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

A Real-world Study Comparing Tisagenlecleucel (Tisa-cel) With Axicabtagene Ciloleucel (Axi-cel) on Healthcare Resource Use (HRU), Costs, and Overall Survival (OS) in Diffuse Large B-cell Lymphoma (DLBCL): A Retrospective Study of Medicare Population

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.

Study Overview

• Status: Completed
• Conditions: Diffuse Large B-cell Lymphoma

• Study Type: Observational
• Enrollment (Actual): 613

Contacts and Locations

Study Locations

• United States
  • New Jersey
    • East Hanover, New Jersey, United States, 07936
      • Novartis

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

This was a retrospective, noninterventional cohort study.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Tisa-cel cohort; Patients with at least one ICD-10 diagnosis for DLBCL who were at least 18 years old. Patients also had at least three months of continuous health plan enrollment before administration of CAR-T therapy and received tisa-cel following DLBCL diagnosis.
Axi-cel cohort; Patients with at least one ICD-10 diagnosis for DLBCL who were at least 18 years old. Patients also had at least three months of continuous health plan enrollment before administration of CAR-T therapy and received axi-cel following DLBCL diagnosis.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of patients with IP admission		Up to approximately 6 years
Number of IP admissions		Up to approximately 6 years
IP days	Described as the cumulative number of days during IP stays including ICU.	Up to approximately 6 years
Number of ICU stays	Described as the cumulative number of days during ICU stays.	Up to approximately 6 years
ICU days		Up to approximately 6 years
Number of patients with OP visit	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.	Up to approximately 6 years
Number of OP visits		Up to approximately 6 years
Number of patients with ER visit		Up to approximately 6 years
Number of ER visits		Up to approximately 6 years
Healthcare reimbursement costs	Healthcare reimbursement costs were defined as the amount paid by Medicare to the provider for medical services.	Up to approximately 6 years
Overall survival (OS)	OS was defined as the time from administration of CAR-T therapy to death due to any cause.	Up to approximately 6 years
Time to next treatment (TTNT) or death	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.	Up to approximately 6 years

Collaborators and Investigators

• Sponsor: Novartis Pharmaceuticals
• Investigators: Study Director: Novartis Pharmaceuticals, Novartis Pharmaceuticals

Study record dates

Study Major Dates

• Study Start (Actual): August 11, 2022
• Primary Completion (Actual): February 15, 2023
• Study Completion (Actual): February 15, 2023

Study Registration Dates

• First Submitted: February 14, 2024
• First Submitted That Met QC Criteria: February 14, 2024
• First Posted (Actual): February 21, 2024

Study Record Updates

• Last Update Posted (Actual): February 21, 2024
• Last Update Submitted That Met QC Criteria: February 14, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Lymphoma, Non-Hodgkin; Lymphoma; Lymphoma, B-Cell; Lymphoma, Large B-Cell, Diffuse
• Other Study ID Numbers: CCTL019CUS13