中国药房2026，Vol.37Issue(8)：1033-1038,6.DOI:10.6039/j.issn.1001-0408.2026.08.11
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
Pharmacoeconomic evaluation of culmerciclib combined with fulvestrant in the second-line treatment of HR+/HER2-locally advanced or metastatic breast cancer
摘要
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
库莫西利/氟维司群/乳腺癌/激素受体阳性/人表皮生长因子受体2阴性/周期蛋白依赖性激酶2/4/6抑制剂/分区生存模型/药物经济学Key words
culmerciclib/fulvestrant/breast cancer/hormone receptor-positive/human epidermal growth factor receptor 2-negative/cyclin-dependent kinase 2/4/6 inhibitor/partitioned survival model/pharmacoeconomics分类
医药卫生引用本文复制引用
刘冉,高胜男,李从欣,张羽曦,张冉冉,王阅,刘紫怡,刘国强..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(8):1033-1038,6.基金项目
河北省自然科学基金项目(No.H2024206062) （No.H2024206062）
