Clinical trial NCT05153135: Description of Treatment Patterns and Description and Comparison of Healthcare Resource Utilization and Costs of Women With Metastatic HR+/HER2- Breast Cancer Treated With CDK4/6 Inhibitors
Official title: Description of Treatment Patterns and Description and Comparison of Healthcare Resource Utilization and Costs of Women With Metastatic HR+/HER2- Breast Cancer Treated With CDK4/6 Inhibitors
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Metastatic Breast Cancer
Keywords: Metastatic breast cancer,
CDK4/6,
health resource utilization,
healthcare costs,
treatment patterns
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2021-12-10
Enrollment: 4320
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Study analyses were conducted among HR+/HER2- women with at least one claim for treatment with CDK4/6 inhibitor for mBC

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

* BC diagnosis: Two diagnosis codes of BC (International Classification of Diseases, 9th Revision, Clinical Modification \[ICD-9-CM\]: 174.xx and International Classification of Diseases, 10th Revision, Clinical Modification \[ICD-10-CM\]: C50.xx \[excluding C50.x2 - male BC\]) on two medical service claims separated by at least 30 days
* Metastatic disease diagnosis: At least two medical claims for a secondary neoplasm (ICD-9-CM codes: 196.xx-197.xx, 198.xx, ICD-10-CM codes: C77.xx, C78.xx, C79.xx) on separate dates, with the first one occurring no more than 30 days before the first diagnosis for BC
* HR+/HER2-: At least one prescription fill or administration of an ET (anastrazole, exemestane, ethinyl estradiol, fulvestrant, fluoxymesterone, letrozole, megestrol acetate, tamoxifen, or toremifene), HR+/HER2- therapy (everolimus), or CDK4/6 inhibitor (i.e., abemaciclib, palbociclib, or ribociclib) at any time following the diagnosis of BC, and no claims for treatments indicated for HER2+ BC, including trastuzumab, lapatinib, afatinib, pertuzumab, or ado-trastuzumab, at any time in the data period
* Women of at least 18 years of age as of the index date
* At least 6 months of continuous health plan coverage prior to and at least 1 month of continuous health plan coverage after the index date

Exclusion Criteria:

* None

Primary outcomes:
measure: Number of inpatient (IP) admissions
timeFrame: 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)
measure: Number of IP days
timeFrame: 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)
measure: Number of days with durable medical equipment (DME) services
timeFrame: 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)
measure: Number of days with emergency department (ED) visits
timeFrame: 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)
measure: Number of days with outpatient (OP) services or visits
timeFrame: 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)
measure: Other medical services
timeFrame: 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)
measure: Total healthcare costs (medical service + pharmacy costs)
timeFrame: 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)
Secondary outcomes:
measure: Treatment patterns
timeFrame: 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)
measure: Monitoring
timeFrame: 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 outcomes:
Locations:
city: East Hanover
country: United States
facility: Novartis Investigative Site
state: New Jersey
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: