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阿可替尼、泽布替尼和伊布替尼一线治疗慢性淋巴细胞白血病的成本-效用分析
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| 篇名： | 阿可替尼、泽布替尼和伊布替尼一线治疗慢性淋巴细胞白血病的成本-效用分析 |
| TITLE： | Cost-utility analysis of acalabrutinib，zanubrutinib，and ibrutinib as first-line treatment for chronic lymphocytic leukemia |
| 摘要： | 目的 评估阿可替尼、泽布替尼和伊布替尼一线治疗慢性淋巴细胞白血病（CLL）的经济性。方法构建分区生存模型模拟初治CLL患者的10年疾病进程，循环周期为4周，成本和效果的年折现率均为4.5%。系统检索相关临床试验文献，提取各干预方案的生存数据，以RESONATE-2试验的伊布替尼组为锚定组，通过锚定间接比较法获取阿可替尼组和泽布替尼组相对于伊布替尼组的疗效参数，结合锚定组生存数据构建各干预方案的无进展生存期和总生存期生存曲线。以质量调整生命年（QALY）为模型产出指标计算增量成本-效果比和增量净货币效益（INMB），将意愿支付（WTP）阈值设定为2倍2025年中国人均国内生产总值，即199330元/QALY，比较3种方案的经济性。采用单因素敏感性分析、概率敏感性分析和情境分析验证基础分析结果的稳健性。结果基础分析结果显示，与伊布替尼组相比，阿可替尼组和泽布替尼组方案均表现出成本节约和健康获益优势；阿可替尼组方案的INMB为149361.37元，泽布替尼组为194783.94元，两者在经济性上均具有绝对优势。单因素敏感性分析结果显示，药品价格、不同治疗方案间的风险比和效用值为主要影响因素。概率敏感性分析表明，当WTP阈值低于450000元/QALY时，阿可替尼组和泽布替尼组方案具有经济性的概率始终高于伊布替尼组。情境分析结果显示，在采用不同锚定组、高危患者队列数据及20年研究时限等假设下，阿可替尼组和泽布替尼组方案相较于伊布替尼组仍具有经济性。结论泽布替尼和阿可替尼相比于伊布替尼一线治疗CLL更具有经济性，且泽布替尼的经济性优势更为显著。 |
| ABSTRACT： | Abstract OBJECTIVE To evaluate the cost-effectiveness of acalabrutinib， zanubrutinib， and ibrutinib as first-line treatments for patients with chronic lymphocytic leukemia （CLL）. METHODS A partitioned survival model was developed to simulate the 10-year disease progression of treatment-naive CLL patients. The model used a 4-week cycle length， and an annual discount rate of 4.5% was applied to both costs and health outcomes. Relevant clinical trial literature was systematically reviewed， and survival data for each treatment strategy were extracted. Using the ibrutinib arm from the RESONATE-2 trial as the anchor arm， an anchored indirect comparison approach was performed to estimate the relative treatment effects of acalabrutinib group and zanubrutinib group versus ibrutinib group. Survival curves for progression-free survival and overall survival for each treatment strategy were generated by combining the relative efficacy estimates with the survival data from the anchor arm. Quality-adjusted life year （QALY） were used as the model outcome measure. The incremental cost-effectiveness ratio and incremental net monetary benefit （INMB） were calculated to assess the economic value of the three treatment regimens. The willingness-to-pay （WTP） threshold was set at twice the 2025 per capita gross domestic product of China， corresponding to 199 330 yuan/QALY. One-way sensitivity analysis， probabilistic sensitivity analysis， and scenario analyses were conducted to evaluate the robustness of the base-case results. RESULTS In the base-case analysis， compared with ibrutinib group， both acalabrutinib group and zanubrutinib group demonstrated cost-saving and health-improving advantages. The INMBs were 149 361.37 yuan for acalabrutinib group and 194 783.94 yuan for zanubrutinib group， indicating that both strategies were dominant over ibrutinib. One-way sensitivity analysis showed that drug prices， hazard ratios between treatment strategies， and utility values were the major factors influencing the results. Probabilistic sensitivity analysis demonstrated that when the WTP threshold was below 450 000 yuan/QALY， acalabrutinib group and zanubrutinib group regimens consistently had higher probabilities of being cost-effective than ibrutinib group. Scenario analyses showed that acalabrutinib group and zanubrutinib group remained cost-effective compared with ibrutinib group under alternative assumptions， including different anchor arms， high-risk patient cohorts， and an extended 20-year time horizon. CONCLUSIONS Compared with ibrutinib， zanubrutinib and acalabrutinib can provide greater economic value as first-line treatments for CLL， with zanubrutinib demonstrating a more pronounced cost-effectiveness advantage. |
| 期刊： | 2026年第37卷第15期 |
| 作者： | 嵇欣悦；王雨菲；田磊 |
| AUTHORS： | JI Xinyue，WANG Yufei，TIAN Lei |
| 关键字： | 阿可替尼；泽布替尼；伊布替尼；布鲁顿酪氨酸激酶抑制剂；慢性淋巴细胞白血病；药物经济学评价；分区生存模型；成本- |
| KEYWORDS： | acalabrutinib； zanubrutinib； ibrutinib； Bruton’s tyrosine kinase inhibitor； chronic lymphocytic leukemia； pharmacoeconomic evaluation； partitioned survival model； cost-utility analysis |
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