Centre Hospitalier Intercommunal, Créteil, France.
MSD France, Courbevoie, France.
Lung Cancer. 2019 Jan;127:44-52. doi: 10.1016/j.lungcan.2018.11.008. Epub 2018 Nov 23.
INTRODUCTION: In the KEYNOTE-024 trial, pembrolizumab demonstrated significant improvements in progression-free survival (PFS) and overall survival (OS) versus Standard-of-Care (SoC) platinum-based doublets for first-line treatment of PD-L1 -positive (≥50%) metastatic Non-Small-Cell Lung Cancer (NSCLC) patients with no EGFR mutations or ALK translocations. This study aims to assess the cost-effectiveness of pembrolizumab versus SoC platinum-based chemotherapy from the French healthcare system perspective. METHODS: A three-state partitioned-survival model was adapted to project outcomes and costs of squamous and non-squamous NSCLC patients respectively, over a 10-year time horizon. Clinical and utility data were collected from the trial. A network meta-analysis was performed to consider platinum-based triplets also used for non-squamous NSCLC. Direct medical costs were considered based on ressources identified from the trial and literature. Costs and outcomes were discounted at 4% per year. Incremental cost-effectiveness ratios (ICERs) were calculated as cost per Life Year (LY) and cost per Quality-Adjusted Life Year (QALY). Sensitivity and scenario analyses were performed to assess the robustness of results. RESULTS: For squamous NSCLC, pembrolizumab was projected to increase life expectancy of patients by 0.93 LY (11 months), and 0.74 QALY (9 months) for an incremental cost of €62,032 compared with platinum-based doublets. The ICER of pembrolizumab versus platinum-based doublets was €66,825/LY and €84,097/QALY. For non-squamous NSCLC, pembrolizumab was projected to increase life expectancy of patients by 0.85-1.32 LYs (10.2-15.8 months) and 0.64-1.02 QALYs (7.7-12.2 months) for an incremental cost varying from €-14,947-+47,064 depending on the specific comparator. The ICER of pembrolizumab versus platinum-based chemotherapy with paclitaxel plus bevacizumab was €62,846/LY and €78,729/QALY; regimens including pemetrexed were dominated. Results were most sensitive to extrapolations of survival outcomes and assumptions for continued effectiveness and treatment duration of pembrolizumab. CONCLUSIONS: Pembrolizumab appears cost-effective versus SoC chemotherapy for first-line treatment of PD-L1-positive (50%) metastatic NSCLC patients in France, assuming willingness-to-pay under 100,000€/QALY (OECD threshold in the discussion section).
简介：在 KEYNOTE-024 试验中，与标准护理（SoC）铂类双联化疗相比，帕博利珠单抗在 PD-L1 阳性（≥50%）转移性非小细胞肺癌（NSCLC）患者的一线治疗中显著改善了无 EGFR 突变或 ALK 易位患者的无进展生存期（PFS）和总生存期（OS）。本研究旨在从法国医疗保健系统的角度评估帕博利珠单抗与 SoC 铂类化疗相比的成本效益。 方法：采用三状态分区生存模型，分别对鳞状和非鳞状 NSCLC 患者的 10 年时间内的结果和成本进行预测。临床和效用数据来自试验。进行了网络荟萃分析，以考虑也用于非鳞状 NSCLC 的铂类三联疗法。直接医疗成本基于试验和文献中确定的资源进行考虑。成本和结果按每年 4%贴现。增量成本效益比（ICER）计算为每生命年（LY）和每质量调整生命年（QALY）的成本。进行敏感性和情景分析以评估结果的稳健性。 结果：对于鳞状 NSCLC，与铂类双联化疗相比，帕博利珠单抗预计可使患者的预期寿命延长 0.93 LY（11 个月）和 0.74 QALY（9 个月），增量成本为 62032 欧元。与铂类双联化疗相比，帕博利珠单抗的 ICER 为 66825 欧元/LY 和 84097 欧元/QALY。对于非鳞状 NSCLC，帕博利珠单抗预计可使患者的预期寿命延长 0.85-1.32 LY（10.2-15.8 个月）和 0.64-1.02 QALY（7.7-12.2 个月），增量成本因特定比较剂而异，从-14947 欧元到+47064 欧元不等。与含紫杉醇加贝伐珠单抗的铂类化疗相比，帕博利珠单抗的 ICER 为 62846 欧元/LY 和 78729 欧元/QALY；含培美曲塞的方案则占主导地位。结果对生存结果的外推和对帕博利珠单抗继续有效性和治疗持续时间的假设最为敏感。 结论：假设愿意支付的费用低于 100000 欧元/QALY（讨论部分的经合组织阈值），帕博利珠单抗在法国用于一线治疗 PD-L1 阳性（50%）转移性 NSCLC 患者的治疗中，相对于 SoC 化疗具有成本效益。
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