ModifiedEmblemHealthPolicy MG.MM.PH.62a

Colony Stimulating Factors: Nivestym (filgrastim-aafi)

Clinical coverage guideline for use of the biosimilar G-CSF Nivestym (filgrastim-aafi) including indications, dosing, coding, and authorization details for EmblemHealth members.

Policy Summary

PayerEmblemHealth

PolicyColony Stimulating Factors: Nivestym (filgrastim-aafi)

Policy CodePolicy MG.MM.PH.62a

Change TypeCriteria and dosing revisionsadded comorbidity and NDC updates

Effective Date

Next Review Date

Key ActionSubmit clinical evidence including regimen FN risk estimate, patient-specific risk factors (including chronic immunosuppression/post-transplant when applicable), and prior G-CSF use for prior authorization.

SourceLink

POLICY UPDATE CHANGES

Updated Max units dose and updated patient risk factors (co-morbidities) for febrile neutropenia; added criteria for patients undergoing myelosuppressive chemotherapy with expected FN incidence <10% and two or more patient-related risk factors.

Added chronic immunosuppression in the post-transplant setting including organ transplant as a co-morbidity for non-myeloid malignancy initial criteria.

Updated dosing chart and initial criteria; clarified prior prophylactic therapy with filgrastim or tbo-filgrastim and noted they should not be used concomitantly with lipegfilgrastim.

Extended coverage duration from 4 to 6 months (effective 01/01/2021).

Added new NDC codes (0069-0291-xx, 0069-0292-xx, 0069-0293-xx, 0069-0294-XX).

6 monthsLength of authorization

Q5110Applicable procedure code

Trek Health ingests and normalizes Transparency in Coverage data and payer policy updates to give provider organizations a clear view of how commercial reimbursement behaves across markets, payers, and services. Our platform transforms raw payer disclosures into structured intelligence that supports contract evaluation, payer negotiations, and service line strategy. By combining market benchmarks with ongoing policy visibility, Trek helps teams identify variability, risk, and opportunity in commercial reimbursement. The result is faster insight, stronger negotiating positions, and more informed financial decisions.

Coverage Criteria for Nivestym (filgrastim-aafi)

Prophylactic use for solid tumors or non-myeloid malignancy

Covered when ANY of the following chemotherapy-related indications are met:

Prophylactic use with high-risk chemotherapy: Patient is undergoing myelosuppressive chemotherapy with an expected incidence of febrile neutropenia >20%.>20%

Refer to NCCN Hematopoietic Growth Factors Clinical Practice Guideline for regimen-specific FN risk estimates

Prophylactic use with intermediate-risk chemotherapy plus risk factors: Patient is undergoing myelosuppressive chemotherapy with an expected incidence of febrile neutropenia 10%–20% AND has one or more patient-related risk factors.10%-20% + >=1 risk factor

See patient risk factors list

Prophylactic use with low-risk chemotherapy with multiple risk factors: Patient is undergoing myelosuppressive chemotherapy with an expected incidence of febrile neutropenia <10% AND has two or more patient-related risk factors.<10% + >=2 risk factors

Use in this setting is based on clinical judgment

Therapeutic use for febrile neutropenia

Treatment of chemotherapy-induced febrile neutropenia — covered when ANY of the following conditions are met:

Therapeutic use following prophylaxis or when prophylaxis not given: Patient has been on prophylactic therapy with filgrastim or tbo-filgrastim (therapy should not be used concomitantly with pegfilgrastim); OR patient has not received prophylactic G-CSF AND has one or more risk factors for infection-related complications (examples: sepsis syndrome; age >65; ANC <100/mcL; duration of neutropenia expected >10 days; pneumonia or other clinically documented infection; invasive fungal infection; hospitalization at time of fever; prior episode of febrile neutropenia).N/A

Includes patients who experienced a neutropenic complication from a prior cycle of the same chemotherapy

Severe chronic neutropenia

Severe chronic neutropenia — covered when ALL of the following are met:

ANC threshold and diagnosis: Absolute neutrophil count <=500/mm3; AND diagnosis of congenital, cyclic, or idiopathic neutropenia.ANC <=500/mm3

Myelodysplastic Syndrome

Myelodysplastic syndrome (MDS) — covered when ALL of the following are met:

MDS coverage criteria: Endogenous serum erythropoietin <500 mUnits/mL; AND patient has lower-risk disease (IPSS-R Very Low, Low, Intermediate); AND used for treatment of symptomatic anemia with no del(5q) mutation; AND patient is receiving concurrent erythropoiesis-stimulating agent (ESA) therapy.EPO <500 mU/mL

BMT/PBPC and Radiation indications

Other covered indications (listed):

Bone marrow transplant / PBPC support: Coverage provided for bone marrow transplant indications and peripheral blood progenitor cell (PBPC) support.

Dose guidance provided in dosing section

Hematopoietic subsyndrome of acute radiation syndrome: Coverage for patients acutely exposed to myelosuppressive doses of radiation (hematopoietic subsyndrome of acute radiation syndrome).

FDA-labeled and compendia-recommended indication

Initial prophylaxis criteria (summary)

Policy criteria were updated to require additional patient-related risk factors for prophylactic G-CSF when chemotherapy FN risk is <10%, and to include chronic immunosuppression post‑transplant as a comorbidity.

Updated prophylaxis criteria summary: Patient undergoing myelosuppressive chemotherapy with expected incidence of febrile neutropenia <10% AND two or more patient-related risk factors (including chronic immunosuppression/post‑transplant status).>=2 risk factors

Refer to policy dosing chart and defined febrile neutropenia

Nivestym is designated as a non-preferred granulocyte colony-stimulating factor (G-CSF). Use of Nivestym without documentation demonstrating a contraindication or severe intolerance to the preferred agents (Granix and Zarxio) is not consistent with the preference policy and requires prior authorization.

Requests for filgrastim therapy should document prior prophylactic filgrastim or tbo-filgrastim use when applicable. The policy clarifies that filgrastim products previously used prophylactically (filgrastim or tbo-filgrastim) should not be used concomitantly with lipegfilgrastim.

Prophylactic use of G-CSF when the expected incidence of febrile neutropenia (FN) for the chemotherapy regimen is 10% is permitted only if the patient has two or more patient-related risk factors. Prophylaxis for regimens with expected FN risk <10% without documentation of at least two patient-related risk factors is considered not routinely supported.

Requests that exceed the updated dosing limits or that do not meet the revised patient risk-factor criteria (for example, prophylactic G-CSF when the regimen FN risk is <10% without the required number of risk factors) may be considered not medically necessary and subject to denial during authorization or post-payment review.

Dosing and Regimen Guidance

Indication	Dose / Frequency	Administration timing constraint
Bone marrow transplant (BMT) / Peripheral blood progenitor cell (PBPC) support / Hematopoietic subsyndrome of acute radiation syndrome (ARS)
10 mcg/kg daily for up to 14 days
Do not administer within 14 days before and 24 hours after cytotoxic chemotherapy.

Product group	Typical dosing for prophylaxis of chemotherapy-induced febrile neutropenia (when criteria met)	Notes / limitations
Filgrastim (including filgrastim biosimilars) and tbo‑filgrastim
5 mcg/kg daily for up to 14 days (general dosing for most non‑BMT indications)
Do not administer within 14 days before and 24 hours after cytotoxic chemotherapy; prior authorization requires documentation that prophylaxis criteria are met.

Line of Therapy Considerations

first-line

First-line use tied to regimen FN risk: Use as prophylaxis during myelosuppressive chemotherapy is determined by the regimen-specific expected incidence of febrile neutropenia (>20%; 10%–20% with >=1 risk factor; <10% with >=2 risk factors).Regimen-specific FN risk per NCCN

Refer to NCCN Hematopoietic Growth Factors guideline for estimates

mixed

Mixed line-of-therapy scenarios: Used as prophylaxis during myelosuppressive chemotherapy regimens; specific line (first-line versus subsequent lines) is not restricted by the policy text — apply regimen FN risk and patient risk factors to determine appropriateness.

Full policy may specify timing relative to chemotherapy cycles

Coding CPT/HCPCS, NDCs, ICD-10, and Billing Limits

Max Units (per dose and over time)

Max billable units per day by indicationSevere chronic neutropenia: 1560; BMT/PBPC/Radiation: 1560 or 1200 depending on line; All other indications: 600

Patient-related risk factors

Patient-related risk factors requirement when FN incidence <10%When the expected incidence of febrile neutropenia from myelosuppressive chemotherapy is <10%, prophylactic use requires presence of two or more patient-related risk factors.

Provider Actions, Prior Authorization, and Documentation

Prior Authorization

Prior Authorization Required for Non-Preferred G-CSF

Prior authorization is required for requests for non-preferred granulocyte colony-stimulating factor (G-CSF) products. Nivestym is designated as a non-preferred G-CSF agent; prior authorization must be obtained and will only be approved when the member has a documented contraindication or severe intolerance to preferred agents (Granix and Zarxio).

Preferred agents: Granix and Zarxio (Commercial, Medicaid, Medicare).
Nivestym: non-preferred — prior authorization required; approval only with contraindication or severe intolerance to preferred agents.

Prior Authorization

Prior Authorization for Filgrastim Products — Documentation Required

Prior authorization is required for filgrastim (and filgrastim-sndz) product requests. The treating clinician must submit documentation supporting the medical indication, the estimated febrile neutropenia (FN) risk of the chemotherapy regimen, the member’s specific FN risk factors, and a history of prior G-CSF agents used (including dates and reasons for discontinuation if applicable). Requests that do not include the required information may not be able to be properly reviewed or may be denied.

Key Definitions

Febrile neutropenia — definition

Temperature criterionA single temperature ≥38.3°C OR ≥38.0°C sustained over 1 hour

Neutropenia criterionANC <500 neutrophils/mcL OR ANC <1,000 neutrophils/mcL with predicted decline to <500 within 48 hours

Combined requirementFebrile neutropenia defined as meeting both the temperature AND neutropenia criteria

Severe chronic neutropenia — definition

ANC thresholdAbsolute neutrophil count ≤500/mm3

Required diagnosesDiagnosis of congenital, cyclic, OR idiopathic neutropenia

Coverage requirement

Background

Filgrastim, a granulocyte colony-stimulating factor (G-CSF), is indicated to reduce the duration of neutropenia and the incidence of febrile neutropenia associated with myelosuppressive chemotherapy. It is also used to treat severe chronic neutropenia, to support bone marrow transplant and peripheral blood progenitor cell (PBPC) procedures, and for hematopoietic subsyndrome following acute radiation exposure.

Revision History and Policy Updates

2025-03-19material_revisionLatest

Updated maximum billable units dose and revised patient co-morbidities for febrile neutropenia; added criterion for prophylaxis when expected FN incidence <10% with two or more patient-related risk factors and created a separate co-morbidity chart and definition for febrile neutropenia.

2024-03-21annual_review

Annual review updated the dosing chart and expanded initial criteria to add chronic immunosuppression in the post-transplant (including organ transplant) setting as a co-morbidity for non-myeloid malignancy.