Comparative Effectiveness Analysis of Granulocyte Colony Stimulating Factor Originator Products Versus Biosimilars

Overview

This comparative effectiveness and descriptive retrospective cohort study will evaluate safety and effectiveness outcomes among commercially insured adults who received a granulocyte colony stimulating factor (G-CSF) biosimilar or originator product during the first cycle of clinical guideline-indicated intermediate or high febrile neutropenia risk chemotherapy.

Full Title of Study: “An Exploratory Comparative Effectiveness Analysis of Granulocyte Colony Stimulating Factor Originator Products Versus Biosimilars in Real-world Practice”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Retrospective
  • Study Primary Completion Date: September 30, 2021

Detailed Description

This comparative effectiveness and descriptive retrospective cohort study includes commercially insured adults enrolled in one of four health plans participating in the Biologics and Biosimilars Collective Intelligence Consortium (BBCIC) Distributed Research Network. We included patients who received a granulocyte colony stimulating factor (G-CSF) biosimilar or originator product during the first cycle of clinical guideline-indicated intermediate or high febrile neutropenia risk chemotherapy. We will collect patient demographics, cancer diagnosis, chemotherapy regimen, and patterns of G-CSF biosimilar and originator product use. We will follow patients from first G-CSF exposure until up to six cycles of chemotherapy receipt, death, or insurance disenrollment. The primary effectiveness outcome is incidence of febrile neutropenia. Secondary outcomes include incidence of adverse events and trends in product use over time. We will compare febrile neutropenia incidence between originator and biosimilar products using inverse probability weighting to control for confounding. Secondary analyses will examine 'as treated' outcomes.

Interventions

  • Drug: Receipt of granulocyte-colony stimulating factor
    • Receipt of originator or biosimilar

Arms, Groups and Cohorts

  • G-CSF originator receipt
  • G-CSF biosimilar receipt

Clinical Trial Outcome Measures

Primary Measures

  • Development of febrile neutropenia
    • Time Frame: Within 30 days of receipt of first chemotherapy

Secondary Measures

  • Development of G-CSF associated adverse events
    • Time Frame: Within 30 days of receipt of first chemotherapy

Participating in This Clinical Trial

Inclusion Criteria

Patients age 20 or older diagnosed with lung, breast, colon, ovarian, pancreatic, testicular, cervical, uterine, or NHL cancers initiating clinical guideline-indicated intermediate or high neutropenia risk chemotherapy. Exclusion Criteria:

We will exclude patients with one inpatient, or two outpatient cancer diagnoses at least 30 days apart in the 183 days prior to the Index Date for cancers that differ from the enrolling cancer diagnosis. Additionally, we will exclude patients with: any chemotherapy or G-CSF product receipt in the 183 days prior to the Index Date; two or more medical claims at least 30 days apart for a skilled nursing facility or hospice care in the 183 days prior to the Index Date; or two or more diagnoses/procedure codes at least 1 day apart for cancer-related radiotherapy, bone marrow or stem cell transplant, diagnosis of HIV/AIDS, severe hepatic disease, chronic kidney disease, or any non-oncology related neutropenia from 183 days prior to the Index Date.

Gender Eligibility: All

Minimum Age: 20 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Catherine M. Lockhart
  • Collaborator
    • Harvard Pilgrim Health Care Institute
  • Provider of Information About this Clinical Study
    • Sponsor-Investigator: Catherine M. Lockhart, Executive Director – Biologics & Biosimilars Collective Intelligence Consortium

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