Real-world Resource Use and Costs of CAR-T Therapies in Diffuse Large B-cell Lymphoma (DLBCL): Inpatient and Outpatient Settings
Completed
- Conditions
- Diffuse Large B-cell Lymphoma
- Registration Number
- NCT05918809
- Lead Sponsor
- Novartis Pharmaceuticals
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1031
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.
Exclusion Criteria
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Total CAR-T infusion-related healthcare reimbursement costs in the CAR-T IP and CAR-T OP cohorts 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 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 Total post-infusion healthcare reimbursement costs in the CAR-T IP and CAR-T OP cohorts Up to approximately 10 months 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 Percentage of patients in the CAR-T IP and CAR-T OP cohorts with OP services Up to approximately 10 months Number of ICU days in the CAR-T IP and CAR-T OP cohorts Up to approximately 10 months
- Secondary Outcome Measures
Name Time Method Number of ICU days in the overall CAR-T and allo-HSCT cohorts Up to approximately 10 months Healthcare reimbursement costs per AE event 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 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 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
Trial Locations
- Locations (1)
Novartis
🇺🇸East Hanover, New Jersey, United States