CurrentViva HealthPolicy IC-0234

Long-Acting Granulocyte Colony Stimulating Factors (LA-GCSF)

Policy governing prior authorization, coverage criteria, dosing, and billing for long-acting pegfilgrastim and related G-CSF products for Viva Health members, including prophylaxis, radiation exposure, transplant-related uses, and pediatric dosing where specified.

Policy Summary

PayerViva Health

PolicyLong-Acting Granulocyte Colony Stimulating Factors (LA-GCSF)

Policy CodePolicy IC-0234

Change TypeNo material change

Effective Date

Next Review DateMay 5, 2026

Key ActionObtain prior authorization (initial authorizations typically valid for 120 days) and document contraindication, intolerance, or failure to specified prior agents when required.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

multiplelisted LA-GCSF agents covered

120 daysinitial PA validity

Extensivecovered diagnosis codes

6;13.2;20 mgtypical product strengths

Coverage Criteria and Medical Necessity

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Initial Therapy / Indications

Covered when ALL of the following are met

Prerequisite and age: Member must have contraindication, intolerance, or failure to Fulphila AND Udenyca prior to consideration of Fylnetra, Neulasta, Nyvepria, Stimufend/Pegfilgrastim-fpgk, OR Ziextenzo; OR member must have contraindication, intolerance, or failure to Rolvedon prior to consideration of Ryzneuta; AND for Rolvedon and Ryzneuta member must be at least 18 years of age.

Indications: One of the following indications must apply: prophylactic use with myelosuppressive chemotherapy based on febrile neutropenia risk thresholds (>20% OR 10–20% with ≥1 risk factor OR <10% with ≥2 risk factors), neutropenic complication from a prior chemotherapy cycle, acute exposure to myelosuppressive radiation (H-ARS), bone marrow transplantation (BMT) failure or engraftment delay (Note: NOT applicable to Rolvedon or Ryzneuta where specified), peripheral blood progenitor cell (PBPC) mobilization and transplant (Note: NOT applicable to Rolvedon or Ryzneuta where specified), Wilms tumor with favorable histology in combination with a cyclophosphamide-based regimen (Note: NOT applicable to Rolvedon or Ryzneuta where specified), or pediatric aggressive mature B-cell lymphomas (Note: NOT applicable to Rolvedon or Ryzneuta where specified).

Dosing and timing: Dosing must follow product-specific dosing: typical pegfilgrastim products (Armlupeg, Fulphila, Fylnetra, Neulasta, Nyvepria, Stimufend, Udenyca, Ziextenzo) 6 mg subcutaneously once per chemotherapy cycle (no more frequently than every 14 days) with pediatric weight-based dosing for <45 kg as specified; Rolvedon 13.2 mg SC once per cycle ~24 hours after chemotherapy; Ryzneuta 20 mg SC once per cycle at least 24 hours after chemotherapy; for acute radiation exposure give two weekly doses per product-specific guidance; do not administer within 14 days before or within 24 hours after cytotoxic chemotherapy.

Product-specific authorization limits: Initial authorization is usually provided for 120 days; single-dose authorizations apply for BMT failure or PBPC mobilization/transplant for many products; two-dose limits for acute radiation exposure for many products; Rolvedon and Ryzneuta have specific non-renewal or dose-limited rules as described in product-specific sections.

Covered indications (diagnosis-based)

Covered when diagnosis is one of the listed ICD-10 codes and medical necessity criteria are met (see Medical Necessity Criteria pages referenced).

Covered diagnosis: Patient has one of the ICD-10 diagnoses listed in Appendix 1 (examples include antineoplastic chemotherapy induced pancytopenia D61.810, agranulocytosis secondary to cancer chemotherapy D70.1, neutropenia D70.9, various malignant neoplasms and lymphomas, radiation sickness and exposure codes, bone marrow transplant status and encounters for chemotherapy).

Full ICD-10 list provided in Appendix 1 of the policy (see pages referenced).

When the policy identifies uses such as bone marrow transplant (BMT) failure/engraftment delay, peripheral blood progenitor cell (PBPC) mobilization and transplant, or specific pediatric/transplant-related indications, those indications are explicitly not applicable to Rolvedon or Ryzneuta where stated. For example, dosing and single‑dose authorizations for BMT failure or PBPC mobilization are described for multiple pegfilgrastim products as 12 billable units x 1 dose, whereas Rolvedon and Ryzneuta have separate billable‑unit assignments and product‑specific indications and limits (see product dosing and unit tables).

Regimen / context	Policy guidance
Dose-dense chemotherapy (general)
Dose-dense chemotherapy requires growth factor support to maintain dose intensity and schedule; in the palliative setting consider dose reduction or a change in regimen.

Product / class	Trial / contextual reference
Pegfilgrastim and biosimilars (Neulasta, Fulphila, Udenyca, Ziextenzo, Nyvepria, Stimufend, Fylnetra, Armlupeg)
Supported by randomized phase II/III trials and referenced compendia (NCCN Drugs & Biologics Compendium) demonstrating efficacy for prophylaxis of chemotherapy-induced neutropenia and febrile neutropenia.
Eflapegrastim (Rolvedon) and efbemalenograstim (Ryzneuta)
Supported by Phase III trials and NCCN compendium entries comparing long-acting G-CSFs and demonstrating effectiveness for prevention of chemotherapy-induced neutropenia; specific phase III trials and integrated analyses cited.

Billing Codes, Diagnosis Codes, and Units

HCPCS Codes listedHCPCS

J2506	Injection, pegfilgrastim, excludes biosimilar, 0.5 mg; 1 billable unit = 0.5 mg (Neulasta only)
Q5108	Injection, pegfilgrastim-jmdb, biosimilar, (Fulphila), 0.5 mg; 1 billable unit = 0.5 mg
Q5111	Injection, pegfilgrastim-cbqv, biosimilar, (Udenyca), 0.5 mg; 1 billable unit = 0.5 mg
Q5120	Injection, pegfilgrastim-bmez, biosimilar, (Ziextenzo), 0.5 mg; 1 billable unit = 0.5 mg
Q5122	Injection, pegfilgrastim-apgf, biosimilar, (Nyvepria), 0.5 mg; 1 billable unit = 0.5 mg
Q5127	Injection, pegfilgrastim-fpgk, biosimilar, (Stimufend), 0.5 mg; 1 billable unit = 0.5 mg (Includes unbranded biologic §)
Q5130	Injection, pegfilgrastim-pbbk, biosimilar, (Fylnetra), 0.5 mg; 1 billable unit = 0.5 mg
Q5169	Injection, pegfilgrastim-unne (Armlupeg), biosimilar, 0.5 mg; 1 billable unit = 0.5 mg (Effective 07/01/2026)
J3590	Unclassified biologics (Armlupeg ONLY) (Discontinue use on 07/01/2026)
J1449	Injection, eflapegrastim-xnst, 0.1 mg; 1 billable unit = 0.1 mg (Rolvedon only)

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NDCs listedNDC

55513-0190-xx	Neulasta 6 mg single-dose prefilled syringe: 55513-0190-xx
55513-0192-xx	Neulasta 6 mg single-dose prefilled syringe Onpro Kit: 55513-0192-xx
55513-0099-xx	Neulasta 4 mg/0.4 mL single-dose vial: 55513-0099-xx
83257-0005-xx	Fulphila 6 mg single-dose prefilled syringe: 83257-0005-xx
67457-0833-xx	Fulphila 6 mg single-dose prefilled syringe: 67457-0833-xx
70114-0101-xx	Udenyca 6 mg single-dose prefilled syringe: 70114-0101-xx
69448-0025-xx	Udenyca 6mg single-dose prefilled syringe: 69448-0025-xx
70114-0120-xx	Udenyca 6 mg single-dose prefilled autoinjector: 70114-0120-xx
69448-0026-xx	Udenyca 6 mg single-dose prefilled autoinjector: 69448-0026-xx
70114-0130-xx	Udenyca 6 mg single-dose prefilled syringe ONBODY kit: 70114-0130-xx

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Covered ICD-10 Diagnosis Codes (sample start)ICD-10Covered

C64.1

Malignant neoplasm of right kidney, except renal pelvis

Covered ICD-10 Diagnosis Codes (selected list)ICD-10Covered

C64.2	Malignant neoplasm of left kidney, except renal pelvis
C64.9	Malignant neoplasm of unspecified kidney, except renal pelvis
C65.1	Malignant neoplasm of right renal pelvis
C83.30	Diffuse large B-cell lymphoma unspecified site
C83.31	Diffuse large B-cell lymphoma, lymph nodes of head, face, and neck
C83.32	Diffuse large B-cell lymphoma intrathoracic lymph nodes
C83.33	Diffuse large B-cell lymphoma intra-abdominal lymph nodes
C83.34	Diffuse large B-cell lymphoma lymph nodes of axilla and upper limb
C83.35	Diffuse large B-cell lymphoma, lymph nodes of inguinal region and lower limb
C83.36	Diffuse large B-cell lymphoma intrapelvic lymph nodes

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Additional Covered ICD-10 Codes for Rolvedon & RyzneutaICD-10Covered

D61.811	Other drug-induced pancytopenia
D61.818	Other pancytopenia

CMS Local Coverage Articles referencedmixed

A54682	Palmetto GBA Local Coverage Article: Neulasta Onpro Kit / UDENYCA On-body Injector (billing/coding)
A56748	Palmetto GBA Local Coverage Article: White Cell Colony Stimulating Factors (billing/coding)

Billable units for pegfilgrastim products (per-dose conversions)

Pegfilgrastim standard dosing (6 mg)12 billable units = per 6 mg dose (1 billable unit = 0.5 mg)

Rolvedon (13.2 mg)132 billable units = per 13.2 mg dose

Ryzneuta (20 mg)40 billable units = per 20 mg dose

Acute radiation exposure dosing (multiple products)Armlupeg, Fulphila, Fylnetra, Neulasta, Nyvepria, Stimufend, Udenyca, Ziextenzo: 12 billable units weekly × 2 doses

BMT failure / PBPC mobilization dosing (multiple products)Armlupeg, Fulphila, Fylnetra, Neulasta, Nyvepria, Stimufend, Udenyca, Ziextenzo: 12 billable units × 1 dose

None specified

None specifiedNo additional coding thresholds or unit conversions specified in this policy beyond those listed for pegfilgrastim and specified products.

Prior Authorization, Documentation, and Step Therapy

Prior Authorization

Prior Authorization Required

Prior authorization is required. Initial authorizations are typically valid for 120 days (4 months) unless a product-specific exception applies. Exceptions include single-dose validity for BMT failure/engraftment delay and PBPC mobilization/transplant, and up to 2 doses for acute H-ARS exposures. Renewals are generally available every 120 days unless otherwise specified.

Initial PA validity: 120 days (4 months) for most products
BMT failure/engraftment delay: PA valid for 1 dose only (no renewal)
PBPC mobilization/transplant: PA valid for 1 dose only (no renewal)
Acute H-ARS (radiation): PA valid for 2 doses only; renewals may be restricted depending on product

Note

PA Considered Due to Cost

Prior authorization may be applied as a utilization management tool and was specifically considered because of the cost of the drugs per the NQTL checklist.

NQTL checklist: 'Cost of drug' identified as a factor supporting PA

Step Therapy

Step Therapy / Prerequisite Agents

Step therapy / prerequisite agent requirements must be documented. Before Fylnetra, Neulasta, Nyvepria, Stimufend/Pegfilgrastim-fpgk, or Ziextenzo are considered, the patient must have a contraindication, intolerance, or documented failure to Fulphila and Udenyca. Before Ryzneuta is considered, the patient must have a contraindication, intolerance, or documented failure to Rolvedon. Age requirement: member must be ≥18 years for Rolvedon and Ryzneuta.

Prerequisite for Fylnetra, Neulasta, Nyvepria, Stimufend/Pegfilgrastim-fpgk, Ziextenzo: contraindication, intolerance, or failure to BOTH Fulphila and Udenyca
Prerequisite for Ryzneuta: contraindication, intolerance, or failure to Rolvedon
Age requirement: ≥18 years for Rolvedon and Ryzneuta

Step Therapy

Step Therapy Not Specified

No additional step therapy beyond the specified prerequisite agents is stated in the policy.

Policy does not specify other step therapy sequences or alternate step requirements

Documentation Required

Required Documentation and Renewal Criteria

Required documentation must demonstrate the contraindication, intolerance, or treatment failure to the specified prior agents. For renewals, documentation must also show continued meeting of indication-specific criteria, authorization duration not exceeded, and absence of unacceptable toxicity.

Documentation of contraindication, intolerance, or failure to prerequisite agents (as applicable)
For renewal: evidence member continues to meet indication-specific criteria (excluding prerequisite therapy), authorization duration not exceeded, and no unacceptable toxicity
Examples of unacceptable toxicity: splenic rupture, ARDS, anaphylaxis/serious allergic reactions, sickle cell crisis, glomerulonephritis, leukocytosis, thrombocytopenia, capillary leak syndrome, aortitis, myelodysplastic syndrome, AML where applicable

Background and Scope

Long‑acting granulocyte colony‑stimulating factor (LA‑GCSF) agents are used primarily to prevent chemotherapy‑induced neutropenia and febrile neutropenia in patients receiving myelosuppressive cytotoxic chemotherapy, and for other supportive indications such as mobilization/transplant and hematopoietic acute radiation syndrome where product labeling supports use. Dosing and frequency are product specific (for example, standard pegfilgrastim products are dosed as 6 mg once per chemotherapy cycle, Rolvedon is 13.2 mg SC once per cycle (~24 hours after chemo), and Ryzneuta is 20 mg SC once per cycle (at least 24 hours after chemo)), and some agents have defined single‑dose or 2‑dose limits for transplant‑ or radiation‑related uses.

Key Definitions

Febrile neutropenia definition

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

Absolute neutrophil count (ANC)ANC <500 neutrophils/mcL

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

Member-related risk factors for febrile neutropenia

Advanced ageAge >65 years receiving full-dose intensity chemotherapy

Prior therapy exposurePrior exposure to chemotherapy or radiation therapy

Persistent cytopenia or marrow involvementPersistent neutropenia or bone marrow involvement by tumor

Comorbid conditionsHIV infection, recent surgery/open wounds, poor performance status

Organ dysfunctionRenal dysfunction (CrCl <50 mL/min) or liver dysfunction (bilirubin >2.0 mg/dL)

Chronic immunosuppressionChronic immunosuppression in the post-transplant setting, including organ transplant

Unbranded biologic

Unbranded biologic definitionAn unbranded biologic is the same as the brand biologic and uses the same cell-line as the brandname reference biologic.

Regimens and Indications Supported

Regimen / intent	Policy guidance
Dose-dense chemotherapy (to maintain schedule and dose intensity)
Growth factor support is required to maintain schedule and dose intensity for dose-dense regimens; in palliative care consider dose reduction or regimen change rather than maintaining dose-dense scheduling.

Agent	Policy role / indication
Pegfilgrastim (Neulasta) and approved biosimilars (Fulphila, Udenyca, Ziextenzo, Nyvepria, Stimufend, Fylnetra, Armlupeg)
Used as supportive prophylaxis to prevent chemotherapy-induced neutropenia and febrile neutropenia; efficacy supported by randomized phase II/III trials and NCCN compendium guidance.
Eflapegrastim (Rolvedon)
Long-acting G-CSF indicated for prophylaxis of chemotherapy-induced neutropenia; supported by phase III trial data and compendia references.
Efbemalenograstim (Ryzneuta)
Long-acting G-CSF indicated for prophylaxis of chemotherapy-induced neutropenia; supported by phase III trial data and NCCN compendium entries.

Revision History

05/05/2026Last reviewLatest

Policy last reviewed (document-level last review date updated).

11/2025Revision

Document reviewed/edited (dates reviewed list includes 11/2025).

05/2025Revision

Document reviewed/edited (dates reviewed list includes 05/2025).

04/2024Revision

Document reviewed/edited (dates reviewed list includes 04/2024).

02/2024Revision

Document reviewed/edited (dates reviewed list includes 02/2024).

10/17/2008Origin

Policy original date of origin recorded.