CurrentViva HealthPolicy IC-0234

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

Policy governing prior authorization, indications, dosing, renewal criteria, billing units, HCPCS and NDC codes for long-acting G-CSF products (pegfilgrastim and long-acting GCSF analogs) including biosimilars and specified branded products for medical benefit use.

Policy Summary

PayerViva Health

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

Policy CodePolicy IC-0234

Change TypeNo material change

Effective DateOct 17, 2008

Next Review DateN/A

Key ActionObtain prior authorization with documentation of febrile neutropenia risk, prior therapy failures/intolerances, and follow specified initial/renewal validity and billing unit limits.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes.

MultipleCovered Products

PA requiredUtilization Management

Rolvedon/Ryzneuta age ≥18Adult-only requirement

Unit limitsBilling Limits

Coverage Summary

Trek Health ingests and normalizes Transparency in Coverage data and payer policy updates to give provider organizations a clear view of how commercial reimbursement behaves across markets, payers, and services. Our platform transforms raw payer disclosures into structured intelligence that supports contract evaluation, payer negotiations, and service line strategy. By combining market benchmarks with ongoing policy visibility, Trek helps teams identify variability, risk, and opportunity in commercial reimbursement. The result is faster insight, stronger negotiating positions, and more informed financial decisions.

Policy governs long-acting granulocyte colony stimulating factors (LA-GCSF) — pegfilgrastim and long-acting G-CSF analogs — for medical benefit use, including branded and biosimilar products such as Fulphila®, Fylnetra®, Neulasta®, Nyvepria™, Pegfilgrastim-fpgk (Stimufend®/unbranded), Rolvedon®, Ryzneuta®, Udenyca®, and Ziextenzo®. (Product list and document ID IC-0234).

Utilization management: prior authorization is required for these LA-GCSF products. Initial prior authorization validity is generally 4 months for most products; specific indications have shorter, single- or two-dose validity (e.g., BMT failure/engraftment delay and PBPC mobilization/transplant: 1 dose; H-ARS: 2 doses for most products; Rolvedon H-ARS: 2 doses; see product-specific exceptions). Renewals may be provided every 4 months when renewal criteria are met, except where renewal is prohibited for listed indications.

Age limits and product sequencing: Rolvedon and Ryzneuta have an adult-only requirement (≥18 years). Prior authorization requires prerequisite therapy sequencing for certain products: patients must have a documented contraindication, intolerance, or failure to Fulphila® AND Udenyca® before consideration of several pegfilgrastim products (Fylnetra®, Neulasta®, Nyvepria™, Stimufend®/pegfilgrastim-fpgk, or Ziextenzo®), OR a contraindication/intolerance/failure to Rolvedon® before consideration of Ryzneuta.

Billing and dosing limits: HCPCS billing units and maximum units are product- and indication-specific. Typical pegfilgrastim 6 mg products use 12 billable units (0.5 mg units) per dose with limits such as 12 units weekly x 2 doses for acute radiation exposure, 12 units x 1 dose for BMT/PBPC indications, and 12 units per 14 days for other indications. Rolvedon uses 132 billable units per dose under analogous limits; Ryzneuta uses 40 billable units per dose. Providers must document regimen-specific febrile neutropenia risk, patient risk factors when applicable, prior neutropenic complications, and prerequisite treatment failures/intolerances for coverage consideration.

Timing note: these agents should not be administered within 14 days before and 24 hours after cytotoxic chemotherapy; prophylactic dosing is typically given ~24 hours after chemotherapy.

Quick facts and thresholds

Febrile neutropenia incidence thresholds>20% OR 10–20% with ≥1 patient-related risk factor OR <10% with ≥2 patient-related risk factors

Age requirement (Rolvedon & Ryzneuta)>= 18 years

Covered ProductsMultiple branded and biosimilar pegfilgrastim and long-acting G-CSF products (Neulasta, Fulphila, Udenyca, Ziextenzo, Nyvepria, Fylnetra, Stimufend/Pegfilgrastim-fpgk, Rolvedon, Ryzneuta)

Utilization ManagementPrior authorization required; initial PA generally 4 months (some indications single- or two-dose limits)

Billing LimitsProduct-specific HCPCS unit limits per indication (e.g., most pegfilgrastim products: 12 units per dose; Rolvedon: 132 units; Ryzneuta: 40 units)

Coding

HCPCS Codes (medical billing units)HCPCS

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
J1449	Injection, eflapegrastim-xnst, 0.1 mg; 1 billable unit = 0.1 mg (Rolvedon only)
J9361	Injection, efbemalenograstim alfa-vuxw, 0.5 mg; 1 billable unit = 0.5 mg (Ryzneuta only)

NDC Codes (product-level identifiers)NDC

55513-0190-xx	Neulasta 6 mg single-dose prefilled syringe
55513-0192-xx	Neulasta 6 mg single-dose prefilled syringe Onpro Kit
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 6mg 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
69448-0027-xx	Udenyca 6 mg single-dose prefilled syringe ONBODY kit

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ICD-10 Covered Diagnosis Codes (Neulasta/Fulphila/Udenyca/...)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

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Provider Actions

Prior Authorization

Prior authorization required with initial and renewal limits

Prior authorization is required. Initial prior authorization validity is generally 4 months for most products; specific indications have single- or two-dose validity as listed below. Renewals may be provided every 4 months unless renewal is prohibited for the listed indications.

Bone marrow transplantation (BMT) failure or engraftment delay: 1 dose validity (Neulasta, Fulphila, Udenyca, Ziextenzo, Nyvepria, Fylnetra, Stimufend/Pegfilgrastim-fpgk) [initial 1 dose; renewal not allowed].
Peripheral blood progenitor cell (PBPC) mobilization and transplant: 1 dose validity (Neulasta, Fulphila, Udenyca, Ziextenzo, Nyvepria, Fylnetra, Stimufend/Pegfilgrastim-fpgk) [initial 1 dose; renewal not allowed].
Hematopoietic Acute Radiation Syndrome (H-ARS): 2 doses validity for most products; Rolvedon and most products: 2 doses only (initial); renewals not allowed for H-ARS.
Rolvedon: initial general 4-month validity applies; H-ARS limited to 2 doses (renewal not allowed for H-ARS).

Billing Rule

HCPCS billing units and limits per indication

Billing limits are specified as product-specific HCPCS billable unit caps per indication. For most pegfilgrastim 6 mg products the policy defines 12 billable units per dose or per time period depending on indication; Rolvedon and Ryzneuta have different unit scales.

J2506
Q5108
Q5111
Q5120
Q5122
Q5127
Q5130
J1449
J9361

Documentation Required

Document febrile neutropenia risk/incidence and prior therapy

Document the expected febrile neutropenia risk/incidence for the chemotherapy regimen, any applicable patient-related risk factors, prior history of neutropenic complications from the same regimen, and prerequisite treatment failures/intolerances to specified products when required for coverage consideration.

Expected regimen-specific febrile neutropenia incidence (>20%, 10–20% with ≥1 risk factor, <10% with ≥2 risk factors).
Patient-related risk factors (e.g., age >65, prior chemo/radiation, persistent neutropenia, marrow involvement, renal/liver dysfunction, poor performance status, recent surgery/wounds, HIV, chronic immunosuppression).
Prior neutropenic complication from a prior cycle of the same chemotherapy.
Documented contraindication, intolerance, or failure to required prerequisite products (e.g., Fulphila AND Udenyca prior to certain alternatives; Rolvedon prior to Ryzneuta when applicable).

Billing Rule

Timing relative to chemotherapy

Do not administer these long-acting G-CSF agents within 14 days before cytotoxic chemotherapy and do not give within 24 hours after chemotherapy. For prophylactic use dosing is typically administered approximately 24 hours after cytotoxic chemotherapy.

Billing Rule

On-body injector handling

On-body injector procedure: a healthcare provider must fill the on-body injector with the product using the prefilled syringe (Neulasta or Udenyca) and then apply the on-body injector to the patient's skin. On-body injectors may be applied the same day as chemotherapy provided the drug is delivered no less than 24 hours after chemotherapy. On-body injectors are not recommended for acute radiation exposure or pediatric patients.

J2506
Q5111

Background and Evidence

Covered clinical uses include: prophylaxis of chemotherapy-induced neutropenia in patients with solid tumors or non-myeloid malignancies (per expected incidence of febrile neutropenia and patient risk factors), treatment of neutropenic complications (including patients who experienced a neutropenic complication from a prior cycle), peripheral blood progenitor cell (PBPC) mobilization and transplant, bone marrow transplant (BMT) failure or engraftment delay, and management of patients acutely exposed to myelosuppressive doses of radiation (Hematopoietic Acute Radiation Syndrome, H-ARS).

Indications are supported by FDA-approved labeling and compendia recommendations (package inserts for listed products and NCCN Drugs & Biologics Compendium). Specific agents have FDA-approved dosing for prophylaxis and H-ARS (examples: 6 mg subcutaneously once per cycle for most pegfilgrastim products; Rolvedon 13.2 mg once per cycle; Ryzneuta 20 mg once per cycle; H-ARS dosing is weekly x2 doses for most products).

NCCN guidance and peer-reviewed evidence are cited as sources for febrile neutropenia incidence thresholds, regimen examples, and supporting clinical trials. Primary evidence sources referenced include product package inserts (2023-2025), the NCCN Drugs & Biologics Compendium (2025), and clinical trial publications and reviews addressing prophylaxis, PBPC mobilization/transplant, and H-ARS models (selected references listed).

Evidence sources

Primary sourcesPackage inserts for listed products (2023–2025)

CompendiaNCCN Drugs & Biologics Compendium (2025)

Febrile neutropenia: defined as a single oral temperature ≥38.3°C or ≥38.0°C sustained over 1 hour AND neutropenia with absolute neutrophil count <500 cells/µL or <1,000 cells/µL with a predicted decline to ≤500 cells/µL within 48 hours.

H-ARS (Hematopoietic Acute Radiation Syndrome): acute exposure to myelosuppressive doses of ionizing radiation leading to hematopoietic suppression.

Date	Determination name and number and type
2024-01-01	Billing and Coding: Neulasta® Onpro® Kit/UDENYCA® ONBODY™ (On-body Injector) — A54682 (LCA)
2025-10-01	Billing and Coding: White Cell Colony Stimulating Factors — A56748 (LCA)

OpenPayer

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

Coverage Summary

Medical-Necessity Criteria

Coding

Provider Actions

Background and Evidence

Medicare Determinations

Revision History