Viva Health LA‑GCSF Coverage & Prior Auth

Coverage Criteria

Initial Therapy — Covered when ALL of the following are met

Covered when ALL of the following are met:

Prerequisite agent and age: (1) Patient has a documented contraindication, intolerance, or treatment failure to Fulphila AND Udenyca prior to consideration of Fylnetra, Neulasta, Nyvepria, Stimufend/pegfilgrastim-fpgk, OR Ziextenzo; OR patient has a documented contraindication, intolerance, or treatment failure to Rolvedon prior to consideration of Ryzneuta; AND (2) patient is at least 18 years of age (Rolvedon and Ryzneuta ONLY).

From Initial Approval Criteria (Section III)

Indications - prophylactic FN prevention: Prophylactic use for patients with solid tumors or non-myeloid malignancy when: (a) receiving myelosuppressive chemotherapy with expected febrile neutropenia (FN) incidence >20%; OR (b) FN incidence 10–20% AND one or more patient-related risk factors; OR (c) FN incidence <10% AND two or more patient-related risk factors (use based on clinical judgment).

Includes note re: dose-dense therapy and palliative considerations (Section III)

Other covered indications: Patients who experienced a neutropenic complication from a prior cycle of the same chemotherapy; patients acutely exposed to myelosuppressive doses of radiation (H-ARS); bone marrow transplantation (BMT) failure or engraftment delay (limited to specified products); peripheral blood progenitor cell (PBPC) mobilization and transplant (limited to specified products); Wilms tumor with favorable histology in combination with cyclophosphamide-based regimens; pediatric aggressive mature B‑cell lymphomas (product-specific limitations apply).

Product-specific limitations and eligible products noted in Section III

Continuation Therapy / Renewal — Authorization may be renewed if ALL the following are met

Authorization may be renewed if ALL the following are met:

Renewal conditions: Patient continues to meet indication‑specific relevant criteria (excluding prerequisite trial/failure requirements), the duration of authorization has not been exceeded (refer to product-specific limits in Section I), AND there is absence of unacceptable toxicity from the drug.

See Renewal Criteria (Section IV)

Non-renewable indications and product exceptions: Prior authorization may NOT be renewed for certain indications/products: BMT failure/engraftment delay, PBPC mobilization and transplant, and acute exposure to myelosuppressive radiation (H-ARS) for products where renewal is explicitly disallowed (see product-specific sections); Rolvedon/Ryzneuta have specified non-renewable or limited-dose rules per product guidance.

Product-specific renewability exceptions (chunks 1–2)

General coverage stance

Covered when consistent with FDA-approved indications, supporting literature, and applicable Medicare NCD/LCD/LCA guidance.

Coverage conditions: Use must align with FDA‑approved indications and recognized compendia (e.g., NCCN/ASCO) and comply with applicable Medicare NCD/LCD/LCA documents (for example, Palmetto GBA A54682 and A56748) where Medicare rules apply.

References and package inserts cited in document support clinical use; see Appendix 2 for Medicare note

Do not administer pegfilgrastim products within 14 days before cytotoxic chemotherapy or within 24 hours after cytotoxic chemotherapy. Prefilled syringe products may be self‑administered or given by a caregiver or healthcare professional. For on‑body injector use (Neulasta or Udenyca), a healthcare provider must fill the device with the product's prefilled syringe and apply the device to the patient; the on‑body injector may be applied the same day as chemotherapy only if the drug is delivered no less than 24 hours after chemotherapy. On‑body injectors are not recommended for patients with acute radiation exposure or pediatric patients. Rolvedon may be self‑administered or given by a caregiver or healthcare professional, while Ryzneuta must be administered subcutaneously by a healthcare professional.

This policy is intended for non‑Medicare coverage determinations. Where Medicare Part B rules apply, providers must follow the Medicare Benefit Policy Manual and any applicable National Coverage Determinations (NCDs), Local Coverage Determinations (LCDs), or Local Coverage Articles (LCAs). Palmetto GBA LCAs A54682 and A56748 are examples of contractor guidance that may affect billing and coverage under Medicare; compliance with applicable Medicare NCD/LCD/LCA guidance is required for Medicare members.

Prior authorization renewal may be considered only if the member continues to meet the indication‑specific criteria (excluding prerequisite agent requirements), the authorization duration has not been exceeded per Section I, and there is an absence of unacceptable toxicity. Renewal may be denied or deemed not medically necessary if the member has experienced 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, or acute myeloid leukemia).

Initial Therapy Criteria (Product-Specific)

Initial therapy dosing & prerequisites — Product-specific initial dosing and prerequisites

Product-specific initial dosing and prerequisites:

Product prerequisites: Document prerequisite therapy per policy (e.g., trial/failure/contraindication to specified comparators as required before certain products) and applicable age criteria for Rolvedon and Ryzneuta (≥18 years).

See Initial Approval Criteria (Section III) and step therapy requirements

Dosing examples — 6 mg pegfilgrastim products: Neulasta and many pegfilgrastim biosimilars: Administer 6 mg subcutaneously once per chemotherapy cycle and dosed no more frequently than every 14 days. Pediatric weight‑based dosing applies for patients <45 kg as specified in product labeling (e.g., <10 kg = 0.1 mg/kg; 10–20 kg = 1.5 mg; 21–30 kg = 2.5 mg; 31–44 kg = 4 mg).

See Neulasta/biosimilar dosing (chunk 10) and maximum billable units (chunk 3)

Dosing examples — Rolvedon and Ryzneuta: Rolvedon: Administer 13.2 mg subcutaneously once per chemotherapy cycle approximately 24 hours after cytotoxic chemotherapy (or 13.2 mg weekly x2 for H-ARS). Ryzneuta: Administer 20 mg subcutaneously once per chemotherapy cycle at least 24 hours after cytotoxic chemotherapy (or 20 mg weekly x2 for H-ARS).

Continuation / Renewal Criteria

Renewal — Renewal may be granted if ongoing criteria met and no unacceptable toxicity.

Renewal may be granted if ongoing criteria are met and no unacceptable toxicity is present:

Renewal eligibility: Patient continues to meet the indication‑specific criteria relevant to ongoing therapy (excluding prerequisite trial/failure requirements), the authorization duration for the product/indication has not been exceeded (see product-specific PA validity), AND there is no evidence of unacceptable toxicity attributable to the agent.

See Renewal Criteria and product PA validity (chunks 9,1,2)

Examples of unacceptable toxicity: Unacceptable toxicities that preclude renewal include, but are not limited to: splenic rupture, acute respiratory distress syndrome (ARDS), serious allergic reactions/anaphylaxis, sickle cell crisis, glomerulonephritis, leukocytosis, thrombocytopenia, capillary leak syndrome, aortitis, myelodysplastic syndrome, and acute myeloid leukemia in certain contexts.

Examples listed in Renewal Criteria (chunk 9)

Ongoing cycle use — Continuation/ongoing use considerations referenced in clinical trials and compendia.

Provider Actions and Documentation Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required. Initial authorizations are generally valid for 4 months unless otherwise specified. Product-specific exceptions: for bone marrow transplantation (BMT) failure or engraftment delay and for peripheral blood progenitor cell (PBPC) mobilization and transplant, prior authorization validity is provided for 1 dose only; for acute exposure to myelosuppressive doses of radiation (Hematopoietic Acute Radiation Syndrome [H-ARS]) some products receive validity for 2 doses only. Renewals may be issued every 4 months thereafter unless an indication-specific exception applies. Providers should document prerequisite therapy (see criteria): the member must have a documented contraindication, intolerance, or treatment failure to the specified comparator agents (e.g., contraindication/intolerance/failure to Fulphila and Udenyca prior to consideration of Fylnetra, Neulasta, Nyvepria, Stimufend/Pegfilgrastim‑fpgk, or Ziextenzo; or to Rolvedon prior to Ryzneuta) when those step requirements apply.

Initial authorizations: generally valid for 4 months (product‑specific exceptions noted above).
BMT failure / engraftment delay and PBPC mobilization/transplant: validity provided for 1 dose only (no renewals).
Acute radiation exposure (H-ARS): validity may be provided for 2 doses only; renewals may be restricted per product.
Renewals: may be requested every 4 months; may NOT be renewed for certain indications (e.g., BMT failure/engraftment delay, PBPC mobilization/transplant, H-ARS where specified).
Providers must document prior trial and contraindication/intolerance/failure to required comparator agents before coverage of alternatives.

Coding (HCPCS, NDC, ICD-10)

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
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)

NDCs listedNDC

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

1–10 of 17

1/2

Covered ICD-10 Codes (diagnoses associated with pegfilgrastim use)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

Maximum billable units / dosing frequency

Neulasta and listed biosimilars (Fulphila, Udenyca, Ziextenzo, Nyvepria, Fylnetra, Stimufend/pegfilgrastim-fpgk)12 billable units per 14 days (typical for 6 mg once-per-cycle dosing); for Acute Radiation Exposure: 12 billable units weekly x 2 doses; pediatric weight-based adjustments for <45 kg apply

Rolvedon (eflapegrastim)132 billable units per 14 days (13.2 mg once per cycle); for Acute Radiation Exposure: 132 billable units weekly x 2 doses

Ryzneuta (efbemalenograstim)40 billable units per 14 days (20 mg once per cycle); for Acute Radiation Exposure: 40 billable units weekly x 2 doses

Dosing frequency rule6 mg products dosed no more frequently than every 14 days for routine chemotherapy cycle prophylaxis; Rolvedon and Ryzneuta follow their product-specific mg dosing shown above

Quantity Limits and Billable Units

Neulasta and pegfilgrastim biosimilars — quantity limits

Products coveredNeulasta; Fulphila; Udenyca; Ziextenzo; Nyvepria; Fylnetra; Stimufend/pegfilgrastim-fpgk

Quantity limit (typical dosing)12 billable units per 14 days (corresponds to standard 6 mg single-dose pegfilgrastim per chemotherapy cycle)

Acute Radiation Exposure (H-ARS)Administer 6 mg subcutaneously weekly x 2 doses (coded as 12 billable units weekly x 2 doses)

BMT failure / PBPC mobilizationProduct-specific single-dose limits: 6 mg subcutaneously for 1 dose only for BMT failure/engraftment delay and PBPC mobilization (applies to specified products)

Rolvedon — quantity limits

ProductRolvedon (eflapegrastim)

Site of Care and Administration

Note

Confirm appropriate site of care and device administration requirements

Products may be self‑administered (pre‑filled syringe or caregiver) or administered by a healthcare professional; on‑body injector products (Neulasta, Udenyca) require a provider to fill and apply the device and have use restrictions.

Do not administer within 14 days before and 24 hours after cytotoxic chemotherapy.
On‑body injector: a healthcare provider must fill the on‑body injector with the prefilled syringe and apply it; on‑body injectors not recommended for acute radiation exposure or pediatric patients.
Ryzneuta must be administered by a healthcare professional (single‑dose prefilled syringe).

Billing Rule

Adhere to Medicare Part B administration and billing rules when applicable

Medicare Part B rules govern outpatient administration and billing for these agents; where Medicare policies apply, follow applicable NCD/LCD/LCA guidance for claims and coverage determinations.

Step Therapy / Prior Trials

Step	Requirement	Documentation needed
1
Prerequisite trial or documented failure to specified comparator agents before coverage of certain alternatives: patient must have contraindication, intolerance, or failure to Fulphila AND Udenyca prior to consideration of Fylnetra, Neulasta, Nyvepria, Stimufend/Pegfilgrastim-fpgk, OR Ziextenzo; OR contraindication, intolerance, or failure to Rolvedon prior to consideration of Ryzneuta
Provider must document prior trial and contraindication/intolerance/failure to the specified comparator agents (as above) and, where applicable, age requirements (Rolvedon and Ryzneuta: patient ≥18 years)

Step	Summary	Policy note
1
Step therapy specifics are not itemized in this policy section; instead utilization management (including prior authorization) is applied based on non-quantitative treatment limitation factors
Per the NQTL checklist, utilization management was considered primarily because of drug cost; the NQTL is applied comparably across MH/SUD and medical/surgical prescription drugs

Biosimilar Products

Billing Rule

Bill using HCPCS codes; PA and limits apply to reference biologic and biosimilars

HCPCS codes are assigned to the reference biologic and biosimilars; prior authorization rules and quantity limits apply to both branded and biosimilar pegfilgrastim products as listed in the policy.

HCPCS codes include J2506 (Neulasta) and multiple Q‑codes for pegfilgrastim biosimilars; J1449 and J9361 represent eflapegrastim and efbemalenograstim.
Quantity limits (billable units per 14 days) apply to both reference and biosimilar products.

Note

Policy groups Neulasta and biosimilars together for PA and coverage rules

The policy lists multiple pegfilgrastim biosimilars and long‑acting G‑CSF products together and references them collectively for coverage, authorization, and quantity limit rules rather than preferring a single product.

Biosimilars named include Fulphila, Udenyca, Ziextenzo, Nyvepria, Fylnetra, Stimufend/Pegfilgrastim‑fpgk and are grouped with Neulasta for policy rules.
The policy’s references and appendices treat the biologic and biosimilars together for coding, PA, and NQTL considerations.

Definitions

Febrile neutropenia and patient risk factors

Febrile neutropenia (definition)A single oral temperature ≥38.3 °C or ≥38.0 °C over 1 hour AND neutropenia: <500 neutrophils/mcL or <1,000 neutrophils/mcL with predicted decline to ≤500 within 48 hours

Key patient risk factorsAge >65; prior chemotherapy or radiation; persistent neutropenia; bone marrow tumor involvement; HIV infection; recent surgery/open wounds; poor performance status; renal dysfunction (CrCl <50 mL/min); elevated bilirubin >2.0 mg/dL; chronic post-transplant immunosuppression

Use guidanceRefer to NCCN Hematopoietic Growth Factors for regimen-specific FN incidence estimates to determine prophylactic use

pegfilgrastim — definition and reference biologic

DefinitionPegfilgrastim: a long-acting granulocyte-colony stimulating factor (G-CSF) used to prevent chemotherapy-induced neutropenia

Includes reference biologic and biosimilars

Background

Pegfilgrastim and other long‑acting granulocyte colony‑stimulating factors (LA‑GCSFs) are used to reduce the incidence of chemotherapy‑induced neutropenia and febrile neutropenia in patients receiving myelosuppressive chemotherapy. These agents (including the reference biologic and multiple biosimilars) provide a single long‑acting dose per chemotherapy cycle to shorten the duration of severe neutropenia and lower the risk of febrile neutropenia, with support from randomized trials and guideline compendia (NCCN/ASCO) cited in the policy.

Revision History

11/04/2025policy_reviewLatest

Document last reviewed and updated; reflects latest package insert and compendium references through October 2025.

05/2025references_update

References and package insert citations updated (e.g., Fylnetra, Stimufend) as listed in the references section.

04/2024administrative_update

OpenPayer

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