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This was a retrospective, non-interventional, observational cohort study using Optum's de-identified Clinformatics® Data Mart Database. Adult patients newly diagnosed with chronic myeloid leukemia (CML) treated with tyrosine kinase inhibitors (TKIs) were identified using the Optum database and classified into the following cohorts:
The observation period spanned from the start of data availability (i.e., 01 January 2007) to the earliest of end of data (i.e., 30 June 2022), end of continuous health plan enrollment, or death (if available). The index date was defined as the first treatment initiation for the first treatment TKI cohort and as the second treatment initiation for the second treatment TKI cohort. The baseline period consisted of the 6 months prior to the index date. The follow-up period started on the index date and ended at the earliest of end of observation period or hematopoietic stem cell transplantation (HSCT).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| First Treatment Cohort | Patients newly diagnosed with CML who received first treatment with imatinib, dasatinib, nilotinib, or bosutinib. | ||
| Second Treatment Cohort | Patients from first treatment cohort with a subsequent line of therapy (i.e., second treatment) with imatinib, dasatinib, nilotinib, bosutinib, or ponatinib. |
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| Measure | Description | Time Frame |
|---|---|---|
| Treatment Patterns | Tyrosine kinase inhibitor (TKI) treatment management patterns in CML patients on first line or second line TKI were assessed. | Up to approximately 10 years |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Days Covered (PDC) | PDC was defined as the number of days of medication covered divided by the number of calendar days during the study period. The study period spanned from index date to the next line of therapy initiation (switch), hematopoietic stem cell transplantation (HSCT), initiation of a CML-related chemotherapy for accelerated phase (AP)/blast crisis (BC) (day prior to HSCT/CML chemotherapy) or last supply day if treatment gap ≥ 90 days, whichever occurred first. The index date was defined as the first treatment initiation for the first treatment cohort and as the second treatment initiation for the second treatment cohort. |
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Inclusion Criteria:
Adult patients who initiated their first treatment with imatinib, dasatinib, nilotinib, or bosutinib (conditional on Food and Drug Administration (FDA) approval dates) with 6 months continuous health plan enrollment prior to the first prescription fill date.
Patients with 2 or more diagnoses for CML (adult as of the first diagnosis for CML).
Patients had index date on or after first CML diagnosis.
Patients had no diagnoses for CML remission/relapse prior to index date.
Patients had no gastrointestinal stomach tumor (GIST) or chronic myelomonocytic leukemia (CMML) at any time.
Patients had no medical claims associated with a clinical trial during the baseline period.
Patients had no hematopoietic stem cell transplantation (HSCT) during the baseline period.
Patients had no CML-related chemotherapy treatments for accelerated phase (AP)/blast crisis (BC) during the baseline period.
First treatment cohort:
Second treatment cohort:
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This was a retrospective, noninterventional cohort study.
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis | East Hanover | New Jersey | 07936 | United States |
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| ID | Term |
|---|---|
| D015464 | Leukemia, Myelogenous, Chronic, BCR-ABL Positive |
| ID | Term |
|---|---|
| D007951 | Leukemia, Myeloid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| Up to approximately 10 years |
| Number of Patients per PDC Category | PDC was defined as the number of days of medication covered divided by the number of calendar days during the study period. The study period spanned from index date to the next line of therapy initiation (switch), HSCT, initiation of a CML-related chemotherapy for AP/BC (day prior to HSCT/CML chemotherapy) or last supply day if treatment gap ≥ 90 days, whichever occurred first. The index date was defined as the first treatment initiation for the first treatment cohort and as the second treatment initiation for the second treatment cohort. PDC categories included:
| Up to approximately 10 years |
| Time to Treatment Discontinuation | Up to approximately 10 years |
| Time to Treatment Switch | Up to approximately 10 years |
| Time to First Treatment Interruption | Up to approximately 10 years |
| Time to First Dose Reduction | Up to approximately 10 years |
| Rate of Treatment Discontinuation | Months 1, 3, 6, 9, 12, 18, and years 2, 3, 4 |
| Rate of Treatment Switching | Months 1, 3, 6, 9, 12, 18, and years 2, 3, 4 |
| Rate of Treatment Interruption | Months 1, 3, 6, 9, 12, 18, and years 2, 3, 4 |
| Rate of Dose Reduction | Months 1, 3, 6, 9, 12, 18, and years 2, 3, 4 |
| Number of Patients With Non-optimal Treatment (NOPT) | Three categories of NOPT were defined:
Index date was defined as the first treatment initiation for the first treatment cohort and as the second treatment initiation for the second treatment cohort. | Up to approximately 10 years |
| Number of Patients With NOPT by First Generation TKI | Three categories of NOPT were defined:
Index date was defined as the first treatment initiation for the first treatment cohort and as the second treatment initiation for the second treatment cohort. | Up to approximately 10 years |
| Number of Patients With NOPT by Second Generation TKI | Three categories of NOPT were defined:
Index date was defined as the first treatment initiation for the first treatment cohort and as the second treatment initiation for the second treatment cohort. | Up to approximately 10 years |
| All-cause Healthcare Resource Utilization (HRU) per Patient per Year in NOPT Patients Compared to Reference Subgroup | The reference subgroup was defined based on the following treatment adherence and persistence criteria denoting potential indicators of TKI treatment success based on observations from the clinical practice: (1) high treatment adherence (defined as PDC >90%) with no observed treatment discontinuation anytime post-index; or (2) high treatment adherence (defined as PDC >90%) with treatment discontinuation occurring >12 months post-index. All-cause HRU included:
| 2 years |
| CML-related HRU per Patient per Year in NOPT Patients Compared to Reference Subgroup | The reference subgroup was defined based on the following treatment adherence and persistence criteria denoting potential indicators of TKI treatment success based on observations from the clinical practice: (1) high treatment adherence (defined as PDC >90%) with no observed treatment discontinuation anytime post-index; or (2) high treatment adherence (defined as PDC >90%) with treatment discontinuation occurring >12 months post-index. All-cause HRU included:
| 2 years |
| All-cause Direct Healthcare Costs per Patient per Year in NOPT Patients Compared to Reference Subgroup | The reference subgroup was defined based on the following treatment adherence and persistence criteria denoting potential indicators of TKI treatment success based on observations from the clinical practice: (1) high treatment adherence (defined as PDC >90%) with no observed treatment discontinuation anytime post-index; or (2) high treatment adherence (defined as PDC >90%) with treatment discontinuation occurring >12 months post-index. All-cause direct healthcare costs included:
| 2 years |
| CML-related Direct Healthcare Costs per Patient per Year in NOPT Patients Compared to Reference Subgroup | The reference subgroup was defined based on the following treatment adherence and persistence criteria denoting potential indicators of TKI treatment success based on observations from the clinical practice: (1) high treatment adherence (defined as PDC >90%) with no observed treatment discontinuation anytime post-index; or (2) high treatment adherence (defined as PDC >90%) with treatment discontinuation occurring >12 months post-index. All-cause direct healthcare costs included:
| 2 years |
| D009196 |
| Myeloproliferative Disorders |
| D001855 | Bone Marrow Diseases |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |