中国药房,2026,37(20):2711-2717.

LIU Sisi,LIU Ran,GAO Shengnan,et al.Cost-utility analysis of datopotamab deruxtecan as first-line treatment for advanced triple-negative breast cancer in patients ineligible for immunotherapy[J].ZHONGGUO YAOFANG,2026,37(20):2711-2717.
刘思思,刘冉,高胜男,等.德达博妥单抗一线治疗免疫疗法不适用的晚期三阴性乳腺癌的成本-效用分析 [J].中国药房,2026,37(20):2711-2717. DOI： 10.6039/j.issn.1001-0408.2026.20.14.

LIU Sisi,LIU Ran,GAO Shengnan,et al.Cost-utility analysis of datopotamab deruxtecan as first-line treatment for advanced triple-negative breast cancer in patients ineligible for immunotherapy[J].ZHONGGUO YAOFANG,2026,37(20):2711-2717. DOI： 10.6039/j.issn.1001-0408.2026.20.14.

摘要

目的

从我国卫生体系角度出发，评价德达博妥单抗相较传统化疗方案一线治疗免疫疗法不适用的晚期三阴性乳腺癌（TNBC）的经济性。

方法

根据TROPION-Breast02研究结果构建分区生存模型，模拟时限设置为 10年，循环周期为21 d，折现率为4.5%，意愿支付（WTP）阈值为2倍2025年我国人均国内生产总值（GDP），计算德达博妥单抗相较化疗方案一线治疗免疫疗法不适用的晚期TNBC的增量成本-效果比（ICER）；采用单因素敏感性分析和概率敏感性分析评估模型的稳健性，同时开展德达博妥单抗降价的情境分析，并测算分别达到以我国2、1、0.5倍人均GDP为WTP阈值时其所需的降价幅度和价格。

结果

与化疗方案相比，德达博妥单抗可使患者多获得0.37质量调整生命年（QALY），ICER为825 725.04元/QALY，高于WTP阈值（199 330元/QALY）。单因素敏感性分析表明，ICER对德达博妥单抗、戈沙妥珠单抗（后续治疗用药）成本及无进展生存状态效用值具有较高的敏感性。单因素与概率敏感性分析结果均证实模型具有良好的稳健性。情境分析表明，当德达博妥单抗分别降价36.30%、42.08%、44.96%时（对应的100 mg价格分别为4 246.18、3 861.15、3 668.66元），ICER将分别低于以我国2、1、0.5倍人均GDP设置的WTP阈值。

结论

当WTP阈值设置为 2025年我国2倍人均GDP时，相比于化疗方案，德达博妥单抗作为一线药物治疗免疫疗法不适用的晚期TNBC不具有经济性。

Abstract

OBJECTIVE

To evaluate the cost-effectiveness of datopotamab deruxtecan versus traditional chemotherapy as first-line treatment for advanced triple-negative breast cancer （TNBC） in patients ineligible for immunotherapy， from the perspective of the health system in China.

METHODS

A partitioned survival model was constructed based on the results of the TROPION-Breast02 study. The time horizon was set at 10 years with a cycle length of 21 d， a discount rate of 4.5%， and a willingness-to-pay （WTP） threshold of 2 times the per capita gross domestic product （GDP） of China in 2025. The incremental cost-effectiveness ratio （ICER） of datopotamab deruxtecan versus chemotherapy was calculated. One-way sensitivity analysis and probabilistic sensitivity analysis were performed to assess the robustness of the model. Scenario analyses of price reductions of datopotamab deruxtecan were also conducted to estimate the required price reduction magnitude and prices for the ICER to fall below the WTP thresholds of 2， 1 and 0.5 times the per capita GDP of China.

RESULTS

Compared with chemotherapy， datopotamab deruxtecan could yield an additional 0.37 quality-adjusted life year （QALY）， with an ICER of 825 725.04 yuan/QALY， which was higher than the WTP threshold （199 330 yuan/QALY）. One-way sensitivity analysis indicated that the ICER was highly sensitive to the cost of datopotamab deruxtecan and sacituzumab govitecan （for subsequent treatment）， and the utility value of the progression-free survival state； the results of both one-way and probabilistic sensitivity analyses supported the good robustness of the model. The scenario analyses showed that when the price of datopotamab deruxtecan was reduced by 36.30%， 42.08% and 44.96%， respectively （corresponding to prices of 4 246.18， 3 861.15 and 3 668.66 yuan per 100 mg）， the ICER fell below the WTP thresholds of 2， 1 and 0.5 times the per capita GDP of China， respectively.

CONCLUSIONS

At a WTP threshold of 2 times the per capita GDP of China in 2025， datopotamab deruxtecan as first-line treatment for advanced TNBC in patients ineligible for immunotherapy is not cost-effective compared with chemotherapy.

关键词

Keywords

references

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