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    v1.0.28
    OpenPayerPolicy UpdatesPharmacy & Specialty DrugsViva Health Plan LA-GCSF Prior Auth | OpenPayer
    Ask Trek AI about this page
    ModifiedViva Health PlanPolicy IC-0234

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

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    This policy governs prior authorization, coverage criteria, dosing, authorization duration, and billing for subcutaneous long-acting granulocyte colony-stimulating factors used for chemotherapy-associated neutropenia, radiation exposure, transplantation-related indications, and specified oncology indications for Viva Health Plan commercial members.

    Policy Summary
    PayerViva Health Plan
    PolicyLong-Acting Granulocyte Colony-Stimulating Factors (LA-GCSF)
    Policy CodePolicy IC-0234
    Change TypeModified
    Effective DateN/A
    Last ReviewMay 5, 2026
    Next Review DateN/A
    Key ActionUse Q5169 for Armlupeg beginning 07/01/2026 and discontinue J3590 for Armlupeg on that date.
    SourceLink
    POLICY UPDATE CHANGES

    HCPCS code Q5169 was added for pegfilgrastim-unne (Armlupeg), effective 07/01/2026.

    HCPCS code J3590 for unclassified biologics is scheduled for discontinuation for Armlupeg on 07/01/2026.

    OpenPayer is powered by Trek Health's payer performance platform. Trek continuously ingests, validates, and normalizes Transparency in Coverage data alongside payer policies and other commercial payer data to create a structured payer intelligence foundation. OpenPayer uses this foundation to deliver personalized search results, dynamically generated policy pages, and tailored policy monitoring based on each user's payers, specialties, billing codes, and areas of interest. The same intelligence powers broader payer performance workflows, including reimbursement benchmarking, contract evaluation, payer negotiations, and financial decision-making.

    120 daysStandard authorization period
    07/01/2026Q5169 and J3590 code transition
    11HCPCS codes listed
    17NDC product listings
    >20%Prophylaxis risk threshold

    Coverage Criteria

    Initial Product and Age Requirements

    Covered when the applicable product prerequisite and age requirement are met, together with at least one covered indication below.

    ALL of the following

    • ONE of the following product prerequisites

      • The member has a contraindication, intolerance, or failure to both Fulphila and Udenyca before consideration of another pegfilgrastim product.
      • For Ryzneuta, the member has a contraindication, intolerance, or failure to Rolvedon.
    • For Rolvedon or Ryzneuta, the member is at least 18 years of age.

    Prophylactic Use With Solid Tumors or Non-Myeloid Malignancy

    Prophylactic use is covered when the member has solid tumors or a non-myeloid malignancy and meets the applicable chemotherapy-related febrile-neutropenia risk criteria.

    ONE of the following

    • The member is undergoing myelosuppressive chemotherapy with an expected incidence of febrile neutropenia greater than 20%.

    • ALL of the following

      • The member is undergoing myelosuppressive chemotherapy with an expected incidence of febrile neutropenia from 10% through 20%.

      • ONE OR MORE member-related risk factors

        • Age greater than 65 years while receiving full-dose-intensity chemotherapy.
        • Prior exposure to chemotherapy or radiation therapy.
        • Persistent neutropenia.

    Other Covered Indications

    Coverage is available when the member meets at least one of the following indication-specific criteria.

    ONE of the following covered indications

    • The member experienced a neutropenic complication during a prior cycle of the same chemotherapy.
    • The member was acutely exposed to myelosuppressive doses of radiation (Hematopoietic Acute Radiation Syndrome [H-ARS]).
    • The member has bone marrow transplantation (BMT) failure or engraftment delay.

      Not applicable to Rolvedon or Ryzneuta.

    • The member requires peripheral blood progenitor cell (PBPC) mobilization and transplant.

      Not applicable to Rolvedon or Ryzneuta.

    • Wilms tumor (nephroblastoma)

    Continuation and Renewal Therapy

    Renewal may be approved when ALL of the following are met:

    ALL of the following

    • The member continues to meet the relevant indication-specific criteria identified in the Initial Approval Criteria, including applicable concomitant-therapy requirements, performance-status requirements, and other conditions; prerequisite therapy is not required for renewal.
    • The duration of authorization has not been exceeded, as specified in the authorization limits.
    • The member has no unacceptable toxicity from the drug. Examples include splenic rupture, acute respiratory distress syndrome (ARDS), serious allergic reaction or anaphylaxis, sickle cell crisis, glomerulonephritis, leukocytosis, thrombocytopenia, capillary leak syndrome, potential stimulation of malignant-cell growth, aortitis, and myelodysplastic syndrome or acute myeloid leukemia in members with breast or lung cancer.

    Initial authorization is generally valid for 4 months (120 days). Exceptions are as follows: BMT failure or engraftment delay, PBPC mobilization and transplant, and acute exposure to myelosuppressive doses of radiation (H-ARS) are authorized for one dose only for the applicable products; H-ARS for Rolvedon or Ryzneuta is authorized for two doses only.

    Renewal may generally occur every 4 months (120 days). Authorization may not be renewed for BMT failure or engraftment delay, PBPC mobilization and transplant, or acute exposure to myelosuppressive doses of radiation (H-ARS) for the products to which those limits apply. For Rolvedon and Ryzneuta, H-ARS authorization may not be renewed.

    Rolvedon and Ryzneuta are not applicable for bone marrow transplantation failure or engraftment delay, peripheral blood progenitor cell mobilization and transplant, Wilms tumor (nephroblastoma), or pediatric aggressive mature B-cell lymphoma.

    Acute exposure to myelosuppressive doses of radiation (H-ARS) is a covered indication for Rolvedon and Ryzneuta subject to the two-dose initial authorization limit and nonrenewable status.

    Coding and Clinical Thresholds

    Covered HCPCS CodesHCPCSCovered
    J2506Injection, pegfilgrastim, excludes biosimilar, 0.5 mg; 1 billable unit = 0.5 mg (Neulasta only)
    Q5108Injection, pegfilgrastim-jmdb, biosimilar, (Fulphila), 0.5 mg; 1 billable unit = 0.5 mg
    Q5111Injection, pegfilgrastim-cbqv, biosimilar, (Udenyca), 0.5 mg; 1 billable unit = 0.5 mg
    Q5120Injection, pegfilgrastim-bmez, biosimilar, (Ziextenzo), 0.5 mg; 1 billable unit = 0.5 mg
    Q5122Injection, pegfilgrastim-apgf, biosimilar, (Nyvepria), 0.5 mg; 1 billable unit = 0.5 mg
    Q5127Injection, pegfilgrastim-fpgk, biosimilar, (Stimufend), 0.5 mg; 1 billable unit = 0.5 mg (Includes unbranded biologic)
    Q5130Injection, pegfilgrastim-pbbk, biosimilar, (Fylnetra), 0.5 mg; 1 billable unit = 0.5 mg
    Q5169Injection, pegfilgrastim-unne (Armlupeg), biosimilar, 0.5 mg; 1 billable unit = 0.5 mg (Effective 07/01/2026)
    J3590Unclassified biologics (Armlupeg ONLY) (Discontinue use on 07/01/2026)
    J1449Injection, eflapegrastim-xnst, 0.1 mg; 1 billable unit = 0.1 mg (Rolvedon only)
    1–10 of 11
    1/2
    Covered NDC CodesNDCCovered
    55513-0190-xxNeulasta 6 mg single-dose prefilled syringe
    55513-0192-xxNeulasta 6 mg single-dose prefilled syringe Onpro Kit
    55513-0099-xxNeulasta 4 mg/0.4 mL single-dose vial
    83257-0005-xxFulphila 6 mg single-dose prefilled syringe
    67457-0833-xxFulphila 6 mg single-dose prefilled syringe
    70114-0101-xxUdenyca 6 mg single-dose prefilled syringe
    69448-0025-xxUdenyca 6 mg single-dose prefilled syringe
    70114-0120-xxUdenyca 6 mg single-dose prefilled autoinjector
    69448-0026-xxUdenyca 6 mg single-dose prefilled autoinjector
    70114-0130-xxUdenyca 6 mg single-dose prefilled syringe ONBODY kit
    1–10 of 19
    1/2
    Neutral HCPCS CodesHCPCS
    J2506Injection, pegfilgrastim, excludes biosimilar, 0.5 mg; 1 billable unit = 0.5 mg (Neulasta only)
    Q5108Injection, pegfilgrastim-jmdb, biosimilar, (Fulphila), 0.5 mg; 1 billable unit = 0.5 mg
    Q5111Injection, pegfilgrastim-cbqv, biosimilar, (Udenyca), 0.5 mg; 1 billable unit = 0.5 mg
    Q5120Injection, pegfilgrastim-bmez, biosimilar, (Ziextenzo), 0.5 mg; 1 billable unit = 0.5 mg
    Q5122Injection, pegfilgrastim-apgf, biosimilar, (Nyvepria), 0.5 mg; 1 billable unit = 0.5 mg
    Q5127Injection, pegfilgrastim-fpgk, biosimilar, (Stimufend), 0.5 mg; 1 billable unit = 0.5 mg (includes unbranded biologic)
    Q5130Injection, pegfilgrastim-pbbk, biosimilar, (Fylnetra), 0.5 mg; 1 billable unit = 0.5 mg
    Q5169Injection, pegfilgrastim-unne (Armlupeg), biosimilar, 0.5 mg; 1 billable unit = 0.5 mg (effective 07/01/2026)
    J3590Unclassified biologics (Armlupeg only) (discontinue use on 07/01/2026)
    J1449Injection, eflapegrastim-xnst, 0.1 mg; 1 billable unit = 0.1 mg (Rolvedon only)
    1–10 of 11
    1/2
    Neutral NDC CodesNDC
    55513-0190-xxNeulasta 6 mg single-dose prefilled syringe
    55513-0192-xxNeulasta 6 mg single-dose prefilled syringe Onpro Kit
    55513-0099-xxNeulasta 4 mg/0.4 mL single-dose vial
    83257-0005-xxFulphila 6 mg single-dose prefilled syringe
    67457-0833-xxFulphila 6 mg single-dose prefilled syringe
    70114-0101-xxUdenyca 6 mg single-dose prefilled syringe
    69448-0025-xxUdenyca 6mg single-dose prefilled syringe
    70114-0120-xxUdenyca 6 mg single-dose prefilled autoinjector
    69448-0026-xxUdenyca 6 mg single-dose prefilled autoinjector
    70114-0130-xxUdenyca 6 mg single-dose prefilled syringe ONBODY kit
    1–10 of 19
    1/2
    Covered Diagnosis Codes: Armlupeg, Fulphila, Fylnetra, Neulasta, Nyvepria, Stimufend/Pegfilgrastim-fpgk, Udenyca, and ZiextenzoICD-10Covered
    C64.1Malignant neoplasm of right kidney, except renal pelvis
    C64.2Malignant neoplasm of left kidney, except renal pelvis
    C64.9Malignant neoplasm of unspecified kidney, except renal pelvis
    C65.1Malignant neoplasm of right renal pelvis
    C65.2Malignant neoplasm of left renal pelvis
    C65.9Malignant neoplasm of unspecified renal pelvis
    C83.30Diffuse large B-cell lymphoma unspecified site
    C83.31Diffuse large B-cell lymphoma, lymph nodes of head, face, and neck
    C83.32Diffuse large B-cell lymphoma intrathoracic lymph nodes
    C83.33Diffuse large B-cell lymphoma intra-abdominal lymph nodes
    1–10 of 58
    1/6
    Covered Diagnosis Codes: Rolvedon & RyzneutaICD-10Covered
    D61.810Antineoplastic chemotherapy induced pancytopenia
    D61.811Other drug-induced pancytopenia
    D61.818Other pancytopenia
    D70.1Agranulocytosis secondary to cancer chemotherapy
    D70.9Neutropenia, unspecified
    T45.1X5AAdverse effect of antineoplastic and immunosuppressive drugs initial encounter
    T45.1X5DAdverse effect of antineoplastic and immunosuppressive drugs subsequent encounter
    T45.1X5SAdverse effect of antineoplastic and immunosuppressive drugs sequela
    T66.XXXARadiation sickness, unspecified, initial encounter
    T66.XXXDRadiation sickness, unspecified, subsequent encounter
    1–10 of 18
    1/2
    Expected febrile neutropenia incidence
    Risk above 20%Expected febrile-neutropenia incidence >20%
    Risk 10%–20%Expected incidence of 10% to 20% with one or more member-related risk factors
    Risk below 10%Expected incidence <10% with two or more member-related risk factors
    Renal dysfunction risk factor
    Risk factorRenal dysfunction
    Threshold

    Authorization and Provider Actions

    Prior Authorization

    Prior Authorization and Initial Duration

    Prior authorization is required for Armlupeg, Fulphila, Fylnetra, Neulasta, Nyvepria, Stimufend/Pegfilgrastim-fpgk, Udenyca, Ziextenzo, Rolvedon, and Ryzneuta. Initial authorization is generally valid for 4 months (120 days), unless an indication-specific exception applies.

    • Bone marrow transplantation failure or engraftment delay: authorization for 1 dose only.
    • Peripheral blood progenitor cell mobilization and transplant: authorization for 1 dose only.
    • Acute exposure to myelosuppressive radiation (H-ARS): authorization for 2 doses only.
    Prior Authorization

    Renewal Duration and Nonrenewable Indications

    Authorization may be renewed every 4 months (120 days), unless otherwise specified. Renewal is not available for the listed nonrenewable indications.

    • Renewal is not permitted for bone marrow transplantation failure or engraftment delay.

    Policy Background

    Long-acting granulocyte colony-stimulating factors support neutrophil recovery and are used primarily to prevent or manage chemotherapy-associated neutropenic complications. Coverage also addresses selected uses involving hematopoietic acute radiation syndrome, transplantation-related engraftment or progenitor-cell mobilization, and specified pediatric oncology conditions. Medical necessity depends on the treatment indication, expected febrile-neutropenia risk, member-specific risk factors, prior neutropenic complications, and appropriate chemotherapy timing.

    Definitions and Clinical Terms

    Febrile neutropenia definition
    TemperatureA single oral temperature ≥38.3 °C or ≥38.0 °C over 1 hour
    Neutropenia threshold<500 neutrophils/mcL
    Alternative neutropenia threshold<1,000 neutrophils/mcL with a predicted decline to ≤500 neutrophils/mcL over the next 48 hours
    Member risk factors for febrile neutropenia
    Age and treatmentAge >65 years receiving full-dose-intensity chemotherapy
    Prior treatment or blood countsPrior exposure to chemotherapy or radiation therapy; persistent neutropenia
    Disease and infection factors

    Initial Therapy Criteria

    Initial Authorization Requirements

    Initial authorization requires all applicable product-selection and age requirements.

    Initial authorization requirements: For another pegfilgrastim product, the member has a contraindication, intolerance, or failure to both Fulphila and Udenyca; for Ryzneuta, the member has a contraindication, intolerance, or failure to Rolvedon; and members receiving Rolvedon or Ryzneuta are at least 18 years of age.Age >=18 years for Rolvedon and Ryzneuta

    The applicable preferred-product prerequisite depends on the requested drug.

    Continuation and Renewal Criteria

    Renewal Criteria

    Renewal requires all of the following conditions.

    Renewal requirements

    Step Therapy Requirements

    StepPreferred product(s)Applies before consideration ofRequirement
    1Fulphila and UdenycaAnother pegfilgrastim productThe member must have a contraindication, intolerance, or failure to both Fulphila and Udenyca.
    1RolvedonRyzneutaThe member must have a contraindication, intolerance, or failure to Rolvedon.

    Quantity and Dosing Limits

    Quantity limit
    ProductsArmlupeg, Fulphila, Fylnetra, and Neulasta
    Quantity limit12 billable units
    ScheduleWeekly for 2 doses
    Quantity limit
    ProductsNyvepria, Stimufend/Pegfilgrastim-fpgk, and Udenyca
    Quantity limit12 billable units
    Schedule1 dose per course

    Administration and Site of Care

    Note

    Follow home-administration requirements

    These products are administered subcutaneously. Prefilled syringe products may be self-administered or administered by a caregiver or healthcare professional; Ryzneuta must be administered by a healthcare professional.

    Documentation Required

    Apply on-body injectors under provider supervision

    A healthcare provider must fill and apply the Neulasta or Udenyca on-body injector. It may be applied on the same day as chemotherapy only when the drug will be administered at least 24 hours after chemotherapy; use is not recommended for acute radiation exposure or pediatric members.

    Biosimilar and Product Selection

    Billing Rule

    Establish Fulphila and Udenyca failure or intolerance

    Another pegfilgrastim product may be considered only after the member has a contraindication, intolerance, or failure to both Fulphila and Udenyca. Document the applicable prerequisite before requesting or billing the nonpreferred product.

    Billing Rule

    Establish Rolvedon failure or intolerance

    Ryzneuta may be considered only after the member has a contraindication, intolerance, or failure to Rolvedon. Document that prerequisite before requesting or billing Ryzneuta.

    Policy Summary
    PayerViva Health Plan
    PolicyLong-Acting Granulocyte Colony-Stimulating Factors (LA-GCSF)
    Policy CodePolicy IC-0234
    Change TypeModified
    Effective DateN/A
    Last ReviewMay 5, 2026
    Next Review DateN/A
    Key ActionUse Q5169 for Armlupeg beginning 07/01/2026 and discontinue J3590 for Armlupeg on that date.
    SourceLink
    On This Page
    Coverage CriteriaCoding and Clinical ThresholdsAuthorization and Provider ActionsPolicy BackgroundDefinitions and Clinical TermsInitial Therapy CriteriaContinuation and Renewal CriteriaStep Therapy RequirementsQuantity and Dosing LimitsAdministration and Site of CareBiosimilar and Product Selection
    Bone marrow involvement by tumor.
  1. Human immunodeficiency virus (HIV) infection.
  2. Recent surgery and/or open wounds.
  3. Poor performance status.
  4. Renal dysfunction with creatinine clearance less than 50 mL/min.
  5. Liver dysfunction with bilirubin greater than 2.0 mg/dL.
  6. Chronic immunosuppression in the post-transplant setting, including organ transplantation.

  7. ALL of the following

    • The member is undergoing myelosuppressive chemotherapy with an expected incidence of febrile neutropenia less than 10%.

    • TWO OR MORE member-related risk factors

      • Age greater than 65 years while receiving full-dose-intensity chemotherapy.
      • Prior exposure to chemotherapy or radiation therapy.
      • Persistent neutropenia.
      • Bone marrow involvement by tumor.
      • Human immunodeficiency virus (HIV) infection.
      • Recent surgery and/or open wounds.
      • Poor performance status.
      • Renal dysfunction with creatinine clearance less than 50 mL/min.
      • Liver dysfunction with bilirubin greater than 2.0 mg/dL.
      • Chronic immunosuppression in the post-transplant setting, including organ transplantation.
    8. The member has favorable histology disease.
  8. The drug is used in combination with a cyclophosphamide-based chemotherapy regimen, specifically Regimen M or Regimen I.
  9. The member has pediatric aggressive mature B-cell lymphoma.

    Not applicable to Rolvedon or Ryzneuta.

    10. Creatinine clearance <50 mL/min
    ClassificationMember-related risk factor for febrile neutropenia
    Liver dysfunction risk factor
    Risk factorLiver dysfunction
    ThresholdElevated bilirubin >2.0 mg/dL
    ClassificationMember-related risk factor for febrile neutropenia
    Febrile neutropenia temperature
    Single oral temperature≥38.3 °C
    Sustained temperature≥38.0 °C over 1 hour
    Required combinationTemperature criterion occurs together with neutropenia
    Neutropenia
    Absolute neutrophil count<500 neutrophils/mcL
    Higher count with predicted decline<1,000 neutrophils/mcL with predicted decline to ≤500 neutrophils/mcL
    Prediction periodDecline predicted within the next 48 hours
  10. Renewal is not permitted for peripheral blood progenitor cell mobilization and transplant.
  11. Renewal is not permitted for acute exposure to myelosuppressive radiation (H-ARS), including Rolvedon and Ryzneuta.
    12. Prior Authorization

    Prior Authorization Applies

    Prior authorization is a utilization-management requirement that applies comparably, and not more stringently, to MH/SUD and medical/surgical medical-benefit prescription drugs. The PA determination considered the following factors.

    • Indication: considered for PA.
    • Safety and efficacy: PA not a priority.
    • Potential for misuse/abuse: PA not a priority.
    • Cost of drug: considered for PA.
    Step Therapy

    Preferred-Product Prerequisite

    Before another pegfilgrastim product will be considered, the member must have a contraindication, intolerance, or failure to both preferred products.

    • Required preferred-product prerequisites: Fulphila and Udenyca.
    • For Ryzneuta, the member must instead have a contraindication, intolerance, or failure to Rolvedon; Rolvedon and Ryzneuta criteria apply only to members at least 18 years of age.

    Unsupported block type: denial_risk

    Denial Risk

    Indication-Specific Criteria Not Met

    Prophylactic use may be denied when the chemotherapy-associated febrile-neutropenia risk threshold and member-specific risk-factor requirements are not met.

    • Expected febrile-neutropenia incidence greater than 20%: criterion may be met.
    • Expected incidence of 10% to 20%: at least 1 member-related risk factor is required.
    • Expected incidence below 10%: at least 2 member-related risk factors are required.

    Unsupported block type: denial_risk

    Denial Risk

    Unacceptable Toxicity

    Renewal may be denied when the member experiences unacceptable toxicity from the requested drug.

    • Examples include splenic rupture, acute respiratory distress syndrome (ARDS), serious allergic reactions/anaphylaxis, sickle cell crisis, glomerulonephritis, leukocytosis, thrombocytopenia, capillary leak syndrome, aortitis, and potential tumor-growth stimulation of malignant cells.
    • Other examples include myelodysplastic syndrome and acute myeloid leukemia in members with breast or lung cancer.
    Denial Risk

    Incorrect Chemotherapy Timing

    Do not administer a long-acting G-CSF within 14 days before or within 24 hours after cytotoxic chemotherapy. Administration outside this timing window is required to avoid a chemotherapy-timing denial or safety concern.

    • For on-body injectors, application on the same day as chemotherapy is permitted only when the drug is administered at least 24 hours after chemotherapy.
    • On-body injectors are not recommended for members with acute radiation exposure or pediatric members.
    Billing Rule

    Use the Replacement Armlupeg Code

    Use the replacement HCPCS code for Armlupeg beginning July 1, 2026. The prior unclassified-biologics code must be discontinued on that date.

    • Effective 07/01/2026: Q5169 — Injection, pegfilgrastim-unne (Armlupeg), biosimilar, 0.5 mg; 1 billable unit = 0.5 mg.
    • Do not use J3590 for Armlupeg after 07/01/2026; J3590 is discontinued for this product effective that date.
    Bone marrow involvement by tumor; human immunodeficiency virus (HIV) infection
    Recent clinical factorsRecent surgery and/or open wounds; poor performance status
    Renal dysfunctionCreatinine clearance <50 mL/min
    Liver dysfunctionElevated bilirubin >2.0 mg/dL
    ImmunosuppressionChronic immunosuppression in the post-transplant setting, including organ transplant
    Unbranded biologic
    Relationship to brandAn unbranded biologic is the same as the brand biologic
    Cell lineIt uses the same cell line as the brand-name reference biologic
    Example listed in the policyPegfilgrastim-fpgk is identified as the unbranded biologic of Stimufend
    Unbranded biologic
    Relationship to brandAn unbranded biologic is the same as the brand biologic
    Reference biologicThe brand-name biologic serves as the reference biologic
    Cell lineThe unbranded biologic uses the same cell line as the brand-name reference biologic
    Quantity limit
    ProductsZiextenzo and Rolvedon
    Quantity limit12 billable units
    Time periodPer 14 days
    Quantity limit
    ProductsArmlupeg, Fulphila, Fylnetra, and Neulasta
    IndicationAcute radiation exposure
    Quantity limit12 billable units weekly for 2 doses
    Quantity limit
    ProductsZiextenzo and Rolvedon
    IndicationsAll other indications
    Quantity limit132 billable units per 14 days
    Quantity limit
    ProductRyzneuta
    IndicationAcute radiation exposure
    Quantity limit40 billable units weekly for 2 doses
    Quantity limit
    ProductRyzneuta
    IndicationsAll other indications
    Quantity limit40 billable units per 14 days