目的 以中国卫生体系为研究角度,评价安罗替尼对比安慰剂三线治疗晚期非小细胞肺癌的经济性,为安罗替尼的临床合理应用以及医保循证决策提供参考依据.方法 利用临床试验数据和相关文献数据,应用TreeAge Pro 2022软件建立安罗替尼治疗晚期非小细胞肺癌的Markov模型,模型以3周为一循环周期,模拟时限为10年,成本和效用值采用5％的贴现率进行贴现,确定两方案各自的成本、寿命年、质量调整生命年(QALYs),模型以增量成本-效用比(ICUR)为评价指标.采用2022年我国3倍人均GDP(257094元/QALY)作为药物经济学评价的意愿支付阈值(WTP),以判断两种方案的经济性.进行单因素敏感性分析和概率敏感性分析以判断参数改变对模型结果稳健性的影响.结果 经模型模拟10年后,安罗替尼组成本为79919.41元,安慰剂组总成本为21938.43元,安罗替尼组可获得1.78个寿命年,0.8个QALYs,安慰剂组可获0.96个寿命年,0.39个QALYs,两组相比的ICUR值为141417.02元/QALY,远低于我国的意愿支付阈值(257094元/QALY).单因素敏感性分析的结果显示无进展状态效用值和安罗替尼的价格是对结果影响最显著的因素.概率敏感性分析结果显示当阈值为257094元/QALY时,安罗替尼组具有经济性的概率为100％.结论 安罗替尼对比安慰剂三线治疗我国晚期非小细胞肺癌患者时更具有经济性.
Pharmacoeconomic evaluation of third-line treatment of advanced non-small cell lung cancer with anlotinib
Objective From the perspective of the Chinese health system,to evaluate the economics of using anlotinib compared to placebo in the third line treatment of advanced non-small cell lung cancer,and provide a reference for the rational clinical application of anlotinib and evidence-based medical insurance decision-making. Methods Using clinical trial data and relevant literature data,TreeAge Pro 2022 software was used to establish a Markov model for the treatment of advanced non-small cell lung cancer with anlotinib. The model had a 3-week cycle and a simulation time limit of 10 years. The cost and utility values were discounted using a 5％ discount rate to determine the cost,life years,and quality adjusted life years (QALYs) of the two regimens,the model used the incremental cost utility ratio (ICUR) as the evaluation indicator. Using three times China's per capita GDP in 2022 (257094 yuan/QALY) as the willingness to pay threshold (WTP) for pharmacoeconomic evaluation to determine the economic viability of the two options. Single factor sensitivity analysis and probability sensitivity analysis were conducted to determine the impact of parameter changes on the robustness of model results. Results After 10 years of model simulation,the cost of the anlotinib group was 79919.41 yuan,while the total cost of the placebo group was 21938.43 yuan. The anlotinib group could obtain 1.78 life years and 0.8 QALYs,while the placebo group could obtain 0.96 life years and 0.39 QALYs. The ICUR value of the two groups compared was 141417.02 yuan/QALY,far lower than the willingness to pay threshold in China (257094 yuan/QALY). The results of the single factor sensitivity analysis showed that the utility value in the state of no progress and the price of anlotinib were the most significant factors affecting the results. The probability sensitivity analysis results showed that when the threshold was 257094 yuan/QALY,the probability of economic viability of the Anlotinib group was 100％. Conclusion Anlotinib is more cost-effective than placebo in the third line treatment of advanced non-small cell lung cancer patients in China.
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