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

Diffuse Large B-cell Lymphoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05918809
• Other study ID #: CCTL019CUS11
• Status: Completed
• Start date: July 25, 2021
• Est. completion date: June 17, 2022

Study information

• Verified date: June 2023
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1031
• Est. completion date: June 17, 2022
• Est. primary completion date: June 17, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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.

Exclusion criteria:

• 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.

Related Conditions & MeSH terms

• Diffuse Large B-cell Lymphoma
• Lymphoma
• Lymphoma, B-Cell
• Lymphoma, Large B-Cell, Diffuse

Locations

Country	Name	City	State
United States	Novartis	East Hanover	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of hospital admissions in the CAR-T IP and CAR-T OP cohorts		Up to approximately 10 months
Primary	Number of inpatient (IP) days in the CAR-T IP and CAR-T OP cohorts		Up to approximately 10 months
Primary	Number of intensive care unit (ICU) stays in the CAR-T IP and CAR-T OP cohorts		Up to approximately 10 months
Primary	Number of ICU days in the CAR-T IP and CAR-T OP cohorts		Up to approximately 10 months
Primary	Number of emergency room (ER) visits in the CAR-T IP and CAR-T OP cohorts		Up to approximately 10 months
Primary	Number of outpatient (OP) visits in the CAR-T IP and CAR-T OP cohorts		Up to approximately 10 months
Primary	Percentage of patients in the CAR-T IP and CAR-T OP cohorts with any IP admission		Up to approximately 10 months
Primary	Percentage of patients in the CAR-T IP and CAR-T OP cohorts with ER visits		Up to approximately 10 months
Primary	Percentage of patients in the CAR-T IP and CAR-T OP cohorts with OP services		Up to approximately 10 months
Primary	Total pre-infusion healthcare reimbursement costs in the CAR-T IP and CAR-T OP cohorts		Up to approximately 10 months
Primary	Total CAR-T infusion-related healthcare reimbursement costs in the CAR-T IP and CAR-T OP cohorts		Up to approximately 10 months
Primary	Total post-infusion healthcare reimbursement costs in the CAR-T IP and CAR-T OP cohorts		Up to approximately 10 months
Secondary	Cumulative percentage of patients admitted in the hospital during the first month after CAR-T OP infusion		Up to approximately 10 months
Secondary	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
Secondary	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
Secondary	Percentage of patients with AEs		Up to approximately 10 months
Secondary	Healthcare reimbursement costs per AE event		Up to approximately 10 months
Secondary	Number of IP admissions in the overall CAR-T and allo-HSCT cohorts		Up to approximately 10 months
Secondary	Number of IP days in the overall CAR-T and allo-HSCT cohorts		Up to approximately 10 months
Secondary	Number of OP visits in the overall CAR-T and allo-HSCT cohorts		Up to approximately 10 months
Secondary	Number of ER visits in the overall CAR-T and allo-HSCT cohorts		Up to approximately 10 months
Secondary	Total healthcare reimbursement costs in the overall CAR-T and allo-HSCT cohorts		Up to approximately 10 months
Secondary	Main cause of IP admission/re-admission among the CAR-T IP and OP cohorts		Up to approximately 10 months
Secondary	Number of intensive care unit (ICU) stays in the overall CAR-T and allo-HSCT cohorts		Up to approximately 10 months
Secondary	Number of ICU days in the overall CAR-T and allo-HSCT cohorts		Up to approximately 10 months