Novartis
East Hanover, New Jersey, 07936, United States
NCT Number: NCT07188428
The aim of this study was to evaluate the real-world treatment patterns, healthcare resource use and costs among patients newly diagnosed with CML who were treated with tyrosine kinase inhibitors (TKIs) in first- and second-line therapy.
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Notify Me18 year and older
All sexes
Observational
East Hanover, New Jersey, 07936, United States
The study used claims from Medicare FFS data from 1 January 2016 to 31 December 2022 (observation period). The patient identification period spanned from 1 January 2017 to 30 June 2022. The index date was the date of treatment line initiation. Patients were followed from index date until death, end of enrollment, or study end (31 December 2022), whichever came first. Each patient's follow-up was variable in length.
Variables were assessed during the follow-up period in first-line (1L) and second-line (2L) treatment cohorts and were stratified by generations of TKIs and treatment profiles. Patients were categorized into non-optimal treatment (NOPT) profiles and reference groups, and treatment patterns, healthcare resource utilization (HCRU), and payer healthcare costs were summarized descriptively for each group.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: Up to approximately 6 years
Time frame: 6 months
Time frame: Up to approximately 6 years
Time frame: Up to approximately 6 years
Adherence was assessed using PDC. The PDC was defined as the number of days of medication covered during the treatment line, divided by the number of calendar days between the start and end dates of the line of treatment.
Time frame: Up to approximately 6 years
Adherence was assessed using PDC. The PDC was defined as the number of days of medication covered during the treatment line, divided by the number of calendar days between the start and end dates of the line of treatment.
Time frame: Up to approximately 6 years
Time frame: Up to approximately 6 years
Time frame: Up to approximately 6 years
Treatment interruption was defined as a gap of ≥14 days in CML treatment with resumption of that treatment after the gap.
Time frame: Up to approximately 6 years
Time frame: Up to approximately 6 years
Time frame: Up to approximately 6 years
Time frame: Up to approximately 6 years
Healthcare visits included inpatient visits, outpatient visits, emergency department visits, and pharmacy visits.
Time frame: Up to approximately 6 years
Healthcare visits included inpatient visits, outpatient visits, emergency department visits, and pharmacy visits.
Time frame: Up to approximately 6 years
Time frame: Up to approximately 6 years
Healthcare costs included:
Time frame: Up to approximately 6 years
Healthcare costs included:
Novartis Pharmaceuticals
Industry
Treatment Patterns and Outcomes Among Patients With Chronic Myeloid Leukemia (CML) in All Lines of Therapy: An Analysis of Medicare Fee-for-Service (FFS) Data
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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