达可替尼对比吉非替尼一线治疗EGFR突变晚期或转移性非小细胞肺癌的成本效果分析

Cost-effectiveness analysis of dacomitinib versus gefitinib in first-line treatment of EGFR-mutation advanced or metastatic non-small cell lung cancer

目的比较达可替尼和吉非替尼一线治疗中国表皮生长因子受体(EGFR)突变晚期或转移性非小细胞肺癌(NSCLC)的成本效果。方法建立无疾病进展、疾病进展和死亡三种健康状态的分区生存模型。基于ARCHER 1050临床试验获取转移概率和安全性数据,根据已发表文献获得健康效用值,从卫生服务体系角度只考虑直接医疗成本,包括药品费用、随访费用、支持治疗费用和不良反应治疗费用。采用单因素和概率敏感性分析观察模型稳定性。结果一线治疗EGFR突变晚期或转移性NSCLC,达可替尼相比吉非替尼增加了0.80质量调整生命年(QALYs),每例患者的费用增加350 916.6元,增量成本效果比为303 033.2元·QALYs-1,高于全国3倍人均GDP的支付意愿阈值,低于北京、上海等经济发达地区3倍人均GDP的支付意愿阈值。单因素敏感性分析和概率敏感性分析结果表明,模型中的参数在一定范围内变化并未对结果产生显著影响。结论达可替尼一线治疗EGFR突变晚期或转移性非小细胞肺癌,与吉非替尼相比在全国人群中不具有成本效果优势,但在北京、上海等经济发达地区具有成本效果优势。

AIM To evaluate the cost effectiveness of dacomitinib with gefitinib in first-line treatment of advanced or metastatic non-small cell lung cancer(NSCLC) with epidermal growth factor receptor(EGFR) mutation in China. METHODS The partition survival model was established, including three states of progression-free survival, progressive survival, and death. Transition probabilities and safety data were collected from the ARCHER 1050 trial. Utility values were derived from literature. From the perspective of the health service systerm, only direct medical costs were considered,including the cost of drugs, chemotherapy, supportive care, routine follow up, and managing adverse events. Sensitivity analysis was performed to observe model stability. RESULTS Compared with gefitinib, the strategy with dacomitinib resulted in a gain of 0.80 quality-adjusted life years(QALYs) at a cost of 350 916.6 CNY per patient, the incremental cost-effectiveness ratios(ICERs) were 303 033.2 CNY per QALY, it was higher than the threshold of willingness to pay which is triple the national GDP per capita, and it was lower than the threshold of willingness to pay which is triple the GDP per capita in developed areas such as Beijing and Shanghai. The results of univariate and probability sensitivity analyses showed that the model parameters vary within a certain rang and have no significant impacts. CONCLUSION Compared with gefitinib, dacomitinib has no cost-effectiveness advantage in overall Chinese population, but it has a cost-effectiveness advantage in some economically developed areas such as Beijing and Shanghai.