Real-world Resource Use and Costs of CAR-T Therapies in Diffuse Large B-cell Lymphoma (DLBCL): Inpatient and Outpatient Settings
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,031
- 试验地点
- 1
- 主要终点
- Total CAR-T infusion-related healthcare reimbursement costs in the CAR-T IP and CAR-T OP cohorts
研究概览
简要总结
A retrospective, non-interventional cohort study was used to address the study objectives. This study aimed to provide a better understanding of real-world healthcare resource utilization (HRU) and healthcare reimbursement costs associated with chimeric antigen receptor modified T cell (CAR-T) therapy among patients with DLBCL.
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
- •CAR-T cohort:
- •Patients had at least one International Classification of Diseases, Tenth Revision (ICD-10) diagnosis code for DLBCL.
- •Patients received CAR-T therapy following DLBCL diagnosis. The administration date of CAR-T therapy was defined as the index date. Patients who received both CAR-T therapy and allo-HSCT were classified based on the first treatment that the patient received.
- •Patients were at least 18 years of age as of the index date.
- •Patients had at least three months of continuous eligibility in the Medicare Part A and Part B data before the index date. Since 2020 Part D data is not available in the current data cut; eligibility requirement in the Part D data was not required.
- •Patients were further classified into CAR-T IP and CAR-T OP cohorts depending on where the administration occurred.
- •Allo-HSCT cohort:
- •Patients had at least one ICD-10 diagnosis code for DLBCL.
- •Patients received allo-HSCT following DLBCL diagnosis. The date of allo-HSCT procedure was defined as the index date. Patients who received both CAR-T therapy and allo-HSCT were classified based on the first treatment the patient received.
- •Patients were at least 18 years of age as of the index date.
- •Patients had at least three months of continuous eligibility in the Medicare Part A and Part B data before the index date. Since 2020 Part D data is not available in the current data cut; eligibility requirement in the Part D data was not required.
- •Exclusion criteria:
- •Patients had a medical claim associated with a clinical trial (ICD-9 CM code V70.7; ICD-10 CM code Z00.6) during one month before and after the index date.
排除标准
- 未提供
结局指标
主要结局
Total CAR-T infusion-related healthcare reimbursement costs in the CAR-T IP and CAR-T OP cohorts
时间窗: Up to approximately 10 months
Total pre-infusion healthcare reimbursement costs in the CAR-T IP and CAR-T OP cohorts
时间窗: Up to approximately 10 months
Number of emergency room (ER) visits in the CAR-T IP and CAR-T OP cohorts
时间窗: Up to approximately 10 months
Number of outpatient (OP) visits in the CAR-T IP and CAR-T OP cohorts
时间窗: Up to approximately 10 months
Percentage of patients in the CAR-T IP and CAR-T OP cohorts with any IP admission
时间窗: Up to approximately 10 months
Percentage of patients in the CAR-T IP and CAR-T OP cohorts with ER visits
时间窗: Up to approximately 10 months
Total post-infusion healthcare reimbursement costs in the CAR-T IP and CAR-T OP cohorts
时间窗: Up to approximately 10 months
Number of hospital admissions in the CAR-T IP and CAR-T OP cohorts
时间窗: Up to approximately 10 months
Number of inpatient (IP) days in the CAR-T IP and CAR-T OP cohorts
时间窗: Up to approximately 10 months
Number of intensive care unit (ICU) stays in the CAR-T IP and CAR-T OP cohorts
时间窗: Up to approximately 10 months
Percentage of patients in the CAR-T IP and CAR-T OP cohorts with OP services
时间窗: Up to approximately 10 months
Number of ICU days in the CAR-T IP and CAR-T OP cohorts
时间窗: Up to approximately 10 months
次要结局
- Main cause of IP admission/re-admission among the CAR-T IP and OP cohorts(Up to approximately 10 months)
- Number of ICU days in the overall CAR-T and allo-HSCT cohorts(Up to approximately 10 months)
- Cumulative percentage of patients admitted in the hospital during the first month after CAR-T OP infusion(Up to approximately 10 months)
- Main cause of IP admission/re-admission among the CAR-T IP and OP cohorts, up to three months following infusion(Up to approximately 10 months)
- Total healthcare reimbursement costs in the overall CAR-T and allo-HSCT cohorts(Up to approximately 10 months)
- Number of intensive care unit (ICU) stays in the overall CAR-T and allo-HSCT cohorts(Up to approximately 10 months)
- Percentage of patients hospitalized each day during the first month after CAR-T infusion among the CAR-T IP and OP cohorts(Up to approximately 10 months)
- Healthcare reimbursement costs per AE event(Up to approximately 10 months)
- Number of IP admissions in the overall CAR-T and allo-HSCT cohorts(Up to approximately 10 months)
- Number of ER visits in the overall CAR-T and allo-HSCT cohorts(Up to approximately 10 months)
- Percentage of patients with AEs(Up to approximately 10 months)
- Number of IP days in the overall CAR-T and allo-HSCT cohorts(Up to approximately 10 months)
- Number of OP visits in the overall CAR-T and allo-HSCT cohorts(Up to approximately 10 months)