Pharmacy Prior Authorization Criteria

Colony-Stimulating Factors (CSFs) - PA, NF

Indications for Prior Authorization

Fulphila (pegfilgrastim-jmdb, G-CSF), Fylnetra (pegfilgrastim-pbbk), Nyvepria (pegfilgrastim-apgf, G-CSF), Stimufend (pegfilgrastim-fpgk), Ziextenzo (pegfilgrastim-bmez, G-CSF)

For diagnosis of Febrile Neutropenia (FN), Prophylaxis
Indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia. Limitations of Use: Pegfilgrastim is not indicated for the mobilization of peripheral blood progenitor cells for hematopoietic stem cell transplantation.
For diagnosis of Hematopoietic Subsyndrome of Acute Radiation Syndrome
To increase survival in patients acutely exposed to myelosuppressive doses of radiation. [1, 33, 35, M]
For diagnosis of 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. [16, 17, 34, 35]

Granix (tbo-filgrastim, G-CSF)

For diagnosis of 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.
For diagnosis of Treatment of High-Risk Febrile Neutropenia (FN)
Has been prescribed 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. [16, 17, 34]
For diagnosis of Hematopoietic Subsyndrome of Acute Radiation Syndrome
To increase survival in patients acutely exposed to myelosuppressive doses of radiation. [16]

Leukine (sargramostim, GM-CSF)

For diagnosis of Acute Myeloid Leukemia (AML) Following Induction Chemotherapy
Indicated to shorten time to neutrophil recovery and to reduce the incidence of severe, life-threatening, or fatal infections following induction chemotherapy in adult patients 55 years and older with acute myeloid leukemia (AML).
For diagnosis of Autologous Peripheral Blood Progenitor Cell Mobilization and Collection
Indicated in adult patients with cancer undergoing autologous hematopoietic stem cell transplantation for the mobilization of hematopoietic progenitor cells into peripheral blood for collection by leukapheresis.
For diagnosis of Autologous Peripheral Blood Progenitor Cell and Bone Marrow Transplantation
Indicated for the acceleration of myeloid reconstitution following autologous peripheral blood progenitor cell (PBPC) or bone marrow transplantation in adult and pediatric patients 2 years of age and older with non-Hodgkin's lymphoma (NHL), acute lymphoblastic leukemia (ALL) and Hodgkin's lymphoma (HL).
For diagnosis of Allogeneic Bone Marrow Transplantation (BMT)
Indicated for the acceleration of myeloid reconstitution in adult and pediatric patients 2 years of age and older undergoing allogeneic bone marrow transplantation from HLA-matched related donors.
For diagnosis of Allogeneic or Autologous Bone Marrow Transplantation: Treatment of Delayed Neutrophil Recovery or Graft Failure
Indicated for the treatment of adult and pediatric patients 2 years and older who have undergone allogeneic or autologous bone marrow transplantation in whom neutrophil recovery is delayed or failed.
For diagnosis of Hematopoietic Syndrome of Acute Radiation Syndrome (H-ARS)
Indicated to increase survival in adult and pediatric patients from birth to 17 years of age acutely exposed to myelosuppressive doses of radiation (Hematopoietic Syndrome of Acute Radiation Syndrome [H-ARS]).
For diagnosis of Febrile Neutropenia (FN), Prophylaxis
Has been used in patients with nonmyeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a significant incidence of severe neutropenia with fever [11]
For diagnosis of Human Immunodeficiency Virus (HIV)-Related Neutropenia
Has been prescribed for HIV-related neutropenia [37]
For diagnosis of Treatment of High-Risk Febrile Neutropenia (FN)
Has been prescribed 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. [16, 17, 34]

Neulasta, Neulasta Onpro (pegfilgrastim, G-CSF)

For diagnosis of Febrile Neutropenia (FN), Prophylaxis
Indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia. Neulasta is not indicated for the mobilization of peripheral blood progenitor cells for hematopoietic stem cell transplantation.
For diagnosis of Hematopoietic Subsyndrome of Acute Radiation Syndrome
Indicated to increase survival in patients acutely exposed to myelosuppressive doses of radiation.
For diagnosis of Treatment of High-Risk Febrile Neutropenia (FN)
Has been prescribed 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. [16, 17, 34]

Neupogen (filgrastim, G-CSF)

For diagnosis of 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.
For diagnosis of 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.
For diagnosis of 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.
For diagnosis of 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.
For diagnosis of 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.
For diagnosis of Hematopoietic Syndrome of Acute Radiation Syndrome
Indicated to increase survival in patients acutely exposed to myelosuppressive doses of radiation.
For diagnosis of Human Immunodeficiency Virus (HIV)-Related Neutropenia
Has been prescribed for HIV-related neutropenia. [11-15, 37]
For diagnosis of Hepatitis-C Interferon Induced Neutropenia
Neupogen has been prescribed for interferon-induced neutropenia in Hepatitis C virus infected patients [4-10, 23, 24]
For diagnosis of Treatment of High-Risk Febrile Neutropenia (FN)
Has been prescribed 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. [16, 17, 34]

Nivestym (filgrastim-aafi, G-CSF), Zarxio (filgrastim-sndz, G-CSF)

For diagnosis of 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.
For diagnosis of 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 patients with AML.
For diagnosis of Patients with Cancer Undergoing Bone Marrow Transplantation
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.
For diagnosis of Patients Undergoing 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.
For diagnosis of 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.
For diagnosis of Hematopoietic Subsyndrome of Acute Radiation Syndrome
Has been used to increase survival in patients acutely exposed to myelosuppressive doses of radiation. [1, 33, 35, M]
For diagnosis of Hepatitis-C Interferon Induced Neutropenia
Has been prescribed for interferon-induced neutropenia in Hepatitis C virus infected patients [4-10, 23, 24, M]
For diagnosis of Human Immunodeficiency Virus (HIV)-Related Neutropenia
Has been prescribed for HIV-related neutropenia. [11, 37]
For diagnosis of Treatment of High-Risk Febrile Neutropenia (FN)
Has been prescribed 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. [16, 17, 34]

Releuko (filgrastim-ayow)

For diagnosis of 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.
For diagnosis of 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 patients with AML.
For diagnosis of Patients with Cancer Undergoing Bone Marrow Transplantation
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.
For diagnosis of 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.
For diagnosis of Patients Undergoing 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.
For diagnosis of Hematopoietic Subsyndrome of Acute Radiation Syndrome
Has been used to increase survival in patients acutely exposed to myelosuppressive doses of radiation. [1, 33, 35, M]
For diagnosis of Hepatitis-C Interferon Induced Neutropenia
Has been prescribed for interferon-induced neutropenia in Hepatitis C virus infected patients [4-10, 23, 24, M]
For diagnosis of Human Immunodeficiency Virus (HIV)-Related Neutropenia
Has been prescribed for HIV-related neutropenia. [11, 37]
For diagnosis of Treatment of High-Risk Febrile Neutropenia (FN)
Has been prescribed 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. [16, 17, 34]

Rolvedon (eflapegrastim-xnst)

For diagnosis of Febrile Neutropenia (FN), Prophylaxis
Indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia. Rolvedon is not indicated for the mobilization of peripheral blood progenitor cells for hematopoietic stem cell transplantation.

Udenyca (pegfilgrastim-cbqv, G-CSF)

For diagnosis of Febrile Neutropenia (FN), Prophylaxis
Indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia. Limitations of Use: Udenyca is not indicated for the mobilization of peripheral blood progenitor cells for hematopoietic stem cell transplantation.
For diagnosis of Hematopoietic Subsyndrome of Acute Radiation Syndrome
To increase survival in patients acutely exposed to myelosuppressive doses of radiation.
For diagnosis of 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. [16, 17, 34, 35]

Criteria

Leukine, Neupogen, Nivestym, Releuko, or Zarxio

Prior Authorization

Length of Approval: 3 months or duration of therapy
For diagnosis of Bone Marrow/Stem Cell Transplant

One of the following:

Patient has non-myeloid malignancies undergoing myeloablative chemotherapy followed by autologous or allogeneic bone marrow transplant (BMT)

Used for mobilization of hematopoietic progenitor cells into the peripheral blood for collection by leukapheresis

Patient has had a peripheral stem cell transplant (PSCT) and has received myeloablative chemotherapy

AND

Prescribed by or in consultation with a hematologist/oncologist

AND

Patient is 2 years of age or older (applies to Leukine only)

AND

Trial and failure or intolerance to both of the following (applies to Neupogen and Releuko only):

Nivestym
Zarxio

Neupogen

Non Formulary

Length of Approval: 3 months or duration of therapy
For diagnosis of Bone Marrow/Stem Cell Transplant

One of the following:

Patient has non-myeloid malignancies undergoing myeloablative chemotherapy followed by autologous or allogeneic bone marrow transplant (BMT)

Used for mobilization of hematopoietic progenitor cells into the peripheral blood for collection by leukapheresis

Patient has had a peripheral stem cell transplant (PSCT) and has received myeloablative chemotherapy

AND

Prescribed by or in consultation with a hematologist/oncologist

AND

Paid claims or submission of medical records (e.g., chart notes) confirming trial and failure or intolerance to both of the following:

Nivestym
Zarxio

Leukine

Prior Authorization

Length of Approval: 3 months or duration of therapy [C]
For diagnosis of Acute Myeloid Leukemia (AML) Induction or Consolidation Therapy

Diagnosis of acute myeloid leukemia (AML) [A]

AND

Patient has completed induction or consolidation chemotherapy [27]

AND

Patient is 55 years of age or older [3, B]

AND

Prescribed by or in consultation with a hematologist/oncologist

Neupogen, Nivestym, Releuko, or Zarxio

Prior Authorization

Length of Approval: 3 months or duration of therapy [C]
For diagnosis of Acute Myeloid Leukemia (AML) Induction or Consolidation Therapy

Diagnosis of acute myeloid leukemia (AML) [A]

AND

Patient has completed induction or consolidation chemotherapy [27]

AND

Prescribed by or in consultation with a hematologist/oncologist

AND

Trial and failure or intolerance to both of the following (applies to Neupogen and Releuko only):

Nivestym
Zarxio

Neupogen

Non Formulary

Length of Approval: 3 months or duration of therapy [C]
For diagnosis of Acute Myeloid Leukemia (AML) Induction or Consolidation Therapy

Diagnosis of acute myeloid leukemia (AML) [A]

AND

Patient has completed induction or consolidation chemotherapy [27]

AND

Prescribed by or in consultation with a hematologist/oncologist

AND

Paid claims or submission of medical records (e.g., chart notes) confirming trial and failure or intolerance to both of the following:

Nivestym
Zarxio

Fulphila, Fylnetra, Granix, Leukine (Off-Label), Neulasta/Neulasta Onpro, Releuko, Neupogen, Nivestym, Nyvepria, Stimufend, Udenyca/Udenyca Onbody, Zarxio, or Ziextenzo

*If patient meets criteria above, please approve both Neulasta/Neulasta Onpro, Udenyca/Udenyca Onbody at GPI list “FILGRASTPA”.

Prior Authorization

Length of Approval: 3 months or duration of therapy
For diagnosis of Febrile Neutropenia Prophylaxis

Patient will be receiving prophylaxis for febrile neutropenia (FN) due to one of the following:

Patient is receiving National Cancer Institute’s Breast Intergroup, INT C9741 dose dense chemotherapy protocol for primary breast cancer (see Table 1 in Background section) [16-19, 34, D, E]

Patient is receiving a dose-dense chemotherapy regimen for which the incidence of FN is unknown [E]

One of the following:

Patient is receiving chemotherapy regimen(s) associated with greater than 20% incidence of FN (see Table 2 in Background section) [16, 17, 34, I]

Both of the following:

Patient is receiving chemotherapy regimen(s) associated with 10-20% incidence of FN (see Table 3 in Background section) [16, J]

AND

Patient has one or more risk factors associated with chemotherapy induced infection, FN, or neutropenia [16, 17, 34, K]

Both of the following:

Patient is receiving myelosuppressive anticancer drugs associated with neutropenia (see Table 4 in Background section) [L]

AND

Patient has a history of FN or dose-limiting event during a previous course of chemotherapy (secondary prophylaxis) [16, 17, 34]

AND

Prescribed by or in consultation with a hematologist/oncologist

AND

One of the following:

Trial and failure or intolerance to both of the following (applies to Neupogen, Releuko, and Granix only):

Nivestym
Zarxio

Trial and failure or intolerance to both of the following (applies to Fulphila, Fylnetra, Nyvepria, Stimufend, and Ziextenzo only):

Neulasta/Neulasta Onpro
Udenyca/Udenyca Onbody

Fulphila, Fylnetra, Granix, Neupogen, Nyvepria, Ziextenzo

Non Formulary

Length of Approval: 3 months or duration of therapy
For diagnosis of Febrile Neutropenia Prophylaxis

Patient will be receiving prophylaxis for febrile neutropenia (FN) due to one of the following:

Patient is receiving National Cancer Institute’s Breast Intergroup, INT C9741 dose dense chemotherapy protocol for primary breast cancer (see Table 1 in Background section) [16-19, 34, D, E]

Patient is receiving a dose-dense chemotherapy regimen for which the incidence of FN is unknown [E]

One of the following:

Patient is receiving chemotherapy regimen(s) associated with greater than 20% incidence of FN (see Table 2 in Background section) [16, 17, 34, I]

Both of the following:

Patient is receiving chemotherapy regimen(s) associated with 10-20% incidence of FN (see Table 3 in Background section) [16, J]

AND

Patient has one or more risk factors associated with chemotherapy induced infection, FN, or neutropenia [16, 17, 34, K]

Both of the following:

Patient is receiving myelosuppressive anticancer drugs associated with neutropenia (see Table 4 in Background section) [L]

AND

Patient has a history of FN or dose-limiting event during a previous course of chemotherapy (secondary prophylaxis) [16, 17, 34]

AND

Prescribed by or in consultation with a hematologist/oncologist

AND

One of the following:

Paid claims or submission of medical records (e.g., chart notes) confirming trial and failure or intolerance to both of the following (applies to Neupogen and Granix only):

Nivestym
Zarxio

Paid claims or submission of medical records (e.g., chart notes) confirming trial and failure or intolerance to both of the following (applies to Fulphila, Fylnetra, Nyvepria, and Ziextenzo only):

Neulasta/Neulasta Onpro
Udenyca/Udenyca Onbody

Rolvedon

Prior Authorization

Length of Approval: 3 months or duration of therapy
For diagnosis of Febrile Neutropenia Prophylaxis

Patient will be receiving prophylaxis for febrile neutropenia (FN) due to one of the following:

Patient is receiving National Cancer Institute’s Breast Intergroup, INT C9741 dose dense chemotherapy protocol for primary breast cancer (see Table 1 in Background section) [16-19, 34, D, E]

Patient is receiving a dose-dense chemotherapy regimen for which the incidence of FN is unknown [E]

One of the following:

Patient is receiving chemotherapy regimen(s) associated with greater than 20% incidence of FN (see Table 2 in Background section) [16, 17, 34, I]

Both of the following:

Patient is receiving chemotherapy regimen(s) associated with 10-20% incidence of FN (see Table 3 in Background section) [16, J]

AND

Patient has one or more risk factors associated with chemotherapy induced infection, FN, or neutropenia [16, 17, 34, K]

Both of the following:

Patient is receiving myelosuppressive anticancer drugs associated with neutropenia (see Table 4 in Background section) [L]

AND

Patient has a history of FN or dose-limiting event during a previous course of chemotherapy (secondary prophylaxis) [16, 17, 34]

AND

Prescribed by or in consultation with a hematologist/oncologist

AND

Trial and failure or intolerance to ONE of the following:

Neulasta/Neulasta Onpro
Udenyca/Udenyca Onbody

Rolvedon

Non Formulary

Length of Approval: 3 months or duration of therapy
For diagnosis of Febrile Neutropenia Prophylaxis

Patient will be receiving prophylaxis for febrile neutropenia (FN) due to one of the following:

Patient is receiving National Cancer Institute’s Breast Intergroup, INT C9741 dose dense chemotherapy protocol for primary breast cancer (see Table 1 in Background section) [16-19, 34, D, E]

Patient is receiving a dose-dense chemotherapy regimen for which the incidence of FN is unknown [E]

One of the following:

Patient is receiving chemotherapy regimen(s) associated with greater than 20% incidence of FN (see Table 2 in Background section) [16, 17, 34, I]

Both of the following:

Patient is receiving chemotherapy regimen(s) associated with 10-20% incidence of FN (see Table 3 in Background section) [16, J]

AND

Patient has one or more risk factors associated with chemotherapy induced infection, FN, or neutropenia [16, 17, 34, K]

Both of the following:

Patient is receiving myelosuppressive anticancer drugs associated with neutropenia (see Table 4 in Background section) [L]

AND

Patient has a history of FN or dose-limiting event during a previous course of chemotherapy (secondary prophylaxis) [16, 17, 34]

AND

Prescribed by or in consultation with a hematologist/oncologist

AND

Paid claims or submission of medical records (e.g., chart notes) confirming trial and failure or intolerance to ONE of the following:

Neulasta/Neulasta Onpro
Udenyca/Udenyca Onbody

Fulphila, Fylnetra, Granix, Leukine, Neulasta/Neulasta Onpro, Neupogen, Nivestym, Nyvepria, Releuko, Stimufend, Udenyca/Udenyca Onbody, Zarxio, or Ziextenzo

*If patient meets criteria above, please approve both Neulasta/Neulasta Onpro, Udenyca/Udenyca Onbody at GPI list “FILGRASTPA”.

Prior Authorization

Length of Approval: 3 Months or duration of therapy
For diagnosis of Treatment of High-Risk Febrile Neutropenia (Off-label) [34]

Patient has received or is receiving myelosuppressive anticancer drugs associated with neutropenia (see Table 4 in Background section) [34, l]

AND

Diagnosis of febrile neutropenia (FN)

AND

Patient is at high risk for infection-associated complications [16, 17, 34]

AND

Prescribed by or in consultation with a hematologist/oncologist

AND

One of the following:

Trial and failure or intolerance to both of the following (applies to Neupogen, Releuko, and Granix only):

Nivestym
Zarxio

Trial and failure or intolerance to both of the following (applies to Fulphila, Fylnetra, Nyvepria, Stimufend, and Ziextenzo only):

Neulasta/Neulasta Onpro
Udenyca/Udenyca Onbody

Fulphila, Fylnetra, Granix, Neupogen, Nyvepria, Ziextenzo

Non Formulary

Length of Approval: 3 Months or duration of therapy
For diagnosis of Treatment of High-Risk Febrile Neutropenia (Off-label) [34]

Patient has received or is receiving myelosuppressive anticancer drugs associated with neutropenia (see Table 4 in Background section) [34, l]

AND

Diagnosis of febrile neutropenia (FN)

AND

Patient is at high risk for infection-associated complications [16, 17, 34]

AND

Prescribed by or in consultation with a hematologist/oncologist

AND

One of the following:

Paid claims or submission of medical records (e.g., chart notes) confirming trial and failure or intolerance to both of the following (applies to Neupogen and Granix only):

Nivestym
Zarxio

Paid claims or submission of medical records (e.g., chart notes) confirming trial and failure or intolerance to both of the following (applies to Fulphila, Fylnetra, Nyvepria, and Ziextenzo only):

Neulasta/Neulasta Onpro
Udenyca/Udenyca Onbody

Neupogen, Nivestym, Releuko, or Zarxio

Prior Authorization

Length of Approval: 12 Month(s)
For diagnosis of Severe Chronic Neutropenia (SCN)

For patients with severe chronic neutropenia (SCN) (i.e., congenital, cyclic, and idiopathic neutropenias with chronic absolute neutrophil count [ANC] less than or equal to 500 cells/mm^3) [16]

AND

Prescribed by or in consultation with a hematologist/oncologist

AND

Trial and failure or intolerance to both of the following (applies to Neupogen and Releuko only):

Nivestym
Zarxio

Neupogen

Non Formulary

Length of Approval: 12 Month(s)
For diagnosis of Severe Chronic Neutropenia (SCN)

For patients with severe chronic neutropenia (SCN) (i.e., congenital, cyclic, and idiopathic neutropenias with chronic absolute neutrophil count [ANC] less than or equal to 500 cells/mm^3) [16]

AND

Prescribed by or in consultation with a hematologist/oncologist

AND

Paid claims or submission of medical records (e.g., chart notes) confirming trial and failure or intolerance to both of the following:

Nivestym
Zarxio

Fulphila (Off-Label), Fylnetra (Off-label), Granix (Off-Label), Leukine, Neulasta, Neupogen, Nivestym (Off-Label), Nyvepria (Off-Label), Releuko (Off-Label), Stimufend (Off-label), Udenyca, Zarxio (Off-Label), or Ziextenzo (Off-Label)

Prior Authorization

Length of Approval: 1 Months [N]
For diagnosis of Acute Radiation Syndrome (ARS)

Patient was/will be acutely exposed to myelosuppressive doses of radiation

AND

Prescribed by or in consultation with a hematologist/oncologist

AND

One of the following:

Trial and failure or intolerance to both of the following (applies to Neupogen, Granix and Releuko only):

Nivestym
Zarxio

Trial and failure or intolerance to both of the following (applies to Fulphila, Fylnetra, Nyvepria, and Stimufend, Ziextenzo only):

Neulasta
Udenyca

Fulphila (Off-Label), Fylnetra (Off-Label), Granix (Off-Label), Neupogen, Nyvepria (Off-Label), Ziextenzo

Non Formulary

Length of Approval: 1 Months [N]
For diagnosis of Acute Radiation Syndrome (ARS)

Patient was/will be acutely exposed to myelosuppressive doses of radiation

AND

Prescribed by or in consultation with a hematologist/oncologist

AND

One of the following:

Paid claims or submission of medical records (e.g., chart notes) confirming trial and failure or intolerance to both of the following (applies to Neupogen only):

Nivestym
Zarxio

Paid claims or submission of medical records (e.g., chart notes) confirming trial and failure or intolerance to both of the following (applies to Fulphila, Fylnetra, Nyvepria, and Ziextenzo only):

Neulasta
Udenyca

Leukine, Neupogen, Nivestym, Releuko, or Zarxio

Prior Authorization

Length of Approval: 6 months [11, 15, H]
For diagnosis of Human Immunodeficiency Virus (HIV)-Related Neutropenia (Off-Label)

Patient is infected with HIV virus [11- 13]

AND

ANC less than or equal to 1,000 (cells/mm3) [12, 13]

AND

Prescribed by or in consultation with one of the following:

Hematologist/oncologist
Infectious disease specialist

AND

Trial and failure or intolerance to both of the following (applies to Neupogen and Releuko only):

Nivestym
Zarxio

Neupogen

Non Formulary

Length of Approval: 6 months [11, 15, H]
For diagnosis of Human Immunodeficiency Virus (HIV)-Related Neutropenia (Off-Label)

Patient is infected with HIV virus [11- 13]

AND

ANC less than or equal to 1,000 (cells/mm3) [12, 13]

AND

Prescribed by or in consultation with one of the following:

Hematologist/oncologist
Infectious disease specialist

AND

Paid claims or submission of medical records (e.g., chart notes) confirming trial and failure or intolerance to both of the following:

Nivestym
Zarxio

Neupogen, Nivestym, Releuko, Zarxio

Prior Authorization

Length of Approval: 12 Month(s)
For diagnosis of Hepatitis-C Treatment Related Neutropenia (Off-Label)

One of the following:

All of the following:

Patient is infected with Hepatitis C virus

AND

Patient is undergoing treatment with Peg-Intron (peginterferon alfa-2b) or Pegasys (peginterferon alfa-2a)

AND

Patient has neutropenia (absolute neutrophil count [ANC] less than or equal to 500 cells/mm3) after dose reduction of Peg-Intron or Pegasys [F]

Both of the following:

Patient is experiencing interferon-induced neutropenia (ANC less than or equal to 500 cells/mm3) due to treatment with Peg-Intron (peginterferon alfa-2b) or Pegasys (peginterferon alfa-2a)

AND

One of the following: [G]

Patient with Human Immunodeficiency Virus (HIV) co-infection

Status post liver transplant

Patient with established cirrhosis

AND

Prescribed by or in consultation with one of the following:

Hematologist/oncologist
Infectious disease specialist
Hepatologist
Gastroenterologist

AND

Trial and failure or intolerance to both of the following (applies to Neupogen and Releuko only):

Nivestym
Zarxio

Neupogen

Non Formulary

Length of Approval: 12 Month(s)
For diagnosis of Hepatitis-C Treatment Related Neutropenia (Off-Label)

One of the following:

All of the following:

Patient is infected with Hepatitis C virus

AND

Patient is undergoing treatment with Peg-Intron (peginterferon alfa-2b) or Pegasys (peginterferon alfa-2a)

AND

Patient has neutropenia (absolute neutrophil count [ANC] less than or equal to 500 cells/mm3) after dose reduction of Peg-Intron or Pegasys [F]

Both of the following:

Patient is experiencing interferon-induced neutropenia (ANC less than or equal to 500 cells/mm3) due to treatment with Peg-Intron (peginterferon alfa-2b) or Pegasys (peginterferon alfa-2a)

AND

One of the following: [G]

Patient with Human Immunodeficiency Virus (HIV) co-infection

Status post liver transplant

Patient with established cirrhosis

AND

Prescribed by or in consultation with one of the following:

Hematologist/oncologist
Infectious disease specialist
Hepatologist
Gastroenterologist

AND

Paid claims or submission of medical records (e.g., chart notes) confirming trial and failure or intolerance to both of the following:

Nivestym
Zarxio

Guideline ID
GL-151741
Formulary
Premium
Effective date
Jun 1, 2024
P&T approval date
Aug 1, 2006

P & T Revisions

2024-08-14, 2024-04-24, 2024-04-03, 2024-03-27, 2024-03-11, 2023-12-11, 2023-11-28, 2023-11-09, 2023-05-26, 2023-04-10, 2023-03-01, 2023-02-03, 2022-11-02, 2022-04-05, 2021-11-30, 2021-09-27, 2021-05-25, 2021-03-18, 2021-02-04, 2020-07-28, 2020-07-28, 2020-04-01, 2019-12-31, 2019-10-11

References

Neulasta Prescribing Information. Amgen Inc. Thousand Oaks, CA. February 2021.
Neupogen Prescribing Information. Amgen Inc. Thousand Oaks, CA. February 2021.
Leukine Prescribing Information. sanofi-aventis U.S. LLC. Bridgewater, NJ. May 2022.
Sulkowski M. Managing the hematologic complications of interferon/ribavirin. Clinical Care Options for Hepatitis Annual Update. Milford, MA: IMedoptions, 2003:101-102.
Soza A, Everhart JE, Gharny MG, et al. Neutropenia during combination therapy of interferon alfa and ribavirin for chronic hepatitis C. Hepatol. 2002;36:1273-1279.
Van Thiel DH, Faruki H. Combination treatment of advanced HCV associated liver disease with interferon and G-CSF. Hepatogastroenterol.1995;42:907-912.
Carreno V, Parra A, Navas S, Quiroga J. Granulocyte macrophage colony stimulating factors as adjuvant therapy for interferon alpha treatment of chronic hepatitis C. Cytokine. 1996;8:318-322.
Shiffman M, Hofmann, Luketic VA, Sanyal AJ. Use of granulocyte macrophage colony stimulating factor alone or in combination with interferon-alpha-2b for treatment of chronic hepatitis C. J Hepatol.1998;28:382-389.
Farmer D, Collantes R, Makay S, et al. Filgrastim for the neutropenia associated with combination therapy in chronic hepatitis C. Gastroenterol. 2005;128(4, Suppl2):a-725.
Stein DF, McKenzie SD. Peg-interferon alfa-2b and ribavirin in treatment naïve African American patients infected with HCV genotype 1. Hepatol.2003;38(4):642A.
DRUGDEX® System [Internet database]. Greenwood Village, Colo: Thomson Micromedex. Updated periodically. Accessed March 3, 2020.
Hermans P, Rozenbaum W, Jou A, et al. Filgrastim to treat neutropenia and support myelosuppressive medication dosing in HIV infections. G-CSF 92105 Study Group. AIDS 1996;10:1627-33.
Kuritzkes, DR, Parenti D, Ward DJ, et al. Filgrastim prevents severe neutropenia and reduces infective morbidity in patients with advanced HIV infection; results of a randomized, multicenter, controlled trial. AIDS 1998;12:65-74.
Levine AM, Karim R, Mack W, et al. Neutropenia in human immunodeficiency virus infection: data from the women's interagency HIV study. Arch Intern Med. 2006;166:405-410.
Centers for Disease Control and Prevention. Guidelines for Preventing Opportunistic Infections Among HIV-Infected Persons – 2002 Recommendations of the U.S. Public Health Service and the Infectious Disease Society of America. MMWR 2002;51(No. RR-8):1-52.
National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology. Hematopoietic Growth Factors. v.2.2023. Available at: https://www.nccn.org/professionals/physician_gls/pdf/growthfactors.pdf. Accessed March 29, 2023.
Smith TJ, Khatcheressian J, Lyman GH, et al. 2006 update of recommendations for the use of white blood cell growth factors: an evidence-based clinical practice guideline. J Clin Oncol. 2006;24:3187-205.
National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology. Breast cancer. v.2.2022 Available at: http://www.nccn.org/professionals/physician_gls/PDF/breast.pdf. Accessed March 29, 2022.
Citron ML, Berry DA, Cirrincione C, et al. Randomized trial of dose-dense versus conventionally scheduled and sequential versus concurrent combination chemotherapy as postoperative adjuvant treatment of node-positive primary breast cancer: first report of Intergroup Trial C9741/Cancer and Leukemia Group B trial. J Clin Oncol. 2003;21(8):1431-9.
Ziextenzo Prescribing Information. Sandoz Inc. Princeton, NJ. March 2021.
Pegasys Prescribing Information. Roche Pharmaceuticals. San Francisco, CA. March 2021.
PegIntron Prescribing Information. Schering Corporation. Kenilworth, NJ. August 2019.
American Gastroenterological Association. Medical Position Statement on the Management of Hepatitis C. Gastroenterol 2006;130:225-30.
Ghany MG, Strader DB, Thomas DL, Seeff LB; American Association for the Study of Liver Diseases. Diagnosis, management, and treatment of hepatitis C: an update. Hepatology. 2009;49(4):1335-74.
Hudis CA, Schmitz. Dose-dense chemotherapy in breast cancer and lymphoma. Seminar in Oncol. 2004;31(Suppl 8):19-23.
National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology. Non-Hodgkin’s Lymphoma. v.1.2016. Available at: http://www.nccn.org/professionals/physician_gls/PDF/nhl.pdf Accessed November 12, 2015.
National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology. Acute Myeloid Leukemia v.1.2018. Available at: http://www.nccn.org/professionals/physician_gls/PDF/aml.pdf Accessed June 5, 2018.
Granix Prescribing Information. Cephalon, Inc. North Wales, PA. October 2019.
Zarxio Prescribing Information. Sandoz Inc. Princeton, NJ. July 2021.
Fulphila Prescribing Information. Mylan. Rockford, IL. March 2021.
Nivestym Prescribing Information. Pfizer, Inc. New York, NY. May 2021.
Udenyca Prescribing Information. Coherus BioSciences Inc. Redwood City, CA. December 2023.
U.S. Food and Drug Administration (FDA). Biosimilar and Interchangeable Products. Silver Spring, MD: FDA; October 23, 2017. Available at: https://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/TherapeuticBiologicApplications/Biosimilars/ucm580419.htm#biosimilar. Accessed March 3, 2020.
Smith TJ, Bohlke K, Lyman GH, et al. Recommendations for the use of WBC growth factors: American Society of Clinical Oncology clinical practice guideline update. J Clin Oncol. 2015;33(28):3199-3212.
Per clinical consult with hematologist/oncologist. December 20, 2018.
Dainiak N, Gent RN, Carr Z, et al. First global consensus for evidence-based management of the hematopoietic syndrome resulting from exposure to ionizing radiation. Disaster Med Public Health Prep. 2011;5(3):202.
Lexi-Comp Online [internet database]. Hudson, OH. Lexi-Comp, Inc. Updated periodically. Available by subscription at: http://online.lexi.com/. Accessed March 3, 2020.
Nyvepria Prescribing Information. Pfizer Laboratories Div Pfizer Inc. New York, NY. April 2021.
Releuko Prescribing Information. Kashiv BioSciences, LLC. Piscataway, NJ. February 2022.
Fylnetra Prescribing Information. Kashiv BioSciences, LLC. Piscataway, NJ. May 2022.
Rolvedon Prescribing Information.Spectrum Pharmaceuticals, Inc.Irvine, CA. September 2022.
Stimufend Prescribing Information.Fresenius Kabi USA, LLC. Lake Zurich, Illinois. September 2022.

Revision History

2024-08-14: Minor update to guideline
2024-04-24: Removed neulasta onpro as a target drug from acute radiation syndrome (ARS) as a step alternative for ARS indication.
2024-04-03: Removed neulasta onpro as a target drug from acute radiation syndrome (ARS) as a step alternative for ARS indication.
2024-03-27: Removed Udenyca Onbody as one of the prerequisites under the ARS (NF) criteria to align with clinical intent.
2024-03-11: Addition of Udenyca onbody as target to guideline, mirroring Udenyca criteria, except for acute radiation sydrome for which the onbody formulation is not recommended.
2023-12-11: Updated to include OptumRx EHB
2023-11-28: Updated incomplete GPIs and criteria section.
2023-11-09: Modify PA, apply drug-specific NF to prefer Udenyca instead of Ziextenzo. Include Fylnetra as a target for trial/failure requirement in Acute Radiation Syndrome (ARS) NF. Addition of incomplete GPIs.
2023-05-26: Addition of Udenyca auto-injector
2023-04-10: 2023 Annual Review
2023-03-01: Addition of NF criteria for Rolvedon and Fylnetra
2023-02-03: Addition of Stimufend
2022-11-02: Addition of Fylnetra and Rolvedon
2022-04-05: Addition of Releuko and 2022 Annual Review, added age criteria for Leukine
2021-11-30: Updated criteria to indicate that the initial PA criteria should also be used for NF reviews. Updated GL name to add "- PA, NF."
2021-09-27: Addition of EHB formulary to guideline, no changes to criteria
2021-05-25: Addition of EHB formulary to guideline, no changes to criteria
2021-03-18: 2021 Annual Review: no changes
2021-02-04: Added new biosimilar for Neulasta (pegfilgrastim), Nyvepria (pegfilgrastim-apgf), to the existing guideline as a target mirroring the existing criteria for Neulasta with an added embedded step through Neulasta and Ziextenzo (pegfilgrastim-bmez)
2020-07-28: Updated formulary strategy for Udenyca (pegfilgrastim-cbqv)
2020-07-28: Updated formulary strategy for Ziextenzo (pegfilgrastim-bmez)
2020-04-01: Annual review: Updated approval duration for Acute Radiation Syndrome (ARS) and added Granix to the criteria. Updated background and references.
2019-12-31: Added new biosimilar for Neulasta (pegfilgrastim), Ziextenzo (pegfilgrastim-bmez), to the existing guideline as a target mirroring the existing clinical criteria for Neulasta with an added embedded step through Neulasta and Udenyca (pegfilgrastim-cbqv)
2019-10-11: Updated search terms

Colony-Stimulating Factors (CSFs) - PA, NF

Indications for Prior Authorization

Fulphila (pegfilgrastim-jmdb, G-CSF), Fylnetra (pegfilgrastim-pbbk), Nyvepria (pegfilgrastim-apgf, G-CSF), Stimufend (pegfilgrastim-fpgk), Ziextenzo (pegfilgrastim-bmez, G-CSF)

Granix (tbo-filgrastim, G-CSF)

Leukine (sargramostim, GM-CSF)

Neulasta, Neulasta Onpro (pegfilgrastim, G-CSF)

Neupogen (filgrastim, G-CSF)

Nivestym (filgrastim-aafi, G-CSF), Zarxio (filgrastim-sndz, G-CSF)

Releuko (filgrastim-ayow)

Rolvedon (eflapegrastim-xnst)

Udenyca (pegfilgrastim-cbqv, G-CSF)

Criteria

Leukine, Neupogen, Nivestym, Releuko, or Zarxio

Neupogen

Leukine

Neupogen, Nivestym, Releuko, or Zarxio

Neupogen

Fulphila, Fylnetra, Granix, Leukine (Off-Label), Neulasta/Neulasta Onpro*, Releuko, Neupogen, Nivestym, Nyvepria, Stimufend, Udenyca/Udenyca Onbody*, Zarxio, or Ziextenzo

Fulphila, Fylnetra, Granix, Neupogen, Nyvepria, Ziextenzo

Rolvedon

Rolvedon

Fulphila, Fylnetra, Granix, Leukine, Neulasta/Neulasta Onpro*, Neupogen, Nivestym, Nyvepria, Releuko, Stimufend, Udenyca/Udenyca Onbody*, Zarxio, or Ziextenzo

Fulphila, Fylnetra, Granix, Neupogen, Nyvepria, Ziextenzo

Neupogen, Nivestym, Releuko, or Zarxio

Neupogen

Fulphila (Off-Label), Fylnetra (Off-label), Granix (Off-Label), Leukine, Neulasta, Neupogen, Nivestym (Off-Label), Nyvepria (Off-Label), Releuko (Off-Label), Stimufend (Off-label), Udenyca, Zarxio (Off-Label), or Ziextenzo (Off-Label)

Fulphila (Off-Label), Fylnetra (Off-Label), Granix (Off-Label), Neupogen, Nyvepria (Off-Label), Ziextenzo

Leukine, Neupogen, Nivestym, Releuko, or Zarxio

Neupogen

Neupogen, Nivestym, Releuko, Zarxio

Neupogen

P & T Revisions

References

Revision History

Provider Tools

Fulphila, Fylnetra, Granix, Leukine (Off-Label), Neulasta/Neulasta Onpro, Releuko, Neupogen, Nivestym, Nyvepria, Stimufend, Udenyca/Udenyca Onbody, Zarxio, or Ziextenzo

Fulphila, Fylnetra, Granix, Leukine, Neulasta/Neulasta Onpro, Neupogen, Nivestym, Nyvepria, Releuko, Stimufend, Udenyca/Udenyca Onbody, Zarxio, or Ziextenzo