
浏览全部资源
扫码关注微信
1.河北医科大学第二医院药学部,石家庄 050061
2.河北医科大学第二医院医保办,石家庄 050061
3.河北医科大学药学院,石家庄 050017
4.河北医科大学第二医院护理部,石家庄 050061
主管药师,硕士。研究方向:药物经济学。E-mail:15175175876@163.com
主任药师,硕士生导师,博士。研究方向:药物经济学。E-mail:lhlong1026@163.com
收稿:2025-08-03,
修回:2025-12-10,
录用:2025-12-10,
纸质出版:2025-12-30
移动端阅览
张扬,康朔,王晓晖,等.卡匹色替联合氟维司群二线治疗HR+/HER2-晚期乳腺癌的成本-效用分析 Δ[J].中国药房,2025,36(24):3073-3078.
ZHANG Yang,KANG Shuo,WANG Xiaohui,et al.Cost-utility analysis of capivasertib combined with fulvestrant in the second-line treatment of HR+/HER2- advanced breast cancer[J].ZHONGGUO YAOFANG,2025,36(24):3073-3078.
张扬,康朔,王晓晖,等.卡匹色替联合氟维司群二线治疗HR+/HER2-晚期乳腺癌的成本-效用分析 Δ[J].中国药房,2025,36(24):3073-3078. DOI: 10.6039/j.issn.1001-0408.2025.24.10.
ZHANG Yang,KANG Shuo,WANG Xiaohui,et al.Cost-utility analysis of capivasertib combined with fulvestrant in the second-line treatment of HR+/HER2- advanced breast cancer[J].ZHONGGUO YAOFANG,2025,36(24):3073-3078. DOI: 10.6039/j.issn.1001-0408.2025.24.10.
目的
2
从我国卫生体系角度,评价卡匹色替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-)晚期乳腺癌的经济性。
方法
2
利用CAPItello-291临床试验公布的临床数据构建分区生存模型,以成本和质量调整生命年(QALYs)作为模型产出指标,以增量成本-效果比(ICER)作为模型评价指标,以3倍2024年我国人均国内生产总值(GDP)作为意愿支付阈值(WTP),分析卡匹色替联合氟维司群方案对比氟维司群单药方案治疗HR+/HER2-晚期乳腺癌的经济性,并进行敏感性分析和卡匹色替分别降价50%、60%、70%、95%时的情境分析。
结果
2
基础分析结果提示,与氟维司群单药治疗方案相比,卡匹色替联合氟维司群的ICER为843 038.46元/QALY,高于WTP(287 247元/QALY)。单因素敏感性分析结果提示,对ICER影响排名前3位的因素分别是疾病进展期效用值、卡匹色替价格和疾病无进展状态效用值。概率敏感性分析结果证实基础分析结果稳健。情境分析结果提示,即使卡匹色替降价95%,卡匹色替联合氟维司群治疗方案在目前的WTP下仍不具有经济性。
结论
2
在3倍2024年我国GDP的WTP下,相比于氟维司群单药治疗方案,卡匹色替联合氟维司群二线治疗HR+/HER2-晚期乳腺癌不具有经济性。
OBJECTIVE
2
To evaluate the cost-utiliby of capivasertib combined with fulvestrant for the second-line treatment of hormone receptor-positive/human epidermal growth factor receptor-2-negative (HR+/HER2-) advanced breast cancer from the perspective of the Chinese healthcare system.
METHODS
2
A partitioned survival model was constructed using clinical data from the CAPItello-291 trial. Costs and quality-adjusted life years (QALYs) were used as the output indicators of the model, and the incremental cost-effectiveness ratio (ICER) was used as the evaluation indicator of the model. Using three times the per capita gross domestic product (GDP) of China in 2024 as the willingness-to-pay threshold (WTP), this study analyzed the cost-utility of capivasertib combined with fulvestrant versus fulvestrant monotherapy in the treatment of HR+/HER2- advanced breast cancer, and conducted sensitivity analysis and scenario analysis under conditions where the price of capivasertib was reduced by 50%, 60%, 70% and 95%, respectively.
RESULTS
2
The results of the basic analysis showed that compared with the fulvestrant monotherapy regimen, the ICER of capivasertib combined with fulvestrant was 843 038.46 yuan/QALY, which was higher than the WTP(287 247 yuan/QALY). The one-way sensitivity analysis revealed that the top three factors with the most substantial influence on ICER were the utility value in the progression disease state, the price of capivasertib, and the utility value in the progression free survival state. Probabilistic sensitivity analysis demonstrated the robustness of the basic analysis results. Scenario analysis revealed that even if the price of capivasertib were reduced by 95%, capivasertib combined with fulvestrant did not exhibit cost-effectiveness at the current WTP.
CONCLUSION
2
At a WTP of three times China’s GDP per capita in 2024, compared to fulvestrant monotherapy, capivasertib combined with fulvestrant as the second-line treatment for HR+/HER2- advanced breast cancer is not cost-effective.
BRAY F , LAVERSANNE M , SUNG H , et al . Global cancer statistics 2022:GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries [J ] . CA Cancer J Clin , 2024 , 74 ( 3 ): 229 - 263 .
郑荣寿 , 陈茹 , 韩冰峰 , 等 . 2022年中国恶性肿瘤流行情况分析 [J ] . 中华肿瘤杂志 , 2024 , 46 ( 3 ): 221 - 231 .
GIAQUINTO A N , SUNG H , NEWMAN L A , et al . Breast cancer statistics 2024 [J ] . CA A Cancer J Clinicians , 2024 , 74 ( 6 ): 477 - 495 .
LEE E Y , LEE D W , LEE K H , et al . Recent developments in the therapeutic landscape of advanced or metastatic hormone receptor-positive breast cancer [J ] . Cancer Res Treat , 2023 , 55 ( 4 ): 1065 - 1076 .
GRINSHPUN A , SANDUSKY Z M , JESELSOHN R . The clinical utility of ESR1 mutations in hormone receptor-positive,HER2-negative advanced breast cancer [J ] . Hematol Oncol Clin North Am , 2023 , 37 ( 1 ): 169 - 181 .
HUANG J Y , ZHENG L , SUN Z C , et al . CDK4/6 inhibitor resistance mechanisms and treatment strategies:review [J ] . Int J Mol Med , 2022 , 50 ( 4 ): 128 .
BROWNE I M , ANDRÉ F , CHANDARLAPATY S , et al . Optimal targeting of PI3K-AKT and mTOR in advanced oestrogen receptor-positive breast cancer [J ] . Lancet Oncol , 2024 , 25 ( 4 ): e139 - e151 .
COLEMAN N , MOYERS J T , HARBERY A , et al . Clinical development of AKT inhibitors and associated predictive biomarkers to guide patient treatment in cancer medicine [J ] . Pharmgenomics Pers Med , 2021 , 14 : 1517 - 1535 .
DAVIES B R , GREENWOOD H , DUDLEY P , et al . Preclinical pharmacology of AZD5363,an inhibitor of AKT:pharmacodynamics,antitumor activity,and correlation of monotherapy activity with genetic background [J ] . Mol Cancer Ther , 2012 , 11 ( 4 ): 873 - 887 .
TURNER N C , OLIVEIRA M , HOWELL S J , et al . Capivasertib in hormone receptor-positive advanced breast cancer [J ] . N Engl J Med , 2023 , 388 ( 22 ): 2058 - 2070 .
KAYKI-MUTLU G , AKSOYALP Z S , WOJNOWSKI L , et al . A year in pharmacology:new drugs approved by the US Food and Drug Administration in 2023 [J ] . Naunyn Schmiedebergs Arch Pharmacol , 2024 , 397 ( 5 ): 2949 - 2970 .
中国抗癌协会乳腺癌专业委员会 , 中华医学会肿瘤学分会乳腺肿瘤学组 . 中国抗癌协会乳腺癌诊治指南与规范:2024年版 [J ] . 中国癌症杂志 , 2023 , 33 ( 12 ): 1092 - 1187 .
石丰豪 , 商叶 , 芮明军 , 等 . R语言survHE程序包在卫生经济学评价中的应用 [J ] . 中国卫生经济 , 2020 , 39 ( 9 ): 9 - 14 .
贾才凤 , 冯章英 , 张森 , 等 . 阿贝西利联合氟维司群二线治疗激素受体阳性的晚期乳腺癌的药物经济学评价 [J ] . 中国现代应用药学 , 2023 , 40 ( 12 ): 1609 - 1614 .
ZHU W T , ZHENG M M , XIA P P , et al . Cost-effectiveness of palbociclib plus fulvestrant as second-line therapy of women with HR+/HER2- advanced breast cancer: a Chinese healthcare system perspective [J ] . Front Oncol , 2023 , 13 : 1068463 .
LE V , ZHONG L X , NARSIPUR N , et al . Cost-effectiveness of ribociclib plus endocrine therapy versus placebo plus endocrine therapy in HR-positive,HER2-negative breast cancer [J ] . J Manag Care Spec Pharm , 2021 , 27 ( 3 ): 327 - 338 .
ZHAN M , HUANG Z J , XU T , et al . Cost-effectiveness analysis of trastuzumab deruxtecan in patients with HER2-low advanced breast cancer based on DESTINY-Breast04 [J ] . Front Public Health , 2023 , 11 : 1049947 .
居文祥 , 赵荧荧 , 路萝兰 , 等 . 贝伐珠单抗联合厄洛替尼一线治疗晚期EGFR突变型非鳞状NSCLC的成本-效用分析 [J ] . 中国药房 , 2024 , 35 ( 11 ): 1357 - 1362 .
国家卫生健康委员会 . 中国居民营养与慢性病状况报告:2020 年[J ] . 营养学报 , 2020 , 42 ( 6 ): 521 .
李雪 , 贾才凤 , 郑颖 , 等 . 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 [J ] . 中国药房 , 2024 , 35 ( 19 ): 2383 - 2390 .
WU W , LIN H , CAI J , et al . Is alpelisib plus fulvestrant cost-effective for treating PIK3CA-mutation,HR+/HER2- advanced breast cancer in the USA? [J ] . Clin Drug Investig , 2023 , 43 ( 12 ): 939 - 948 .
刘国恩 . 中国药物经济学评价指南2020 [M ] . 北京 : 中国市场出版社 , 2020 : 27 - 46 .
国家统计局 . 中华人民共和国2024年国民经济和社会发展统计公报 [EB/OL ] .( 2025-02-28 )[ 2025-06-20 ] . https://www.stats.gov.cn/sj/zxfb/202502/t20250228_1958-817.html https://www.stats.gov.cn/sj/zxfb/202502/t20250228_1958-817.html .
国家医保局 . 国家医保局2024年国家基本医疗保险、工伤保险和生育保险药品目录调整新闻发布会实录 [EB/OL ] .( 2024-11-28 )[ 2025-07-10 ] . https://www.nhsa.gov.cn/art/2024/11/28/art_52_14890.html https://www.nhsa.gov.cn/art/2024/11/28/art_52_14890.html .
张少华 , 王晓稼 , 江泽飞 , 等 . 乳腺癌内分泌治疗专家共识: 2023版 [J ] . 中华医学杂志 , 2023 , 103 ( 38 ): 2993 - 3001 .
王艺茸 , 李瑜 , 李琳琳 , 等 . 依维莫司联合依西美坦用于晚期乳腺癌的药物经济学评价 [J ] . 中国新药杂志 , 2018 , 27 ( 12 ): 1437 - 1442 .
NGUYEN T T H , MITAL S . Cost-effectiveness of capi-vasertib as a second-line therapy for advanced breast cancer [J ] . Pharmacoeconomics , 2025 , 43 ( 3 ): 351 - 361 .
邵荣杰 , 唐文熙 , 马爱霞 . 分区生存模型在药物经济学评价中的应用 [J ] . 中国卫生经济 , 2019 , 38 ( 9 ): 60 - 63 .
刘新义 , 谭重庆 , 曾小慧 , 等 . 分区生存模型在药物经济学评价中的应用简介及实例解析 [J ] . 中国现代应用药学 , 2019 , 36 ( 24 ): 3090 - 3093 .
0
浏览量
0
下载量
0
CSCD
关联资源
相关文章
相关作者
相关机构
京公网安备11010802024621