决定异体 CAR T 细胞排斥与扩增的细胞和分子机制
Cellular and molecular mechanisms determining allogeneic CAR T cell rejection and expansion.
我们评估了11例接受单一批次cemacabtagene ansegedleucel(cema-cel)治疗的大B细胞淋巴瘤患者,cemacabtagene ansegedleucel是一种异体抗CD19 CAR T产品。
英文原题:The Economic Burden of CAR T Cell Therapies Ciltacabtagene Autoleucel and Idecabtagene Vicleucel for the Treatment of Adult Patients with Relapsed or Refractory Multiple Myeloma in the US.
本研究发现,用于 rrMM 的 CAR T 细胞基因疗法 ciltacabtagene autoleucel 和 idecabtagene vicleucel 对美国医疗支付方构成了显著的经济负担。
两种嵌合抗原受体工程T(CAR T)细胞治疗药物最近获批用于治疗复发或难治性多发性骨髓瘤(rrMM)患者。然而,其财务影响却鲜有描述。
目的:评估CAR T细胞疗法ciltacabtagene autoleucel和idecabtagene vicleucel用于治疗至少接受过四线治疗的rrMM患者的经济负担,并从美国医疗支付方角度,在假设的100万成员健康计划中比较这些CAR T细胞疗法的年度成本。
ciltacabtagene autoleucel和idecabtagene vicleucel的年度经济负担通过对关键临床试验数据的评估进行估算。药物采购、给药及不良事件(AE)管理的成本数据提取自IBM-Micromedex Red Book在线数据库、美国医疗保险和医疗补助服务中心费用表及文献回顾。我们采用描述性统计方法进行分析。
ciltacabtagene autoleucel和idecabtagene vicleucel每例患者每年的药物获取、给药和AE管理成本(美元)分别为465,000美元、60,167美元和40,368美元,以及419,500美元、61,250美元和47,270美元。ciltacabtagene autoleucel的年总成本(565,534美元)高于idecabtagene vicleucel(528,020美元)。然而,在一个假设的100万成员计划中,ciltacabtagene autoleucel的年总成本反而少180万美元。
BACKGROUND: Two chimeric antigen receptor-engineered T (CAR T) cell therapy drugs were recently approved for the treatment of patients with relapsed or refractory multiple myeloma (rrMM). Their financial impact, however, is poorly described. OBJECTIVE: The aim was to evaluate the economic burden of CAR T cell therapies ciltacabtagene autoleucel and idecabtagene vicleucel for the treatment of rrMM patients after at least four lines of therapy, and to compare the annual cost of these CAR T cell therapies over a hypothetical 1-million-member health plan from the US healthcare payer perspective. PATIENTS AND METHODS: The annual economic burden of ciltacabtagene autoleucel and idecabtagene vicleucel was estimated using data from pivotal clinical trials. The costs of drug acquisition, administration, and adverse event (AE) management were extracted from the IBM-Micromedex Red Book online, the Centers for Medicare & Medicaid Services fee schedules, and a review of the literature. We used descriptive statistics for the analysis. RESULTS: The annual costs (US dollars) of drug acquisition, administration, and AE management per patient were $465,000, $60,167, and $40,368 and $419,500, $61,250, and $47,270 for ciltacabtagene autoleucel and idecabtagene vicleucel, respectively. The total annual cost was higher for ciltacabtagene autoleucel ($565,534) than for idecabtagene vicleucel ($528,020). However, the total annual cost in a hypothetical 1-million-member plan was less with ciltacabtagene autoleucel, by $1.8 million. CONCLUSION: This study found that the CAR T cell gene therapies ciltacabtagene autoleucel and idecabtagene vicleucel for rrMM represent a significant economic burden for healthcare payers in the USA.
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