阿法替尼和吉非替尼一线治疗EGFR突变阳性非小细胞肺癌的成本效用分析

Cost-utility Analysis of Afatinib and Gefitinib in First-line Treatment of EGFR Mutation-positive Non-small Cell Lung Cancer

关键词:  阿法替尼  吉非替尼  非小细胞肺癌  成本效用分析

Key words:  afatinib  gefitinib  non-small cell lung cancer  cost-utility analysis

摘要:

目的 从中国医疗保健支付者的角度，评价阿法替尼与吉非替尼在表皮生长因子受体（epidermal growth factor receptor，EGFR）突变阳性非小细胞肺癌一线治疗中的成本效用。方法 基于一项高质量、多中心的二期随机临床试验（LUNG7），依据疾病发展进程建立三状态Markov模型（无进展生存状态、疾病进展状态、死亡状态），模型各状态转移概率与不良反应发生率通过临床试验数据提取并计算，效用值取自研究文献中的中国人群效用值，直接医疗成本取自本地收费或相关文献。对总人群Markov模型进行为期10年的成本效用评估，并对模型分析结果的稳定性进行确定敏感性和概率敏感性分析。结果 在基础分析中，10年间阿法替尼组相对于吉非替尼组需多花费$16 499.77，但同时可多获得0.29个质量调整生命年（quality-adjusted life years，QALYs），其增量成本效果比（incremental cost-effectiveness ratio，ICER）为$57 428.17/QALY。此时ICER值高于中国支付意愿阈值（willingness to pay，WTP）$26 331/QALY，表明阿法替尼目前相对于吉非替尼不具经济优势。一维敏感性分析结果显示疾病进展阶段的效用值、吉非替尼和阿法替尼的价格以及无进展生存期效用值对结果的稳定性影响较大，但除吉非替尼价格外，其他变量均不能使ICER值降至WTP之下，表明模型结果稳定。结论 对于中国EFGR突变阳性非小细胞肺癌患者，阿法替尼在一线治疗中相对于吉非替尼当前没有表现出经济性。

Abstract:

OBJECTIVE To evaluate the cost-utility of afatinib and gefitinib in the first-line treatment of epidermal growth factor receptor(EGFR) mutation-positive non-small cell lung cancer from the perspective of Chinese health care payers. METHODS Based on a high-quality, multicenter, phase 2 randomized clinical trial(LUNG7), a three-state Markov model(no progression survival status, disease progression status, death status) was established based on disease progression. The state transition probability and the incidence of adverse drug reaction were extracted and calculated from clinical trial data. The utility values were taken from the Chinese population utility values in the research literature. Direct medical costs were taken from local fees or related literature. A 10-year cost-utility assessment was performed in total population. Sensitivity analysis was performed on the stability of the model analysis results. RESULTS In the basic analysis, the afatinib group spent more $16 499.77 and received an additional 0.29 quality-adjusted life years(QALYs) relative to the gefitinib group. The incremental cost-effectiveness ratio(ICER) of the afatinib regimen and gefitinib regimen in the general population was $57 428.17/QALY which was much higher than the Chinese willingness to pay threshold(WTP) of $26 331/QALY. It indicated that afatinib had no economic advantage currently. Sensitivity analysis showed that the utility value of the stage of disease progression, the price of gefitinib and afatinib, and the utility of progression-free disease had a greater impact on the stability of the results. However, expect for the price of gefitinib, non of those variables could make the ICER lower than the WTP. It indicated robustness of the model. CONCLUSION For patients with EFGR mutation-positive non-small cell lung cancer in China, afatinib is not economical compared to gefitinib in first-line treatment.