Real-World Usage of Asciminib Among Patients With Chronic Myeloid Leukemia in Chronic Phase in the United States Using a Large Claims Database

Chronic Myeloid Leukemia Clinical Trial

Official title:

Real-World Usage of Asciminib Among Patients With Chronic Myeloid Leukemia in Chronic Phase in the United States Using a Large Claims Database

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06148493
• Other study ID #: CABL001A0US01
• Status: Completed
• Start date: September 20, 2022
• Est. completion date: December 15, 2022

Study information

• Verified date: November 2023
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 425
• Est. completion date: December 15, 2022
• Est. primary completion date: December 15, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Myeloid Leukemia
• Leukemia
• Leukemia, Myelogenous, Chronic, BCR-ABL Positive
• Leukemia, Myeloid

Locations

Country	Name	City	State
United States	Novartis	East Hanover	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Age of patients		Baseline
Primary	Sex of patients		Baseline
Primary	Geographic region of patients		Baseline
Primary	Payer type for prescriptions		Baseline
Primary	Total duration of available follow-up		Up to 6 months
Primary	Number of patients with chronic myeloid leukemia (CML) diagnosis		Up to 6 months
Primary	Specialty of prescribing physician		Up to 6 months
Primary	Number of patients with T315I mutation proxy		Up to 6 months
Primary	National Cancer Institute (NCI) comorbidity index for patients	The NCI comorbidity index score range is 0, 1 to 2, 2 to 3, and 3+, with higher scores indicating more comorbidity.	Up to 6 months
Primary	Number of patients with comorbidities		Up to 6 months
Primary	Pre-index medication use		Up to 6 months
Primary	Number of patients with any prior TKI use		Up to 6 months
Primary	Number of patients with any prior non-TKI CML treatment		Up to 6 months
Primary	Starting dose of index medication		Up to 6 months
Primary	Total day supply of index medication		Up to 6 months
Primary	Number of prescriptions of index medication		Up to 6 months
Primary	Number of patients still on index therapy at the end of Month 3 post-index		Up to 3 months