CurrentHAP CareSource MI Coordinated HealthPolicy N/A

Colony Stimulating Factors - Filgrastim Products Utilization Management Medical Policy

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This policy governs prior authorization and medical-benefit coverage of filgrastim and specified filgrastim biosimilar products for cancer-related neutropenia, hematopoietic progenitor cell collection, radiation syndrome, chronic neutropenia, HIV/AIDS-associated neutropenia, drug-induced neutropenia, CAR T-cell therapy-related neutropenia, and myelodysplastic syndromes.

Policy Summary

PayerHAP CareSource MI Coordinated Health

PolicyColony Stimulating Factors - Filgrastim Products

Policy CodePolicy N/A

Change TypeMaterial revision

Effective DateN/A

Last ReviewOct 22, 2025

Next Review DateN/A

Key ActionSubmit prior authorization with the treated indication, requested dose and route, treatment duration, and required specialist documentation.

SourceLink

POLICY UPDATE CHANGES

Radiation-induced neutropenia was removed from the other uses with supportive evidence section.

The febrile-neutropenia risk-factor examples for chemotherapy patients were revised to specify age over 65 receiving full-dose chemotherapy, bilirubin greater than 2.0 mg/dL, creatinine clearance below 50 mL/min, and HIV infection with low CD4 counts.

The prior chemotherapy neutropenic-complication criterion was revised to require a complication from a prior chemotherapy cycle.

The PBPC collection and therapy dosing limit was reduced from 32 mcg/kg to 10 mcg/kg per day.

The ALL dosing criterion was revised to include intravenous injection as an approved route.

Ryzneuta and Rolvedon were added to the examples of colony-stimulating factors, and Leukine was removed.

Additional CAR T-cell therapy examples, including Abecma, Breyanzi, Carvykti, and Tecartus, were added.

Filkri and Nypozi were added to the products covered by the policy.

6Filgrastim products listed

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CurrentHAP CareSource MI Coordinated HealthPolicy N/A

Colony Stimulating Factors - Filgrastim Products Utilization Management Medical Policy

Customize your policy alerts

Sign up for all hap_caresource_mi_coordinated_health policy alerts

Know when hap_caresource_mi_coordinated_health releases new policies or updates existing guidance.

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Policy Summary

PayerHAP CareSource MI Coordinated Health

PolicyColony Stimulating Factors - Filgrastim Products

Policy CodePolicy N/A

Change TypeMaterial revision

Effective DateN/A

Last ReviewOct 22, 2025

Next Review DateN/A

Key ActionSubmit prior authorization with the treated indication, requested dose and route, treatment duration, and required specialist documentation.

SourceLink

POLICY UPDATE CHANGES

Radiation-induced neutropenia was removed from the other uses with supportive evidence section.

The prior chemotherapy neutropenic-complication criterion was revised to require a complication from a prior chemotherapy cycle.

The PBPC collection and therapy dosing limit was reduced from 32 mcg/kg to 10 mcg/kg per day.

The ALL dosing criterion was revised to include intravenous injection as an approved route.

Ryzneuta and Rolvedon were added to the examples of colony-stimulating factors, and Leukine was removed.

Additional CAR T-cell therapy examples, including Abecma, Breyanzi, Carvykti, and Tecartus, were added.

Filkri and Nypozi were added to the products covered by the policy.

6Filgrastim products listed

11Covered clinical indications

10 mcg/kg/dayMaximum dose for several indications

14 days/monthChemotherapy treatment duration

6 monthsMaximum listed approval duration

Not recommendedUnlisted circumstances

Covered Indications

Acute myeloid leukemia

Covered when the patient has AML receiving chemotherapy and the prescriber is or consults with an oncologist or hematologist.

AML chemotherapy: Patient has acute myeloid leukemia and is receiving chemotherapy.

The medication must be prescribed by or in consultation with an oncologist or hematologist. Approval duration: 6 months. Dose: up to 10 mcg/kg per day by intravenous or subcutaneous injection.

Bone marrow transplant

Covered when the patient has cancer, received chemotherapy, and is undergoing bone marrow transplantation with the required specialist involvement.

Cancer with bone marrow transplant: Patient has cancer, received chemotherapy, and is undergoing bone marrow transplantation.

The medication must be prescribed by or in consultation with a hematologist, oncologist, or physician who specializes in transplantation. Approval duration: 1 month. Dose: up to 30 mcg/kg per day by intravenous or subcutaneous injection.

Cancer receiving myelosuppressive chemotherapy

Covered when BOTH A and B are met.

A and B required

Peripheral blood progenitor cell collection and therapy

Covered when the patient is undergoing peripheral blood progenitor cell collection or therapy and the required specialist is involved.

PBPC collection and therapy: Patient is undergoing peripheral blood progenitor cell collection and therapy.

The medication must be prescribed by or in consultation with an oncologist, hematologist, or physician who specializes in transplantation. Approval duration: 1 month. Dose: up to 10 mcg/kg per day by intravenous or subcutaneous injection.

Radiation syndrome

Covered when the patient has hematopoietic acute radiation syndrome and the prescriber has the required expertise.

Hematopoietic acute radiation syndrome: Patient has hematopoietic syndrome of acute radiation syndrome after acute exposure to myelosuppressive radiation doses.

The medication must be prescribed by or in consultation with a physician who has expertise in treating acute radiation syndrome. Approval duration: 1 month. Dose: up to 10 mcg/kg per day by subcutaneous injection.

Severe chronic neutropenia

Covered when the patient has severe chronic neutropenia and the required specialist is involved.

Severe chronic neutropenia: Patient has severe chronic neutropenia, such as congenital neutropenia, cyclic neutropenia, or idiopathic neutropenia.

The medication must be prescribed by or in consultation with a hematologist. Approval duration: 6 months. Dose: up to 12 mcg/kg per day by subcutaneous injection.

Acute lymphoblastic leukemia

Covered when the patient has ALL receiving chemotherapy and the required specialist is involved.

ALL chemotherapy: Patient has acute lymphoblastic leukemia and is receiving chemotherapy.

The medication must be prescribed by or in consultation with an oncologist or hematologist. Approval duration: 1 month. Dose: up to 10 mcg/kg per day by intravenous or subcutaneous injection.

CAR T-cell therapy-related neutropenia

Covered when the patient has neutropenia associated with immunotherapy-related toxicity from CAR T-cell therapy.

CAR T-cell therapy-related neutropenia: Patient has neutropenia associated with immunotherapy-related toxicity from chimeric antigen receptor T-cell therapy.

Examples of CAR T-cell therapy include Abecma (idecabtagene vicleucel), Breyanzi (lisocabtagene maraleucel), Carvykti (ciltacabtagene autoleucel), Kymriah (tisagenlecleucel), Tecartus (brexucabtagene autoleucel), and Yescarta (axicabtagene ciloleucel). Approval duration: 1 month. Dose: up to 10 mcg/kg per day by intravenous or subcutaneous injection.

Drug-induced agranulocytosis or neutropenia

Covered for drug-induced, non-chemotherapy agranulocytosis or neutropenia.

Drug-induced neutropenia: Patient has agranulocytosis or neutropenia caused by a non-chemotherapy drug.

Approval duration: 1 month. Dose: up to 10 mcg/kg per day by subcutaneous injection.

Myelodysplastic syndromes

Covered when the patient has MDS and the required specialist is involved.

Myelodysplastic syndromes: Patient has myelodysplastic syndromes.

The medication must be prescribed by or in consultation with an oncologist or hematologist. Approval duration: 3 months. Dose: up to 5 mcg/kg per day by intravenous or subcutaneous injection.

HIV/AIDS-associated neutropenia

Covered when the patient has HIV/AIDS-associated neutropenia and the required specialist is involved.

HIV/AIDS-associated neutropenia: Patient has neutropenia associated with human immunodeficiency virus infection or acquired immunodeficiency syndrome.

The medication must be prescribed by or in consultation with a physician who specializes in infectious diseases, a hematologist, or a physician who specializes in management of HIV/AIDS. Approval duration: 4 months. Dose: up to 10 mcg/kg per day by subcutaneous injection.

Circumstances not listed in the Recommended Authorization Criteria are not recommended for coverage. The criteria may be updated as new published data become available.

Clinical Risk Thresholds

High chemotherapy-associated febrile-neutropenia risk

Risk thresholdAt least 20% febrile-neutropenia risk based on the chemotherapy regimen

Clinical settingMyelosuppressive anti-cancer medications associated with a high risk of febrile neutropenia

Coverage pathwayQualifies as one pathway for patients with cancer receiving myelosuppressive chemotherapy

Liver dysfunction risk factor

Risk-factor thresholdBilirubin greater than 2.0 mg/dL

Risk factorLiver dysfunction

Clinical setting

Authorization and Submission Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required for medical-benefit coverage of filgrastim products. Approval is recommended only when the member meets the applicable clinical criteria and dosing requirements in the policy.

Submit the request for clinical review before treatment when required.
Coverage review applies to the medical benefit and is based on the listed indication, authorization criteria, and established dosing.

Prior Authorization

Route EviCore Indications to EviCore

Indications marked [EviCore] are managed by EviCore Healthcare for clients using EviCore for oncology or oncology-related reviews. Direct prior authorization requests for these conditions to www.EviCore.com.

EviCore-routed indications: acute myeloid leukemia receiving chemotherapy; peripheral blood progenitor cell collection and therapy; radiation syndrome (hematopoietic syndrome of acute radiation syndrome); acute lymphoblastic leukemia receiving chemotherapy; CAR T-cell therapy–associated immunotherapy toxicities; and myelodysplastic syndromes.

Policy Background

Filgrastim is a granulocyte colony-stimulating factor that increases or restores neutrophil production and supports neutrophil recovery. This policy addresses its use for chemotherapy-associated febrile neutropenia, hematopoietic progenitor cell mobilization, neutropenia related to cancer therapies or other conditions, hematopoietic acute radiation syndrome, and other listed neutropenia-related indications.

Key Terms

Filgrastim

ClassGranulocyte colony-stimulating factor (G-CSF)

FunctionStimulates neutrophil production

Clinical roleSupports neutrophil recovery and is used for prevention or treatment of neutropenia-related complications

H-ARS

Full termHematopoietic Syndrome of Acute Radiation Syndrome

CauseAcute exposure to myelosuppressive doses of radiation

Policy useFilgrastim may be used to increase survival after acute exposure to myelosuppressive radiation doses

Initial Filgrastim Therapy

Initial filgrastim therapy

Coverage is recommended when the patient meets ONE of the following FDA-approved or supportive-evidence indications.

ONE qualifying indication

Acute myeloid leukemia: Patient has acute myeloid leukemia and is receiving chemotherapy; the medication is prescribed by or in consultation with an oncologist or hematologist.
Approval: 6 months. Dose: up to 10 mcg/kg/day IV or subcutaneous.
Bone marrow transplant: Patient with cancer received chemotherapy and is undergoing bone marrow transplantation; the medication is prescribed by or in consultation with a hematologist, oncologist, or transplant specialist.
Approval: 1 month. Dose: up to 30 mcg/kg/day IV or subcutaneous.
Cancer receiving myelosuppressive chemotherapy

Extended Approval

Extended approval

Extended approval is allowed when BOTH continuation requirements are met.

Continuation approval

Patient continues to meet the applicable approved indication criteria.
Patient continues to meet the applicable dosing requirements.
Approval duration remains indication-specific; when authorization is expressed in months, 1 month equals 30 days.

Dosing and Duration Limits

Filgrastim products

Maximum doseUp to 10 mcg/kg per day

RouteIntravenous or subcutaneous injection

Listed useAcute myeloid leukemia in a patient receiving chemotherapy

Filgrastim products for bone marrow transplant

Maximum doseUp to 30 mcg/kg per day

RouteIntravenous or subcutaneous injection

Listed useBone marrow transplant in a patient with cancer who received chemotherapy

Filgrastim Product Substitution

Billing Rule

Filkri may substitute for Neupogen

Filkri (filgrastim-laha) is an FDA-approved biosimilar and an appropriate substitute for Neupogen (filgrastim).

Billing Rule

Nivestym may substitute for Neupogen

Nivestym (filgrastim-aafi) is an FDA-approved biosimilar and an appropriate substitute for Neupogen (filgrastim).

Billing Rule

Nypozi may substitute for Neupogen

Nypozi (filgrastim-txid) is an FDA-approved biosimilar and an appropriate substitute for Neupogen (filgrastim).

Policy Summary

PayerHAP CareSource MI Coordinated Health

PolicyColony Stimulating Factors - Filgrastim Products

Policy CodePolicy N/A

Change TypeMaterial revision

Effective DateN/A

Last ReviewOct 22, 2025

Next Review DateN/A

Key ActionSubmit prior authorization with the treated indication, requested dose and route, treatment duration, and required specialist documentation.

SourceLink

On This Page

A qualifying patient risk factor when chemotherapy-associated febrile-neutropenia risk is below 20%

Renal dysfunction risk factor

Risk-factor thresholdCreatinine clearance below 50 mL/min

Risk factorRenal dysfunction

Clinical settingA qualifying patient risk factor when chemotherapy-associated febrile-neutropenia risk is below 20%

Severe neutropenia risk factor

Risk-factor thresholdAbsolute neutrophil count below 100 cells/mm3

Risk factorSevere neutropenia

Clinical settingA risk factor for poor clinical outcomes or infection-associated complications after chemotherapy-associated febrile neutropenia

Expected prolonged neutropenia risk factor

Risk-factor thresholdExpected neutropenia lasting more than 10 days

Risk factorProlonged neutropenia

Clinical settingA risk factor for poor clinical outcomes or infection-associated complications after chemotherapy-associated febrile neutropenia

Prior Authorization

Continuation and Authorization Duration

Extended approvals are allowed when the patient continues to meet the applicable criteria and dosing requirements. All approvals are issued for the duration specified by the indication; when a duration is expressed in months, 1 month equals 30 days.

Acute myeloid leukemia receiving chemotherapy: 6 months.
Bone marrow transplant in a patient with cancer who received chemotherapy: 1 month.
Peripheral blood progenitor cell collection and therapy: 1 month.
Radiation syndrome: 1 month.
Severe chronic neutropenia: 6 months.
Acute lymphoblastic leukemia receiving chemotherapy: 1 month.
CAR T-cell therapy–associated immunotherapy toxicities: 1 month.
Drug-induced non-chemotherapy agranulocytosis or neutropenia: 1 month.
Myelodysplastic syndromes: 3 months.
Neutropenia associated with HIV/AIDS: 4 months.
For any continuation request, document ongoing eligibility under the applicable criteria and dosing.

Documentation Required

Clinical and Prescribing Documentation

Submit sufficient clinical and prescribing documentation for review, including the diagnosis or indication, causative or associated therapy, prescribed dose, route, treatment details, and required specialist involvement.

Identify the indication and relevant treatment: chemotherapy, bone marrow transplant, peripheral blood progenitor cell collection, radiation exposure, CAR T-cell therapy, drug-induced neutropenia, severe chronic neutropenia, myelodysplastic syndrome, or HIV/AIDS-associated neutropenia.
Document the prescribed dose and route. Policy dosing is generally expressed in mcg/kg/day and may require intravenous or subcutaneous administration as specified for the indication.
AML: up to 10 mcg/kg/day IV or subcutaneous; oncology or hematology prescriber or consultation required.
Bone marrow transplant: up to 30 mcg/kg/day IV or subcutaneous; hematology, oncology, or transplantation specialist prescriber or consultation required.
The policy's febrile-neutropenia criteria include relevant risk factors such as sepsis syndrome, age over 65, severe neutropenia (ANC below 100 cells/mm3), expected neutropenia over 10 days, pneumonia or other documented infection, invasive fungal infection, hospitalization at fever onset, or prior febrile neutropenia; document oncology or hematology involvement. Dosing is up to 10 mcg/kg/day IV or subcutaneous for up to 14 days per month.
Peripheral blood progenitor cell collection: up to 10 mcg/kg/day IV or subcutaneous; oncology, hematology, or transplantation specialist prescriber or consultation required.
Radiation syndrome: up to 10 mcg/kg/day subcutaneously; prescriber or consultation with a physician experienced in acute radiation syndrome required.
Severe chronic neutropenia: up to 12 mcg/kg/day subcutaneously; hematology prescriber or consultation required.
Acute lymphoblastic leukemia: up to 10 mcg/kg/day IV or subcutaneous; oncology or hematology prescriber or consultation required.
CAR T-cell therapy–associated neutropenia: up to 10 mcg/kg/day IV or subcutaneous; document neutropenia and the associated CAR T-cell therapy.
Drug-induced non-chemotherapy agranulocytosis or neutropenia: up to 10 mcg/kg/day subcutaneously.
Myelodysplastic syndromes: up to 5 mcg/kg/day IV or subcutaneous; oncology or hematology prescriber or consultation required.
HIV/AIDS-associated neutropenia: up to 10 mcg/kg/day subcutaneously; infectious-disease, hematology, or HIV/AIDS specialist prescriber or consultation required.

Denial Risk

Unlisted Indication Not Recommended

Coverage of filgrastim products is not recommended for circumstances not listed in the Recommended Authorization Criteria. Criteria may be updated as new published data become available.

Do not assume coverage for an unlisted diagnosis, indication, or circumstance.

Prior Authorization

Nonstandard Dosing Requires Clinical Review

Requests for doses outside the established dosing documented in the policy require case-by-case clinical review by a clinician, such as a Medical Director or Pharmacist.

Document the requested dose, route, indication, clinical rationale, and supporting treatment details for nonstandard dosing.
Approval is not automatic when the requested dose falls outside the policy's stated dosing limits.

PBPC collection

Full termPeripheral blood progenitor cell collection

DefinitionCollection of hematopoietic progenitor cells from peripheral blood by leukapheresis

Clinical purposeMobilization of hematopoietic progenitor cells into peripheral blood for collection

High risk of febrile neutropenia

DefinitionA chemotherapy-regimen-associated febrile-neutropenia risk of at least 20%

Treatment contextApplies to myelosuppressive anti-cancer medications

Coverage relevanceSupports prophylactic filgrastim use when the chemotherapy regimen has a high febrile-neutropenia risk

Peripheral blood progenitor cell collection and therapy:

Patient requires peripheral blood progenitor cell collection and therapy; the medication is prescribed by or in consultation with an oncologist, hematologist, or transplant specialist.

Approval: 1 month. Dose: up to 10 mcg/kg/day IV or subcutaneous.

Hematopoietic acute radiation syndrome: Patient has hematopoietic syndrome of acute radiation syndrome after acute exposure to myelosuppressive radiation doses; the medication is prescribed by or in consultation with a physician experienced in treating acute radiation syndrome.

Approval: 1 month. Dose: up to 10 mcg/kg/day subcutaneous.

Severe chronic neutropenia: Patient has severe chronic neutropenia, such as congenital, cyclic, or idiopathic neutropenia; the medication is prescribed by or in consultation with a hematologist.

Approval: 6 months. Dose: up to 12 mcg/kg/day subcutaneous.

Acute lymphoblastic leukemia: Patient has acute lymphoblastic leukemia and is receiving chemotherapy; the medication is prescribed by or in consultation with an oncologist or hematologist.

Approval: 1 month. Dose: up to 10 mcg/kg/day IV or subcutaneous.

CAR T-cell therapy-related neutropenia: Patient has neutropenia associated with immunotherapy-related toxicity from CAR T-cell therapy.

Examples include Abecma, Breyanzi, Carvykti, Kymriah, Tecartus, and Yescarta. Approval: 1 month. Dose: up to 10 mcg/kg/day IV or subcutaneous.

Drug-induced neutropenia: Patient has non-chemotherapy drug-induced agranulocytosis or neutropenia.

Approval: 1 month. Dose: up to 10 mcg/kg/day subcutaneous.

Myelodysplastic syndromes: Patient has myelodysplastic syndromes; the medication is prescribed by or in consultation with an oncologist or hematologist.

Approval: 3 months. Dose: up to 5 mcg/kg/day IV or subcutaneous.

HIV/AIDS-associated neutropenia: Patient has neutropenia associated with HIV or AIDS; the medication is prescribed by or in consultation with an infectious-disease physician, hematologist, or physician specializing in HIV/AIDS management.

Approval: 4 months. Dose: up to 10 mcg/kg/day subcutaneous.

Filgrastim products for chemotherapy-associated cancer

Maximum doseUp to 10 mcg/kg per day

Maximum durationUp to 14 days per month

RouteIntravenous or subcutaneous injection

Filgrastim products for severe chronic neutropenia

Maximum doseUp to 12 mcg/kg per day

RouteSubcutaneous injection

Listed useSevere chronic neutropenia, including congenital, cyclic, or idiopathic neutropenia

Filgrastim products for MDS

Maximum doseUp to 5 mcg/kg per day

RouteIntravenous or subcutaneous injection

Listed useMyelodysplastic syndromes

Filgrastim products for other listed indications

Maximum doseUp to 10 mcg/kg per day

RouteIntravenous or subcutaneous injection unless the indication specifies subcutaneous injection only

Listed usesOther listed indications include PBPC collection and therapy, H-ARS, acute lymphoblastic leukemia, CAR T-cell therapy-related neutropenia, drug-induced neutropenia, and HIV/AIDS-associated neutropenia

Billing Rule

Releuko may substitute for Neupogen

Releuko (filgrastim-ayow) is an FDA-approved biosimilar and an appropriate substitute for Neupogen (filgrastim).

Billing Rule

Zarxio may substitute for Neupogen

Zarxio (filgrastim-sndz) is an FDA-approved biosimilar and an appropriate substitute for Neupogen (filgrastim).