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

NCT06148493 | Completed

• 1 other identifier: CABL001A0US01
• Study Type: observational
• Target: 425
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Myeloid Leukemia

Outcome Measures

Primary Outcomes (17)

• Age of patients

  Baseline

• Sex of patients

  Baseline

• Geographic region of patients

  Baseline

• Payer type for prescriptions

  Baseline

• Total duration of available follow-up

  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

• 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

• Number of patients with comorbidities

  Up to 6 months

• Pre-index medication use

  Up to 6 months

• Number of patients with any prior TKI use

  Up to 6 months

• Number of patients with any prior non-TKI CML treatment

  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 prescriptions of index medication

  Up to 6 months

• Number of patients still on index therapy at the end of Month 3 post-index

  Up to 3 months

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This was a retrospective, noninterventional cohort study

You may qualify if:

• 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.

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (1)

Novartis

East Hanover, New Jersey, 07936, United States

Location

MeSH Terms

Conditions

Leukemia, Myelogenous, Chronic, BCR-ABL Positive

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Myeloproliferative Disorders; Bone Marrow Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 20, 2023
• First Posted: November 28, 2023
• Study Start: September 20, 2022
• Primary Completion: December 15, 2022
• Study Completion: December 15, 2022
• Last Updated: November 28, 2023

Record last verified: 2023-11

Locations

US (1)