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美国嵌合抗原受体T细胞疗法与标准疗法治疗复发/难治性套细胞淋巴瘤的治疗模式、医疗资源利用及成本

Treatment patterns, health care resource utilization, and costs of chimeric antigen receptor T-cell vs standard therapy for relapsed/refractory mantle cell lymphoma in the United States.

作者信息

Kilgore Karl M, Chan Philip K, Teigland Christie, Wade Sally W, Mohammadi Iman

机构信息

Inovalon, Inc., Bowie, MD.

Wade Outcomes Research and Consulting, Salt Lake City, UT.

出版信息

J Manag Care Spec Pharm. 2025 Mar;31(3):262-276. doi: 10.18553/jmcp.2025.31.3.262.

Abstract

BACKGROUND

Standard of care (SOC) for relapsed/refractory mantle cell lymphoma (R/R MCL) has included chemoimmunotherapy and targeted therapies (eg, Bruton tyrosine kinase inhibitors [BTKis]). The approval of novel chimeric antigen receptor T-cell (CAR T) therapy in 2020 expanded therapeutic options.

OBJECTIVE

To compare real-world patient characteristics, treatment patterns, health care resource utilization (HRU), and costs in traditional Medicare and commercially insured patients with R/R MCL treated with CAR T vs non-CAR T SOC (non-CAR T).

METHODS

Adult patients with R/R MCL who had received 2 or more lines of therapy (LOTs) and continuously enrolled in their health plan between July 1, 2016, and December 31, 2021 (Medicare), or June 30, 2023 (commercial), were stratified into non-CAR T and CAR T cohorts based on therapy received during the study period after MCL diagnosis. Index date was 2L initiation for the non-CAR T cohort and CAR T infusion date for the CAR T cohort. Outcomes included time to next treatment (TTNT), treatment-free interval, MCL-related HRU (inpatient days, emergency department visits, and outpatient visits), and costs (medical and pharmacy).

RESULTS

2,835 non-CAR T and 122 CAR T patients were included. Compared with non-CAR T patients, CAR T patients were more often commercially insured (27% vs 17.3%; P < 0.01), younger (median age 69 vs 74; P < 0.0001), and male (75.4% vs 64.4%; P = 0.012). Median follow-up after index was 209.5 (CAR T) and 413 (non-CAR T) days. More than one-third (36.9%) of non-CAR T patients received 3L or higher LOT after index and median TTNT decreased with LOT from 689 days (2L) to 184 days (6L). In contrast, only 15% of CAR T patients required additional LOT, and median TTNT post-CAR T was not reached. Duration of treatment-free interval similarly declined with LOT for non-CAR T patients, and the CAR T interval was significantly longer than all non-CAR T LOT. Use of targeted therapies in non-CAR T increased sequentially by LOT (2L: 76%; 6L: 93.2%; BTKi 2L: 26.8%; BTKi 6L: 34.1%). Following CAR T, 9% of patients received targeted therapy, predominantly lenalidomide based. All MCL-related HRU and medical and pharmacy costs were lower post-CAR T than post-index non-CAR T.

CONCLUSIONS

Non-CAR T was associated with a greater use of post-index LOT, which also had shorter TTNT and treatment-free intervals. This suggests frequent and earlier progression as patients cycle through non-CAR T therapies. Standardized costs were higher in post-index non-CAR T vs post-CAR T episode periods. This suggests that earlier adoption of CAR T may reduce cycling through increasingly more expensive and less effective non-CAR T LOTs, potentially reducing HRU and financial burdens on patients with R/R MCL and the health system.

摘要

背景

复发/难治性套细胞淋巴瘤(R/R MCL)的标准治疗(SOC)包括化疗免疫疗法和靶向疗法(如布鲁顿酪氨酸激酶抑制剂[BTKis])。2020年新型嵌合抗原受体T细胞(CAR T)疗法的获批扩大了治疗选择。

目的

比较接受CAR T治疗与非CAR T标准治疗(非CAR T)的传统医疗保险和商业保险的R/R MCL患者的真实世界患者特征、治疗模式、医疗保健资源利用(HRU)和成本。

方法

2016年7月1日至2021年12月31日(医疗保险)或2023年6月30日(商业保险)期间接受过2线或更多线治疗(LOTs)且持续参加其健康计划的成年R/R MCL患者,根据MCL诊断后研究期间接受的治疗分为非CAR T和CAR T队列。非CAR T队列的索引日期为第2线治疗开始日期,CAR T队列的索引日期为CAR T输注日期。结局包括下次治疗时间(TTNT)、无治疗间隔、MCL相关的HRU(住院天数、急诊科就诊次数和门诊就诊次数)以及成本(医疗和药房)。

结果

纳入了2835例非CAR T患者和122例CAR T患者。与非CAR T患者相比,CAR T患者更常参加商业保险(27%对17.3%;P<0.01),更年轻(中位年龄69岁对74岁;P<0.0001),男性比例更高(75.4%对64.4%;P = 0.012)。索引后的中位随访时间为209.5天(CAR T)和413天(非CAR T)。超过三分之一(36.9%)的非CAR T患者在索引后接受了第3线或更高线治疗,且TTNT中位数随治疗线数从689天(第2线)降至184天(第6线)。相比之下,只有15%的CAR T患者需要额外的治疗线,且CAR T后的TTNT中位数未达到。非CAR T患者的无治疗间隔持续时间也随治疗线数下降,且CAR T间隔明显长于所有非CAR T治疗线。非CAR T患者中靶向疗法的使用随治疗线数依次增加(第2线:76%;第6线:93.2%;第2线BTKi:26.8%;第6线BTKi:34.1%)。CAR T治疗后,9%的患者接受了靶向治疗,主要是基于来那度胺的治疗。所有MCL相关的HRU以及医疗和药房成本在CAR T治疗后均低于索引后非CAR T治疗。

结论

非CAR T与索引后更多地使用治疗线相关,且TTNT和无治疗间隔更短。这表明随着患者循环接受非CAR T治疗,疾病进展频繁且更早。索引后非CAR T治疗期间的标准化成本高于CAR T治疗后。这表明更早采用CAR T可能减少循环接受越来越昂贵且效果越来越差的非CAR T治疗线,潜在地减轻R/R MCL患者及其医疗系统的HRU和经济负担。

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