Jagannath Sundar, Joseph Nedra, Crivera Concetta, Kharat Akshay, Jackson Carolyn C, Valluri Satish, Cost Patricia, Phelps Hilary, Slowik Rafal, Klein Timothy, Smolen Lee, Yu Xueting, Cohen Adam D
Icahn School of Medicine at Mount Sinai, New York, NY, USA.
Janssen Scientific Affairs, LLC, Horsham, PA, USA.
Oncol Ther. 2023 Jun;11(2):263-275. doi: 10.1007/s40487-023-00228-5. Epub 2023 Apr 4.
Ciltacabtagene autoleucel (cilta-cel), is a B-cell maturation antigen-directed, genetically modified autologous chimeric antigen receptor T-cell (CAR-T) immunotherapy. It is indicated for treatment for adult patients with relapsed or refractory multiple myeloma (RRMM) after four or more prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody. The objective of this study was to estimate the per-patient US commercial healthcare costs related to cilta-cel (CARVYKTI) CAR-T therapy (i.e., costs separate from cilta-cel therapy acquisition) for patients with RRMM.
US prescribing information for cilta-cel, publicly available data, and published literature were used with clinician input to identify the cost components and unit costs associated with administration of cilta-cel. Cost components included apheresis, bridging therapy, conditioning therapy, administration, and postinfusion monitoring for 1 year of follow-up. Adverse event (AE) management costs for all grades of cytokine release syndrome and neurologic toxicities, and additional AEs grade ≥ 3 occurring in > 5% of patients were included in the analysis.
The estimated per-patient average costs of cilta-cel CAR-T therapy administered exclusively in an inpatient setting, excluding cilta-cel therapy acquisition costs, totaled US$160,933 over a 12 month period. Costs assuming different proportions of inpatient/outpatient administration (85%/15% and 70%/30%) were US$158,095 and US$155,257, respectively.
Cost estimates from this analysis, which disaggregates CAR-T therapy costs, provide a comprehensive view of the cost components of CAR-T therapy that can help healthcare decision-makers make informed choices regarding the use of cilta-cel. Real-world costs may differ with improved AE prevention and mitigation strategies.
西达基奥仑赛（cilta-cel）是一种针对B细胞成熟抗原的基因改造自体嵌合抗原受体T细胞（CAR-T）免疫疗法。它适用于接受过四种或更多线先前治疗（包括蛋白酶体抑制剂、免疫调节剂和抗CD38单克隆抗体）后复发或难治性多发性骨髓瘤（RRMM）的成年患者。本研究的目的是估计RRMM患者接受西达基奥仑赛（CARVYKTI）CAR-T治疗（即与西达基奥仑赛治疗费用分开的费用）的人均美国商业医疗保健成本。
使用西达基奥仑赛的美国处方信息、公开可用数据和已发表文献，并结合临床医生的意见，确定与西达基奥仑赛给药相关的成本组成部分和单位成本。成本组成部分包括采集白细胞单采术、桥接治疗、预处理治疗、给药以及随访1年的输注后监测。分析纳入了所有级别的细胞因子释放综合征和神经毒性的不良事件（AE）管理成本，以及在超过5%的患者中发生的额外≥3级AE。
仅在住院环境中进行的西达基奥仑赛CAR-T治疗的估计人均平均成本（不包括西达基奥仑赛治疗采购成本）在12个月期间总计160,933美元。假设住院/门诊给药比例不同（85%/15%和70%/30%）时的成本分别为158,095美元和155,257美元。
本分析中的成本估计分解了CAR-T治疗成本，全面展示了CAR-T治疗的成本组成部分，有助于医疗保健决策者在使用西达基奥仑赛时做出明智选择。实际成本可能会因AE预防和缓解策略的改进而有所不同。
