Real-World Usage of Asciminib Among Patients With Chronic Myeloid Leukemia in Chronic Phase in the United States Using a Large Claims Database
- Conditions
- Chronic Myeloid Leukemia
- Registration Number
- NCT06148493
- Lead Sponsor
- Novartis Pharmaceuticals
- 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 the index medication.
All patients with at least 1 pharmacy claim for asciminib occurring between 01 January 2021 and 30 April 2022 in (Phase 1) were grouped into the asciminib cohort. A data refresh was conducted (Phase 1 refresh) and all patients with at least 1 pharmacy claim for asciminib occurring between 01 January 2021 and 29 August 2022 were included in the asciminib cohort. Patients were required to have at least 6 months of continuous data availability prior to the start of treatment and were followed from the start of treatment until the end of available follow-up. The end of available follow up in open source data was defined as 1) last claim date in medical or pharmacy data, OR 2) last day of index pharmacy stability, OR 3) end of study period, whichever came first. While no post-index data availability were required in Phase 1, a subgroup analysis was conducted in patients with at least 3 and 6 months of available follow-up after the index date in Phase 1 refresh.
In Phase 2 of the study, patients with no exposure to asciminib and with at least 1 pharmacy claim for imatinib mesylate, dasatinib, nilotinib, bosutinib or ponatinib were indexed to the first new tyrosine kinase inhibitor (TKI) observed between 01 January 2021 and 29 August 2022 and grouped into the other TKI cohort. The index date was the initiation date of the index medication. Patients were required to have linkage to the open-source medical claims database and at least 3 months of available follow-up after the index date.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 425
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Age of patients Baseline Geographic region of patients Baseline Total duration of available follow-up Up to 6 months Number of patients with comorbidities Up to 6 months Number of patients with any prior TKI use Up to 6 months Sex of patients Baseline Payer type for prescriptions Baseline Pre-index medication use Up to 6 months Starting dose of index medication Up to 6 months Total day supply of index medication Up to 6 months Number of patients with chronic myeloid leukemia (CML) diagnosis Up to 6 months Specialty of prescribing physician Up to 6 months Number of patients with T315I mutation proxy Up to 6 months Number of patients with any prior non-TKI CML treatment Up to 6 months Number of patients still on index therapy at the end of Month 3 post-index Up to 3 months National Cancer Institute (NCI) comorbidity index for patients Up to 6 months The NCI comorbidity index score range is 0, 1 to 2, 2 to 3, and 3+, with higher scores indicating more comorbidity.
Number of prescriptions of index medication Up to 6 months
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Novartis
🇺🇸East Hanover, New Jersey, United States