Status:
COMPLETED
Real-World Usage of Asciminib Among Patients With Chronic Myeloid Leukemia in Chronic Phase in the United States Using a Large Claims Database
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Chronic Myeloid Leukemia
Eligibility:
All Genders
18+ years
Brief Summary
This was a retrospective descriptive analysis of health care claims data using the IQVIA open source medical and pharmacy claims databases. Patients were grouped into one of two cohorts depending on t...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Patients meeting the below inclusion criteria were included in the study.
- Patients with ≥ 1 claim for asciminib (asciminib cohort) or another third-line TKI used to treat CML (imatinib mesylate, dasatinib, nilotinib, bosutinib, ponatinib) in the open-source pharmacy claims database occurring during the index period. All patients with at least one claim for asciminib during the index window were placed into the asciminib cohort and the index date was date of the first asciminib claim. Patients with no claims for asciminib were placed in the other TKI cohort. These patients were indexed on their third-line TKI (i.e., 2 prior TKIs must have been observed at any time prior to the index date) and the index date was the date of the first claim observed during the index period.
- Age ≥ 18 years on the index date.
- Patients with ≥ 6 months of continuous pre-index data availability. This was defined as:
- The index pharmacy was a stable provider for each of the 6 months prior to the index date; and
- The patient had at least 1 claim (for any drug) in the open-source pharmacy claims database more than 6 months prior to the index date.
- In Phase 2, patients were required to meet the following criteria:
- Patients with linkage to the open-source medical claims database.
- Patients with ≥ 3 months of post-index data availability. Post-index data availability was defined as:
- The index pharmacy was a stable provider for each of the 3 months after the index date; and
- The patient had at least 1 claim (for any drug) in the open-source pharmacy claims database more than 3 months after the index date.
- Exclusion criteria:
- • Patients with data quality issues, defined as missing or invalid age. In order to retain the maximum sample of asciminib patients for the primary objectives, no additional exclusion criteria were applied.
Exclusion
Key Trial Info
Start Date :
September 20 2022
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 15 2022
Estimated Enrollment :
425 Patients enrolled
Trial Details
Trial ID
NCT06148493
Start Date
September 20 2022
End Date
December 15 2022
Last Update
November 28 2023
Active Locations (1)
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1
Novartis
East Hanover, New Jersey, United States, 07936