劳拉替尼一线治疗间变性淋巴瘤激酶阳性晚期非小细胞肺癌的药物经济学评价

Pharmacoeconomic evaluation of loratinib in the first-line treatment of anaplastic lymphoma kinasepositive advanced non-small cell lung cancer

目的从中国卫生体系角度出发,评价劳拉替尼对比克唑替尼一线治疗间变性淋巴瘤激酶(ALK)阳性晚期非小细胞肺癌的经济性,为该药在我国除香港以外其他地区的产品定价及相关医疗决策提供参考。方法基于CROWN试验数据同时构建Markov模型和分区生存模型(模拟时限为10年,循环周期为4周),以质量调整生命年(QALY)作为效果指标计算增量成本-效果比(ICER),并通过单因素敏感性分析、概率敏感性分析、情景分析验证基础分析结果的稳健性。结果基于Markov模型的基础分析结果显示,相较于克唑替尼组,劳拉替尼组人均成本增加了17867588.63元,人均效用增加了1.76 QALYs,ICER为10152038.99元/QALY;基于分区生存模型的基础分析结果显示,相较于克唑替尼组,劳拉替尼组人均成本增加了18009592.54元,人均效用增加了1.74 QALYs,ICER为10350340.54元/QALY。2种模型单因素敏感性分析结果显示,无进展生存状态效用值、疾病进展状态效用值及劳拉替尼成本等参数对结果影响较大。概率敏感性分析结果显示,以1~3倍2020年中国人均国内生产总值作为意愿支付阈值时,劳拉替尼具有经济性的概率为0。建议劳拉替尼每100 mg的单价为657.10~815.60元。结论对于一线治疗ALK阳性晚期非小细胞肺癌患者,劳拉替尼相对于克唑替尼的疗效更好,但以当前药价而言在我国并不具有经济性;合理降低药价可增加其具有经济性的概率。

OBJECTIVE To evaluate the economy of loratinib versus crizotinib in the first-line treatment of anaplastic lymphoma kinase(ALK)-positive advanced non-small cell lung cancer(NSCLC)from the perspective of China’s health system,and to provide reference for the product pricing and related medical decisions of the drug in other regions of China except for Hong Kong.METHODS Markov model and partition survival model both constructed based on the CROWN data(the simulation time limit was 10 years and the cycle period was 4 weeks);the quality adjusted life year(QALY)was used as the outcome index to calculate the incremental cost-effectiveness ratio(ICER).One-way sensitivity analysis,probability sensitivity analysis and scenario analysis were used to verify the robustness of the results.RESULTS The basic analysis results based on Markov model showed that compared with crizotinib group,the per capita cost of loratinib group increased by 17867588.63 yuan,the per capita utility increased by 1.76 QALYs,and the ICER was 10152038.99 yuan/QALY.The basic analysis results based on the partition survival model showed that compared with the crizotinib group,the per capita cost of loratinib group increased by 18009592.54 yuan,the per capita utility increased by 1.74 QALYs,and the ICER was 10350340.54 yuan/QALY.The results of one-way sensitivity analysis of the two models both showed that progression-free survival(PFS)state utility value,progression-disease(PD)state utility value and loratinib cost had great influence on the results.The results of probability sensitivity analysis showed that when 1-3 times of China’s per capita GDP in 2020 was taken as the willingness to pay threshold,the probability of loratinib being economical was 0.The recommended unit price of loratinib per 100 mg was 657.10-815.60 yuan.CONCLUSIONS For patients with ALK-positive advanced NSCLC,loratinib is more effective than crizotinib in the first-line treatment,but it is not economical under the current price;reasonably lowering the price of loratinib can increase the probability of its economy.