Treatment Patterns and Outcomes Among Patients With Chronic Myeloid Leukemia (CML) in All Lines of Treatment
- Conditions
- Leukemia, Chronic Myeloid
- Registration Number
- NCT07188428
- Lead Sponsor
- Novartis Pharmaceuticals
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 2298
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Number of Patients Who Switched to Another CML-related Treatment by TKI Generation and Treatment Profile Up to approximately 6 years Number of Patients Who Switched to Another CML-related Treatment Within 6 Months of Starting Treatment by TKI Generation and Treatment Profile 6 months Time to Treatment Switch by TKI Generation and Treatment Profile Up to approximately 6 years
- Secondary Outcome Measures
Name Time Method Proportion of Days Covered (PDC) by TKI Generation and Treatment Profile 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.
Number of Patients With PDC >80% by TKI Generation and Treatment Profile 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.
Number of Patients who Discontinued Treatment by TKI Generation and Treatment Profile Up to approximately 6 years Time to Treatment Discontinuation by TKI Generation and Treatment Profile Up to approximately 6 years Number of Patients With Treatment Interruption by TKI Generation and Treatment Profile 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 to First Treatment Interruption by TKI Generation and Treatment Profile Up to approximately 6 years Number of Patients With a Dose Reduction by TKI Generation and Treatment Profile Up to approximately 6 years Time to Dose Reduction by TKI Generation and Treatment Profile Up to approximately 6 years Mean Number of All-cause Healthcare Visits per Person per Year (PPPY) by Treatment Profile Up to approximately 6 years Healthcare visits included inpatient visits, outpatient visits, emergency department visits, and pharmacy visits.
Mean Number of CML-related Healthcare Visits per Person per Year (PPPY) by Treatment Profile Up to approximately 6 years Healthcare visits included inpatient visits, outpatient visits, emergency department visits, and pharmacy visits.
Mean Length of Stay (LoS) of Inpatient Visits PPPY by Treatment Profile Up to approximately 6 years Mean All-cause Healthcare Cost PPPY by Treatment Profile Up to approximately 6 years Healthcare costs included:
* Total costs
* Inpatient costs
* Emergency department costs
* Outpatient costs
* Other costs
* Pharmacy costsMean CML-related Healthcare Cost PPPY by Treatment Profile Up to approximately 6 years Healthcare costs included:
* Total costs
* Inpatient costs
* Emergency department costs
* Outpatient costs
* Other costs
* Pharmacy costs
Trial Locations
- Locations (1)
Novartis
🇺🇸East Hanover, New Jersey, United States
Novartis🇺🇸East Hanover, New Jersey, United States