奥希替尼用于EGFR+晚期非小细胞肺癌患者一线治疗的药物经济学评价

Pharmacoeconomic evaluation of osimertinib in the first-line treatment of locally advanced or metastatic NSCLC with an EGFR mutation

目的评估奥希替尼在2020年国家谈判价格下用于有表皮生长因子受体(epidermal growth factor receptor,EGFR)阳性突变的局部晚期或转移性非小细胞肺癌(non-small cell lung cancer,NSCLC)患者一线治疗的成本效用。方法基于卫生服务支付方角度,构建包含无进展生存期(progression-free survival,PFS)和疾病进展期(progressive disease,PD)的分区生存模型,以质量调整生命年(quality-adjusted life years,QALYs)作为结果指标计算增量成本效用比(incremental cost-utility,ICER)。疗效数据来自多中心、随机、对照、双盲的FLAURA试验,成本数据来自招采挂网数据和专家咨询,不同健康状态的健康效用值源于文献。对关键参数进行敏感度分析。结果与厄洛替尼、吉非替尼、阿法替尼和埃克替尼相比,奥希替尼在国家谈判价格下终身成本更高,获得的QALYs也更高。与已过专利期的厄洛替尼和吉非替尼相比,奥希替尼ICER值分别为122 695元和117 359元,约为我国人均GDP的1.7倍;与同样仍在专利期的阿法替尼和埃克替尼相比,奥希替尼ICER值分别为16 502元和43 337元,远低于我国人均GDP。单因素敏感度分析显示,奥希替尼价格是对ICER值影响最大的因素。概率敏感度分析显示,当支付意愿为我国三倍人均GDP时,奥希替尼具有成本效果的概率为100%。结论与厄洛替尼、吉非替尼、阿法替尼和埃克替尼相比,奥希替尼用于EGFR+的局部晚期或转移性NSCLC患者一线治疗更具成本效用。

Objective To evaluate the cost-utility of osimertinib as first-line therapy for locally advanced or metastatic non-small cell lung cancer (NSCLC) with an epidermal growth factor receptor(EGFR) mutation at the 2020 nationally negotiated price.Methods From the payer’s perspective,a partitioned survival model including disease progression-free (PF) and progressive disease (PD) was constructed,and the quality-adjusted life years (QALYs) was calculated to evaluate the incremental cost-utility ratio (ICER).The efficacy data of these therapies was retrieved from the FLAURA trial,and the cost was collected from the official procurement website and expert consultation,while the health utility was derived from literature.Sensitivity analysis was applied on key parameters to test the robustness of the model.Results Compared with erlotinib,gefitinib,afatinib and icotinib,osimertinib with nationally negotiated price had a higher lifetime cost and higher QALYs.Compared with erlotinib and gefitinib,whose patents have expired,the ICER of osimertinib were 122 695 yuan and 117 359 yuan,respectively,which were about 1.7 times of GDP per capita in China.Compared with afatinib and icotinib,which were still in the patent period,the ICER of osimertinib were 16 502 yuan and 43 337 yuan,respectively,which were far lower than GDP per capita.According to the single factor sensitivity analysis,the price of osimertinib was the most sensitive factor affecting ICER.The result of the probability sensitivity analysis showed that when the willingness to pay was set as three time of GDP per capita in China,the probability of osimertinib being cost-effective was 100%.Conclusion Compared with erlotinib,gefitinib,afatinib and icotinib,osimertinib was more cost-effective as the first-line treatment for locally advanced or metastatic NSCLC with the EGFR mutation.