Rutgers Cancer Institute of New Jersey, New Brunswick, NJ, USA.
F. Hoffmann-La Roche, Basel, Switzerland.
J Med Econ. 2024 Jan-Dec;27(1):766-776. doi: 10.1080/13696998.2024.2352820. Epub 2024 Jun 6.
Mosunetuzumab has received accelerated approval by the US Food and Drug Administration for adult patients with relapsed or refractory (R/R) follicular lymphoma (FL) after two or more lines of systemic therapy. We evaluated the cost-effectiveness of mosunetuzumab for the treatment of R/R FL from a US private payer perspective.
A partitioned survival model simulated lifetime costs and outcomes of mosunetuzumab against seven comparators: axicabtagene ciloleucel (axi-cel), tisagenlecleucel (tisa-cel), tazemetostat (taz, EZH2 wild-type only), rituximab plus lenalidomide (R-Len) or bendamustine (R-Benda), obinutuzumab plus bendamustine (O-Benda), and a retrospective real-world cohort (RW) based on current patterns of care derived from US electronic health records (Flatiron Health). Efficacy data for mosunetuzumab were from the pivotal Phase II GO29781 trial (NCT02500407). Relative treatment efficacy was estimated from indirect treatment comparisons (ITCs). Costs included were related to treatment, adverse events, routine care, and terminal care. Except for drug costs (March 2023), all costs were inflated to 2022 US dollars. Costs and quality-adjusted life-years (QALYs) were used to calculate incremental cost-effectiveness ratios (ICERs). Net monetary benefit (NMB) was calculated using a willingness-to-pay (WTP) threshold of $150,000/QALY.
Mosunetuzumab dominated taz, tisa-cel, and axi-cel with greater QALYs and lower costs. Mosunetuzumab was projected to be cost-effective against R-Benda, O-Benda, and RW with ICERs of $78,607, $42,731, and $21,434, respectively. Mosunetuzumab incurred lower costs but lower QALYs vs. R-Len. NMBs showed that mosunetuzumab was cost-effective against comparators except R-Len.
Without head-to-head comparative data, the model had to rely on ITCs, some of which were affected by residual bias. Model inputs were obtained from multiple sources. Extensive sensitivity analyses assessed the importance of these uncertainties.
Mosunetuzumab is estimated to be cost-effective compared with approved regimens except R-Len for the treatment of adults with R/R FL.
美国食品和药物管理局（FDA）已加速批准莫努匹韦单抗用于二线或多线全身治疗后复发或难治性（R/R）滤泡性淋巴瘤（FL）的成年患者。我们从美国私人支付者的角度评估了莫努匹韦单抗治疗 R/R FL 的成本效益。
一个分割生存模型模拟了莫努匹韦单抗与七种对照药物（axicabtagene ciloleucel（axi-cel）、tisagenlecleucel（tisa-cel）、tazemetostat（taz，仅野生型 EZH2）、rituximab 加 lenalidomide（R-Len）或 bendamustine（R-Benda）、obinutuzumab 加 bendamustine（O-Benda）以及基于当前美国电子健康记录（Flatiron Health）中护理模式的回顾性真实世界队列（RW））的终生成本和结果。莫努匹韦单抗的疗效数据来自关键的 II 期 GO29781 试验（NCT02500407）。相对治疗效果是通过间接治疗比较（ITC）来估计的。包括与治疗、不良事件、常规护理和终末护理相关的成本。除药物成本（2023 年 3 月）外，所有成本均按 2022 年美元通胀调整。成本和质量调整生命年（QALY）用于计算增量成本效益比（ICER）。使用 150,000 美元/QALY 的意愿支付（WTP）阈值计算净货币收益（NMB）。
莫努匹韦单抗在 QALYs 更高且成本更低的情况下优于 taz、tisa-cel 和 axi-cel。与 R-Benda、O-Benda 和 RW 相比，莫努匹韦单抗的增量成本效益比（ICER）分别为 78607 美元、42731 美元和 21434 美元。与 R-Len 相比，莫努匹韦单抗的成本较低，但 QALYs 较低。NMB 表明，莫努匹韦单抗除了 R-Len 之外，与对照药物相比都是有效的。
由于没有头对头的比较数据，该模型必须依赖 ITC，其中一些受到残余偏差的影响。模型输入来自多个来源。广泛的敏感性分析评估了这些不确定性的重要性。
与批准的治疗方案相比，莫努匹韦单抗用于治疗 R/R FL 的成年患者，除了 R-Len 之外，估计是具有成本效益的。
