Real-world Resource Use and Costs of CAR-T Therapies in Diffuse Large B-cell Lymphoma (DLBCL): Inpatient and Outpatient Settings

NCT05918809 | Completed

• 1 other identifier: CCTL019CUS11
• Study Type: observational
• Target: 1,031
• Locations: 1 country
• Sites: 1

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.

Conditions

Diffuse Large B-cell Lymphoma

Outcome Measures

Primary Outcomes (12)

• 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 Outcomes (13)

• Cumulative percentage of patients admitted in the hospital during the first month after CAR-T OP infusion

  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

Study Arms (4)

CAR-T IP

Chimeric antigen receptor modified T cells inpatient cohort

CAR-T OP

Chimeric antigen receptor modified T cells outpatient cohort

CAR-T Overall

Chimeric antigen receptor modified T cells overall cohort

allo-HSCT

Allogeneic hematopoietic stem cell transplant cohort

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:

• 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.

You may not qualify if:

• 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.

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: June 16, 2023
• First Posted: June 26, 2023
• Study Start: July 25, 2021
• Primary Completion: June 17, 2022
• Study Completion: June 17, 2022
• Last Updated: June 26, 2023

Record last verified: 2023-06

Locations

US (1)