Clinical trial NCT05643885: A Study to Compare Health Care Costs Between Apixaban and Low Molecular Weight Heparin in Patients With Venous Thromboembolism and Cancer
Official title: Cost Comparison Between Apixaban and Low Molecular Weight Heparin (LMWH) Among Venous Thromboembolism (VTE) Cancer Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Thromboembolism
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
Collaborators: name: Bristol-Myers Squibb
First posted: 2022-12-09
Enrollment: 10000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with active cancer who are newly diagnosed with venous thromboembolism (VTE) and treated with apixaban or low molecular weight heparin within 30 days following the VTE.

Patients will be identified from the PharMetrics Plus health care claims database between the period of January 2017 and October 2021 if they have a VTE diagnosis and claim for apixaban or low molecular weight heparin during this time.

Brief summary: The purpose of this study is to evaluate the health care resource utilization and costs associated with treating patients diagnosed with cancer and venous thromboembolism with apixaban or low molecular weight heparin. This is a retrospective database analysis of health care claims data. All-cause costs as well as costs associated with recurrent VTE, major bleeding, and clinically relevant nonmajor bleeding will be assessed.


Eligibility criteria: Inclusion Criteria:

* Venous thromboembolism (VTE) diagnosis between January 1 2017 and October 31 2021
* Evidence of active cancer
* At least 1 claim for apixaban or low molecular weight heparin (LMWH)
* Age 18 years or older

Exclusion Criteria:

* diagnosis of atrial fibrillation/flutter
* procedure for mechanical heart valve or inferior vena cava filter
* VTE diagnosis in the baseline period
* anticoagulant therapy in the baseline period
* pregnancy

Primary outcomes:
measure: Total all-cause Healthcare Costs: Total Healthcare Costs Per Person Per Month (PPPM)
timeFrame: from index date up to the earliest of health plan disenrollment, treatment discontinuation or switch, or end of study period. Assessed up to 60 months
measure: All-cause Healthcare Costs: Outpatient Pharmacy Costs Per Person Per Month
timeFrame: from index date up to the earliest of health plan disenrollment, treatment discontinuation or switch, or end of study period. Assessed up to 60 months
measure: All-cause Healthcare Costs: Outpatient Medical Costs Per Person Per Month
timeFrame: from index date up to the earliest of health plan disenrollment, treatment discontinuation or switch, or end of study period. Assessed up to 60 months
measure: All-cause Healthcare Costs: Hospitalization Costs Per Person Per Month
timeFrame: from index date up to the earliest of health plan disenrollment, treatment discontinuation or switch, or end of study period. Assessed up to 60 months
measure: Recurrent Venous Thromboembolism (VTE) related Costs: Total costs Per Person Per Month
timeFrame: from event date up to the earliest of health plan disenrollment, treatment discontinuation or switch, or end of study period. Assessed up to 60 months
measure: Recurrent VTE related costs: Outpatient Medical Costs Per Person Per Month
timeFrame: from event date up to the earliest of health plan disenrollment, treatment discontinuation or switch, or end of study period. Assessed up to 60 months
measure: Recurrent VTE related Costs: Hospitalization Costs Per Person Per Month
timeFrame: from event date up to the earliest of health plan disenrollment, treatment discontinuation or switch, or end of study period. Assessed up to 60 months
measure: Major Bleeding Related Costs: Total Costs Per Person Per Month
timeFrame: from event date up to the earliest of health plan disenrollment, treatment discontinuation or switch, or end of study period. Assessed up to 60 months
measure: Major Bleeding Related Costs: Outpatient Medical Costs Per Person Per Month
timeFrame: from event date up to the earliest of health plan disenrollment, treatment discontinuation or switch, or end of study period. Assessed up to 60 months
measure: Major Bleeding Related Costs: Hospitalization Costs Per Person Per Month
timeFrame: from event date up to the earliest of health plan disenrollment, treatment discontinuation or switch, or end of study period. Assessed up to 60 months
measure: Clinically Relevant Non-Major Bleeding Related Costs: Total Costs Per Person Per Month
timeFrame: from event date up to the earliest of health plan disenrollment, treatment discontinuation or switch, or end of study period. Assessed up to 60 months
measure: Clinically relevant Non-Major Bleed Related Costs: Outpatient Medical Costs Per Person Per Month
timeFrame: from event date up to the earliest of health plan disenrollment, treatment discontinuation or switch, or end of study period. Assessed up to 60 months
measure: Clinically Relevant Non-Major Bleeding Related Costs: Hospitalization Costs Per Person Per Month
timeFrame: from event date up to the earliest of health plan disenrollment, treatment discontinuation or switch, or end of study period. Assessed up to 60 months
Secondary outcomes:
measure: All-cause Health Care Resource Utilization: Number of Hospitalizations Per Person Per Month
timeFrame: from index date up to the earliest of health plan disenrollment, treatment discontinuation or switch, or end of study period. Assessed up to 60 months
measure: All-cause Health Care Resource Utilization: Number of Emergency Room Visits Per Person Per Month
timeFrame: from index date up to the earliest of health plan disenrollment, treatment discontinuation or switch, or end of study period. Assessed up to 60 months
measure: All-cause Health Care Resource Utilization: Number of Outpatient Medical Visits Per Person Per Month
timeFrame: from index date up to the earliest of health plan disenrollment, treatment discontinuation or switch, or end of study period. Assessed up to 60 months
measure: All-cause Health Care Resource utilization: Number of Prescription Fills Per Person Per Month
timeFrame: from index date up to the earliest of health plan disenrollment, treatment discontinuation or switch, or end of study period. Assessed up to 60 months
measure: Recurrent Venous Thromboembolism (VTE) Related Health Care Resource Utilization: Number of Hospitalizations Per Person Per Month
timeFrame: from event date up to the earliest of health plan disenrollment, treatment discontinuation or switch, or end of study period. Assessed up to 60 months
measure: Recurrent VTE Related Health Care Resource Utilization: Number of Outpatient Medical Visits Per Person Per Month
timeFrame: from event date up to the earliest of health plan disenrollment, treatment discontinuation or switch, or end of study period. Assessed up to 60 months
measure: Recurrent VTE Related Health Care Resource Utilization: Number of Emergency Room Visits Per Patient Per Month
timeFrame: from event date up to the earliest of health plan disenrollment, treatment discontinuation or switch, or end of study period. Assessed up to 60 months
measure: Major Bleeding Related Health Care Resource Utilization: Number of Hospitalizations Per Person Per Month
timeFrame: from event date up to the earliest of health plan disenrollment, treatment discontinuation or switch, or end of study period. Assessed up to 60 months
measure: Major Bleeding Related Health Care Resource Utilization: Number of Outpatient Medical Visits Per Person Per Month
timeFrame: from event date up to the earliest of health plan disenrollment, treatment discontinuation or switch, or end of study period. Assessed up to 60 months
measure: Major Bleeding Related Health Care Resource Utilization: Number of Emergency Room Visits Per Person Per Month
timeFrame: from event date up to the earliest of health plan disenrollment, treatment discontinuation or switch, or end of study period. Assessed up to 60 months
measure: Clinically Relevant Non-Major Bleeding Related Health Care Resource Utilization: Number of Hospitalizations Per Person Per Month
timeFrame: from event date up to the earliest of health plan disenrollment, treatment discontinuation or switch, or end of study period. Assessed up to 60 months
measure: Clinically Relevant Non-Major Bleeding Related Health Care Resource Utilization: Number of Outpatient Medical Visits Per Person Per Month
timeFrame: from event date up to the earliest of health plan disenrollment, treatment discontinuation or switch, or end of study period. Assessed up to 60 months
measure: Clinically Relevant Non-Major Bleeding Health Care Resource Utilization: Number of Emergency Room Visits Per Person Per Month
timeFrame: from event date up to the earliest of health plan disenrollment, treatment discontinuation or switch, or end of study period. Assessed up to 60 months
Other outcomes:
Locations:
city: New York
country: United States
facility: Pfizer Investigational
state: New York
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: