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

Catherine M. Lockhart16,506 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

16,506

Conditions

Cancer, Breast Cancer, Lung Cancer of Colon

Eligibility

Sex: ALLMin age: 20 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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.

Time frame: Within 30 days of receipt of first chemotherapy

Secondary Outcomes

Number of patients who develop G-CSF associated adverse events

ICD-9 or ICD-10 codes indicating splenic rupture, anaphylaxis, or leukocytosis.