目的 评价安罗替尼联合派安普利单抗对比索拉非尼一线治疗不可切除肝细胞癌的长期成本效果，分析该方案的最优定价策略。方法 基于APOLLO临床试验数据，从中国卫生体系视角构建分区生存模型，模拟时限为3～10年，周期为3周。模型估算2种方案的总直接医疗成本、质量调整生命年（QALYs）及增量-成本效果比（ICER）。成本参数参考2025年药品中标价、医疗服务价格与已发表文献，效用值来源于临床研究。成本和效果均5%进行贴现，意愿支付（WTP）阈值设定为3倍2024年人均国内生产总值。采用单因素与概率敏感性分析检验结果稳健性，并通过安罗替尼和派安普利单抗的价格调整进行最优定价策略分析。结果 5年用药时限下ICER为525 882.33元/QALY，虽随用药时间延长略有下降，但仍远高于WTP阈值。单因素敏感性分析表明，疾病无进展和进展状态的健康效用值以及派安普利单抗价格是影响结果的关键参数。概率敏感性分析提示联合方案具有经济性的概率仅为3.86%。情景分析显示大幅度药品价格调整可显著改善其经济性。结论 在当前定价下，安罗替尼联合派安普利单抗不具备成本效果优势。

Objective To evaluate the cost-effectiveness of anlotinib plus penpulimab versus sorafenib as first-line treatment for unresectable hepatocellular carcinoma（uHCC）. Methods Based on data from the APOLLO clinical trial, a three-state partitioned survival model was constructed from the Chinese healthcare system perspective, with a time horizon of 3 to 10 years and a cycle length of three weeks. The model estimated total direct medical costs, quality-adjusted life years（QALYs）, and the incremental costeffectiveness ratio（ICER） for the two strategies. Cost parameters were derived from the 2025 average tender prices of drugs, healthcare service prices, and published literature, while utility values were sourced from relevant clinical studies. Both costs and effects were discounted at an annual rate of 5%. The willingness-to-pay（WTP） threshold was set at three times China’s 2024 per capita GDP. Oneway sensitivity analysis and probabilistic sensitivity analysis were performed to test the robustness of the results, and optimal pricing strategy analysis was conducted through price adjustments of anlotinib and penpulimab. Results At the 5-year time horizon, the ICER was 525 882.33 Chinese yuan per QALY. Although the ICER decreased slightly with extended time horizons, it remained substantially higher than the WTP threshold. One-way sensitivity analysis indicated that health utility values for progression-free survival and progressive disease states, as well as the price of penpulimab, were key drivers of the ICER. Probabilistic sensitivity analysis showed that the probability of the combination regimen being cost-effective was only 3.86%. Scenario analysis demonstrated that drug price adjustments could significantly improve its cost-effectiveness. Conclusion At current drug prices, anlotinib combined with penpulimab is not a cost-effective option. Future price adjustments and inclusion in the national reimbursement drug list could be key strategies for enhancing its economic value.

R979.1

国家自然基金面上资助项目(82574735); 成都中医药大学临床-基础联合研究专项(LHJJ202402017)