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

NCT04971304 | Completed FDA Drug

• 1 other identifier: BBCIC-GCSF-02
• Study Type: observational
• Target: 16,506
• Locations: 0 countries
• Sites: N/A

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.

Conditions

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

Keywords

colony stimulating factor

Outcome Measures

Primary Outcomes (1)

• 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.

  Within 30 days of receipt of first chemotherapy

Secondary Outcomes (1)

• Number of patients who develop G-CSF associated adverse events

  Within 30 days of receipt of first chemotherapy

Study Arms (2)

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

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

Interventions

Receipt of granulocyte-colony stimulating factor DRUG

Receipt of originator or biosimilar

G-CSF biosimilar receipt; G-CSF originator receipt

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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
• \< medical claims at least 30 days apart for a skilled nursing facility or hospice care
• \< 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

Sponsors & Collaborators

• Catherine M. Lockhart: lead
• Harvard Pilgrim Health Care: collaborator
• HealthPartners Institute: collaborator

MeSH Terms

Conditions

Breast Neoplasms; Lung Neoplasms; Colonic Neoplasms; Pancreatic Neoplasms; Ovarian Neoplasms; Lymphoma, Non-Hodgkin

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases; Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Endocrine Gland Neoplasms; Pancreatic Diseases; Endocrine System Diseases; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Gonadal Disorders; Lymphoma; Neoplasms by Histologic Type; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Executive Director

Study Record Dates

• First Submitted: July 12, 2021
• First Posted: July 21, 2021
• Study Start: March 1, 2015
• Primary Completion: September 30, 2022
• Study Completion: December 31, 2022
• Last Updated: July 27, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share