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

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

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).

Study Overview

• Status: Completed
• Conditions: Diffuse Large B-cell Lymphoma (DLBCL)
• Intervention / Treatment: Other: CAR-T; Other: Allo-HSCT cohort

Detailed 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.

• Study Type: Observational
• Enrollment (Actual): 160602

Contacts and Locations

Study Locations

• United States
  • New Jersey
    • East Hanover, New Jersey, United States, 07936-1080
      • Novartis Investigative Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Adult patients with DLBCL who received CAR-T therapy or allo-HSCT procedure between January 1, 2017 to September 31, 2019

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
CAR-T: Inpatient (IP) Cohort; Patients received CAR-T infusion in IP setting	Other: CAR-T; infusion of CAR-T therapy among patients with r/r DLBCL
CAR-T: Outpatient (OP) Cohort; Patients received CAR-T infusion in OP setting	Other: CAR-T; infusion of CAR-T therapy among patients with r/r DLBCL
Allo-HSCT cohort; Patients received allogeneic hematopoietic stem cell transplant	Other: Allo-HSCT cohort; Patients received allogeneic hematopoietic stem cell transplant

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)

Collaborators and Investigators

• Sponsor: Novartis Pharmaceuticals

Publications and helpful links

Helpful Links

• Results for CCTL019CUS08 from the Novartis Clinical Trials Results Databse

Study record dates

Study Major Dates

• Study Start (Actual): August 17, 2020
• Primary Completion (Actual): May 10, 2021
• Study Completion (Actual): May 10, 2021

Study Registration Dates

• First Submitted: May 4, 2022
• First Submitted That Met QC Criteria: May 4, 2022
• First Posted (Actual): May 9, 2022

Study Record Updates

• Last Update Posted (Actual): July 5, 2022
• Last Update Submitted That Met QC Criteria: June 29, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Keywords: Outpatient; DLBCL,; CAR-T,; Inpatient,
• 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: CCTL019CUS08

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No