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

Sponsor

Catherine M. Lockhart (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT04971304

Collaborator

Harvard Pilgrim Health Care (Other), HealthPartners Institute (Other)

20,000

Enrollment

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cancer, Breast Cancer, Lung Cancer of Colon Cancer of Pancreas Cancer, Ovarian Lymphoma, Non-Hodgkin	Drug: Receipt of granulocyte-colony stimulating factor

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.

Study Design

Study Type:

Observational

Anticipated Enrollment :

20000 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

Official Title:

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

Actual Study Start Date :

Mar 1, 2015

Anticipated Primary Completion Date :

Sep 30, 2021

Anticipated Study Completion Date :

Dec 31, 2021

Arms and Interventions

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

Arm

Intervention/Treatment

G-CSF originator receipt

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

Drug: Receipt of granulocyte-colony stimulating factor

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.

Drug: Receipt of granulocyte-colony stimulating factor

Receipt of originator or biosimilar

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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