CurrentEmblemHealthPolicy MG.MM.PH.126

Colony Stimulating Factors: Udenyca (pegfilgrastim-cbqv)

Medical necessity criteria, dosing, coding, and authorization rules for Udenyca (pegfilgrastim‑cbqv) for EmblemHealth and ConnectiCare members; applies to clinicians requesting coverage for Udenyca.

Policy Summary

PayerEmblemHealth

PolicyColony Stimulating Factors: Udenyca (pegfilgrastim-cbqv)

Policy CodePolicy MG.MM.PH.126

Change TypeRevised clinical criteria and dosing clarifications

Effective Date

Next Review Date

Key ActionSubmit clinical evidence that the member meets criteria when requesting prior authorization; coverage provided for six months and may be renewed.

SourceLink

POLICY UPDATE CHANGES

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

Updated dosing chart (annual review).

Extended coverage duration from 4 to 6 months (prior revision).

6 monthsLength of authorization

6 mgStandard dose

12 units/14dMax units (non-acute rad)

>20% / 10–20% / <10%Prophylaxis thresholds

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Coverage and Medical Necessity Criteria

Initial Therapy / Prophylactic Use / Acute Radiation

Udenyca may be considered medically necessary when ONE of the following is met AND use is consistent with the medical necessity criteria that follow:

Initial Approval Conditions: 1) The patient is continuing previously established therapy with Udenyca for their current chemotherapy regimen.

Initial Approval Conditions: 2) Member lacks access to, or benefits for, home health services.

Initial Approval Conditions: 3) Member is expected to receive G-CSF for 5 consecutive days or more.

Initial Approval Conditions: 4) Udenyca is used in combination with a specified dose-dense chemotherapy regimen:

See chunk 5 for regimen specifics

Dose-dense regimens (children of previous node)

A. Bladder cancer: Dose dense MVAC (methotrexate, vinblastine, doxorubicin, cisplatin)
B. Breast cancer: Dose dense AC followed by T (doxorubicin, cyclophosphamide, paclitaxel)
C. Non-Hodgkin lymphoma: Dose dense CHOP-14 (cyclophosphamide, doxorubicin, vincristine, prednisone)

Prophylactic use in solid tumors/nonmyeloid malignancy: A) Patient undergoing myelosuppressive chemotherapy with expected incidence of febrile neutropenia >20%. OR B) Expected incidence 10–20% AND one or more patient-related risk factors. OR C) Expected incidence <10% AND two or more patient-related risk factors (use based on clinical judgment).See NCCN Hematopoietic Growth Factors guideline for regimen-specific percentages

Patient-related risk factors listed in chunk 7

Acute radiation exposure dosing: Acute radiation exposure indication with dosing of 6 mg subcutaneously weekly for 2 doses (use weight-based dosing for pediatric patients <45 kg).

See chunk 12 for dosing/administration

Renewal

Renewal Criteria

Renewal requests will be reviewed using the same criteria as initial prior authorization; continued coverage may be authorized for up to 6 months per prior authorization guidance.6 months authorization period

See prior authorization rules in chunk 5 and renewal statement in chunk 11

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

Use of Udenyca for any indication not specified in the initial prior authorization criteria is not medically necessary and may be denied.

Chemotherapy Regimens Requiring Support

Regimen	Cancer type / agents	Notes
Dose-dense MVAC	Bladder cancer — methotrexate, vinblastine, doxorubicin, cisplatin (MVAC)	Growth factor support required to maintain dose intensity; listed as an indication for Udenyca use
Dose-dense AC followed by T	Breast cancer — doxorubicin, cyclophosphamide followed by paclitaxel (AC → T)	Specified dose-dense breast regimen included in initial approval criteria for Udenyca
Dose-dense CHOP-14	Non-Hodgkin lymphoma — cyclophosphamide, doxorubicin, vincristine, prednisone given every 14 days (CHOP-14)	Dose-dense CHOP-14 explicitly listed as requiring growth factor support

Billing Codes and Diagnosis Mapping

Applicable CPT/HCPCS CodesHCPCS

Q5111

Injection, pegfilgrastim-cbqv, biosimilar (Udenyca), 0.5 mg; 1 billable unit = 0.5 mg

NDCsNDC

70114-0101-01

Udenyca 6 mg prefilled syringe

Applicable ICD-10 DiagnosesICD-10

D70.1	Agranulocytosis secondary to cancer chemotherapy
D70.9	Neutropenia, unspecified
T45.1X5A	Adverse effect of antineoplastic and immunosuppressive drugs, initial encounter
T45.1X5D	Adverse effect of antineoplastic and immunosuppressive drugs, subsequent encounter
T45.1X5S	Adverse effect of antineoplastic and immunosuppressive drugs, sequela
T66.XXXA	Radiation sickness, unspecified, initial encounter
Z41.8	Encounter for other procedures for purposes other than remedying health state
Z48.290	Encounter for aftercare following bone marrow transplant
Z51.11	Encounter for antineoplastic chemotherapy
Z51.12	Encounter for antineoplastic immunotherapy

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Expected febrile neutropenia incidence thresholds — prophylactic G‑CSF

High expected FN incidence>20% expected incidence of febrile neutropenia

Intermediate expected FN incidence10–20% expected incidence AND one or more patient-related risk factors

Low expected FN incidence with risk factors<10% expected incidence AND two or more patient-related risk factors (use based on clinical judgment)

Provider Requirements and Administrative Actions

Prior Authorization

Prior Authorization and Renewal

Prior authorization is required for Udenyca. Initial approvals are granted when the member meets the documented medical necessity criteria; renewal requests are reviewed against the same criteria. Coverage duration is 6 months per authorization; renewal requires submission of current clinical information demonstrating ongoing need.

Prior authorization required
Coverage duration: 6 months per authorization
Renewal uses same criteria as initial approval

Documentation Required

Clinical Documentation Requirement

The treating physician or primary care provider must submit clinical evidence that the member meets the policy criteria. This includes relevant medical records, chemotherapy regimen details, documentation of prior G-CSF use, and any other information necessary to demonstrate medical necessity.

Key Clinical Definitions

Febrile neutropenia definition

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

Neutropenia criterionAbsolute neutrophil count <500 neutrophils/mcL

Predicted decline criterionANC <1,000 neutrophils/mcL with predicted decline to ≤500 neutrophils/mcL within 48 hours

Line of Therapy Notes

any

Line of therapy: Covered when member is continuing previously established therapy with Udenyca for their current chemotherapy regimen.

Background and Clinical Context

Pegfilgrastim (a granulocyte‑colony stimulating factor, G‑CSF) is indicated to prevent febrile neutropenia in patients receiving myelosuppressive chemotherapy and to treat neutropenic complications; it is also indicated for acute radiation syndrome. Dose‑dense chemotherapy regimens frequently require growth factor support to maintain dose intensity and schedule, and clinical judgment is advised for use in palliative settings.

For prophylactic use in patients with solid tumors or non‑myeloid malignancies, pegfilgrastim is recommended when the expected incidence of febrile neutropenia is >20%, or when the expected incidence is 10–20% with one or more patient‑related risk factors, or <10% with two or more patient‑related risk factors. Patient risk factors include age >65 years, prior chemotherapy or radiation, preexisting neutropenia, bone marrow involvement by tumor, poor performance status, and certain comorbidities.

For the acute radiation indication, the typical regimen is 6 mg subcutaneously once weekly for 2 doses (weight‑based dosing applies for pediatric patients <45 kg).