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

Diffuse Large B-cell Lymphoma (DLBCL) 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: NCT05366257
• Other study ID #: CCTL019CUS08
• Status: Completed
• Start date: August 17, 2020
• Est. completion date: May 10, 2021

Study information

• Verified date: June 2022
• 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 CAR-T therapy among patients with r/r Diffuse Large B-cell Lymphoma (DLBCL).

Description:

A retrospective, non-interventional cohort study was used to address the study objectives. This study aimed to provide a better understanding of real-world HRU and healthcare reimbursement costs associated with CAR-T therapy among patients with r/r DLBCL.

Eligible adult patients with r/r DLBCL who were treated with CAR-T therapy or allo-HSCT between January 1, 2017 to September 31, 2019 were identified from the Centers for Medicare & Medicaid Services (CMS) 100% Medicare Database. The CAR-T cohort was further classified into CAR-T IP and CAR-T OP cohorts based on the infusion setting.

The index date was defined as the date of CAR-T therapy administration or allo-HSCT. 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.

Two sets of comparisons on HRU and healthcare reimbursement costs were conducted, one between IP vs. OP infusion of CAR-T, and the other between patients who received CAR-T therapy vs. allo-HSCT.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 160602
• Est. completion date: May 10, 2021
• Est. primary completion date: May 10, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

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 2019 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 2019 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 (DLBCL)
• Lymphoma
• Lymphoma, B-Cell
• Lymphoma, Large B-Cell, Diffuse

Intervention

Other:
• CAR-T
infusion of CAR-T therapy among patients with r/r DLBCL
• Allo-HSCT cohort
Patients received allogeneic hematopoietic stem cell transplant

Locations

Country	Name	City	State
United States	Novartis Investigative Site	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	Mean length of follow-up in CAR-T cohorts	Mean length of follow up was reported to compare Health Resource Use (HRU) between IP vs. OP infusion of CAR-T therapy among patients with r/r DLBCL.	throughout the study, approximately 2 years ( January 1, 2017 to September 31, 2019)
Primary	Number of patients with IP visit in CAR-T cohorts	Number of patients with IP visit were reported to compare Health Resource Use (HRU) between IP vs. OP infusion of CAR-T therapy among patients with r/r DLBCL.	throughout the study, approximately 2 years ( January 1, 2017 to September 31, 2019)
Primary	Number of IP admissions in CAR-T cohorts	Number of IP admissions were reported to compare Health Resource Use (HRU) between IP vs. OP infusion of CAR-T therapy among patients with r/r DLBCL.	throughout the study, approximately 2 years ( January 1, 2017 to September 31, 2019)
Primary	Number of IP days in CAR-T cohorts	Number of patients with IP visit were reported to compare Health Resource Use (HRU) between IP vs. OP infusion of CAR-T therapy among patients with r/r DLBCL.	throughout the study, approximately 2 years ( January 1, 2017 to September 31, 2019)
Primary	Number of ICU stays in CAR-T cohorts	Number of ICU stays were reported to compare Health Resource Use (HRU) between IP vs. OP infusion of CAR-T therapy among patients with r/r DLBCL.	throughout the study, approximately 2 years ( January 1, 2017 to September 31, 2019)
Primary	Number of ICU days in CAR-T cohorts	Number of ICU days were reported to compare Health Resource Use (HRU) between IP vs. OP infusion of CAR-T therapy among patients with r/r DLBCL.	throughout the study, approximately 2 years ( January 1, 2017 to September 31, 2019)
Primary	Number of patients with OP visit in CAR-T cohorts	Number of patients with OP visit were reported to compare Health Resource Use (HRU) between IP vs. OP infusion of CAR-T therapy among patients with r/r DLBCL.	throughout the study, approximately 2 years ( January 1, 2017 to September 31, 2019)
Primary	Number of OP visits in CAR-T cohorts	Number of OP visits were reported to compare Health Resource Use (HRU) between IP vs. OP infusion of CAR-T therapy among patients with r/r DLBCL.	throughout the study, approximately 2 years ( January 1, 2017 to September 31, 2019)
Primary	Number of patients with ER visit in CAR-T cohorts	Number of patients with ER visit were reported to compare Health Resource Use (HRU) between IP vs. OP infusion of CAR-T therapy among patients with r/r DLBCL.	throughout the study, approximately 2 years ( January 1, 2017 to September 31, 2019)
Primary	Number of ER visits in CAR-T cohorts	Number of ER visits were reported to compare Health Resource Use (HRU) between IP vs. OP infusion of CAR-T therapy among patients with r/r DLBCL.	throughout the study, approximately 2 years ( January 1, 2017 to September 31, 2019)
Primary	Total healthcare reimbursement costs in CAR-T cohorts	Total healthcare reimbursement costs, including medical service costs and pharmacy costs, inflated to 2020 US dollars (USD) were reported in CAR-T IP and CAR-T OP cohorts.	throughout the study, approximately 2 years ( January 1, 2017 to September 31, 2019)
Secondary	Mean length of follow-up for CAR-T therapy vs. allo-HSCT cohort	Mean length of follow up was reported to compare Health Resource Use (HRU) of CAR-T therapy vs. allo-HSCT among patients with r/r DLBCL.	throughout the study, approximately 2 years ( January 1, 2017 to September 31, 2019)
Secondary	Number of patients with IP visit in CAR-T vs allo-HSCT cohort	Number of patients with IP visit were reported to compare Health Resource Use (HRU) of CAR-T therapy vs. allo-HSCT among patients with r/r DLBCL.	throughout the study, approximately 2 years ( January 1, 2017 to September 31, 2019)
Secondary	Number of IP admissions in CAR-T therapy vs. allo-HSCT cohort	Number of IP admissions were reported to compare Health Resource Use (HRU) of CAR-T therapy vs. allo-HSCT among patients with r/r DLBCL.	throughout the study, approximately 2 years ( January 1, 2017 to September 31, 2019)
Secondary	Number of IP days in CAR-T therapy vs. allo-HSCT cohort	Number of IP days were reported to compare Health Resource Use (HRU) of CAR-T therapy vs. allo-HSCT among patients with r/r DLBCL.	throughout the study, approximately 2 years ( January 1, 2017 to September 31, 2019)
Secondary	Number of ICU stays in CAR-T therapy vs. allo-HSCT cohort	Number of ICU stays were reported to compare Health Resource Use (HRU) of CAR-T therapy vs. allo-HSCT among patients with r/r DLBCL.	throughout the study, approximately 2 years ( January 1, 2017 to September 31, 2019)
Secondary	Number of ICU days in CAR-T therapy vs. allo-HSCT cohort	Number of ICU days were reported to compare Health Resource Use (HRU) of CAR-T therapy vs. allo-HSCT among patients with r/r DLBCL.	throughout the study, approximately 2 years ( January 1, 2017 to September 31, 2019)
Secondary	Number of patients with OP visit in CAR-T vs allo-HSCT cohort	Number of patients with OP visit were reported to compare Health Resource Use (HRU) of CAR-T therapy vs. allo-HSCT among patients with r/r DLBCL.	throughout the study, approximately 2 years ( January 1, 2017 to September 31, 2019)
Secondary	Number of OP visits in CAR-T therapy vs. allo-HSCT cohort	Number of OP visits were reported to compare Health Resource Use (HRU) of CAR-T therapy vs. allo-HSCT among patients with r/r DLBCL.	throughout the study, approximately 2 years ( January 1, 2017 to September 31, 2019)
Secondary	Number of patients with ER visit in CAR-T vs allo-HSCT cohort	Number of patients with ER visit were reported to compare Health Resource Use (HRU) of CAR-T therapy vs. allo-HSCT among patients with r/r DLBCL.	throughout the study, approximately 2 years ( January 1, 2017 to September 31, 2019)
Secondary	Number of ER visits in CAR-T therapy vs. allo-HSCT cohort	Number of ER visits were reported to compare Health Resource Use (HRU) of CAR-T therapy vs. allo-HSCT among patients with r/r DLBCL.	throughout the study, approximately 2 years ( January 1, 2017 to September 31, 2019)
Secondary	IP re-admission/admission among CAR-T IP and OP cohorts	IP re-admission/admission were reported to assess post-infusion IP admission/readmission among patients with r/r DLBCL who received CAR-T therapy.	throughout the study, approximately 2 years ( January 1, 2017 to September 31, 2019)
Secondary	AE rate during the study period among CAR-T cohorts	Rate of adverse events (AEs) were reported among patients with r/r DLBCL who received CAR-T therapy.	throughout the study, approximately 2 years ( January 1, 2017 to September 31, 2019)
Secondary	Cost of AEs among CAR-T cohorts during the study period	Cost per AE event were reported among patients with r/r DLBCL who received CAR-T therapy.	throughout the study, approximately 2 years ( January 1, 2017 to September 31, 2019)
Secondary	Total healthcare reimbursement costs in CAR-T vs allo-HSCT cohort	Total healthcare reimbursement costs, including medical service costs and pharmacy costs, defined as the amount paid by Medicare, inflated to 2020 USD were reported in overall CAR T and allo-HSCT cohorts.	throughout the study, approximately 2 years ( January 1, 2017 to September 31, 2019)

External Links

•   Results for CCTL019CUS08 from the Novartis Clinical Trials Results Databse