Pharmacoeconomic evaluation of culmerciclib combined with fulvestrant in the second-line treatment of HR+/HER2－ locally advanced or metastatic breast cancer

LIU Ran; GAO Shengnan; LI Congxin; ZHANG Yuxi; ZHANG Ranran; WANG Yue; LIU Ziyi; LIU Guoqiang

doi:10.6039/j.issn.1001-0408.2026.08.11

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Pharmacoeconomic evaluation of culmerciclib combined with fulvestrant in the second-line treatment of HR+/HER2－ locally advanced or metastatic breast cancer

更新时间：2026-04-24

- Pharmacoeconomic evaluation of culmerciclib combined with fulvestrant in the second-line treatment of HR+/HER2－ locally advanced or metastatic breast cancer
- ZHONGGUO YAOFANG Vol. 37, Issue 8, Pages: 1033-1038(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.1001-0408.2026.08.11
  CLC： R956
- Received：07 January 2026，
  
  Revised：2026-04-09，
  
  Accepted：10 April 2026，
  
  Published：30 April 2026
- 稿件说明：
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刘冉,高胜男,李从欣,等.库莫西利联合氟维司群二线治疗HR+/HER2－局部晚期或转移性乳腺癌患者的药物经济学评价 [J].中国药房,2026,37(08):1033-1038.

LIU Ran,GAO Shengnan,LI Congxin,et al.Pharmacoeconomic evaluation of culmerciclib combined with fulvestrant in the second-line treatment of HR+/HER2－ locally advanced or metastatic breast cancer[J].ZHONGGUO YAOFANG,2026,37(08):1033-1038.
刘冉,高胜男,李从欣,等.库莫西利联合氟维司群二线治疗HR+/HER2－局部晚期或转移性乳腺癌患者的药物经济学评价 [J].中国药房,2026,37(08):1033-1038. DOI： 10.6039/j.issn.1001-0408.2026.08.11.

LIU Ran,GAO Shengnan,LI Congxin,et al.Pharmacoeconomic evaluation of culmerciclib combined with fulvestrant in the second-line treatment of HR+/HER2－ locally advanced or metastatic breast cancer[J].ZHONGGUO YAOFANG,2026,37(08):1033-1038. DOI： 10.6039/j.issn.1001-0408.2026.08.11.

摘要

目的

从我国卫生体系角度出发，评价库莫西利联合氟维司群二线治疗激素受体阳性（HR+）/人表皮生长因子受体2阴性（HER2－）局部晚期或转移性乳腺癌患者的经济性。

方法

根据CULMATE-1研究结果构建分区生存模型，模拟时限设置为15年，循环周期为28 d，计算库莫西利联合氟维司群相较于氟维司群单药二线治疗HR+/HER2－乳腺癌的增量成本-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，同时开展库莫西利降价的情境分析并测算达到本研究意愿支付（WTP）阈值所需的降价幅度和价格。

结果

基础分析结果显示，与氟维司群单药方案相比，库莫西利联合氟维司群方案可使患者多获得0.823质量调整生命年（QALY），对应的ICER为371 696.26元/QALY，高于WTP阈值（199 330元/QALY）。单因素敏感性分析结果显示，库莫西利成本、折现率、疾病进展和无进展生存期状态效用值对ICER有较大的影响；单因素敏感性分析和概率敏感性分析都验证了模型结果的稳健性。情境分析结果表明，当库莫西利分别降价30%、55%、85%时，对应的ICER 值分别低于我国3、2、1倍2025年人均GDP，具有经济性的概率分别为3.00%、94.90%、100%；当库莫西利（60 mg）成本下降52.6%至50.96元时，ICER方可低于本研究的WTP阈值。

结论

当WTP阈值为2倍2025年我国人均GDP时，相比于氟维司群单药方案，库莫西利联合氟维司群二线治疗HR+/HER2－局部晚期或转移性乳腺癌不具有经济性优势，需进行合理降价，才能减轻患者的经济负担。

Abstract

OBJECTIVE

To evaluate the cost-effectiveness of culmerciclib combined with fulvestrant as second-line treatment for patients with hormone receptor-positive（HR+）/human epidermal growth factor receptor 2-negative （HER2–） locally advanced or metastatic breast cancer， within the context of the Chinese healthcare system.

METHODS

A partitioned survival model was established based on the CULMATE-1 study， with a simulation time horizon set at 15 years and a cycle length of 28 days. The incremental cost-effectiveness ratio （ICER） of culmerciclib combined with fulvestrant versus fulvestrant monotherapy as second-line treatment for HR+/HER2– breast cancer was calculated. One-way sensitivity analysis and probabilistic sensitivity analysis were performed to assess the robustness of the model. Meanwhile， scenario analysis of culmerciclib price reduction was conducted； the required price reduction and price to reach the willingness-to-pay （WTP） threshold in this study were calculated.

RESULTS

The results of the base-case analysis indicated that， compared with the fulvestrant monotherapy regimen， culmerciclib combined with fulvestrant yielded an additional 0.823 quality-adjusted life year （QALY）， with a corresponding ICER of 371 696.26 yuan/QALY， which exceeded the WTP threshold （199 330 yuan/QALY）. The results of the univariate sensitivity analysis indicated that the cost of culmerciclib， the discount rate， the utility values for progression disease and progression free survival status were significant factors influencing the ICER； both the univariate sensitivity analysis and the probabilistic sensitivity analysis validated the robustness of the model results. Scenario analysis indicated that when the price of culmerciclib was reduced by 30%， 55% and 85% respectively， the corresponding ICER values fell below 3， 2， and 1 times China’s per capita GDP in 2025， with the probability of cost-effectiveness being 3.00%， 94.90%， 100%. When the cost of culmerciclib （60 mg） was reduced by 52.6% to 50.96 yuan， the ICER value met the WTP threshold established in this study.

CONCLUSIONS

When the WTP threshold is set at twice China’s per capita GDP in 2025， second-line treatment with culmerciclib combined with fulvestrant for HR+/HER2– locally advanced or metastatic breast cancer does not exhibit cost-effectiveness advantage over fulvestrant monotherapy. Therefore， a reasonable price reduction is required to alleviate the financial burden on patients.

关键词

Keywords

references

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