【摘要】 目的：从中国卫生体系角度出发，评价洛拉替尼对比伊鲁阿克一线治疗间变性淋巴瘤激酶（anaplastic lymphoma kinase,ALK）阳性非小细胞肺癌（non-small cell lung cancer,NSCLC）的经济性。方法：基于INSPIRE和CROWN试验，建立三状态分区生存模型模拟疾病发展进程，模拟周期为3周，时限为10年；以增量成本-效果比（incremental cost-effectiveness ratio,ICER）为主要结局指标，总成本和质量调整生命年（quality adjusted life years,QALY）为次要结局指标；成本和健康产出按5.0%贴现。以1～3倍我国2023年人均GDP(89 358～268 074元)作为意愿支付阈值（willingness to pay,WTP），采用成本-效用分析法进行分析，并以敏感性分析和情境分析验证模型稳定性。结果：相较于伊鲁阿克，洛拉替尼成本（1 106 990.2元vs. 780 990.0元）和QALY(3.84 vs. 3.42)更高，ICER为775 645.1元/QALY，高于3倍WTP阈值（268 074元）；单因素敏感性分析显示洛拉替尼的成本、伊鲁阿克的成本等因素对ICER影响显著；概率敏感性分析显示，在WTP为268 074元时，伊鲁阿克治疗方案具有经济性的概率为97.8%。在提高疾病进展状态下的效用值和改善伊鲁阿克疗效情境下的结果与基础分析结果一致，而在降低洛拉替尼的价格情境下时，结果翻转。结论：与伊鲁阿克相比，洛拉替尼一线治疗ALK阳性NSCLC不具备经济性。更多还原

【Abstract】 OBJECTIVE To evaluate the cost-effectiveness of lorlatinib versus iruplinalkib as first-line therapy for anaplastic lymphoma kinase(ALK)-positive non-small cell lung cancer(NSCLC) from the perspective of the Chinese health system.METHODS Based on the INSPIRE and CROWN trials, a three-state partitioned survival model was developed to simulate disease progression, with a model cycle of 3 weeks and a 10-year time limit. The primary outcome was the incremental costeffectiveness ratio(ICER), and total costs and quality-adjusted life years(QALY) served as secondary outcomes. Both costs and health outputs used a 5. 0% discount rate. Cost-utility analysis was performed using 1-3 times per capita GDP in China （??89 358 to ??268 074） in 2023 as the willingness-to-pay(WTP) threshold. The sensitivity analysis and scenario analysis were conducted to assess model robustness. RESULTS Compared to iruplinalkib, lorlatinib incurred higher costs （ ??1 106 990. 2 vs. ??780 990. 0） and gained more QALYs(3. 84 vs. 3. 42), resulting in an ICER of ??775 645. 1/QALY that was higher than the three times WTP threshold （??268 074）. One-way sensitivity analysis showed that the cost of lorlatinib and iruplinalkib had a significant impact on the ICER. Probabilistic sensitivity analysis demonstrated that at the ??268 074 WTP threshold, the probability of iruplinalkib being cost-effective was 97. 8%. The results under the scenario of increasing utility values in the progressive disease state and improving the efficacy of lorlatinib were consistent with the basic analytic results, while the results were reversed in the scenario of reducing the price of lorlatinib. CONCLUSION Compared to iruplinalkib, lorlatinib is not cost-effective for ALK-positive NSCLC as a first-line treatment.更多还原