Clinical trial NCT05366257: Real-world Resource Use and Costs of CAR-T Therapies in Diffuse Large B-cell Lymphoma (DLBCL)
Official title: Real-world Resource Use and Costs of CAR-T Therapies in Diffuse Large B-cell Lymphoma (DLBCL): Inpatient and Outpatient Settings
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diffuse Large B-cell Lymphoma (DLBCL)
Keywords: CAR-T,
DLBCL,
Inpatient,
Outpatient
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2022-05-09
Enrollment: 160602
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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

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 CAR-T therapy among patients with r/r Diffuse Large B-cell Lymphoma (DLBCL).

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.

Eligibility criteria: 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

Primary outcomes:
measure: Mean length of follow-up in CAR-T cohorts
timeFrame: throughout the study, approximately 2 years ( January 1, 2017 to September 31, 2019)
measure: Number of patients with IP visit in CAR-T cohorts
timeFrame: throughout the study, approximately 2 years ( January 1, 2017 to September 31, 2019)
measure: Number of IP admissions in CAR-T cohorts
timeFrame: throughout the study, approximately 2 years ( January 1, 2017 to September 31, 2019)
measure: Number of IP days in CAR-T cohorts
timeFrame: throughout the study, approximately 2 years ( January 1, 2017 to September 31, 2019)
measure: Number of ICU stays in CAR-T cohorts
timeFrame: throughout the study, approximately 2 years ( January 1, 2017 to September 31, 2019)
measure: Number of ICU days in CAR-T cohorts
timeFrame: throughout the study, approximately 2 years ( January 1, 2017 to September 31, 2019)
measure: Number of patients with OP visit in CAR-T cohorts
timeFrame: throughout the study, approximately 2 years ( January 1, 2017 to September 31, 2019)
measure: Number of OP visits in CAR-T cohorts
timeFrame: throughout the study, approximately 2 years ( January 1, 2017 to September 31, 2019)
measure: Number of patients with ER visit in CAR-T cohorts
timeFrame: throughout the study, approximately 2 years ( January 1, 2017 to September 31, 2019)
measure: Number of ER visits in CAR-T cohorts
timeFrame: throughout the study, approximately 2 years ( January 1, 2017 to September 31, 2019)
measure: Total healthcare reimbursement costs in CAR-T cohorts
timeFrame: throughout the study, approximately 2 years ( January 1, 2017 to September 31, 2019)
Secondary outcomes:
measure: Mean length of follow-up for CAR-T therapy vs. allo-HSCT cohort
timeFrame: throughout the study, approximately 2 years ( January 1, 2017 to September 31, 2019)
measure: Number of patients with IP visit in CAR-T vs allo-HSCT cohort
timeFrame: throughout the study, approximately 2 years ( January 1, 2017 to September 31, 2019)
measure: Number of IP admissions in CAR-T therapy vs. allo-HSCT cohort
timeFrame: throughout the study, approximately 2 years ( January 1, 2017 to September 31, 2019)
measure: Number of IP days in CAR-T therapy vs. allo-HSCT cohort
timeFrame: throughout the study, approximately 2 years ( January 1, 2017 to September 31, 2019)
measure: Number of ICU stays in CAR-T therapy vs. allo-HSCT cohort
timeFrame: throughout the study, approximately 2 years ( January 1, 2017 to September 31, 2019)
measure: Number of ICU days in CAR-T therapy vs. allo-HSCT cohort
timeFrame: throughout the study, approximately 2 years ( January 1, 2017 to September 31, 2019)
measure: Number of patients with OP visit in CAR-T vs allo-HSCT cohort
timeFrame: throughout the study, approximately 2 years ( January 1, 2017 to September 31, 2019)
measure: Number of OP visits in CAR-T therapy vs. allo-HSCT cohort
timeFrame: throughout the study, approximately 2 years ( January 1, 2017 to September 31, 2019)
measure: Number of patients with ER visit in CAR-T vs allo-HSCT cohort
timeFrame: throughout the study, approximately 2 years ( January 1, 2017 to September 31, 2019)
measure: Number of ER visits in CAR-T therapy vs. allo-HSCT cohort
timeFrame: throughout the study, approximately 2 years ( January 1, 2017 to September 31, 2019)
measure: IP re-admission/admission among CAR-T IP and OP cohorts
timeFrame: throughout the study, approximately 2 years ( January 1, 2017 to September 31, 2019)
measure: AE rate during the study period among CAR-T cohorts
timeFrame: throughout the study, approximately 2 years ( January 1, 2017 to September 31, 2019)
measure: Cost of AEs among CAR-T cohorts during the study period
timeFrame: throughout the study, approximately 2 years ( January 1, 2017 to September 31, 2019)
measure: Total healthcare reimbursement costs in CAR-T vs allo-HSCT cohort
timeFrame: throughout the study, approximately 2 years ( January 1, 2017 to September 31, 2019)
Other outcomes:
Locations:
city: East Hanover
country: United States
facility: Novartis Investigative Site
state: New Jersey
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: