1.河北医科大学第三医院临床药学部,石家庄 050051
2.河北省药物与卫生技术综合评估学会,石家庄 050051
Received:16 September 2025,
Revised:2026-01-22,
Accepted:23 January 2026,
Published:15 February 2026
移动端阅览
闫文英,杨娜,张冉冉,等.安罗替尼联合派安普利单抗一线治疗不可切除肝细胞癌的成本-效用分析 [J].中国药房,2026,37(03):344-349.
YAN Wenying,YANG Na,ZHANG Ranran,et al.Cost-utility analysis of anlotinib combined with penpulimab in first-line treatment of unresectable hepatocellular carcinoma[J].ZHONGGUO YAOFANG,2026,37(03):344-349.
闫文英,杨娜,张冉冉,等.安罗替尼联合派安普利单抗一线治疗不可切除肝细胞癌的成本-效用分析 [J].中国药房,2026,37(03):344-349. DOI: 10.6039/j.issn.1001-0408.2026.03.12.
YAN Wenying,YANG Na,ZHANG Ranran,et al.Cost-utility analysis of anlotinib combined with penpulimab in first-line treatment of unresectable hepatocellular carcinoma[J].ZHONGGUO YAOFANG,2026,37(03):344-349. DOI: 10.6039/j.issn.1001-0408.2026.03.12.
目的
2
从我国卫生体系角度出发,评价安罗替尼联合派安普利单抗与索拉非尼相比一线治疗不可切除肝细胞癌(uHCC)的经济性。
方法
2
基于APOLLO研究数据,建立分区生存模型,以21 d为一个模型周期,模拟10年内患者使用安罗替尼联合派安普利单抗方案或者单用索拉非尼方案的生存状态,采用质量调整生命年(QALY)作为核心评价参数,进而评估不同治疗方案的增量成本-效果比(ICER)。以3倍2024年我国人均国内生产总值(GDP)(287 247 元/QALY)作为意愿支付(WTP)阈值,采用成本-效用分析法评估治疗方案的经济性,并利用敏感性分析验证基础分析结果的稳健性。通过情境分析探讨安罗替尼和派安普利单抗援助计划对结果的影响;并考察在不同WTP阈值(分别为1、2、3倍2024年我国人均GDP)条件下,联合方案具有经济性时派安普利单抗所需的降价幅度。
结果
2
基础分析结果显示,安罗替尼联合派安普利单抗方案相对于索拉非尼方案的ICER为338 611.20 元/QALY,高于本研究设定的WTP阈值。单因素敏感性分析结果表明,无进展生存状态效用值、派安普利单抗价格对基础分析结果的影响较大。概率敏感性分析结果验证了基础结果的稳健性。情境分析结果表明,考虑安罗替尼和派安普利单抗援助计划时,所得ICER值均低于以3倍2024年我国人均GDP设定的WTP阈值;当派安普利单抗分别降价58%、35%、13%时,所得ICER值分别低于以1、2、3倍2024年我国人均GDP设定的WTP阈值。
结论
2
从我国卫生体系角度出发,相较于索拉非尼方案,安罗替尼联合派安普利单抗方案一线治疗uHCC不具有经济性;但若考虑安罗替尼和派安普利单抗援助计划或使派安普利单抗降价13%及以上,该结论会发生翻转。
OBJECTIVE
2
To evaluate the cost-effectiveness of anlotinib combined with penpulimab versus sorafenib as first-line treatment for unresectable hepatocellular carcinoma (uHCC) from the perspective of China’s healthcare system.
METHODS
2
Based on data from the APOLLO study, a partitioned survival model was established with a 21-day model cycle to simulate patient survival status over 10 years under anlotinib combined with penpulimab regimen or sorafenib monotherapy. Quality-adjusted life year (QALY) was used as the core evaluation parameter to assess the incremental cost-effectiveness ratio (ICER) of different treatment regimens. Using 3 times China’s per capita gross domestic product (GDP) in 2024 (287 247 yuan/QALY) as the willingness-to-pay (WTP) threshold, cost-utility analysis was performed to evaluate the cost-effectiveness of the treatment regimens. Sensitivity analysis was conducted to validate the robustness of the baseline analysis conclusion. Scenario analysis was performed to consider the impact of anlotinib and penpulimab assistance programs on the results; the price reduction of penpulimab to ensure the cost-effectiveness of the combination regimen was examined under varying WTP thresholds (specifically, 1, 2, and 3 times China’s per capita GDP in 2024).
RESULTS
2
The baseline analysis revealed that the ICER of anlotinib combined with penpulimab regimen relative to the sorafenib regimen was 338 611.20 yuan/QALY, which exceeded the WTP threshold set in this study. Univariate sensitivity analysis indicated that the utility value of progression free survival and penpulimab price significantly influenced the baseline analysis results. Probabilistic sensitivity analysis validated the robustness of the baseline results. The results of scenario analysis indicated that when considering the assistance programs for anlotinib and penpulimab, the obtained ICER values were all below the WTP threshold set at 3 times China’s per capita GDP in 2024. When the price of penpulimab was reduced by 58%, 35%, and 13%, the ICER values were below the WTP threshold, which was 1, 2 and 3 times the per capita GDP of China in 2024, respectively.
CONCLUSIONS
2
From the perspective of China’s healthcare system, anlotinib combined with penpulimab regimen for first-line treatment of uHCC lacks cost-effectiveness compared to sorafenib regimen. However, this conclusion would be reversed if the anlotinib and penpulimab assistance programs are taken into account or if the price of penpulimab is reduced by more than 13% and above.
HAN B F , ZHENG R S , ZENG H M , et al . Cancer incidence and mortality in China,2022 [J ] . J Natl Cancer Cent , 2024 , 4 ( 1 ): 47 - 53 .
国家卫生健康委员会医政司 . 原发性肝癌诊疗指南:2024年版 [J ] . 中国实用外科杂志 , 2024 , 44 ( 4 ): 361 - 386 .
刘一村 , 程苕莼 , 卞兆连 . 联合免疫检查点抑制剂治疗肝细胞癌的进展与挑战 [J ] . 中国免疫学杂志 , 2023 , 39 ( 4 ): 860 - 864 .
周延平 , 王帅 , 王学祥 . 盐酸安罗替尼治疗晚期肝细胞癌的疗效及其预后影响因素 [J ] . 海南医学 , 2025 , 36 ( 1 ): 40 - 44 .
王佩佩 , 单亮 , 谢林虎 . 卡博替尼治疗肝癌的多靶点作用及其研究进展 [J ] . 中国医院用药评价与分析 , 2025 , 25 ( 3 ): 376 - 380 .
中国临床肿瘤学会指南工作委员会 . 中国临床肿瘤学会(CSCO)原发性肝癌诊疗指南2024 [M ] . 北京 : 人民卫生出版社 , 2024 : 545 - 558 .
佘明金 , 吴亚运 , 程蒙蒙 , 等 . 基于免疫的联合疗法一线治疗晚期肝细胞癌有效性和安全性的Meta分析 [J ] . 临床合理用药 , 2025 , 18 ( 4 ): 17 - 24 .
蒋媛 , 朱盈盈 , 张惠娟 . 卡瑞利珠单抗联合阿帕替尼一线治疗晚期不可切除肝细胞癌的成本-效用分析 [J ] . 中国新药与临床杂志 , 2024 , 43 ( 4 ): 273 - 279 .
YOU X Y , QIN J L , WANG X M , et al . Cost-effectiveness analysis of penpulimab combined with paclitaxel and carboplatin as first-line treatment for advanced squamous non-small cell lung cancer [J ] . Front Pharmacol , 2025 , 16 : 1563788 .
ZHOU J , BAI L , LUO J , et al . Anlotinib plus penpulimab versus sorafenib in the first-line treatment of unresectable hepatocellular carcinoma (APOLLO):a randomised,controlled,phase 3 trial [J ] . Lancet Oncol , 2025 , 26 ( 6 ): 719 - 731 .
段正新 , 王俊超 , 赵卫 . 肝动脉灌注化疗治疗晚期肝细胞癌合并门静脉癌栓的研究进展 [J ] . 介入放射学杂志 , 2025 , 34 ( 4 ): 341 - 346 .
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 : 36 - 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 )[ 2025-08-10 ] . https://www.stats.gov.cn/sj/zxfb/202502/t20250228_1958817.html https://www.stats.gov.cn/sj/zxfb/202502/t20250228_1958817.html .
BASCH E , BECKER C , ROGAK L J , et al . Composite grading algorithm for the National Cancer Institute’s Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) [J ] . Clin Trials , 2021 , 18 ( 1 ): 104 - 114 .
曹潆丹 , 石丰豪 , 孟蕊 , 等 . 纳武利尤单抗二线治疗转移性肾透明细胞癌的成本-效果分析 [J ] . 中国药房 , 2022 , 33 ( 10 ): 1233 - 1239 .
ZHOU T , CAO Y D , WANG X T , et al . Economic evaluation of sintilimab plus bevacizumab versus sorafenib as a first-line treatment for unresectable hepatocellular carcinoma [J ] . Adv Ther , 2022 , 39 ( 5 ): 2165 - 2177 .
GAO J , LIU S , LI S J , et al . Cost-effectiveness analysis of hepatic arterial chemotherapy for advanced hepatocellular carcinoma in China:a comparative analysis of HAIC-FO and sorafenib [J ] . Med Sci Monit , 2024 , 30 : e944526 .
陈秋平 , 孙权 , 沈政男 , 等 . 舒格利单抗联合化疗方案一线治疗PD-L1高表达晚期食管鳞状细胞癌的成本-效用分析 [J ] . 中国药房 , 2024 , 35 ( 23 ): 2896 - 2902 .
XIANG G Y , HUANG Y Y , ZHANG N , et al . First-line camrelizumab plus rivoceranib in advanced hepatocellular carcinoma:a China-based cost-effectiveness analysis [J ] . Clin Med Insights Oncol , 2024 , 18 : 11795549241299393 .
李越 , 孔树佳 , 赵嫔 , 等 . 阿得贝利单抗联合化疗一线治疗广泛期小细胞肺癌的成本效果分析 [J ] . 中国现代应用药学 , 2024 , 41 ( 9 ): 1267 - 1274 .
赵荧荧 , 居文祥 , 张小涵 , 等 . 替雷利珠单抗联合化疗一线治疗晚期或转移性食管鳞状细胞癌的成本-效果分析 [J ] . 中国医院药学杂志 , 2025 , 45 ( 4 ): 418 - 426 .
郑水莲 , 郑小卫 , 杨秀丽 , 等 . 多纳非尼治疗晚期肝细胞癌的药物经济学评价 [J ] . 中国药学杂志 , 2023 , 58 ( 17 ): 1622 - 1628 .
LANG Y T , CHAI Q Q , LIN Y , et al . Adding capivasertib to fulvestrant in patients with hormone receptor-positive advanced breast cancer:a cost-effectiveness analysis [J ] . Front Pharmacol , 2025 , 15 : 1495082 .
上海生命绿洲公益服务中心 . 医药筹安罗替尼患者救助项目公告 [EB/OL ] . [ 2025-08-10 ] . https://www.shoases.com/public/index.php/index/shows catid https://www.shoases.com/public/index.php/index/showscatid = 5 & id= 111 .
医药筹 . 安心有尼患者救助项目调整公告 [EB/OL ] . [ 2025-08-10 ] . https://mp.weixin.qq.com/s/UHg7T2pVvR- 4X1hIEC_tEFg https://mp.weixin.qq.com/s/UHg7T2pVvR-4X1hIEC_tEFg .
魏磊 , 刘演 , 吴焱 , 等 . 信迪利单抗联合贝伐珠单抗用于晚期不可切除肝细胞癌患者TACE后的临床观察 [J ] . 中国药房 , 2024 , 35 ( 24 ): 3029 - 3034 .
0
Views
17
下载量
0
CSCD
Publicity Resources
Related Articles
Related Author
Related Institution
京公网安备11010802024621
