Introduction

Historically, there have been limited curative treatment options for patients (pts) who relapse or have refractory Large B Cell Lymphoma (LBCL). Recently, autologous anti-CD19 chimeric antigen receptor T-Cell (CAR T) therapies were approved for the treatment of pts with relapsed or refractory LBCL after ≥ 2 prior systemic therapies.

Objectives

To describe the demographic and clinical characteristics of Medicare pts receiving CAR T therapy (axicabtagene ciloleucel or tisagenlecleucel), and compare healthcare utilization, costs, and outcomes pre- and post-CAR T therapy.

Methods

The study utilized a single-group pre-test/post-test design and Center for Medicare and Medicaid Services 100% Medicare Fee-for-Service (FFS) Part A & B claims data. (Part D has not been released.) Pts with LBCL, received CAR T therapy between 10/1/2017 and 9/30/2018, and were continuously enrolled in Medicare FFS for 6 months prior to and 100 days after CAR T infusion. Index episode of care was CAR T infusion and associated inpatient stay, if any. Baseline characteristics included age, gender, race, specific LBCL diagnosis, and comorbidities. Measures of utilization and cost pre- and post-CAR T were standardized as per patient per month (PPPM) to account for different follow-up durations, and included hospitalizations, intensive care unit (ICU) transfers, and emergency department (ED) visits. Pre- and post- CAR T statistical analyses excluded the index episode.

Results

177 pts are included with an average age of 70 years; male (58.8%); white (87.6%); a primary diagnosis of diffuse LBCL (91.5%) and infrequent autologous stem cell transplant (< 5%). Charlson Comorbidity Index score ≥ 3 were common (74.6%) and included 1 or more comorbidities that would have disqualified them from CAR T clinical trials (43%) (e.g. renal failure, heart failure, recent history of DVT/PE).

Pts spent a median of 16 days in hospital during their index episode of care and nearly half (45.5%) were transferred to ICU during their stay.

During the 6-month pre-index period, over half the pts had ≥ 1 hospitalization, and nearly 20% had ≥3. Of these, 27.1% were re-admitted during the post-index period. For those hospitalized, the median length of stay (LOS) pre- and post-index was 7 and 5 days, respectively.

The number of pts with an ED visit was reduced by half during post- vs. pre-index (15.8% vs. 29.9%).

There was no evidence of subsequent intravenous outpatient during the 100-day post-index period although claims may lag for some pts.

Exclusive of index episode costs, total healthcare costs during the pre-index period were $9,749 PPPM pre- vs. $7,121 post-index, a 27% decrease.

Conclusions

The results of this real-world study indicate that older pts with multiple comorbidities can be treated successfully with CAR T therapy, and that post-index care was associated with lower hospitalization rates, bed days, ED visits, and total costs.

中文翻译：

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医疗保险接受非霍奇金淋巴瘤嵌合抗原受体T细胞疗法的患者：患者特征，医疗保健利用率和成本的真实观察

介绍

从历史上看，复发或难治性大B细胞淋巴瘤（LBCL）的患者（pts）的治疗选择有限。最近，自体抗CD19嵌合抗原受体T细胞（CAR T）疗法被批准用于≥2次先前的全身疗法后复发或难治性LBCL的pts治疗。

目标

描述接受CAR T治疗的Medicare pts的人口统计学和临床​​特征（阿西卡布塔因ciloleucel或tisagenlecleucel），并比较CAR T治疗前后的医疗保健利用率，成本和结果。

方法

该研究采用了单组测试前/测试后设计以及Medicare和Medicaid Services中心100％Medicare服务收费（FFS）A和B部分的索赔数据。（尚未发布D部分。）患有LBCL的患者，在2017年1月1日至2018年9月30日之间接受CAR T治疗，并在CAR T输注前6个月和100天后连续入选Medicare FFS。护理的主要指标是CAR T输注和相关的住院天数（如果有）。基线特征包括年龄，性别，种族，特定的LBCL诊断和合并症。根据每个患者每月（PPPM）对使用率和CAR T前后成本进行标准化，以说明不同的随访时间，包括住院，重症监护病房（ICU）转移和急诊（ED）探访。

结果

其中包括177分，平均年龄为70岁；男性（58.8％）; 白色（87.6％）; 对弥漫性LBCL（91.5％）和罕见的自体干细胞移植（<5％）的初步诊断。Charlson合并症指数得分≥3是常见的（74.6％），包括1种或多种可能使它们不符合CAR T临床试验资格的合并症（43％）（例如，肾衰竭，心力衰竭，近期DVT / PE病史）。

Pts在其护理指数期间平均住院时间为16天，近一半（45.5％）的患者在住院期间转入了ICU。

在6个月的预索引期间，超过一半的患者住院≥1，近20％的患者≥3。其中27.1％在指数编制后期间被重新录取。对于那些住院的患者，住院前后的中位住院时间（LOS）分别为7天和5天。

在索引后与索引前相比，进行急诊就诊的人数减少了一半（分别为15.8％和29.9％）。

尽管在某些情况下索赔可能会滞后，但没有证据表明在指数化后的100天内有随后的静脉门诊病人。

不包括指数变动成本，在指数编制前期间，PPPM前的医疗总成本为9,749美元，而指数编制后为7,121美元，下降了27％。

结论

这项真实世界研究的结果表明，可以通过CAR T治疗成功治疗具有多种合并症的老年患者，并且指数后护理与较低的住院率，就寝天数，急诊就诊和总费用相关。