A Real-world Study Comparing Tisagenlecleucel (Tisa-cel) With Axicabtagene Ciloleucel (Axi-cel) on Healthcare Resource Use (HRU), Costs, and Overall Survival (OS) in Diffuse Large B-cell Lymphoma (DLBCL): A Retrospective Study of Medicare Population
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 613
- 试验地点
- 1
- 主要终点
- IP days
研究概览
简要总结
This was a retrospective non-interventional cohort study design using the Centers for Medicare and Medicaid Services (CMS) 100% Medicare data (2015Q1-2020Q4).
Eligible adult patients with r/r DLBCL who were treated with CAR-T therapy were identified from the CMS 100% Medicare data. Patients who received chimeric antigen receptor modified T cell (CAR-T) therapy were further classified into tisa-cel and axi-cel cohorts based on the type of CAR-T treatment received. The index date was defined as the date of tisa-cel or axi-cel therapy administration. Baseline period was defined as three months prior to the index date. Study period was defined from the index date to the end of health plan coverage based on insurance enrollment file or death, whichever occurred earlier.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients had at least one International Classification of Diseases, 10th Revision (ICD-10) diagnosis code for DLBCL.
- •Patients received CAR-T therapy, including both tisa-cel and axi-cel, following DLBCL diagnosis. The administration date of CAR-T therapy was defined as the index date.
- •Patients were at least 18 years of age as of the index date.
- •Patients had at least three months of continuous health plan enrollment before the index date.
排除标准
- •Patients who had a medical claim associated with a clinical trial within one month before and after the index date.
- •Patients who had zero cost on index date for CAR-T infusion.
结局指标
主要结局
IP days
时间窗: Up to approximately 6 years
Described as the cumulative number of days during IP stays including ICU.
Number of ICU stays
时间窗: Up to approximately 6 years
Described as the cumulative number of days during ICU stays.
Number of OP visits
时间窗: Up to approximately 6 years
Number of patients with ER visit
时间窗: Up to approximately 6 years
ICU days
时间窗: Up to approximately 6 years
Number of patients with IP admission
时间窗: Up to approximately 6 years
Number of IP admissions
时间窗: Up to approximately 6 years
Number of patients with OP visit
时间窗: Up to approximately 6 years
OP services include office visits, skilled-nursing facility, home care, durable medical equipment, and other services that are not included in IP stays or ER visits.
Healthcare reimbursement costs
时间窗: Up to approximately 6 years
Healthcare reimbursement costs were defined as the amount paid by Medicare to the provider for medical services.
Time to next treatment (TTNT) or death
时间窗: Up to approximately 6 years
TTNT was defined as the time from administration of CAR-T therapy to the initiation of the next line of treatment or death due to any cause.
Number of ER visits
时间窗: Up to approximately 6 years
Overall survival (OS)
时间窗: Up to approximately 6 years
OS was defined as the time from administration of CAR-T therapy to death due to any cause.
次要结局
未报告次要终点