Cancer, Breast, Cancer, Lung, Cancer of Colon, Cancer of Pancreas, Cancer, Ovarian, Lymphoma, Non-Hodgkin
Conditions
Keywords
colony stimulating factor
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.
Interventions
DRUGReceipt of granulocyte-colony stimulating factor
Receipt of originator or biosimilar
Sponsors
Harvard Pilgrim Health Care
HealthPartners Institute
Catherine M. Lockhart
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of patients who develop febrile neutropenia | Within 30 days of receipt of first chemotherapy | ICD-9 or ICD-10 codes for inpatient or outpatient visit indicating fever with infection per validated algorithms. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of patients who develop G-CSF associated adverse events | Within 30 days of receipt of first chemotherapy | ICD-9 or ICD-10 codes indicating splenic rupture, anaphylaxis, or leukocytosis. |
Outcome results
None listed