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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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An Exploratory Comparative Effectiveness Analysis of Granulocyte Colony Stimulating Factor Originator Products Versus Biosimilars in Real-world Practice

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

Intervention / Treatment
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* Drug: Receipt of granulocyte-colony stimulating factor


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| G-CSF originator receipt<br>Patients receiving filgrastim (Neupogen) or pegfilgrastim (Neulasta) per Health Care Procedural Coding System (HCPCS) J-codes. | Drug: Receipt of granulocyte-colony stimulating factor<br>* Receipt of originator or biosimilar<br>|
| G-CSF biosimilar receipt<br>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<br>* Receipt of originator or biosimilar<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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colony stimulating factor