Real-world Resource Use and Costs of CAR-T Therapies in Diffuse Large B-cell Lymphoma (DLBCL): Inpatient and Outpatient Settings
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| CAR-T IP Chimeric antigen receptor modified T cells inpatient cohort |
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| CAR-T OP Chimeric antigen receptor modified T cells outpatient cohort |
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| CAR-T Overall Chimeric antigen receptor modified T cells overall cohort |
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| allo-HSCT Allogeneic hematopoietic stem cell transplant cohort |
Outcome Measures
Primary Outcome Measures
- Number of hospital admissions in the CAR-T IP and CAR-T OP cohorts [Up to approximately 10 months]
- Number of inpatient (IP) days in the CAR-T IP and CAR-T OP cohorts [Up to approximately 10 months]
- Number of intensive care unit (ICU) stays in the CAR-T IP and CAR-T OP cohorts [Up to approximately 10 months]
- Number of ICU days in the CAR-T IP and CAR-T OP cohorts [Up to approximately 10 months]
- Number of emergency room (ER) visits in the CAR-T IP and CAR-T OP cohorts [Up to approximately 10 months]
- Number of outpatient (OP) visits in the CAR-T IP and CAR-T OP cohorts [Up to approximately 10 months]
- Percentage of patients in the CAR-T IP and CAR-T OP cohorts with any IP admission [Up to approximately 10 months]
- Percentage of patients in the CAR-T IP and CAR-T OP cohorts with ER visits [Up to approximately 10 months]
- Percentage of patients in the CAR-T IP and CAR-T OP cohorts with OP services [Up to approximately 10 months]
- Total pre-infusion healthcare reimbursement costs in the CAR-T IP and CAR-T OP cohorts [Up to approximately 10 months]
- Total CAR-T infusion-related healthcare reimbursement costs in the CAR-T IP and CAR-T OP cohorts [Up to approximately 10 months]
- Total post-infusion healthcare reimbursement costs in the CAR-T IP and CAR-T OP cohorts [Up to approximately 10 months]
Secondary Outcome Measures
- Cumulative percentage of patients admitted in the hospital during the first month after CAR-T OP infusion [Up to approximately 10 months]
- 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]
- 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]
- Percentage of patients with AEs [Up to approximately 10 months]
- Healthcare reimbursement costs per AE event [Up to approximately 10 months]
- Number of IP admissions in the overall CAR-T and allo-HSCT cohorts [Up to approximately 10 months]
- Number of IP days in the overall CAR-T and allo-HSCT cohorts [Up to approximately 10 months]
- Number of OP visits in the overall CAR-T and allo-HSCT cohorts [Up to approximately 10 months]
- Number of ER visits in the overall CAR-T and allo-HSCT cohorts [Up to approximately 10 months]
- Total healthcare reimbursement costs in the overall CAR-T and allo-HSCT cohorts [Up to approximately 10 months]
- Main cause of IP admission/re-admission among the CAR-T IP and OP cohorts [Up to approximately 10 months]
- Number of intensive care unit (ICU) stays in the overall CAR-T and allo-HSCT cohorts [Up to approximately 10 months]
- Number of ICU days in the overall CAR-T and allo-HSCT cohorts [Up to approximately 10 months]
Eligibility Criteria
Criteria
Inclusion Criteria:
CAR-T cohort:
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Patients had at least one International Classification of Diseases, Tenth Revision (ICD-10) diagnosis code for DLBCL.
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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.
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Patients were at least 18 years of age as of the index date.
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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.
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Patients were further classified into CAR-T IP and CAR-T OP cohorts depending on where the administration occurred.
Allo-HSCT cohort:
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Patients had at least one ICD-10 diagnosis code for DLBCL.
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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.
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Patients were at least 18 years of age as of the index date.
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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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Novartis | East Hanover | New Jersey | United States | 07936 |
Sponsors and Collaborators
- Novartis Pharmaceuticals
Investigators
- Study Director: Novartis Pharmaceuticals, Novartis Pharmaceuticals
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CCTL019CUS11