Diffuse Large B-cell Lymphoma
Conditions
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.
Interventions
None listed
Sponsors
Novartis Pharmaceuticals
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | 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
| Measure | Time frame |
|---|---|
| Cumulative percentage of patients admitted in the hospital during the first month after CAR-T OP infusion | Up to approximately 10 months |
| Number of ICU days 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 |
| 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 |
Countries
United States
Outcome results
None listed