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The study was an observational, retrospective cohort design, using US administrative insurance claims data, to better understand Healthcare resource utilization (HRU) and healthcare costs among women with mBC initiated on a CDK4/6 inhibitor.
This study used an observational, retrospective cohort design, using US administrative insurance claims data, previously employed in an existing project, to better understand HRU and healthcare costs among women with mBC initiated on a CDK4/6 inhibitor.
Adult women with HR+/HER2- mBC initiated on a CDK4/6 inhibitor were included in the study and were stratified into cohorts based on the first CDK4/6 inhibitor they received (i.e., abemaciclib, palbociclib, or ribociclib), regardless of the line of therapy and menopausal status.
The initiation of the first CDK4/6 inhibitor was defined as the index date. The index treatment was defined as the CDK4/6 inhibitor initiated on the index date (i.e., abemaciclib, palbociclib, or ribociclib).
The 6-month period preceding the index date was considered as the baseline period, and was used to measure patient characteristics.
Outcomes were measured between the index date and 1) the end of the study period (persistence, switch, HRU, costs) OR 2) the end of the index treatment (adherence, dose modification, frequency of monitoring), as relevant. The end of the study period was defined as the earliest occurrence between the end of continuous enrollment and the end of data availability.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ribociclib | Participants who initiated CDK4/6i therapy |
| |
| Palbociclib | Participants who initiated CDK4/6i therapy |
| |
| Abemaciclib | Participants who initiated CDK4/6i therapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ribociclib | Drug | Participants who initiated CDK4/6i therapy |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Number of inpatient (IP) admissions | Healthcare Resource Utilization (HRU) was measured between index date and end of follow-up, and was separately measured during the studied line of therapy, and after the studied line of therapy. Because women have different durations of follow-up, the number of events were reported as the average total number of visits per patient-per-6-months (PPP6M). HRU PPP6M was defined as the total number of visits or services for a patient occurring during the relevant period, reported on a six-month basis. | From the index date defined as initiation of CDK4/6 inhibitor to the end of follow-up i.e. approximately 6 months (Q1/2001 - Q3/2018) |
| Number of IP days | HRU was measured between index date and end of follow-up, and was separately measured during the studied line of therapy, and after the studied line of therapy. Because women have different durations of follow-up, the number of events were reported as the average total number of visits per patient-per-6-months (PPP6M). HRU PPP6M was defined as the total number of visits or services for a patient occurring during the relevant period, reported on a six-month basis. | From the index date defined as initiation of CDK4/6 inhibitor to the end of follow-up i.e. approximately 6 months (Q1/2001 - Q3/2018) |
| Number of days with durable medical equipment (DME) services | HRU was measured between index date and end of follow-up, and was separately measured during the studied line of therapy, and after the studied line of therapy. Because women have different durations of follow-up, the number of events were reported as the average total number of visits per patient-per-6-months (PPP6M). HRU PPP6M was defined as the total number of visits or services for a patient occurring during the relevant period, reported on a six-month basis. | From the index date defined as initiation of CDK4/6 inhibitor to the end of follow-up i.e. approximately 6 months (Q1/2001 - Q3/2018) |
| Number of days with emergency department (ED) visits |
| Measure | Description | Time Frame |
|---|---|---|
| Treatment patterns | Treatment patterns included:
| From the index date defined as initiation of CDK4/6 inhibitor to the end of follow-up i.e. approximately 6 months (Q1/2001 - Q3/2018) |
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Inclusion Criteria:
- Evidence of treatment with a CDK4/6 inhibitor regardless of the line of therapy.
The initiation of the first CDK4/6 inhibitor was defined as the index date, and the first CDK4/6 inhibitor initiated was defined as the index treatment
Exclusion Criteria:
Study analyses were conducted among HR+/HER2- women with at least one claim for treatment with CDK4/6 inhibitor for mBC
Study analyses were conducted among HR+/HER2- women with at least one claim for treatment with CDK4/6 inhibitor for mBC
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigative Site | East Hanover | New Jersey | 07936 | United States |
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| Label | URL |
|---|---|
| Results for CLEE011AUS65 from the Novartis Clinical Trials Website | View source |
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| Palbociclib |
| Drug |
Participants who initiated CDK4/6i therapy |
|
| Abemaciclib | Drug | Participants who initiated CDK4/6i therapy |
|
HRU was measured between index date and end of follow-up, and was separately measured during the studied line of therapy, and after the studied line of therapy. Because women have different durations of follow-up, the number of events were reported as the average total number of visits per patient-per-6-months (PPP6M). HRU PPP6M was defined as the total number of visits or services for a patient occurring during the relevant period, reported on a six-month basis.
| From the index date defined as initiation of CDK4/6 inhibitor to the end of follow-up i.e. approximately 6 months (Q1/2001 - Q3/2018) |
| Number of days with outpatient (OP) services or visits | OP services included:
| From the index date defined as initiation of CDK4/6 inhibitor to the end of follow-up i.e. approximately 6 months (Q1/2001 - Q3/2018) |
| Other medical services | In addition to the all-cause HRU components, specific condition-related HRU was also analyzed. Conditions considered included those frequently encountered in clinical trials of CDK4/6 inhibitors. This included the number of days with medical services, number of IP days, number of non-IP days, and proportion of women with at least one medical service associated with a diagnosis for the following conditions:
| From the index date defined as initiation of CDK4/6 inhibitor to the end of follow-up i.e. approximately 6 months (Q1/2001 - Q3/2018) |
| Total healthcare costs (medical service + pharmacy costs) | Medical service costs included: IP costs, ER costs, OP costs, DME costs, Laboratory test costs, Medical drug administration costs and OP costs - excluding drug administration costs Pharmacy costs (pharmacy costs covered by pharmacy benefits) included: CDK4/6 inhibitor costs, Endocrine and chemotherapy costs and Other drug costs | From the index date defined as initiation of CDK4/6 inhibitor to the end of follow-up i.e. approximately 6 months (Q1/2001 - Q3/2018) |
| Monitoring | electrocardiogram [EKG], hematologic tests, hepatic function tests, imaging | From the index date defined as initiation of CDK4/6 inhibitor to the end of follow-up i.e. approximately 6 months (Q1/2001 - Q3/2018) |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| C000589651 | ribociclib |
| C500026 | palbociclib |
| C000590451 | abemaciclib |
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