ModifiedEmblemHealthPolicy MG.MM.PH.365

Colony Stimulating Factors: Fylnetra (pegfilgrastim‑pbbk)

Covers medical necessity and prior authorization criteria for Fylnetra (pegfilgrastim‑pbbk) use for prevention/treatment of chemotherapy- or radiation-related neutropenia for EmblemHealth members.

Policy Summary

PayerEmblemHealth

PolicyColony Stimulating Factors: Fylnetra (pegfilgrastim‑pbbk)

Policy CodePolicy MG.MM.PH.365

Change TypeCriteria, dosing, and coding updates

Effective DateN/A

Next Review DateMar 18, 2025

Key ActionObtain prior authorization with documentation of chemotherapy regimen FN risk and patient-related risk factors and use billing code Q5130.

SourceLink

POLICY UPDATE CHANGES

Updated risk factors (patient co-morbidities) for febrile neutropenia and added criteria allowing use when expected FN incidence is <10% if two or more risk factors are present.

Updated dosing limit and dosing chart during annual review.

Updated procedure code: removed J3590 and added Q5130 for Fylnetra.

Q5130billing code for Fylnetra

6 mgstandard strength

>20%,10–20%,<10%FN risk strata

3+revision events

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Coverage and Medical Necessity Criteria

Initial Approval Criteria

Fylnetra is covered when ANY ONE of the following groups of conditions is met AND use is consistent with the medical necessity criteria that follow:

Continuation of prior Fylnetra therapy: Patient is continuing previously established therapy with Fylnetra for their current chemotherapy regimen.

Step therapy exception or failure: Patient has failed treatment with Neulasta AND Udenyca or both agents are contraindicated.

Access/benefit exception: Member does not have access to or benefits for home health services.

Extended duration chemotherapy: Member is expected to receive G‑CSF for 5 consecutive days or more.

Specific chemotherapy regimens: Fylnetra is used in combination with one of the following dose‑dense chemotherapy regimens: dose‑dense MVAC for bladder cancer; dose‑dense AC followed by T for breast cancer; or dose‑dense CHOP‑14 for non‑Hodgkin lymphoma.

Pegylated filgrastim is the only G‑CSF product used in the published clinical trials for these regimens; provider should supply citations for other regimens if requested.

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

Prophylactic use — intermediate FN risk with risk factors: Patient is undergoing myelosuppressive chemotherapy with an expected FN incidence 10–20% AND has ≥1 patient‑related risk factor (see policy risk‑factor list).10–20% + ≥1 risk factor

Prophylactic use — low FN risk with multiple risk factors: Patient is undergoing myelosuppressive chemotherapy with an expected FN incidence <10% AND has ≥2 patient‑related risk factors (use in this setting is based on clinical judgment).<10% + ≥2 risk factors

Risk factors include items such as age >65 years receiving full‑dose chemotherapy, persistent neutropenia (ANC <1000/mm3), prior chemo/radiation, bone marrow involvement, significant immunosuppression, recent surgery/open wounds, poor performance status, renal dysfunction (CrCl <50 mL/min), chronic post‑transplant immunosuppression, and liver dysfunction (bilirubin >2.0 mg/dL).

Prophylactic G-CSF for lower-risk regimens with patient risk factors

Covered when ALL of the following are met

Primary: Patient is undergoing myelosuppressive chemotherapy with an expected incidence of febrile neutropenia (FN) of <10% AND has two or more patient‑related risk factors as defined in the policy's risk‑factor chart.expected FN incidence <10% with >=2 risk factors

Risk factors were updated and separated into a chart for reference.

Fylnetra is not considered medically necessary for indications other than those expressly listed in this policy due to insufficient evidence of therapeutic value.

None are explicitly listed in this section of the document.

Use of Fylnetra for indications not included in the policy’s listed coverage criteria is considered not medically necessary and may be denied on review.

Providers should note that dosing limits and the dosing chart were updated in the policy’s revision history; exceeding established dosing limits or frequencies may render a request not medically necessary and subject to denial.

Chemotherapy Regimens and Use Cases

Regimen	Cancer type / indication	Coverage stance	Notes / rationale
Dose-dense MVAC (methotrexate, vinblastine, doxorubicin, cisplatin)	Bladder cancer	Covered	Pegylated filgrastim is the only G-CSF used in published trials for this regimen; provider should supply citations if requesting other G-CSFs.
Dose-dense AC followed by T (doxorubicin, cyclophosphamide, paclitaxel)	Breast cancer	Covered	Supported as a dose-dense regimen where pegylated filgrastim was used in trials; documentation of regimen and citation recommended.
Dose-dense CHOP-14 (cyclophosphamide, doxorubicin, vincristine, prednisone)	Non-Hodgkin lymphoma	Covered	Listed as an allowed dose-dense NHL regimen; pegylated filgrastim is the G-CSF used in published trials for this regimen.

Regimen FN risk	Patient risk-factor requirement	Coverage stance	Notes / required documentation
Myelosuppressive chemotherapy with expected FN incidence <10%	Two or more patient-related risk factors (as defined in policy risk-factor chart)	Covered	Covered when patient has ≥2 documented risk factors; policy revision explicitly allows prophylaxis in <10% FN regimens if criteria met — include documentation of each risk factor per chart.

Billing Codes, Dosing Limits, and Diagnosis Codes

Covered HCPCS/CPT CodesHCPCSCovered

Q5130

Injection, pegfilgrastim-pbbk (Fylnetra), 1 billable unit

Covered NDCsNDCCovered

70121-1627-1

Fylnetra 6 mg prefilled syringe

Relevant ICD-10 Diagnosis CodesICD-10

D70.1	Agranulocytosis secondary to cancer chemotherapy
D70.9	Neutropenia, unspecified
T45.1XSA	Adverse effect of antineoplastic and immunosuppressive drugs, initial encounter
T45.1XSD	Adverse effect of antineoplastic and immunosuppressive drugs, subsequent encounter
T45.1XSS	Adverse effect of antineoplastic and immunosuppressive drugs, sequela
Z41.8	Encounter for other procedures for purposes other than remedying health state
Z51.89	Encounter for other specified aftercare

ICD-10 and Other Billing Codes Referencedmixed

252.001	Unspecified donor, stem cells
252.011	Autologous donor, stem cells
Z52.091	Other blood donor, stem cells
294.81	Bone marrow transplant status
294.84	Stem cells transplant status
251.11	Encounter for antineoplastic chemotherapy
251.12	Encounter for antineoplastic immunotherapy
251.89	Encounter for other specified aftercare

Maximum dosing frequency/units

Maximum dosing frequency/unitsAcute radiation exposure: 6 mg subcutaneously weekly for 2 doses (12 billable units weekly x 2 doses). All other indications: 6 mg max per 14 days (12 billable units per 14 days).

Expected incidence threshold for FN

Expected incidence threshold for FNPatient is undergoing myelosuppressive chemotherapy with an expected incidence of febrile neutropenia of < 10% AND two or more patient-related risk factors.

Prior Authorization, Documentation, and Billing Guidance

Prior Authorization

Prior Authorization Required

Prior authorization is required for Fylnetra (Fylnetra requires prior authorization). Fylnetra is medically necessary only when the specified initial approval criteria are met and appropriate documentation is submitted with the request.

Prior authorization required for initiation or continuation of Fylnetra
Requests lacking required documentation may be denied or not properly reviewed

Documentation Required

Clinical Evidence Required

The treating provider must submit clinical evidence that the member meets the medical necessity criteria. EmblemHealth will not be able to properly review the request for preauthorization or for post-payment review without this documentation.

Include relevant clinical notes, chemotherapy regimen, and rationale for G-CSF use
Provide journal citations if requesting Fylnetra for regimens not listed in the policy

Positioning and Line of Therapy

First-line

Lines: Used prophylactically with chemotherapy regimens based on FN risk and patient risk factors; also for continuation of established Fylnetra therapy; may be used when Neulasta/Udenyca failed or are contraindicated.

Key Definitions

Fylnetra — definition as a pegylated colony stimulating factor

Drug classPegylated colony‑stimulating factor (pegfilgrastim biosimilar)

Mechanism of actionActs on hematopoietic cells by binding to specific cell surface receptors to stimulate proliferation, differentiation, and functional activation

Brand/GenericFylnetra (pegfilgrastim‑pbbk)

Febrile neutropenia (FN) — diagnostic temperature and neutropenia thresholds

Fever criterionSingle temperature ≥38.3°C OR ≥38.0°C sustained over 1 hour

Neutropenia criterionAbsolute neutrophil count (ANC) <500 neutrophils/µL OR ANC <1,000 neutrophils/µL with a predicted decline to <500 neutrophils/µL within 48 hours

Background and Clinical Context

Fylnetra (pegfilgrastim‑pbbk) is a pegylated colony stimulating factor that acts on hematopoietic cells by binding to specific cell surface receptors to stimulate proliferation, differentiation, and activation of neutrophil precursors; it is used to prevent or treat chemotherapy- and radiation-induced neutropenia, including the hematopoietic subsyndrome of acute radiation exposure.

Policy Revision Timeline

2025-03-13material_revisionLatest

Updated patient comorbidity risk factors for febrile neutropenia and added criterion allowing prophylactic G-CSF when expected FN incidence is <10% with two or more patient-related risk factors; separated risk-factor list into a referenced chart.

2024-03-21dosing_update

Annual review updated the dosing limit and dosing chart for Fylnetra.

2023-09-13