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

NCT06271369 | Completed

• 1 other identifier: CCTL019CUS13
• Study Type: observational
• Target: 613
• Locations: 1 country
• Sites: 1

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.

Conditions

Diffuse Large B-cell Lymphoma

Outcome Measures

Primary Outcomes (12)

• 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

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This was a retrospective, noninterventional cohort study.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (1)

Novartis

East Hanover, New Jersey, 07936, United States

Location

MeSH Terms

Conditions

Lymphoma, Large B-Cell, Diffuse

Condition Hierarchy (Ancestors)

Lymphoma, B-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 14, 2024
• First Posted: February 21, 2024
• Study Start: August 11, 2022
• Primary Completion: February 15, 2023
• Study Completion: February 15, 2023
• Last Updated: February 21, 2024

Record last verified: 2024-02

Locations

US (1)