Department of Pharmacy, Guangxi Academy of Medical Sciences and the People's Hospital of Guangxi Zhuang Autonomous Region, Nanning, Guangxi, People's Republic of China.
Phase 1 Clinical Trial Laboratory, Guangxi Academy of Medical Sciences and the People's Hospital of Guangxi Zhuang Autonomous Region, Nanning, Guangxi, People's Republic of China.
Sci Rep. 2024 Mar 21;14(1):6807. doi: 10.1038/s41598-024-57277-7.
In the CheckMate 651 study, nivolumab plus ipilimumab versus EXTREME (cisplatin/carboplatin + cetuximab + fluorouracil) regimen was compared for effectiveness. It is not known whether these immunotherapy agents are cost-effective for recurrent or metastatic squamous cell carcinomas of the head and neck (R/M SCCHN). The purpose of this study was to compare the cost-effectiveness of nivolumab plus ipilimumab with EXTREME in the first-line setting from the standpoint of third-party payers in the United States. The projecting of costs and outcomes over 15 years was done using a three-state partitioned survival model discounted by 3% per year. Long-term extrapolation of CheckMate 651 was used to model progression-free survival and overall survival (OS). The incremental net health benefit (INHB), incremental net monetary benefit (INMB), quality-adjusted life years (QALYs), and incremental cost-effectiveness ratio (ICER) were calculated. The uncertainty and stability of the model were accounted for via one-way and probabilistic sensitivity analyses. As compared with nivolumab plus ipilimumab, EXTREME was associated with an increase of 0.154 life-years and 0.076 QALYs, as well as a cost increase of $572 per patient. The corresponding ICERs were $7545/QALY along with the values of INMB and INHB were $113,267 and 0.076 QALYs, respectively, at a willingness to pay (WTP) threshold of $150,000/QALY. The probability of nivolumab plus ipilimumab being cost-effective was > 99% in patients with combined positive score (CPS) ≥ 1, CPS 1-19, or CPS ≥ 20. Moreover, hazard ratio for OS and body weight were the most sensitive parameters for the model. According to sensitivity analyses, these results were generally robust. In overall populations with R/M SCCHN, the EXTREME regimen is cost-effective compared with nivolumab plus ipilimumab. Given a WTP threshold of $150,000 per QALY, the probability of the EXTREME regiment being cost-effective compared with nivolumab and ipilimumab, was 64%. Importantly, there was heterogeneity in the cost-effectiveness probabilities, based on primary sites and expression levels of PD-L1. Therefore, tailored treatment based on individual patient and clinical characteristics, remains important, and may impact the cost-effectiveness of the regimens under study.
在 CheckMate 651 研究中，nivolumab 联合 ipilimumab 与 EXTREME（顺铂/卡铂+西妥昔单抗+氟尿嘧啶）方案进行了疗效比较。尚不清楚这些免疫治疗药物对于复发性或转移性头颈部鳞状细胞癌（R/M SCCHN）是否具有成本效益。本研究旨在从美国第三方支付者的角度比较 nivolumab 联合 ipilimumab 与 EXTREME 在一线治疗中的成本效益。通过每年贴现 3%的三状态分区生存模型来预测 15 年的成本和结果。使用 CheckMate 651 的长期外推来对无进展生存期和总生存期（OS）进行建模。计算增量净健康收益（INHB）、增量净货币收益（INMB）、质量调整生命年（QALYs）和增量成本效益比（ICER）。通过单向和概率敏感性分析考虑了模型的不确定性和稳定性。与 nivolumab 联合 ipilimumab 相比，EXTREME 方案导致患者寿命增加 0.154 年，QALY 增加 0.076 年，患者成本增加 572 美元。相应的 ICER 为每 QALY7545 美元，INMB 和 INHB 的值分别为 113267 美元和 0.076QALY。在 150000 美元/QALY 的意愿支付（WTP）阈值下。对于 CPS≥1、CPS1-19 或 CPS≥20 的患者，nivolumab 联合 ipilimumab 的概率大于 99%。此外，OS 和体重的风险比是模型最敏感的参数。根据敏感性分析，这些结果基本稳健。在患有 R/M SCCHN 的总体人群中，与 nivolumab 联合 ipilimumab 相比，EXTREME 方案具有成本效益。对于 WTP 阈值为每 QALY150000 美元，与 nivolumab 和 ipilimumab 相比，EXTREME 方案具有成本效益的概率为 64%。重要的是，根据 PD-L1 的主要部位和表达水平，成本效益概率存在异质性。因此，基于个体患者和临床特征的个体化治疗仍然很重要，并且可能会影响研究中方案的成本效益。
