Clinical trial NCT04971304: Comparative Effectiveness Analysis of Granulocyte Colony Stimulating Factor Originator Products Versus Biosimilars
Official title: An Exploratory Comparative Effectiveness Analysis of Granulocyte Colony Stimulating Factor Originator Products Versus Biosimilars in Real-world Practice
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cancer, Breast
Cancer, Lung
Cancer of Colon
Cancer of Pancreas
Cancer, Ovarian
Lymphoma, Non-Hodgkin
Keywords: colony stimulating factor
Lead sponsor: Biologics & Biosimilars Collective Intelligence Consortium
Sponsor class: OTHER
Collaborators: name: Harvard Pilgrim Health Care
name: HealthPartners Institute
First posted: 2021-07-21
Enrollment: 16506
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with lung, breast, colon, ovarian, pancreatic, testicular, cervical, uterine, or NHL cancers initiating clinical guideline-indicated intermediate or high neutropenia risk chemotherapy between March 1, 2015 and December 31, 2019. Study period observation ends by June 30, 2020 for participant follow-up. A 12-month look-back prior to the study period (i.e. as early as March 1, 2014) will be used to ensure health plan enrollment, find incident cancer diagnoses, and provide a description of reference G-CSF utilization before biosimilar introduction to the US market.

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of patients who develop febrile neutropenia
timeFrame: Within 30 days of receipt of first chemotherapy
Secondary outcomes:
measure: Number of patients who develop G-CSF associated adverse events
timeFrame: Within 30 days of receipt of first chemotherapy
Other outcomes:
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