CurrentHighmark Blueshield NenyPolicy N/A

Outpatient Medical Injectable Granulocyte Colony-Stimulating Factors (pegfilgrastim, eflapegrastim) Coverage Criteria

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Defines outpatient medical benefit authorization and coverage considerations for pegfilgrastim and eflapegrastim products (including biosimilars and brand variants) for prevention of chemotherapy-induced febrile neutropenia and related indications for Highmark members.

Policy Summary

PayerHighmark Blueshield Neny

PolicyOutpatient Medical Injectable G-CSF coverage criteria

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Next Review DateN/A

Key ActionSubmit prior authorization via fax to 833-581-1861 including diagnosis, chemo regimen, FN risk level, and supporting clinical documentation.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

8non-preferred products listed

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CurrentHighmark Blueshield NenyPolicy N/A

Outpatient Medical Injectable Granulocyte Colony-Stimulating Factors (pegfilgrastim, eflapegrastim) Coverage Criteria

Customize your policy alerts

Sign up for all Highmark Blueshield Neny policy alerts

Know when Highmark Blueshield Neny releases new policies or updates existing guidance.

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Policy Summary

PayerHighmark Blueshield Neny

PolicyOutpatient Medical Injectable G-CSF coverage criteria

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Next Review DateN/A

Key ActionSubmit prior authorization via fax to 833-581-1861 including diagnosis, chemo regimen, FN risk level, and supporting clinical documentation.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

8non-preferred products listed

Coverage Criteria

Initial authorization criteria

Covered when clinically indicated for prevention of chemotherapy-induced febrile neutropenia with documentation of:

Core documentation and indication: Member's cancer diagnosis and staging; complete chemotherapy regimen; intended use (prevention of chemotherapy-induced febrile neutropenia) and requested start date with ICD-10 diagnosis code(s)

Providers must attach pertinent clinical information

Risk factors warranting prophylaxis: Member classified as intermediate or high risk for febrile neutropenia OR presence of specific risk factors

Examples include persistent neutropenia (ANC of 1500/mm3 or less), history of febrile neutropenia, prior exposure to chemotherapy or radiation, bone marrow involvement by tumor, recent surgery/open wounds, liver or renal dysfunction, age >65 receiving full chemo dose intensity, or comorbidities that increase risk of serious infection

Non-preferred product use: Use of a non-preferred product may be authorized only when there is documented therapy failure after an adequate therapeutic trial of a preferred product, or when the preferred product is not tolerated or is contraindicated

Medicare members currently established on a non-preferred therapy are not required to try a preferred option

The form does not list any explicit exclusions. It is structured to request clinical details to determine medical necessity for outpatient injectable granulocyte colony-stimulating factors (pegfilgrastim and eflapegrastim) and instead defines documentation and risk-based criteria required for coverage rather than listing excluded indications.

Requests for a non-preferred product are permitted only when there is documentation of one of the following: therapy failure after an adequate trial of a preferred product, intolerance to the preferred product, or a contraindication to the preferred product. The form specifically notes that Medicare members who are already established on a non-preferred therapy are not required to try a preferred option prior to continuation of their existing therapy.

Initial Therapy Criteria

Initial authorization requirements

Authorization for initial use requires documentation of clinical indication and febrile neutropenia (FN) risk.

Initial authorization data: Provide cancer diagnosis and staging, complete chemotherapy regimen, assessment of FN risk (low/intermediate/high), requested start date, and ICD-10 diagnosis code(s)

Attach all pertinent clinical information

FN risk documentation: Document classification of the member's FN risk as low, intermediate, or high with supporting details

Form lists risk factors to support classification (see examples)

Supporting risk factors (one or more may apply): Persistent neutropenia (ANC of 1500/mm3 or less); history of febrile neutropenia; prior exposure to chemotherapy or radiation; bone marrow involvement by tumor; recent surgery and/or open wounds; liver or renal dysfunction; age >65 years receiving full chemo dose intensity; comorbidities that increase risk of serious infection

Continuation and Established Therapy

Established therapy exception

Considerations for members already established on therapy:

Existing therapy exception: Medicare members currently established on a non-preferred therapy are not required to try a preferred option

Explicitly noted on the form

Provider Actions and Requirements

Prior Authorization

Prior Authorization Required

Prior authorization for outpatient medical benefit injectable G-CSF agents must be submitted via fax to 833-581-1861. Include the servicing facility/vendor name, NPI, address, ICD-10 diagnosis code(s), and the requested start date of service.

Fax: 833-581-1861
Include: Servicing facility/vendor name, NPI, address
Include: ICD-10 diagnosis code(s)
Include: Requested start date of service

Denial Risk

Preferred-Product Trial Requirement / Denial Risk

Non-preferred products will be considered only after documentation of therapy failure of a preferred product, documented intolerance, or a contraindication to a preferred product. Medicare members already established on a non-preferred therapy are not required to try a preferred option.

Coding and Clinical Thresholds

Non-preferred and listed product HCPCS/J-codesHCPCS

Q5111	Udenyca
Q5127	Stimufend
Q5122	Nyvepria
Q5130	Fylnetra
J2506	Neulasta
J1449	Rolvedon
Q5108	Fulphila
Q5120	Ziextenzo

Absolute neutrophil count (ANC) threshold

ANC thresholdANC of 1500/mm3 or less

Related findingPersistent neutropenia is listed as a risk factor for febrile neutropenia on the form

Use contextApplied when assessing need for prophylactic G-CSF to prevent chemotherapy-induced febrile neutropenia

Site of Care

Note

Form is for outpatient medical benefit administration

This form is for outpatient medical benefit administration of injectable G‑CSFs and applies to administration settings such as office, infusion center, or hospital outpatient.

Use this form for medical-benefit (outpatient) G‑CSF administrations only

Biosimilar and Product Preference

Billing Rule

Neulasta (J2506) designated non-preferred — preferred-try requirement applies

Neulasta (J2506) is listed among non-preferred products; non-preferred products require documented failure of, intolerance to, or contraindication to a preferred product before they will be considered.

J2506 (Neulasta) appears on the non-preferred product list and is subject to the preferred-try requirement

Definitions

Febrile neutropenia (FN) risk categories and factors

Risk categories requested on formProviders must classify member FN risk as low, intermediate, or high

Example risk factor — persistent neutropeniaANC of 1500/mm3 or less

Other listed risk factorsHistory of febrile neutropenia; prior exposure to chemotherapy or radiation; bone marrow involvement by tumor

Additional clinical contributorsRecent surgery/open wounds; liver or renal dysfunction; age >65 receiving full chemo dose intensity; comorbidities increasing infection risk

Step Therapy / Product Sequencing

Step	Preferred products (must try first)	Non-preferred products (consider only after documented failure/intolerance/contraindication)
1	Preferred product(s) as indicated on the plan's preferred list (documented adequate therapeutic trial required before non-preferred will be considered)	Udenyca (Q5111); Stimufend (Q5127); Nyvepria (Q5122); Fylnetra (Q5130); Neulasta (J2506); Rolvedon (J1449); Ryzneuta; Fulphila (Q5108); Ziextenzo (Q5120). A non-preferred product will be considered only when the member has documented therapy failure after an adequate therapeutic trial of a preferred product, or the preferred product is not tolerated or is contraindicated. Medicare members currently established on a non-preferred therapy are not required to try a preferred option.

Background

Granulocyte colony-stimulating factors (G-CSFs) such as pegfilgrastim and eflapegrastim are used to prevent chemotherapy-induced febrile neutropenia in patients receiving myelosuppressive chemotherapy. The form requests classification of the patient’s febrile neutropenia risk as low, intermediate, or high and lists patient-specific risk factors that inform the need for prophylaxis, including persistent neutropenia (ANC of 1500/mm3 or less), history of febrile neutropenia, prior chemo or radiation exposure, bone marrow involvement by tumor, recent surgery/open wounds, liver or renal dysfunction, age >65 receiving full-dose chemotherapy, and comorbidities that increase infection risk. Providers are instructed to attach all pertinent clinical information to support the requested prophylactic use.