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

Study Overview

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

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.

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. The investigators 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. The investigators will collect patient demographics, cancer diagnosis, chemotherapy regimen, and patterns of G-CSF biosimilar and originator product use. The investigators 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. The investigators 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.

Cancer, Breast
Cancer, Lung
Cancer of Colon
Cancer of Pancreas
Cancer, Ovarian
Lymphoma, Non-Hodgkin

DRUG: Receipt of granulocyte-colony stimulating factor

BBCIC-GCSF-02

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2021-07-12	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2023-07-25
First Submitted that Met QC Criteria 2021-07-12	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2023-07-27
First Posted (ACTUAL) 2021-07-21	Results First Posted N/A	Last Verified 2023-07

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
N/A

Allocation:
N/A

Interventional Model:
N/A

Masking:
N/A

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
: G-CSF originator receipt Patients receiving filgrastim (Neupogen) or pegfilgrastim (Neulasta) per Health Care Procedural Coding System (HCPCS) J-codes.	DRUG: Receipt of granulocyte-colony stimulating factor Receipt of originator or biosimilar
: G-CSF biosimilar receipt Patients receiving filgrastim biosimilars (filgrastim-aafi, filgrastim-sndz, tbo-filgrastim) or pegfilgrastim biosimilars (pegfilgrastim-jmdb, pegfilgrastim-bmez, pegfilgrastim-cbqv) per Health Care Procedural Coding System (HCPCS) J-codes.	DRUG: Receipt of granulocyte-colony stimulating factor Receipt of originator or biosimilar

Participant Group/Arm

Intervention/Treatment

: G-CSF originator receipt

Patients receiving filgrastim (Neupogen) or pegfilgrastim (Neulasta) per Health Care Procedural Coding System (HCPCS) J-codes.

DRUG: Receipt of granulocyte-colony stimulating factor

Receipt of originator or biosimilar

: G-CSF biosimilar receipt

Patients receiving filgrastim biosimilars (filgrastim-aafi, filgrastim-sndz, tbo-filgrastim) or pegfilgrastim biosimilars (pegfilgrastim-jmdb, pegfilgrastim-bmez, pegfilgrastim-cbqv) per Health Care Procedural Coding System (HCPCS) J-codes.

DRUG: Receipt of granulocyte-colony stimulating factor

Receipt of originator or biosimilar

Primary Outcome Measures	Measure Description	Time Frame
Number of patients who develop febrile neutropenia	ICD-9 or ICD-10 codes for inpatient or outpatient visit indicating fever with infection per validated algorithms.	Within 30 days of receipt of first chemotherapy

Secondary Outcome Measures	Measure Description	Time Frame
Number of patients who develop G-CSF associated adverse events	ICD-9 or ICD-10 codes indicating splenic rupture, anaphylaxis, or leukocytosis.	Within 30 days of receipt of first chemotherapy

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
20 Years

Accepts Healthy Volunteers:

Patients age 20 or older
Diagnosis of lung, breast, colon, ovarian, pancreatic, testicular, cervical, uterine, or NHL cancer
Beginning intermediate or high neutropenia risk chemotherapy

One inpatient or two outpatient cancer diagnoses at least 30 days apart in the 183 days prior to the Index Date for cancer different from enrolling cancer diagnosis
Any of the following in 183 days prior to Index Date:
Any chemotherapy or G-CSF product receipt
2< medical claims at least 30 days apart for a skilled nursing facility or hospice care
2< 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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Harvard Pilgrim Health Care
HealthPartners Institute

Investigators

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

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Resources

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Caregivers

Clinical Trial Record