Sanofi, Reading, UK.
Precision HEOR, BC, Canada.
Value Health. 2021 Mar;24(3):377-387. doi: 10.1016/j.jval.2020.09.014. Epub 2021 Jan 22.
To evaluate the cost-effectiveness of cemiplimab in patients with advanced cutaneous squamous cell carcinoma (CSCC) from a payer perspective in the United States.
A partitioned survival model was developed to assess the cost-effectiveness of cemiplimab versus historical standard of care (SOC). All inputs were identified based on a systematic literature review, supplemented by expert opinion where necessary. Clinical inputs for cemiplimab were based on individual patient data from a cemiplimab phase 2 single-arm trial (NCT27060498). For SOC, analysis was based on a pooled analysis of single-arm clinical trials and retrospective studies evaluating chemotherapy and epidermal growth factor receptor inhibitors (cetuximab, erlotinib, and gefitinib) identified via a systematic literature review (6 of the 27 included studies). Overall survival and progression-free survival were extrapolated over a lifetime horizon. Costs were included for drug acquisition, drug administration, management of adverse events, subsequent therapy, disease management, and terminal care. Unit costs were based on published 2019 US list prices.
In the base case, cemiplimab versus SOC resulted in an incremental cost-effectiveness ratio of $99 447 per quality adjusted-life year (QALY), where incremental costs and QALYs were $372 108 and 3.74, respectively. At a willingness-to-pay threshold of $150 000/QALY, the probabilistic sensitivity analysis suggests a 90% probability that cemiplimab is cost-effective compared to SOC. Scenario analyses resulted in incremental cost-effectiveness ratios ranging from $90 590 to $148 738.
Compared with historical SOC, cemiplimab is a cost-effective use of US payer resources for the treatment of advanced CSCC and is expected to provide value for money.
从支付者角度评估西妥昔单抗在治疗美国晚期皮肤鳞状细胞癌（CSCC）患者中的成本效果。
采用分区生存模型评估西妥昔单抗与历史标准治疗（SOC）相比的成本效果。所有输入均基于系统文献综述确定，并在必要时补充专家意见。西妥昔单抗的临床输入基于西妥昔单抗 2 期单臂试验（NCT027060498）的个体患者数据。对于 SOC，分析基于系统文献综述中确定的单臂临床试验和评估化疗和表皮生长因子受体抑制剂（西妥昔单抗、厄洛替尼和吉非替尼）的回顾性研究的汇总分析。总生存期和无进展生存期在终身范围内进行外推。包括药物获取、药物管理、不良事件管理、后续治疗、疾病管理和终末护理的成本。单位成本基于 2019 年公布的美国目录价格。
在基线情况下，与 SOC 相比，西妥昔单抗的增量成本效果比为每质量调整生命年（QALY）99447 美元，增量成本和 QALY 分别为 372108 美元和 3.74。在 150000 美元/QALY 的支付意愿阈值下，概率敏感性分析表明，与 SOC 相比，西妥昔单抗具有 90%的成本效果可能性。情景分析导致增量成本效果比范围为 90590 美元至 148738 美元。
与历史 SOC 相比，西妥昔单抗是美国支付者资源治疗晚期 CSCC 的一种具有成本效果的方法，预计将物有所值。
