Real-World HRU and Costs in DLBCL Pts With Tisa-cel and Axi-cel, a Medicare Study.

Completed

• Conditions: Diffuse Large B-cell Lymphoma

• Registration Number: NCT06271369
• Lead Sponsor: Novartis Pharmaceuticals

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-08-11
• Primary Completion: 2023-02-15
• Study Completion: 2023-02-15
• Status Verified: 2024-02
• Study First Submitted: 2024-02-14
• Study First Submitted QC: 2024-02-14
• Last Update Submitted: 2024-02-14
• Study First Posted: 2024-02-21
• Last Update Posted: 2024-02-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 613

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of OP visits	Up to approximately 6 years
Number of patients with ER visit	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 IP admission	Up to approximately 6 years
Number of IP admissions	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.
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.
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.
Number of ER visits	Up to approximately 6 years
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.

Trial Locations

Locations (1)

Novartis; 🇺🇸 East Hanover, New Jersey, United States