CurrentEmblemHealthPolicy MG.MM.PH.206

Colony Stimulating Factors: Ziextenzo (pegfilgrastim-bmez)

Defines medical necessity, authorization, dosing, coding, and coverage criteria for Ziextenzo (pegfilgrastim-bmez) for EmblemHealth members receiving myelosuppressive chemotherapy or acute radiation exposure.

Policy Summary

PayerEmblemHealth

PolicyColony Stimulating Factors: Ziextenzo (pegfilgrastim-bmez)

Policy CodePolicy MG.MM.PH.206

Change TypeCriteria revisedcodes addedauthorization length extended

Effective Date

Next Review DateMar 20, 2025

Key ActionObtain prior authorization and submit clinical evidence that the member meets the policy criteria; coverage is provided for six months and may be renewed.

SourceLink

POLICY UPDATE CHANGES

Updated risk factors (patient co-morbidities) for febrile neutropenia and added coverage when expected FN incidence is <10% with two or more patient-related risk factors.

Extended coverage duration from 4 to 6 months.

Added Q-code Q5120 for Ziextenzo (pegfilgrastim-bmez) and applicable NDC.

6 monthsLength of authorization

6 mgStandard adult dose

Q5120HCPCS

61314-0866-01NDC

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Coverage Criteria for Ziextenzo (pegfilgrastim-bmez)

Initial Approval Criteria

Covered when ANY one of the following conditions is met AND use is consistent with the detailed medical necessity criteria:

Step therapy or contraindication: Patient has failed treatment with Neulasta AND Udenyca or those agents are contraindicated

Step therapy applies to Commercial, Medicaid, and Medicare members; provider should supply citations if requesting for regimens other than listed.

Continuation of established therapy: Patient is continuing previously established therapy with Ziextenzo for their current chemotherapy regimen

No home health services access: Member does not have access to, or benefits for, home health services

Expected prolonged G-CSF use: Member is expected to receive G-CSF for 5 consecutive days or more>=5 consecutive days

Specific chemotherapy regimens (dose-dense): Ziextenzo is used in combination with specified dose-dense chemotherapy regimens (examples include dose-dense MVAC for bladder cancer, dose-dense AC->T for breast cancer, dose-dense CHOP-14 for NHL)

Pegylated filgrastim is the only G-CSF used in published trials for these regimens; provider should provide citations for other regimens.

Prophylactic use based on FN risk

Patient-related risk factors (examples): Age >65 years receiving full dose intensity chemotherapy; persistent neutropenia (ANC <1000/mm3); prior exposure to chemotherapy or radiation; bone marrow involvement by tumor; conditions increasing infection risk (e.g., HIV/AIDS with low CD4); recent surgery/open wounds; poor performance status; renal dysfunction (creatinine clearance <50 mL/min); chronic immunosuppression post-transplant; liver dysfunction (bilirubin >2.0 mg/dL)
List of patient-related risk factors from policy.

Acute radiation exposure: Patient acutely exposed to myelosuppressive doses of radiation (Hematopoietic Subsyndrome of Acute Radiation Syndrome)Dose = 6 mg subcutaneously weekly for 2 doses (weight-based pediatric dosing if <45 kg)

FDA-labeled indication; use weight-based dosing for pediatric patients <45 kg.

Regimen	Cancer type	Notes / evidence
Dose-dense MVAC (methotrexate, vinblastine, doxorubicin, cisplatin)	Bladder cancer	Pegylated filgrastim has been used with dose-dense MVAC; Ziextenzo may be considered when used in combination with this regimen
Dose-dense AC followed by T (doxorubicin, cyclophosphamide, paclitaxel)	Breast cancer	Pegylated filgrastim is the G-CSF used in published trials for dose-dense AC→T; Ziextenzo may be considered when used in combination with this regimen
Dose-dense CHOP-14 (cyclophosphamide, doxorubicin, vincristine, prednisone)	Non-Hodgkin's lymphoma	Pegylated filgrastim has clinical trial evidence in dose-dense CHOP-14; Ziextenzo may be considered when used in combination with this regimen

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

Any use of Ziextenzo outside the listed indications and criteria in this policy is considered not medically necessary.

Coding and Diagnosis Codes

Applicable HCPCS CodesHCPCSCovered

Q5120

Injection, pegfilgrastim-bmez, biosimilar (Ziextenzo), 1 billable unit

Applicable NDCsNDCCovered

61314-0866-01

Ziextenzo 6 mg prefilled syringe

Applicable ICD-10 Diagnoses (selected from document)ICD-10

D70.1	Agranulocytosis secondary to cancer chemotherapy
D70.9	Neutropenia, unspecified
T45.1XSS	Adverse effect of antineoplastic and immunosuppressive drugs sequela
T45.1XSA	Adverse effect of antineoplastic and immunosuppressive drugs initial encounter
T45.1XSD	Adverse effect of antineoplastic and immunosuppressive drugs subsequent encounter
Z51.12	Encounter for antineoplastic immunotherapy
Z51.11	Encounter for antineoplastic chemotherapy

Expected incidence of febrile neutropenia

>20% expected FN incidenceProphylactic G-CSF (Ziextenzo) indicated when expected incidence of febrile neutropenia is greater than 20%

10–20% expected FN incidenceProphylactic G-CSF indicated when expected incidence is 10–20% and patient has one or more patient-related risk factors

<10% expected FN incidenceProphylactic G-CSF indicated when expected incidence is <10% only if patient has two or more patient-related risk factors

Provider Requirements and Authorization

Prior Authorization

Prior Authorization Required

Prior authorization is required. Initial approval criteria must be met and renewals follow the same criteria. Coverage is provided for up to six months when the medical necessity criteria are satisfied.

Prior authorization required for initial and renewal requests.
Coverage duration: up to 6 months when criteria are met.

Step Therapy

Step Therapy — Trial of Preferred Agents

Step therapy applies to initial approvals. Members must have failed treatment with Neulasta AND Udenyca, or those agents must be contraindicated, prior to approval of Ziextenzo. Neulasta and Udenyca are the preferred agents for Commercial, Medicaid, and Medicare members unless contraindicated or failure documented.

Member must fail Neulasta AND Udenyca, or both must be contraindicated, before Ziextenzo is approved.
Preferred agents: Neulasta and Udenyca for Commercial, Medicaid, and Medicare members.

Background and Clinical Context

Ziextenzo is a pegylated filgrastim biosimilar colony stimulating factor that binds to specific hematopoietic cell surface receptors to stimulate proliferation, differentiation, commitment, and end-cell functional activation. It is indicated for prophylactic use to reduce the incidence of febrile neutropenia in patients receiving myelosuppressive chemotherapy and for treatment of the hematopoietic subsyndrome following acute radiation exposure.

Definitions

Ziextenzo

MechanismZiextenzo is a colony stimulating factor that acts on hematopoietic cells by binding to specific cell surface receptors thereby stimulating proliferation, differentiation, commitment, and end cell functional activation.

Drug classPegylated filgrastim biosimilar (pegfilgrastim-bmez)

Primary useProphylaxis to reduce incidence of febrile neutropenia in patients receiving myelosuppressive chemotherapy and for hematopoietic subsyndrome after acute radiation exposure

Febrile neutropenia (FN)

Temperature criteriaSingle oral temperature ≥ 38.3°C OR ≥ 38.0°C sustained over 1 hour

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

Policy Revision History

2025-03-20criteria_revisionLatest

Updated patient-related risk factors for febrile neutropenia and added coverage when expected FN incidence is <10% with two or more patient-related risk factors; risk factors were separated into a referenced chart.

2024-03-21annual_review

Annual review with updates to dosing limits and the dose chart.

2023-09-15code_revision