Diffuse Large B-cell Lymphoma
Conditions
Brief summary
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.
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
* 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.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of ER visits | Up to approximately 6 years | — |
| Number of patients with IP admission | Up to approximately 6 years | — |
| Number of IP admissions | Up to approximately 6 years | — |
| IP days | Up to approximately 6 years | Described as the cumulative number of days during IP stays including ICU. |
| Number of ICU stays | Up to approximately 6 years | Described as the cumulative number of days during ICU stays. |
| ICU days | Up to approximately 6 years | — |
| Number of patients with OP visit | 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. |
| Number of OP visits | Up to approximately 6 years | — |
| Number of patients with ER visit | Up to approximately 6 years | — |
| Healthcare reimbursement costs | Up to approximately 6 years | Healthcare reimbursement costs were defined as the amount paid by Medicare to the provider for medical services. |
| Overall survival (OS) | Up to approximately 6 years | OS was defined as the time from administration of CAR-T therapy to death due to any cause. |
| Time to next treatment (TTNT) or death | 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. |
Countries
United States
Outcome results
None listed