CurrentViva HealthPolicy IC-0234

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

Defines prior authorization, initial and renewal criteria, dosing, indications, billing units, HCPCS and NDC codes, covered ICD-10 diagnoses, and utilization limits for multiple pegfilgrastim and related LA-GCSF products for Viva Health (Document IC-0234). Applies to listed branded and biosimilar pegfilgrastim products, eflapegrastim (Rolvedon) and efbemalenograstim (Ryzneuta).

Policy Summary

PayerViva Health

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

Policy CodePolicy IC-0234

Change TypeNo material change

Effective Date

Next Review Date

Key ActionPrior authorization is required; initial PA generally valid for 4 months (120 days) with specified exceptions for BMT failure/PBPC mobilization and H-ARS and renewal rules.

POLICY UPDATE CHANGES

No material changes — has_material_change=false

Multiple (>=11)Listed LA-GCSF Products

4 monthsTypical PA validity

2Acute radiation doses allowed

12/132/40Representative billable units

Coverage Summary

This policy covers long-acting granulocyte colony stimulating factors (LA-GCSFs) including pegfilgrastim products and biosimilars (Neulasta, Fulphila, Udenyca, Fylnetra, Nyvepria, Stimufend/Pegfilgrastim-fpgk, Ziextenzo, Armlupeg), plus eflapegrastim (Rolvedon) and efbemalenograstim (Ryzneuta). It addresses use for prophylaxis of chemotherapy-induced neutropenia, treatment of neutropenic complications, peripheral blood progenitor cell (PBPC) mobilization, bone marrow transplant (BMT) engraftment failure/delay, and hematopoietic acute radiation syndrome (H-ARS). Coverage is covered with criteria requiring prior authorization per the stated clinical and product-specific requirements.

General initial PA validity4 months (120 days) for most products

BMT failure / PBPC mobilization / Wilms TumorPA valid for 1 dose only (no renewal)

Acute radiation exposure (H-ARS)PA valid for 2 doses only (renewal not allowed for Rolvedon/Ryzneuta)

Age restriction for Rolvedon and RyzneutaMember must be ≥18 years of age

Febrile neutropenia — temperature thresholdSingle temp ≥38.3°C orally or ≥38.0°C over 1 hour

Febrile neutropenia — neutrophil threshold<500 neutrophils/mcL OR <1,000 neutrophils/mcL with predicted decline to ≤500 within 48 hours

Medical-Necessity Criteria

General Initial Authorization Criteria

Prior authorization validity is provided when ALL of the following are met:

ALL of the following

Patient must have a contraindication, intolerance, or failure to Fulphila AND Udenyca prior to consideration of Fylnetra, Neulasta, Nyvepria, Stimufend/Pegfilgrastim-fpgk, OR Ziextenzo; OR patient must have a contraindication, intolerance, or failure to Rolvedon prior to consideration of Ryzneuta.
Member is at least 18 years of age (Rolvedon and Ryzneuta ONLY).

Prophylactic use for members with solid tumors or non-myeloid malignancy

Covered when ANY of the following are met:

ANY of the following

Member is undergoing myelosuppressive chemotherapy with an expected incidence of febrile neutropenia of > 20%.
10-20% incidence plus risk factor
- Member is undergoing myelosuppressive chemotherapy with an expected incidence of febrile neutropenia of 10% to 20%.
- Member has one or more member-related risk factors for febrile neutropenia.
<10% incidence plus 2 risk factors
- Member is undergoing myelosuppressive chemotherapy with an expected incidence of febrile neutropenia of <10%.
- Member has two or more member-related risk factors for febrile neutropenia.
Members who experience a neutropenic complication from a prior cycle of the same chemotherapy.

Other Covered Indications

Covered when ALL of the following apply (indication-specific as listed):

ANY of the following

Members acutely exposed to myelosuppressive doses of radiation (Hematopoietic Acute Radiation Syndrome [H-ARS]).
Bone marrow transplantation (BMT) failure or engraftment delay (NOT applicable to Rolvedon or Ryzneuta).
Peripheral blood progenitor cell (PBPC) mobilization and transplant (NOT applicable to Rolvedon or Ryzneuta).
Wilms Tumor (Nephroblastoma)
- Member has favorable histology disease.

Member-Related Risk Factors for Febrile Neutropenia

Risk factors (counted as 1 each) used to meet criteria above:

ANY of the following

Age >65 years receiving full dose intensity chemotherapy
Prior exposure to chemotherapy or radiation therapy
Persistent neutropenia
Bone marrow involvement by tumor
Human immunodeficiency virus (HIV) infection

Definition of Febrile Neutropenia

Both criteria below must be met:

ALL of the following

Temperature: a single temperature ≥38.3 °C orally or ≥38.0 °C over 1 hour
Neutropenia: <500 neutrophils/mcL OR <1,000 neutrophils/mcL and a predicted decline to ≤500 neutrophils/mcL over the next 48 hours

Renewal Criteria

Prior authorization may be renewed when ALL of the following are met:

ALL of the following

Member continues to meet indication-specific relevant criteria identified in section III.
Duration of authorization has not been exceeded (refer to Section I limits).
Absence of unacceptable toxicity from the drug (examples: splenic rupture, ARDS, serious allergic reactions/anaphylaxis, sickle cell crisis, glomerulonephritis, leukocytosis, thrombocytopenia, capillary leak syndrome, potential tumor growth stimulation, aortitis, myelodysplastic syndrome and acute myeloid leukemia in members with breast and lung cancer, etc.).

Coding (HCPCS, NDC, ICD-10, Medicare references)

HCPCS Codes (Products)HCPCSCovered

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)

1–10 of 11

1/2

NDC Codes (Products)NDCCovered

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

1–10 of 19

1/2

Covered ICD-10 Diagnosis Codes (Appendix 1)ICD-10Covered

C64.1	Malignant neoplasm of right kidney, except renal pelvis
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
C65.2	Malignant neoplasm of left renal pelvis
C65.9	Malignant neoplasm of unspecified 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

1–10 of 60

1/6

Medicare Part B / CMS Referencesmixed

A56748	Palmetto GBA Local Coverage Article: Billing and Coding: White Cell Colony Stimulating Factors
A54682	Palmetto GBA Local Coverage Article: Billing and Coding: Neulasta Onpro Kit / UDENYCA ONBODY

Provider Actions and Billing Guidance

Prior Authorization

Prior authorization required and validity periods

Prior authorization is required. Initial PA is generally valid for 4 months (120 days). Exceptions: for BMT failure/engraftment delay and PBPC mobilization/transplant the PA is valid for 1 dose only; for acute radiation exposure (H-ARS) the PA is valid for 2 doses. Renewals may be requested every 4 months unless the indication specifically disallows renewal (BMT failure, PBPC mobilization/transplant, H-ARS).

General PA validity: 4 months (120 days).
BMT failure / PBPC mobilization/transplant: PA valid for 1 dose only.
H-ARS (acute radiation exposure): PA valid for 2 doses.
Renewal cadence: may be renewed every 4 months unless indication disallows renewal (BMT failure, PBPC mobilization/transplant, H-ARS).

Documentation Required

Prerequisite therapy requirement for certain biosimilars

Certain biosimilars have prerequisite therapy requirements. For consideration of Fylnetra, Neulasta, Nyvepria, Stimufend/Pegfilgrastim-fpgk, or Ziextenzo the member must have a contraindication, intolerance, or documented failure to both Fulphila AND Udenyca prior to approval. For Ryzneuta the member must have a contraindication, intolerance, or failure to Rolvedon.

Billing Rule

Dose/unit billing rules and max units per time

Billable units vary by product and indication. Most pegfilgrastim products use 0.5 mg HCPCS units (12 units = 6 mg dose) with different allowed frequencies depending on indication; Rolvedon uses 0.1 mg HCPCS units (132 units = 13.2 mg) and Ryzneuta uses 0.5 mg units with a different total unit count (40 units = 20 mg).

Representative unit rules: 12 units = 6 mg for most pegfilgrastim products (Armlupeg/Fulphila/Fylnetra/Neulasta/Nyvepria/Stimufend/Udenyca/Ziextenzo).
Rolvedon: 132 units = 13.2 mg (1 unit = 0.1 mg).
Ryzneuta: 40 units = 20 mg.
Typical dosing intervals: acute radiation exposure — weekly x2 doses; BMT failure/PBPC mobilization — single dose; other indications — one dose per chemotherapy cycle dosed no more frequently than every 14 days (or per product-specific guidance).

Billing Rule

On-body injector handling

On‑body injector devices for Neulasta and Udenyca must be filled by a healthcare provider using the prefilled syringe and then applied to the member's skin (abdomen or back of arm). On‑body injectors may be applied the same day as chemotherapy only if the dose is administered no less than 24 hours after chemotherapy. On‑body injectors are not recommended for acute radiation exposure or pediatric members.

Affected HCPCS codes: J2506 and Q5111.

Documentation Required

Dosing timing restriction

Do not administer these long‑acting G‑CSFs within 14 days before cytotoxic chemotherapy and do not administer within 24 hours after chemotherapy; dosing should occur approximately 24 hours after cytotoxic chemotherapy per product guidance.

Denial Risk

Renewal denial conditions

Renewal requests may be denied if the duration of prior authorization has been exceeded, the member no longer meets the indication‑specific criteria, or there is unacceptable toxicity from the drug. Examples of unacceptable toxicities include splenic rupture, ARDS, serious allergic reactions/anaphylaxis, sickle cell crisis, glomerulonephritis, leukocytosis, thrombocytopenia, capillary leak syndrome, potential tumor growth stimulation, aortitis, and development of myelodysplastic syndrome or acute myeloid leukemia in certain cancers.

Background and Definitions

The scope includes branded and biosimilar pegfilgrastim products and related long-acting G-CSFs (listed in the document) for the clinical use cases of febrile neutropenia prophylaxis, treatment of neutropenic complications, PBPC mobilization/transplant, BMT failure/engraftment delay, and H-ARS. Product-specific PA validity and renewal rules vary by product and indication: most pegfilgrastim products have an initial prior authorization validity of 4 months (120 days) with exceptions for BMT failure and PBPC mobilization (PA valid for 1 dose only) and H-ARS (PA valid for 2 doses only). Rolvedon and Ryzneuta follow similar PA timing with H-ARS limited to 2 doses and specific renewal restrictions.

Primary evidence and references include the NCCN Drugs & Biologics Compendia for pegfilgrastim, eflapegrastim, and efbemalenograstim, multiple product package inserts (Neulasta, Fulphila, Udenyca, Ziextenzo, Nyvepria, Fylnetra, Stimufend, Rolvedon, Ryzneuta), and peer-reviewed randomized and phase III trials evaluating pegfilgrastim and the long-acting G-CSFs for prevention of chemotherapy-induced febrile neutropenia and related indications.

Febrile neutropenia: Temperature — a single temperature ≥38.3°C orally or ≥38.0°C over 1 hour; Neutropenia — <500 neutrophils/mcL OR <1,000 neutrophils/mcL with predicted decline to ≤500 within 48 hours.

H-ARS: Hematopoietic Acute Radiation Syndrome defined as acute exposure to myelosuppressive doses of radiation.

Unbranded biologic: defined as the same as the brand biologic and uses the same cell-line as the brand-name reference biologic.

OpenPayer

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

Coverage Summary

Medical-Necessity Criteria

Coding (HCPCS, NDC, ICD-10, Medicare references)

Provider Actions and Billing Guidance

Background and Definitions

Medicare Determinations

Revision History

Effective Date	Name	Number	Type
2025-10-01	Billing and Coding: White Cell Colony Stimulating Factors	A56748	LCA
2024-01-01	Billing and Coding: Neulasta Onpro Kit / UDENYCA ONBODY	A54682	LCA