Filgrastim G-CSF Biosimilar (ZARXIO™) Injection, for Subcutaneous or Intravenous Use
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June 5, 2015

Filgrastim G-CSF Biosimilar (ZARXIO™) Injection, for Subcutaneous or Intravenous Use

Filgrastim-G-CSF (ZARXIO™) is a leukocyte growth factor approved by the FDA on March 6, 2015, for the following indications:

  • Patients with Cancer Receiving Myelosuppressive Chemotherapy: to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with nonmyeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a significant incidence of severe neutropenia with fever.
  • Patients with Acute Myeloid Leukemia Receiving Induction or Consolidation Chemotherapy: to reduce the time to neutrophil recovery and the duration of fever, following induction or consolidation chemotherapy treatment of patients with acute myeloid leukemia (AML).
  • Patients with Cancer Undergoing Bone Marrow Transplantation: to reduce the duration of neutropenia and neutropenia-related clinical sequelae, e.g., febrile neutropenia, in patients with nonmyeloid malignancies undergoing myeloablative chemotherapy followed by bone marrow transplantation.
  • Patients Undergoing Autologous Peripheral Blood Progenitor Cell Collection and Therapy: for the mobilization of autologous hematopoietic progenitor cells into the peripheral blood for collection by leukapheresis.
  • Patients with Severe Chronic Neutropenia: for chronic administration to reduce the incidence and duration of sequelae of neutropenia (e.g, fever, infections, oropharyngeal ulcers) in symptomatic patients with congenital neutropenia, cyclic neutropenia, or idiopathic neutropenia.

For claims with dates of service March 6, 2015, through June 30, 2015, please submit claims for this injection using the Not Otherwise Classified (NOC) HCPCS code J3490 or J3590. Please refer to this article for claim filing instructions for using NOC codes.

Claims submitted on and after July 1, 2015, for dates of service on and after March 6, 2015, are to be submitted with HCPCS code Q5101 based on 1 microgram.

Filgrastim G-CSF Biosimilar will be covered when administered under direct supervision of the physician in the office (Part B) or hospital setting (Part A). When administered by the patient or caregiver, this drug will be considered self-administered and not payable by CGS A/B MAC.


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