帕博利珠单抗一线治疗非小细胞肺癌的药物经济学分析

Pharmacoeconomic Analysis of Pembrolizumab as First-line Therapy for Advanced Non-Small Cell Lung Cancer

目的 评估抗PD-1免疫治疗药物帕博利珠单抗与含铂双药化疗作为晚期非小细胞肺癌(nonsmall cell lung cancer,NSCLC)一线治疗的成本效用。方法 基于KEYNOTE-024研究比较一线帕博利珠单抗与铂双药治疗程序性死亡受体-配体1(programmed cell death-Ligand 1,PD-L1)组织多肽特异抗原(tissue polypeptide specific antigen,TPS)≥50%、无表皮生长因子受体(epidermal growth factor receptor,EGFR)、间变性淋巴瘤激酶(anaplastic lymphoma kinase,ALK)驱动基因突变的晚期NSCLC初治患者的生存、进展和安全性数据。使用已发表的成本数据计算增量成本效益比(incremental cost effectiveness ratio,ICER)。研究基于贝叶斯马尔可夫模型模拟终身的疾病转化,以美元估算成本并将有效性总结为质量调整生命年(quality-adjusted life-years,QALY)。结果 接受帕博利珠单抗治疗患者累积1.80 QALY(95%CrI 1.56~1.89),而含铂双药化疗为1.06 QALYs(0.94~1.13)。ICER为每个生命终了(end-of-life,EoL)调整后的QALY 52 000美元,超过了30 780美元的支付阈值门槛。结论 与含铂双药化疗相比帕博利珠单抗用于NSCLC一线治疗的成本效用有限,除非个体有更高的支付意愿。

OBJECTIVE To evaluate the anti-PD-1 immunotherapy drug-pembrolizumab compared to platinum-doublet chemotherapy as first-line therapy for advanced nonsmall cell lung cancer(NSCLC). METHODS Retrieved survival,progression, and safety data comparing first-line pembrolizumab to platinum-doublets for advanced NSCLC patients with PD-L1expression≥50%, non-mutated EGFR, and non-translocated ALK, from KEYNOTE-024. The analysis was based on a Bayesian Markov model of disease with full lifetime horizon. Estimated costs in USD and summarized effectiveness as quality-adjusted life-years(QALYs). RESULTS Patients treated with pembrolizumab accumulated 1.80 QALYs(95% CrI 1.56–1.89), compared to 1.06 QALYs(0.94–1.13) with chemotherapy. The ICER was $52 000 per end-of-life(EoL) adjusted QALY gained, above the$30 780 threshold. CONCLUSION Compared with platinum-doublets, pembrolizumab is not cost-effective in the first-line setting for patients with NSCLC, unless the individual has a higher willingness to pay.