Kilgore Karl M, Chan Philip K, Teigland Christie, Wade Sally W, Mohammadi Iman
Inovalon, Inc., Bowie, MD.
Wade Outcomes Research and Consulting, Salt Lake City, UT.
J Manag Care Spec Pharm. 2025 Mar;31(3):262-276. doi: 10.18553/jmcp.2025.31.3.262.
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.
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).
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).
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.
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.
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。
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。
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)。
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。
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。