Filgrastim agents (Nivestym, Zarxio, Neupogen, Granix, Releuko)

Nivestym (filgrastim-aafi); Zarxio (filgrastim-sndz); Neupogen (filgrastim); Granix (tbo-filgrastim); Releuko (filgrastim-ayow)

Office-Administration or Self-Administration

* preferred filgrastim agents for pharmacy benefit only

Diagnosis considered for coverage:

Febrile Neutropenia (FN), Prophylaxis – Indicated to reduce the duration of severe neutropenia in adult and pediatric patients 1 month and older with nonmyeloid malignancies receiving myelosuppressive anticancer drugs associated with a clinically significant incidence of febrile neutropenia. (Granix)
Febrile Neutropenia (FN), Prophylaxis – Indicated to decrease the incidence of infection, as manifested by FN, in patients with nonmyeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a significant incidence of severe neutropenia with fever. (Neupogen, Zarxio, Nivestym, Releuko)
Patients with Acute Myeloid Leukemia (AML) Receiving Induction or Consolidation Chemotherapy – Indicated for reducing the time to neutrophil recovery and the duration of fever, following induction or consolidation chemotherapy treatment of adults with AML. (Neupogen, Zarxio, Nivestym, Releuko)
Patients with Cancer Undergoing Bone Marrow Transplantation (BMT) – Indicated 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. (Neupogen, Zarxio, Nivestym, Releuko)
Patients Undergoing Autologous Peripheral Blood Progenitor Cell (PBPC) Collection and Therapy – Indicated for the mobilization of autologous hematopoietic progenitor cells into the peripheral blood for collection by leukapheresis. (Neupogen, Zarxio, Nivestym)
Patients with Severe Chronic Neutropenia (SCN) – Indicated 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. (Neupogen, Zarxio, Nivestym, Releuko)
Hematopoietic Syndrome of Acute Radiation Syndrome (H-ARS) – Indicated to increase survival in patients acutely exposed to myelosuppressive doses of radiation. (Neupogen)

Off Label Uses:
Treatment of High-Risk Febrile Neutropenia (FN) – For the treatment of FN in patients who have received or are receiving myelosuppressive anticancer drugs associated with neutropenia who are at high risk for infection-associated complications. (Granix, Neupogen, Zarxio, Nivestym, Releuko)
Hematopoietic Subsyndrome of Acute Radiation Syndrome – To increase survival in patients acutely exposed to myelosuppressive doses of radiation. (Granix, Zarxio, Nivestym, Releuko)
Human Immunodeficiency Virus (HIV)-Related Neutropenia – Has been prescribed for HIV-related neutropenia. (Neupogen, Zarxio, Nivestym, Releuko)
Hepatitis-C Interferon Induced Neutropenia – Has been prescribed for interferon-induced neutropenia in Hepatitis C virus infected patients. (Neupogen, Zarxio, Nivestym, Releuko)
Patients Undergoing Autologous Peripheral Blood Progenitor Cell (PBPC) Collection and Therapy – For the mobilization of autologous hematopoietic progenitor cells into the peripheral blood for collection by leukapheresis. (Granix, Releuko)
Myelodysplastic syndrome (MDS)-related neutropenia – Has been prescribed for patients with MDS-related neutropenia. (Granix, Neupogen, Nivestym, Releuko, Zarxio)

Coverage Criteria:

For prophylaxis of febrile neutropenia (FN) or treatment of FN (off-label) caused by myelosuppressive chemotherapy and request for Granix, Neupogen, Zarxio, Nivestym, or Releuko:

Dose does not exceed recommended maximum:
- Granix: 5 mcg/kg/day for up to 14 days per chemotherapy cycle
- Neupogen, Zarxio, Nivestym, Releuko: 10 mcg/kg/day for up to 14 days per chemotherapy cycle; AND
Prescribed by or in consultation with a hematologist or oncologist; AND
Medical records document ONE of the following:
- Patient is receiving chemotherapy regimen(s) associated with greater than 20% incidence of FN (see Table 1).
- All of the following:
  - Diagnosis of acute febrile neutropenia (FN).
  - Patient is at high risk for infection-associated complications (see Table 4).
  - Absolute neutrophil count (ANC) is less than 1000 cells/mm3.
- Both of the following:
  - Patient is receiving chemotherapy regimen(s) associated with 10-20% incidence of FN (see Table 2).
  - Patient has one or more risk factors associated with chemotherapy induced infection, FN, or neutropenia.
- Both of the following:
  - Patient is receiving myelosuppressive anticancer drugs associated with neutropenia (see Table 3).
  - Patient has a history of FN or dose-limiting event during a previous course of chemotherapy (i.e., secondary prophylaxis); AND
Requested G-CSF agent will not be used in combination with other G-CSF/GM-CSF agents; AND
One of the following:
- For requests prescribed through the medical benefit: no product preference
- For requests prescribed through the pharmacy benefit:
  - For Granix, Neupogen, or Releuko only – Tried and failed, contraindicated, or intolerant to BOTH of the following:
    - Nivestym
    - Zarxio

For prevention or reduction of neutropenia associated with acute myeloid leukemia (AML) induction or consolidation chemotherapy and request for Neupogen, Zarxio, Nivestym, or Releuko:

Dose does not exceed 10 mcg/kg/day for up to 14 days per chemotherapy cycle; AND
Prescribed by or in consultation with a hematologist or oncologist; AND
Medical records document the patient is receiving induction or consolidation chemotherapy for AML; AND
Requested G-CSF agent will not be used in combination with other G-CSF/GM-CSF agents; AND
One of the following:
- For requests prescribed through the medical benefit: no product preference
- For requests prescribed through the pharmacy benefit:
  - For Neupogen and Releuko only – Tried and failed, contraindicated, or intolerant to BOTH of the following:
    - Nivestym
    - Zarxio

For stem cell mobilization or bone marrow transplant (BMT) and request for Granix, Neupogen, Zarxio, Nivestym, or Releuko:

Dose does not exceed 10 mcg/kg/day; AND
Prescribed by or in consultation with a hematologist or oncologist; AND
Medical records document ONE of the following:
- Used for the mobilization of hematopoietic progenitor cells into the peripheral blood for collection by leukapheresis.
- Patient has had a peripheral stem cell transplant (PSCT) treated with myeloablative chemotherapy.
- Patient has a non-myeloid malignancy treated with myeloablative chemotherapy followed by allogeneic or autologous BMT; AND
Requested G-CSF agent will not be used in combination with other G-CSF/GM-CSF agents; AND
One of the following:
- For requests prescribed through the medical benefit: no product preference
- For requests prescribed through the pharmacy benefit:
  - For Granix, Neupogen, or Releuko only – Tried and failed, contraindicated, or intolerant to BOTH of the following:
    - Nivestym
    - Zarxio

For diagnosis of severe chronic neutropenia (SCN) (i.e., congenital, cyclic, or idiopathic neutropenia; agranulocytosis) and request for Neupogen, Nivestym, Releuko, or Zarxio:

Starting dose does not exceed:
- Congenital Neutropenia: 6 mcg/kg twice daily
- Idiopathic or Cyclic Neutropenia: 5 mcg/kg once daily
- Subsequent doses are individualized based on the patient’s clinical course as well as ANC; AND
Prescribed by or in consultation with a hematologist or oncologist; AND
Medical records document SCN with a history of absolute neutrophil count (ANC) less than or equal to 500 cells/mm³; AND
Medical records document one of the following:
- Patient has had multiple clinically significant infections requiring treatment with antibiotics within the past year.
- Patient has been hospitalized for a clinically significant infection requiring IV antibiotics within the past year; AND
Requested G-CSF agent will not be used in combination with other G-CSF/GM-CSF agents; AND
One of the following:
- For requests prescribed through the medical benefit: no product preference
- For requests prescribed through the pharmacy benefit:
  - For Neupogen and Releuko only – Tried and failed, contraindicated, or intolerant to BOTH of the following:
    - Nivestym
    - Zarxio

For prevention or treatment of acute radiation syndrome (ARS) neutropenia and request for Neupogen, Nivestym (off-label), Releuko (off-label), or Zarxio (off-label):

Dose does not exceed 10 mcg/kg/day; AND
Prescribed by or in consultation with a radiologist, hematologist or oncologist; AND
Medical records document the patient was, or will be, exposed to myelosuppressive doses of radiation; AND
Requested G-CSF agent will not be used in combination with other G-CSF/GM-CSF agents; AND
One of the following:
- For requests prescribed through the medical benefit: no product preference
- For requests prescribed through the pharmacy benefit:
  - For Neupogen and Releuko only – Tried and failed, contraindicated, or intolerant to BOTH of the following:
    - Nivestym
    - Zarxio

For diagnosis of human immunodeficiency virus (HIV)-related neutropenia and request for Neupogen (off-label), Nivestym (off-label), Releuko (off-label), or Zarxio (off-label):

Dose does not exceed the recommended dose of 10 mcg/kg per day; AND
Prescribed by or in consultation with a hematologist, oncologist, or infectious disease specialist; AND
Patient has documented HIV with absolute neutrophil count (ANC) less than or equal to 1,000 cells/mm3; AND
Requested G-CSF agent will not be used in combination with other G-CSF/GM-CSF agents; AND
One of the following:
- For requests prescribed through the medical benefit: no product preference
- For requests prescribed through the pharmacy benefit:
  - For Neupogen and Releuko only – Tried and failed, contraindicated, or intolerant to BOTH of the following:
    - Nivestym
    - Zarxio

For diagnosis of peginterferon-related neutropenia and request for Neupogen (off-label), Nivestym (off-label), Releuko (off-label), or Zarxio (off-label):

Dose does not exceed recommended FDA-maximum of 10 mcg/kg per day; AND
Prescribed by or in consultation with a hematologist, oncologist, infectious disease specialist, hepatologist, or gastroenterologist; AND
Patient is undergoing treatment with Peg-Intron (peginterferon alfa-2b) or Pegasys (peginterferon alfa-2a); AND
One of the following is supported by medical record documentation:
- Patient has documented hepatitis C virus (HCV) and ANC is less than or equal to 500 cells/mm3 after a dose reduction of peginterferon (i.e., 135 mcg or less per week).
- Patient has a co-infection with human immunodeficiency virus (HIV):
- Patient is status post liver transplant
- Patient has established cirrhosis (fibrosis score of F4); AND
Requested G-CSF agent will not be used in combination with other G-CSF/GM-CSF agents; AND
One of the following:
- For requests prescribed through the medical benefit: no product preference
- For requests prescribed through the pharmacy benefit:
  - For Neupogen and Releuko only – Tried and failed, contraindicated, or intolerant to BOTH of the following:
    - Nivestym
    - Zarxio

For diagnosis of myelodysplastic syndrome (MDS)-related neutropenia (off-label) and request for Granix (off-label), Neupogen (off-label), Nivestym (off-label), Releuko (off-label), or Zarxio (off-label):

Dose does not exceed recommended maximum 1-2 mcg/kg twice weekly; AND
Prescribed by or in consultation with a hematologist, oncologist; AND
Medical records document patient has MDS; AND
Absolute neutrophil count (ANC) less than or equal to 500 cells/mm³; AND
Medical records document one of the following:
- Patient has had multiple clinically significant infections requiring treatment with antibiotics within the past year.
- Patient has been hospitalized for a clinically significant infection requiring IV antibiotics within the past year; AND
Requested G-CSF agent will not be used in combination with other G-CSF/GM-CSF agents; AND
One of the following:
- For requests prescribed through the medical benefit: no product preference
- For requests prescribed through the pharmacy benefit:
  - For Granix, Releuko, or Neupogen only – Tried and failed, contraindicated, or intolerant to BOTH of the following:
    - Nivestym
    - Zarxio

Reauthorization Criteria:

For prophylaxis of febrile neutropenia (FN) or treatment of FN (off-label) caused by myelosuppressive chemotherapy and request for Granix, Neupogen, Zarxio, Nivestym, or Releuko:

Dose does not exceed recommended maximum:
- Granix: 5 mcg/kg/day for up to 14 days per chemotherapy cycle
- Neupogen, Zarxio, Nivestym, Releuko: 10 mcg/kg/day for up to 14 days per chemotherapy cycle; AND
Medical records document the patient continues to receive myelosuppressive chemotherapy; AND
Requested G-CSF agent will not be used in combination with other G-CSF/GM-CSF agents.

For diagnosis of severe chronic neutropenia (SCN) (i.e., congenital, cyclic, or idiopathic neutropenia; agranulocytosis) and request for Neupogen, Nivestym, Releuko, or Zarxio:

Dose has been individualized based on the patient’s clinical course as well as ANC; AND
Medical records document the patient’s absolute neutrophil count (ANC) has stabilized while on G-CSF therapy; AND
Requested G-CSF agent will not be used in combination with other G-CSF/GM-CSF agents.

For diagnosis of human immunodeficiency virus (HIV)-related neutropenia and request for Neupogen (off-label), Nivestym (off-label), Releuko (off-label), or Zarxio (off-label):

Dose does not exceed the recommended dose of 10 mcg/kg per day; AND
Medical records document the patient’s absolute neutrophil count (ANC) has stabilized while on G-CSF therapy; AND
Requested G-CSF agent will not be used in combination with other G-CSF/GM-CSF agents.

Dose does not exceed recommended maximum 1-2 mcg/kg twice weekly; AND
Medical records document the patient’s absolute neutrophil count (ANC) has stabilized while on G-CSF therapy; AND
Requested G-CSF agent will not be used in combination with other G-CSF/GM-CSF agents.

Coverage Duration:

FN prophylaxis or high-risk FN treatment
- Initial: 3 months
- Reauthorization: duration of chemotherapy
AML: 2 months
BMT: 2 months
SCN
- Initial: 6 months
- Reauthorization: 1 year
ARS: 1 month
HIV-related neutropenia
- Initial: 6 months
- Reauthorization: 6 months
PEG-related neutropenia: same end date as peginterferon authorization
MDS-related neutropenia
- Initial: 3 months
- Reauthorization: 6 months

Authorization is not covered for the following:

The use of this drug for indications not listed in this policy does not meet the coverage criteria established by the Western Health Advantage (WHA) Pharmacy and Therapeutics (P&T) Committee.

Additional Information:

The FDA defines biosimilar as a biological product that is highly similar to and has no clinically meaningful differences from an existing FDA-approved reference product. The American Society of Clinical Oncology states that pegfilgrastim, filgrastim, tbo-filgrastim, and filgrastim-sndz (and other biosimilars as they become available) can be used for the prevention of treatment-related febrile neutropenia. The choice of agent depends on convenience, cost, and clinical situation. NCCN lists FDA-approved biosimilars as appropriate substitutes for filgrastim and pegfilgrastim. Limited data suggest that patients can alternate between the biosimilar and the originator biologic without any clinically meaningful differences regarding efficacy or safety.
Dose dense chemotherapy is a treatment plan in which drugs are given with less time between treatments than in a standard chemotherapy treatment plan.
FN is described by clinical practice guidelines as neutropenia with a single oral or tympanic temperature greater than or equal to 101°F (38.3°C) or greater than or equal to 100.4°F (38°C) for at least one hour.
The Infectious Diseases Society of America (IDSA) guidelines recommend against their use for all patients with established fever and neutropenia, whereas the American Society of Clinical Oncology and National Comprehensive Cancer Network guidelines state that their use can be "considered" for patients at high risk for infection-associated complications or who have prognostic factors that are predictive of a poor clinical outcome.
There are no studied that have addressed therapeutic use of filgrastim for febrile neutropenia in patients who have already received prophylactic pegfilgrastim. However pharmacokinetic data of pegfilgrastim demonstrated high levels during neutropenia and suggest that additional G-CSFs may not be beneficial; however, in patients with prolonged neutropenia additional G-CSFs may be considered.
Non-myeloid malignancies are cancers that are not classified as: (1) myelodysplastic syndromes (MDSs); (2) myeloproliferative neoplasms (MPNs); (3) myelodysplastic/myeloproliferative neoplasms (MDS/MPN); or (4) myeloid malignancies associated with eosinophilia and abnormalities of growth factor receptors derived from platelets or fibroblasts.
Bone marrow transplants are most commonly used in the following diseases: leukemias, lymphomas, multiple myeloma, immune deficiency disorders, severe aplastic anemia, and some solid-tumor cancers (in rare circumstances).
Hematopoietic progenitor cells (HPCs) or hematopoietic stem cells (HSCs) are cells present in blood and bone marrow. HPCs are capable of forming mature blood cells, such as red blood cells (the cells that carry oxygen), platelets (the cells that help stop bleeding) and white blood cells (the cells that fight infections). Hematopoietic stem cell transplantation is the IV infusion of hematopoietic stem and progenitor cells designed to establish marrow and immune function in patients with a variety of acquired and inherited malignant and nonmalignant disorders.
- Allogeneic stem cell transplantation involves transferring the stem cells from a healthy person (the donor) to the patient’s body after high-intensity chemotherapy or radiation. The donated stem cells can come from either a related or an unrelated donor.
- An autologous stem cell transplant uses healthy blood stem cells from your own body to replace your diseased or damaged bone marrow. An autologous stem cell transplant is also called an autologous bone marrow transplant.
One cubic millimeter (mm3) = One microliter (µL).
Meters squared (m2) is the unit used to describe body surface area (BSA). The calculation is derived from height and weight measurements. A calculator to determine BSA can be found at http://www.medcalc.com/body.html or https://www.calculator.net/body-surface-area-calculator.html

Review History:

07/24/2016 - Previous review
02/15/2022 - P&T review of filgrastim drug class; separation of filgrastim policy from other myeloid colony stimulating factors (i.e. pegfilgrastim agents, Leukine); new criteria created including addition of Granix and all FDA-approved filgrastim biosimilar agents to policy; update dosing guidance based on package inserts and drug compendia; added coverage criteria for FDA-approved indications and off-label uses; add off-label coverage criteria for MDS, update coverage durations; add preferred agents under pharmacy benefit only if clinically appropriate.
12/1/2022- Addition of Releuko to filgrastim criteria as a non-preferred product. Updated dosing for SCN and MDS

References:

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Last review date: December 1, 2022

Nivestym (filgrastim-aafi)*; Zarxio (filgrastim-sndz)*; Neupogen (filgrastim); Granix (tbo-filgrastim); Releuko (filgrastim-ayow)