A Study to Compare Health Care Costs Between Apixaban and Low Molecular Weight Heparin in Patients With Venous Thromboembolism and Cancer

Cost Comparison Between Apixaban and Low Molecular Weight Heparin (LMWH) Among Venous Thromboembolism (VTE) Cancer Patients

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.

Study Overview

• Status: Completed
• Conditions: Thromboembolism

• Study Type: Observational
• Enrollment (Actual): 7304

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10017
      • Pfizer Investigational

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• 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.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
apixaban; patients treated with apixaban
Low molecular weight heparin (LMWH); patients treated with low molecular weight heparin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean All-Cause Healthcare Costs Per Participant Per Month (PPPM) for VTE Events	The all-cause healthcare cost for VTE event was defined as the sum of total cost associated with the total inpatient, total outpatient, and total pharmacy costs for the VTE event. Costs were converted to 2021 United States dollars (USD) using the medical component of the consumer price index and was expressed as cost per participant per month. The date of the first apixaban or LMWH prescription on or within the 30 days following a VTE diagnosis was considered as the index date.	From index date until health plan disenrollment, index therapy discontinuation, switch to another anticoagulant or end of study period (up to 72 months); data observed retrospectively over 24 months
Mean All-Cause Healthcare Outpatient Pharmacy Costs PPPM for VTE Events	The all-cause healthcare outpatient pharmacy cost for VTE event was defined as the total cost associated with the outpatient pharmacy costs for the VTE event. Costs were converted to 2021 USD using the medical component of the consumer price index and was expressed as cost per participant per month. The date of the first apixaban or LMWH prescription on or within the 30 days following a VTE diagnosis was considered as the index date.	From index date until health plan disenrollment, index therapy discontinuation, switch to another anticoagulant or end of study period (up to 72 months); data observed retrospectively over 24 months
Mean All-Cause Healthcare Outpatient Medical Costs PPPM for VTE Events	The all-cause healthcare outpatient medical cost for VTE event was defined as the total cost associated with the outpatient medical costs (excluding pharmacy costs) for the VTE event. Costs were converted to 2021 USD using the medical component of the consumer price index and was expressed as cost per participant per month. The date of the first apixaban or LMWH prescription on or within the 30 days following a VTE diagnosis was considered as the index date.	From index date until health plan disenrollment, index therapy discontinuation, switch to another anticoagulant or end of study period (up to 72 months); data observed retrospectively over 24 months
Mean All-Cause Healthcare Hospitalization Costs PPPM for VTE Events	The all-cause healthcare hospitalization cost for VTE event was defined as the cost associated with the inpatient hospitalization for the VTE event. Costs were converted to 2021 USD using the medical component of the consumer price index and was expressed as cost per participant per month. The date of the first apixaban or LMWH prescription on or within the 30 days following a VTE diagnosis was considered as the index date.	From index date until health plan disenrollment, index therapy discontinuation, switch to another anticoagulant or end of study period (up to 72 months); data observed retrospectively over 24 months
Mean All-Cause Healthcare Costs PPPM for Recurrent VTE Events	Recurrent VTE was identified based on inpatient claims with VTE as the primary diagnosis on any claim (international classification of diseases, tenth revision, clinical modification [ICD-10-CM] diagnosis codes). Recurrent VTE all cause healthcare costs were defined as the costs associated with the first recurrent VTE hospitalization and all subsequent VTE costs in the inpatient (primary or secondary diagnosis) or outpatient (any position) setting. Costs were converted to 2021 USD using the medical component of the consumer price index and was expressed as cost per participant per month. The date of the first apixaban or LMWH prescription on or within the 30 days following a VTE diagnosis was considered as the index date.	From index date until health plan disenrollment, index therapy discontinuation, switch to another anticoagulant or end of study period (up to 72 months); data observed retrospectively over 24 months
Mean All-Cause Healthcare Outpatient Medical Costs PPPM for Recurrent VTE Events	Recurrent VTE was identified based on inpatient claims with VTE as the primary diagnosis on any claim (ICD-10-CM diagnosis codes). Recurrent VTE outpatient medical costs included costs associated with physician office visits, emergency room visits, laboratory or pathology visits, radiology exams, and outpatient surgical visits. Costs were converted to 2021 USD using the medical component of the consumer price index and was expressed as cost per participant per month. The date of the first apixaban or LMWH prescription on or within the 30 days following a VTE diagnosis was considered as the index date.	From index date until health plan disenrollment, index therapy discontinuation, switch to another anticoagulant or end of study period (up to 72 months); data observed retrospectively over 24 months
Mean All-Cause Healthcare Hospitalization Costs PPPM for Recurrent VTE Events	Recurrent VTE was identified based on inpatient claims with VTE as the primary diagnosis on any claim (ICD-10-CM diagnosis codes). The all-cause healthcare hospitalization cost for recurrent VTE event was defined as the cost associated with the inpatient hospitalization for the recurrent VTE event. Costs were converted to 2021 USD using the medical component of the consumer price index and was expressed as cost per participant per month. The date of the first apixaban or LMWH prescription on or within the 30 days following a VTE diagnosis was considered as the index date.	From index date until health plan disenrollment, index therapy discontinuation, switch to another anticoagulant or end of study period (up to 72 months); data observed retrospectively over 24 months
Mean All-Cause Healthcare Costs PPPM for Major Bleeding Related VTE Events	Major bleeding was defined by primary discharge diagnosis on any claim in the inpatient setting, including gastrointestinal (GI) bleeding, intracranial hemorrhage (ICH), and other major bleeding. Major bleeding-related all cause healthcare costs were defined as costs associated with the first major bleeding hospitalization plus all subsequent bleeding costs occurring in the inpatient (primary or secondary diagnosis) or outpatient setting (any position). Costs were converted to 2021 USD using the medical component of the consumer price index and was expressed as cost per participant per month. The date of the first apixaban or LMWH prescription on or within the 30 days following a VTE diagnosis was considered as the index date.	From index date until health plan disenrollment, index therapy discontinuation, switch to another anticoagulant or end of study period (up to 72 months); data observed retrospectively over 24 months
Mean All-Cause Outpatient Medical Costs PPPM for Major Bleeding Related VTE Events	Major bleeding was defined by primary discharge diagnosis on any claim in the inpatient setting, including GI bleeding, ICH and other major bleeding. Major bleeding-related all cause outpatient medical costs were major bleeding related outpatient costs associated with physician office visits, emergency room visits, laboratory or pathology visits, radiology exams, and outpatient surgical visits. Costs were converted to 2021 USD using the medical component of the consumer price index and was expressed as cost per participant per month. The date of the first apixaban or LMWH prescription on or within the 30 days following a VTE diagnosis was considered as the index date.	From index date until health plan disenrollment, index therapy discontinuation, switch to another anticoagulant or end of study period (up to 72 months); data observed retrospectively over 24 months
Mean All-Cause Hospitalization Costs PPPM for Major Bleeding Related VTE Events	Major bleeding was defined by primary discharge diagnosis on any claim in the inpatient setting, including GI bleeding, ICH, and other major bleeding. Major bleeding-related all cause healthcare costs were defined as costs associated with the first major bleeding hospitalization plus all subsequent bleeding costs occurring in the inpatient (primary or secondary diagnosis). Costs were converted to 2021 USD using the medical component of the consumer price index and was expressed as cost per participant per month. The date of the first apixaban or LMWH prescription on or within the 30 days following a VTE diagnosis was considered as the index date.	From index date until health plan disenrollment, index therapy discontinuation, switch to another anticoagulant or end of study period (up to 72 months); data observed retrospectively over 24 months
Mean All-Cause Healthcare Costs PPPM for Clinically Relevant Non-Major (CRNM) Bleeding Related VTE Events	CRNM bleeding-related all cause healthcare costs were combination of bleeding related inpatient and outpatient costs. CRNM bleeding was defined as an inpatient encounter with a secondary diagnosis code for bleeding (without a major bleeding code in the primary position) or an outpatient encounter with a diagnosis code in any position for CRNM GI bleeding or other non-critical types of bleeding. Any CRNM bleeding events that followed a major bleeding event were not included in the analysis of CRNM bleeding. Costs were converted to 2021 USD using the medical component of the consumer price index and was expressed as cost per participant per month. The date of the first apixaban or LMWH prescription on or within the 30 days following a VTE diagnosis was considered as the index date.	From index date until health plan disenrollment, index therapy discontinuation, switch to another anticoagulant or end of study period (up to 72 months); data observed retrospectively over 24 months
Mean All-Cause Outpatient Medical Costs PPPM for CRNM Bleeding Related VTE Events	CRNM bleeding was defined as an inpatient encounter with a secondary diagnosis code for bleeding (without a major bleeding code in the primary position) or an outpatient encounter with a diagnosis code in any position for CRNM GI bleeding or other non-critical types of bleeding. CRNM bleeding all cause outpatient medical costs were major bleeding related outpatient costs associated with physician office visits, emergency room (ER) visits, laboratory or pathology visits, radiology exams, and outpatient surgical visits. Any CRNM bleeding events that followed a major bleeding event were not included in the analysis of CRNM bleeding. Costs were converted to 2021 USD using the medical component of the consumer price index and was expressed as cost per participant per month. The date of the first apixaban or LMWH prescription on or within the 30 days following a VTE diagnosis was considered as the index date.	From index date until health plan disenrollment, index therapy discontinuation, switch to another anticoagulant or end of study period (up to 72 months); data observed retrospectively over 24 months
Mean All-Cause Hospitalization Costs PPPM for CRNM Bleeding Related VTE Events	CRNM bleeding was defined as an inpatient encounter with a secondary diagnosis code for bleeding (without a major bleeding code in the primary position) or an outpatient encounter with a diagnosis code in any position for CRNM GI bleeding or other non-critical types of bleeding. Any CRNM bleeding events that followed a major bleeding event were not included in the analysis of CRNM bleeding. Costs were converted to 2021 USD using the medical component of the consumer price index and was expressed as cost per participant per month. The date of the first apixaban or LMWH prescription on or within the 30 days following a VTE diagnosis was considered as the index date.	From index date until health plan disenrollment, index therapy discontinuation, switch to another anticoagulant or end of study period (up to 72 months); data observed retrospectively over 24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Number of Hospitalizations Per Participant Per Month (PPPM) for VTE Events	Mean number of hospitalizations PPPM for VTE events are reported in this outcome measure. Index date was defined as the date of the first apixaban or LMWH prescription claim on or within the 30 days following a VTE diagnosis.	From index date until health plan disenrollment, index therapy discontinuation, switch to another anticoagulant or end of study period (up to 72 months); data observed retrospectively over 24 months
Mean Number of Outpatient Medical Visits PPPM for VTE Events	Mean number of outpatient medical visits PPPM for VTE events are reported in this outcome measure. Outpatient visits included physician office visits, ER visits, laboratory or pathology visits, radiology exams, and outpatient surgical visits and ancillary or other services. Index date was defined as the date of the first apixaban or LMWH prescription claim on or within the 30 days following a VTE diagnosis.	From index date until health plan disenrollment, index therapy discontinuation, switch to another anticoagulant or end of study period (up to 72 months); data observed retrospectively over 24 months
Mean Number of Prescription Fills PPPM for VTE Events	Mean number of prescription fills PPPM for VTE events are reported in this outcome measure. Index date was defined as the date of the first apixaban or LMWH prescription claim on or within the 30 days following a VTE diagnosis.	From index date until health plan disenrollment, index therapy discontinuation, switch to another anticoagulant or end of study period (up to 72 months); data observed retrospectively over 24 months
Mean Number of Hospitalizations PPPM for Recurrent VTE Events	Recurrent VTE was identified based on inpatient claims with VTE as the primary diagnosis on any claim (ICD-10-CM diagnosis codes). Mean number of hospitalizations PPPM for recurrent VTE events are reported in this outcome measure. Index date was defined as the date of the first apixaban or LMWH prescription claim on or within the 30 days following a VTE diagnosis.	From index date until health plan disenrollment, index therapy discontinuation, switch to another anticoagulant or end of study period (up to 72 months); data observed retrospectively over 24 months
Mean Number of Outpatient Medical Visits PPPM for Recurrent VTE Events	Recurrent VTE was identified based on inpatient claims with VTE as the primary diagnosis on any claim (ICD-10-CM diagnosis codes). Outpatient visits included physician office visits, ER only visits, laboratory or pathology visits, radiology, and surgical services and ancillary or other services. Index date was defined as the date of the first apixaban or LMWH prescription claim on or within the 30 days following a VTE diagnosis.	From index date until health plan disenrollment, index therapy discontinuation, switch to another anticoagulant or end of study period (up to 72 months); data observed retrospectively over 24 months
Mean Number of Hospitalizations PPPM for Major Bleeding Related VTE Events	Major bleeding was defined by primary discharge diagnosis on any claim in the inpatient setting, including GI bleeding, ICH and other major bleeding. Mean number of hospitalizations PPPM for recurrent VTE events are reported in this outcome measure. Index date was defined as the date of the first apixaban or LMWH prescription claim on or within the 30 days following a VTE diagnosis.	From index date until health plan disenrollment, index therapy discontinuation, switch to another anticoagulant or end of study period (up to 72 months); data observed retrospectively over 24 months
Mean Number of Outpatient Medical Visits PPPM for Major Bleeding Related VTE Events	Major bleeding was defined by primary discharge diagnosis on any claim in the inpatient setting, including GI bleeding, ICH and other major bleeding. Outpatient visits included physician office visits, ER only visits, laboratory or pathology visits, radiology, and surgical services and ancillary or other services. Index date was defined as the date of the first apixaban or LMWH prescription claim on or within the 30 days following a VTE diagnosis.	From index date until health plan disenrollment, index therapy discontinuation, switch to another anticoagulant or end of study period (up to 72 months); data observed retrospectively over 24 months
Mean Number of Hospitalizations PPPM for CRNM Bleeding Related VTE Events	CRNM bleeding was defined as an inpatient encounter with a secondary diagnosis code for bleeding (without a major bleeding code in the primary position) or an outpatient encounter with a diagnosis code in any position for CRNM GI bleeding or other non-critical types of bleeding. Mean number of hospitalizations PPPM for recurrent VTE events are reported in this outcome measure. Index date was defined as the date of the first apixaban or LMWH prescription claim on or within the 30 days following a VTE diagnosis.	From index date until health plan disenrollment, index therapy discontinuation, switch to another anticoagulant or end of study period (up to 72 months); data observed retrospectively over 24 months
Mean Number of Outpatient Medical Visits PPPM for CRNM Bleeding Related VTE Events	CRNM bleeding was defined as an inpatient encounter with a secondary diagnosis code for bleeding (without a major bleeding code in the primary position) or an outpatient encounter with a diagnosis code in any position for CRNM GI bleeding or other non-critical types of bleeding. Outpatient visits included physician office visits, ER only visits, laboratory or pathology visits, radiology, and surgical services and ancillary or other services. Index date was defined as the date of the first apixaban or LMWH prescription claim on or within the 30 days following a VTE diagnosis.	From index date until health plan disenrollment, index therapy discontinuation, switch to another anticoagulant or end of study period (up to 72 months); data observed retrospectively over 24 months

Collaborators and Investigators

• Sponsor: Pfizer
• Collaborators: Bristol-Myers Squibb
• Investigators: Study Director: Pfizer CT.gov Call Center, Pfizer

Publications and helpful links

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

Study Major Dates

• Study Start (Actual): August 31, 2022
• Primary Completion (Actual): August 30, 2024
• Study Completion (Actual): August 30, 2024

Study Registration Dates

• First Submitted: November 17, 2022
• First Submitted That Met QC Criteria: December 1, 2022
• First Posted (Actual): December 9, 2022

Study Record Updates

• Last Update Posted (Actual): October 20, 2025
• Last Update Submitted That Met QC Criteria: September 26, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Embolism and Thrombosis; Thromboembolism
• Other Study ID Numbers: B0661183; NCT05643885 (Registry Identifier: ClinicalTrials.gov)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.