Real-world Resource Use and Costs of CAR-T Therapies in Diffuse Large B-cell Lymphoma (DLBCL): Inpatient and Outpatient Settings

Study Overview
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Brief Summary
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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.

Official Title
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Real-world Resource Use and Costs of CAR-T Therapies in Diffuse Large B-cell Lymphoma (DLBCL): Inpatient and Outpatient Settings

Conditions
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Diffuse Large B-cell Lymphoma

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| CAR-T IP<br>Chimeric antigen receptor modified T cells inpatient cohort | |
| CAR-T OP<br>Chimeric antigen receptor modified T cells outpatient cohort | |
| CAR-T Overall<br>Chimeric antigen receptor modified T cells overall cohort | |
| allo-HSCT<br>Allogeneic hematopoietic stem cell transplant cohort | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of hospital admissions in the CAR-T IP and CAR-T OP cohorts |  | Up to approximately 10 months | 
| Number of inpatient (IP) days in the CAR-T IP and CAR-T OP cohorts |  | Up to approximately 10 months | 
| Number of intensive care unit (ICU) stays in the CAR-T IP and CAR-T OP cohorts |  | Up to approximately 10 months | 
| Number of ICU days in the CAR-T IP and CAR-T OP cohorts |  | Up to approximately 10 months | 
| Number of emergency room (ER) visits in the CAR-T IP and CAR-T OP cohorts |  | Up to approximately 10 months | 
| Number of outpatient (OP) visits in the CAR-T IP and CAR-T OP cohorts |  | Up to approximately 10 months | 
| Percentage of patients in the CAR-T IP and CAR-T OP cohorts with any IP admission |  | Up to approximately 10 months | 
| Percentage of patients in the CAR-T IP and CAR-T OP cohorts with ER visits |  | Up to approximately 10 months | 
| Percentage of patients in the CAR-T IP and CAR-T OP cohorts with OP services |  | Up to approximately 10 months | 
| Total pre-infusion healthcare reimbursement costs in the CAR-T IP and CAR-T OP cohorts |  | Up to approximately 10 months | 
| Total CAR-T infusion-related healthcare reimbursement costs in the CAR-T IP and CAR-T OP cohorts |  | Up to approximately 10 months | 
| Total post-infusion healthcare reimbursement costs in the CAR-T IP and CAR-T OP cohorts |  | Up to approximately 10 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cumulative percentage of patients admitted in the hospital during the first month after CAR-T OP infusion |  | 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 | 
| 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 | 
| Percentage of patients with AEs |  | 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 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 | 
| Number of ER visits in the overall CAR-T and allo-HSCT cohorts |  | Up to approximately 10 months | 
| Total healthcare reimbursement costs in the overall CAR-T and allo-HSCT cohorts |  | Up to approximately 10 months | 
| Main cause of IP admission/re-admission among the CAR-T IP and OP 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 | 
| Number of ICU days in the overall CAR-T and allo-HSCT cohorts |  | Up to approximately 10 months |