CurrentViva HealthPolicy IC-0234

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

Policy governs prior authorization, dosing, indications, renewal, and billing codes for long-acting pegfilgrastim products (including biosimilars and eflapegrastim/efbemalenograstim) for Viva Health members.

Policy Summary

PayerViva Health

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

Policy CodePolicy IC-0234

Change TypeMinor / No material change

Effective Date

Next Review DateMay 5, 2026

Key ActionObtain prior authorization with documentation of contraindication/intolerance/failure to listed comparator agents where required.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

10+HCPCS codes included

120 daysInitial PA validity

MultipleNamed products listed

40+References

Coverage Criteria for LA-GCSF Products

Initial Therapy / Covered Indications

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General prerequisites: Member meets age requirements where specified (e.g., ≥18 years for Rolvedon and Ryzneuta); AND dosing/timing rules are followed (do not administer within 14 days before and 24 hours after cytotoxic chemotherapy); AND agent-specific contraindication/intolerance/failure requirements are documented as applicable.see dosing rules

On-body injector handling and pediatric dosing specified in document

Indications for prophylactic use in solid tumors/non-myeloid malignancy: Member is undergoing myelosuppressive chemotherapy with expected febrile neutropenia (FN) risk >20% OR FN risk 10–20% with ≥1 patient-related risk factor OR FN risk <10% with ≥2 patient-related risk factors OR member experienced a neutropenic complication from a prior cycle of the same chemotherapy.FN risk categories and patient risk factors per policy

Risk factor list provided in document

Other covered indications: Member has one of the following: acute exposure to myelosuppressive doses of radiation (H-ARS); bone marrow transplantation (BMT) failure or engraftment delay; peripheral blood progenitor cell (PBPC) mobilization and transplant; Wilms tumor with favorable histology used in combination with a cyclophosphamide-based regimen (Regimen M or I only); or pediatric aggressive mature B-cell lymphomas.Agent-specific applicability (some agents not applicable to Rolvedon or Ryzneuta)

Document notes which indications are not applicable to Rolvedon and Ryzneuta

Agent-specific prerequisite therapy: When specified, documentation must show contraindication, intolerance, or treatment failure to listed comparator agents before alternative agents will be considered (e.g., contraindication/intolerance/failure to Fulphila AND Udenyca prior to consideration of Fylnetra/Neulasta/Nyvepria/Stimufend/Udenyca/Ziextenzo; or contraindication/intolerance/failure to Rolvedon prior to consideration of Ryzneuta).

Renewal Therapy

Renewal criteria

Renewal requirements: Member continues to meet the indication-specific criteria identified for initial approval (including concomitant therapy requirements and performance status where relevant); AND duration of prior authorization has not been exceeded; AND there is absence of unacceptable toxicity from the drug (examples include splenic rupture, ARDS, serious allergic reactions/anaphylaxis, sickle cell crisis, glomerulonephritis, leukocytosis, thrombocytopenia, capillary leak syndrome, aortitis, myelodysplastic syndrome, acute myeloid leukemia, etc.).

General covered indications

Covered when diagnosis code matches included ICD-10 codes and indication aligns with chemotherapy-induced neutropenia, prophylaxis, mobilization, or transplant aftercare

Primary conditions: Member has one of the covered ICD-10 diagnoses listed in Appendix 1 (oncologic malignancies, chemotherapy-induced pancytopenia/neutropenia, adverse effects of antineoplastic drugs, radiation sickness/exposure, transplant status, or related codes).

See Appendix 1 for full code list.

Certain long-acting G-CSF products have limited applicability for specific indications. Rolvedon and Ryzneuta are not applicable for the following uses: bone marrow transplantation (BMT) failure or engraftment delay; peripheral blood progenitor cell (PBPC) mobilization and transplant; Wilms tumor (nephroblastoma); and pediatric aggressive mature B‑cell lymphomas. These exceptions align with the agent‑specific indications and prerequisite therapy requirements described in the policy and must be observed when requesting coverage for these products.

This document is intended for non‑Medicare coverage determinations. Where Medicare rules apply, providers must follow applicable Medicare policies, including the Medicare Benefit Policy Manual and any relevant National Coverage Determinations (NCDs), Local Coverage Determinations (LCDs), or Local Coverage Articles (LCAs). Palmetto GBA LCAs referenced in the policy include document numbers A56748 and A54682. Use the CMS Medicare Coverage Database to identify current NCD/LCD/LCA guidance for Part B drugs and biologics.

Adhere to timing and administration rules for all long‑acting pegfilgrastim products: do not administer within 14 days before and 24 hours after cytotoxic chemotherapy. For prefilled syringe products, administration may be by the member, a caregiver, or a healthcare professional as indicated in the product instructions. When using an on‑body injector with Neulasta or Udenyca, a healthcare provider must fill the device with the prefilled syringe and apply it to the member's skin; the on‑body injector may be applied on the same day as chemotherapy only if the pegfilgrastim dose will be delivered at least 24 hours after chemotherapy. On‑body injectors are not recommended for members with acute radiation exposure or for pediatric members. Specific administration routes for other agents: Rolvedon may be self‑administered or given by a caregiver/healthcare professional, while Ryzneuta must be administered subcutaneously via a single‑dose prefilled syringe by a healthcare professional.

Regimen / Indication	Key criteria	Coverage status
Wilms tumor (nephroblastoma) — favorable histology
Member has favorable histology disease; used in combination with a cyclophosphamide-based chemotherapy regimen (Regimen M or Regimen I only).
Covered

Product / Class	Common uses in policy	Coverage status
Neulasta (pegfilgrastim) and pegfilgrastim biosimilars (Fulphila, Udenyca, Ziextenzo, Nyvepria, Fylnetra, Stimufend [pegfilgrastim-fpgk], Armlupeg)
Prophylaxis of chemotherapy-induced neutropenia/febrile neutropenia; peripheral blood progenitor cell mobilization; acute radiation exposure (where indicated).
Covered

Billing Codes and Diagnosis Lists

HCPCS CodesHCPCS

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 (selected examples)NDC

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
76961-0101-xx	Rolvedon 13.2 mg single-dose prefilled syringe: 76961-0101-xx
72893-0016-xx	Ryzneuta 20 mg/mL prefilled syringe: 72893-0016-xx
70748-0273-xx	Armlupeg 6 mg single-dose prefilled syringe: 70748-0273-xx

Covered ICD-10 Diagnosis CodesICD-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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Billable units per dose/time — dosing unit guidance per product

Armlupeg, Fulphila, Fylnetra, Neulasta, Nyvepria, Stimufend, Udenyca, Ziextenzo (typical indications)12 billable units per dose; 12 units per 14 days for most indications; 12 units x1 dose for BMT failure/engraftment delay or PBPC mobilization; 12 units weekly x2 doses for acute radiation exposure (H-ARS).

Rolvedon132 billable units per dose; 132 units per 14 days for most indications; 132 units weekly x2 doses for acute radiation exposure (H-ARS).

Ryzneuta40 billable units per dose; 40 units per 14 days for most indications; 40 units weekly x2 doses for acute radiation exposure (H-ARS).

Dose timing notesAcute radiation exposure dosing often authorized as weekly x2 doses; BMT failure/engraftment delay and PBPC mobilization typically limited to a single dose for listed agents as specified.

None specified — placeholder key/value

Placeholder — no thresholds specifiedNo additional coding thresholds specified in this section.

Covered diagnosis examplesSee Appendix 1 for full ICD-10 list including D61.810 (antineoplastic chemotherapy induced pancytopenia), D70.1 (agranulocytosis secondary to cancer chemotherapy), and multiple malignancy codes.

Medicare noteMedicare/NCD/LCD/LCA requirements may apply; follow CMS/local coverage guidance where applicable.

Provider Requirements, Prior Authorization, and Documentation

Prior Authorization

Prior Authorization Validity and Nonrenewable Indications

Prior authorization validity will be provided initially for 4 months (120 days) for most products unless otherwise specified. Certain indications are nonrenewable and limited to specific dose counts as described below. Renewal of prior authorization may be granted every 4 months (120 days) thereafter unless the indication is listed as nonrenewable.

Initial PA validity: 4 months (120 days) for most products.
Renewal PA validity: May be renewed every 4 months (120 days) unless otherwise specified.
Nonrenewable indications: Bone marrow transplantation (BMT) failure or engraftment delay; Peripheral blood progenitor cell (PBPC) mobilization and transplant; Acute exposure to myelosuppressive doses of radiation (Hematopoietic Acute Radiation Syndrome [H-ARS]).
Dose-limited initial PA for certain indications: BMT failure/engraftment delay — 1 dose only; PBPC mobilization/transplant — 1 dose only; H-ARS — 2 doses only (product-specific exceptions may apply).

Note

Prior Authorization Considerations and Medicare Compliance

Prior authorization is considered primarily due to drug cost and utilization management (an NQTL). Medicare NCDs/LCDs/LCAs may impose additional restrictions and must be followed where applicable.

PA considered as a cost-driven NQTL per Appendix A; cost of drug was identified as a factor.
Comply with applicable Medicare coverage determinations (NCD/LCD) and Local Coverage Articles (LCA) where relevant; see CMS Medicare Coverage Database.
Examples of Medicare contractor documents: A56748, A54682 (Palmetto GBA).

Documentation Required

Prerequisite Therapy and Documentation Requirements

A documented trial, contraindication, intolerance, or failure to specified comparator agents is required before considering certain products. Documentation must clearly state the prior agent(s) tried and the clinical reason for discontinuation or inability to use the comparator.

For Fylnetra, Neulasta, Nyvepria, Stimufend/Pegfilgrastim-fpgk, Udenyca, and Ziextenzo: Documentation of contraindication, intolerance, or failure to Fulphila AND Udenyca is required prior to consideration.
For Ryzneuta: Documentation of contraindication, intolerance, or failure to Rolvedon is required prior to consideration.
Documentation must include agent name(s), dosing/timing, and clinical reason (e.g., adverse event, lack of efficacy, allergy).

Step Therapy

Step Therapy (Not Specified)

This section does not impose a step-therapy algorithm beyond the prerequisite therapy requirement described above; utilization management is applied but no additional explicit step sequence is specified here.

Step therapy: A specific step-by-step algorithm is not specified in this section; clinical documentation of prior agent trial or contraindication is required instead.
Utilization management may include other policies or product-specific requirements not detailed here.

Line of Therapy Guidance

first-line

First-line use: Use for prophylaxis when febrile neutropenia risk is high (expected incidence >20%) or per member-specific risk-factor rules (see policy) and for members who experienced neutropenic complications from prior cycles; also includes use for acute radiation exposure (H-ARS), BMT failure/engraftment delay, PBPC mobilization/transplant, Wilms tumor with favorable histology in combination with cyclophosphamide-based regimens, and pediatric aggressive mature B-cell lymphomas (agent applicability noted).

not_specified

Evidence/support: Randomized trials, phase II/III studies, and NCCN compendium references support use of pegfilgrastim and long-acting G-CSF products for prophylaxis of febrile neutropenia and for stem cell mobilization; specific line-of-therapy placement is not otherwise specified in this document portion.

See references section for trial and compendium citations.

Background and Rationale

Long‑acting pegfilgrastim agents and related G‑CSFs are used to prevent or treat chemotherapy‑induced neutropenia, to mobilize peripheral blood progenitor cells for transplant procedures, and to treat hematopoietic acute radiation syndrome (H‑ARS). The policy supports prophylactic use in members receiving myelosuppressive chemotherapy when the expected risk of febrile neutropenia is >20%, or when risk is 10–20% with ≥1 patient risk factor, or <10% with ≥2 patient risk factors, and for members who experienced neutropenic complications with a prior cycle. Product selection and applicability vary by indication: some agents require documentation of prior contraindication/intolerance/failure to listed comparators before alternatives will be considered, and the policy specifies age requirements and other agent‑specific notes (for example, Rolvedon and Ryzneuta are indicated only for members ≥18 years).

Definitions and Risk Factors

Febrile neutropenia definition — temperature and neutrophil thresholds

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

Neutrophil absolute count criterionAbsolute neutrophils <500 neutrophils/mcL OR <1,000 neutrophils/mcL with a predicted decline to ≤500 neutrophils/mcL within 48 hours.

Combined requirementBoth the temperature criterion AND the neutropenia criterion must be met to define febrile neutropenia.

Risk factors for febrile neutropenia

AgeAge >65 years receiving full-dose intensity chemotherapy.

Prior therapyPrior exposure to chemotherapy or radiation therapy.

Hematologic and disease factorsPersistent neutropenia; bone marrow involvement by tumor.

Immunosuppression and comorbidityHuman immunodeficiency virus (HIV) infection; chronic immunosuppression post-transplant.

Physiologic riskRecent surgery/open wounds; poor performance status; renal dysfunction (creatinine clearance <50 mL/min); liver dysfunction (elevated bilirubin >2.0 mg/dL).

Unbranded biologic — definition

DefinitionAn unbranded biologic is the same as the brand biologic and uses the same cell-line as the brand-name reference biologic.

Implication for codingUnbranded biologic references are used in NDC/HCPCS groupings where noted in the policy (see coding tables).

Example notationPolicy notes § symbol indicating unbranded biologic equivalence in the NDC/HCPCS lists.

Policy Revision History

2026-05-05Last reviewLatest

Policy last reviewed on 05/05/2026; document status marked CURRENT with routine review dates maintained.

2025-11-01Revision

Document underwent an update in November 2025 as part of routine reviews (listed in Dates Reviewed), reflecting ongoing periodic updates to coverage criteria and code lists.

2025-05-01Revision

Policy reviewed May 2025 during scheduled maintenance (listed in Dates Reviewed) with updates to references and product listings.

2008-10-17Origin

Policy originated on 10/17/2008 (Date of Origin recorded).