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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

16506 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-03-01

Study Completion Date

2022-12-31

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.

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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.

Conditions

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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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G-CSF originator receipt

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

Receipt of granulocyte-colony stimulating factor

Intervention Type DRUG

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.

Receipt of granulocyte-colony stimulating factor

Intervention Type DRUG

Receipt of originator or biosimilar

Interventions

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Receipt of granulocyte-colony stimulating factor

Receipt of originator or biosimilar

Intervention Type DRUG

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

Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No