Clinical trial NCT05918809: Real-world Resource Use and Costs of CAR-T Therapies in Diffuse Large B-cell Lymphoma (DLBCL): Inpatient and Outpatient Settings
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
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2023-06-26
Enrollment: 1031
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This was a retrospective, noninterventional cohort study.

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.


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 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.

Primary outcomes:
measure: Number of hospital admissions in the CAR-T IP and CAR-T OP cohorts
timeFrame: Up to approximately 10 months
measure: Number of inpatient (IP) days in the CAR-T IP and CAR-T OP cohorts
timeFrame: Up to approximately 10 months
measure: Number of intensive care unit (ICU) stays in the CAR-T IP and CAR-T OP cohorts
timeFrame: Up to approximately 10 months
measure: Number of ICU days in the CAR-T IP and CAR-T OP cohorts
timeFrame: Up to approximately 10 months
measure: Number of emergency room (ER) visits in the CAR-T IP and CAR-T OP cohorts
timeFrame: Up to approximately 10 months
measure: Number of outpatient (OP) visits in the CAR-T IP and CAR-T OP cohorts
timeFrame: Up to approximately 10 months
measure: Percentage of patients in the CAR-T IP and CAR-T OP cohorts with any IP admission
timeFrame: Up to approximately 10 months
measure: Percentage of patients in the CAR-T IP and CAR-T OP cohorts with ER visits
timeFrame: Up to approximately 10 months
measure: Percentage of patients in the CAR-T IP and CAR-T OP cohorts with OP services
timeFrame: Up to approximately 10 months
measure: Total pre-infusion healthcare reimbursement costs in the CAR-T IP and CAR-T OP cohorts
timeFrame: Up to approximately 10 months
measure: Total CAR-T infusion-related healthcare reimbursement costs in the CAR-T IP and CAR-T OP cohorts
timeFrame: Up to approximately 10 months
measure: Total post-infusion healthcare reimbursement costs in the CAR-T IP and CAR-T OP cohorts
timeFrame: Up to approximately 10 months
Secondary outcomes:
measure: Cumulative percentage of patients admitted in the hospital during the first month after CAR-T OP infusion
timeFrame: Up to approximately 10 months
measure: Percentage of patients hospitalized each day during the first month after CAR-T infusion among the CAR-T IP and OP cohorts
timeFrame: Up to approximately 10 months
measure: Main cause of IP admission/re-admission among the CAR-T IP and OP cohorts, up to three months following infusion
timeFrame: Up to approximately 10 months
measure: Percentage of patients with AEs
timeFrame: Up to approximately 10 months
measure: Healthcare reimbursement costs per AE event
timeFrame: Up to approximately 10 months
measure: Number of IP admissions in the overall CAR-T and allo-HSCT cohorts
timeFrame: Up to approximately 10 months
measure: Number of IP days in the overall CAR-T and allo-HSCT cohorts
timeFrame: Up to approximately 10 months
measure: Number of OP visits in the overall CAR-T and allo-HSCT cohorts
timeFrame: Up to approximately 10 months
measure: Number of ER visits in the overall CAR-T and allo-HSCT cohorts
timeFrame: Up to approximately 10 months
measure: Total healthcare reimbursement costs in the overall CAR-T and allo-HSCT cohorts
timeFrame: Up to approximately 10 months
measure: Main cause of IP admission/re-admission among the CAR-T IP and OP cohorts
timeFrame: Up to approximately 10 months
measure: Number of intensive care unit (ICU) stays in the overall CAR-T and allo-HSCT cohorts
timeFrame: Up to approximately 10 months
measure: Number of ICU days in the overall CAR-T and allo-HSCT cohorts
timeFrame: Up to approximately 10 months
Other outcomes:
Locations:
city: East Hanover
country: United States
facility: Novartis
state: New Jersey
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: