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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
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| 篇名： | 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 |
| TITLE： | Cost-utility analysis of anlotinib combined with penpulimab in first-line treatment of unresectable hepatocellular carcinoma |
| 摘要： | 目的 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。方法基于APOLLO研究数据，建立分区生存模型，以21d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）（287247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338611.20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。 |
| ABSTRACT： | OBJECTIVE 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 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 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 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. |
| 期刊： | 2026年第37卷第03期 |
| 作者： | 闫文英；杨娜；张冉冉；陶心悦；高胜男；刘国强 |
| AUTHORS： | YAN Wenying，YANG Na，ZHANG Ranran，TAO Xinyue，GAO Shengnan，LIU Guoqiang |
| 关键字： | 安罗替尼；派安普利单抗；索拉非尼；肝细胞癌；成本-效用分析；经济性；分区生存模型 |
| KEYWORDS： | anlotinib； penpulimab； sorafenib； hepatocellular carcinoma； cost-utility analysis； cost-effectiveness； partitioned |
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