基于Markov模型的帕博利珠单抗单药与化疗在中国一线治疗非小细胞肺癌的成本效果分析

目的 从卫生体系角度出发，评价帕博利珠单抗单药与化疗一线治疗PD-L1肿瘤比例分数（tumor proportion score，TPS）≥1%的局部晚期或转移性非小细胞肺癌的经济性，为相关卫生决策提供依据。方法 根据疾病发展进程建立无进展、进展和死亡三状态Markov模型，以质量调整生命年（quality-adjusted life years，QALY）作为产出指标计算增量成本效果比。生存数据来自一项多中心随机对照非盲的Ⅲ期临床试验KEYNOTE-042，成本数据来自米内网和8个省市医疗卫生服务项目价格中位数，效用数据源于已发表文献，并对关键参数进行情景分析和敏感性分析。结果 基础分析结果表明，帕博利珠单抗单药治疗相对于化疗的增量成本效果比在PD-L1 TPS不同的人群中分别为395 332.25元/QALY（TPS≥50%）、735 613.67元/QALY（TPS≥20%）和597 770.09元/QALY（TPS≥1%）。单因素敏感性分析显示帕博利珠单抗价格和PFS状态效用值对ICER有较大影响。概率敏感度分析结果表明模型结构稳定，稳健性较好。结论 在中国3倍人均GDP（212 676.00元）的意愿支付阈值下，帕博利珠单抗单药治疗与化疗相比不具有成本-效果，其经济性未来可通过降低价格来实现。

Cost-effectiveness Analysis of Pembrolizumab Versus Chemotherapy as First-line Treatment in Non-small Cell Lung Cancer in China Based on Markov Model

OBJECTIVE To evaluate the economics of pembrolizumab monotherapy and chemotherapy in the first-line treatment with different PD-L1 tumor proportion scores(TPS) ≥ 1% in locally advanced or metastatic non-small cell lung cancer from the perspective of health system and to provide a basis for health decisions. METHODS According to the disease development process, a three-state Markov model:progression-free, progressive disease and death was established, and the quality-adjusted life year(QALY) was used as the output to calculate the incremental cost-effectiveness ratio. Survival analysis data came from a multi-center randomized, open-label, phase Ⅲ clinical trial KEYNOTE-042. Cost data came from the Minei website and median of eight provinces health care service prices. Utility data came from published literature. Sensitivity analysis and scenario analysis were also performed. RESULTS Based on the results of the basic analysis, compared to the standard chemotherapy group, the incremental cost-effectiveness ratio of pembrolizumab monotherapy was 395 332.25 yuan/QALY(TPS ≥ 50%), 735 613.67 yuan/QALY(TPS ≥ 20%) and 597 770.09 yuan/QALY(TPS ≥ 1%) in people with different PD-L1 TPS. The deterministic sensitivity analysis showed that the price of pembrolizumab and the utility of PFS had a greater impact on the changes in ICER. The results of probability sensitivity analysis showed that the model structure was stable and robust. CONCLUSION Under the willingness to pay threshold of three times per capita GDP of China(212 676.00 yuan), pembrolizumab monotherapy does not cost-effectiveness compared with chemotherapy, and its economic can be achieved by reducing prices in the future.