Loading...

    Explore
    • Policy Monitoring
    • Live Policy Feed
    • Billing Codes
    • Healthcare Providers
    • Health Insurance Payers
    • States
    • Service Lines
    • Taxonomy Codes
    Lookup tools
    • Billing Code Lookup
    • CPT Modifier Lookup
    • Provider Taxonomy Code Lookup
    • Healthcare Provider & Facility Lookup
    • Health Insurance Payer Lookup
    • Payer Contact Directory

    Policy & Benchmark Tools

    • Prior Authorization Lookup
    • Coverage Criteria Lookup
    • Timely Filing Lookup
    • Billing Code Reimbursement Rates
    • Payer Comparison Dashboard
    • Facility Comparison Dashboard
    • All tools

    Company

    • About OpenPayer
    • Data Sources
    • Trek Health
    OpenPayerby Trek Health
    LinkedInYouTube

    © 2026 Trek Health. All rights reserved.

    OpenPayer is built and maintained by Trek Health.

    v1.0.30
    OpenPayerPolicy UpdatesPharmacy & Specialty DrugsOklahoma Nyvepria Stimufend Prior Auth | OpenPayer
    Ask Trek AI about this page
    CurrentOklahoma Health Care AuthorityPolicy N/A

    Nyvepria and Stimufend (pegfilgrastim-apgf and pegfilgrastim-fpgk) Approval Criteria

    Customize your policy alerts

    Sign up for all Oklahoma Health Care Authority policy alerts

    Know when Oklahoma Health Care Authority releases new policies or updates existing guidance.

    Monitor payer policy activity

    Receive email alerts as soon as relevant payer policies are published or updated.

    This policy governs prior authorization and coverage criteria for Nyvepria and Stimufend for SoonerCare members, requiring an FDA-approved diagnosis and a patient-specific, clinically significant reason preferred pegfilgrastim products cannot be used.

    Policy Summary
    PayerOklahoma Health Care Authority
    PolicyNyvepria and Stimufend Approval Criteria
    Policy CodePolicy N/A
    Change TypeNo material clinical or coverage change
    Effective DateJune 15, 2026
    Next Review DateN/A
    Key ActionSubmit Form PHARM-208 with an FDA-approved diagnosis and a patient-specific, clinically significant reason the member cannot use preferred pegfilgrastim products.
    SourceLink
    POLICY UPDATE CHANGES

    No material clinical or coverage changes in this revision.

    2Pegfilgrastim products addressed
    6Products without prior authorization
    2Medical-only benefits without prior authorization
    2Core approval criteria

    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.

    Coverage Criteria

    Nyvepria and Stimufend Initial Approval

    Nyvepria and Stimufend are covered when ALL of the following criteria are met:

    ALL of the following

    • The member has an FDA-approved diagnosis.
    • A patient-specific, clinically significant reason is provided explaining why the member cannot use Fulphila® (pegfilgrastim-jmdb), Fylnetra® (pegfilgrastim-pbbk), Neulasta® (pegfilgrastim), Neulasta® Onpro® (pegfilgrastim) as a medical-only benefit, Udenyca® (pegfilgrastim-cbqv) as a medical-only benefit, or Ziextenzo® (pegfilgrastim-bmez).

      Biosimilars and/or reference products are preferred based on the lowest net-cost product(s) and may be moved to preferred or non-preferred status if the net cost changes compared with the reference product and/or other available biosimilar products. Neulasta® Onpro® (pegfilgrastim) and Udenyca® (pegfilgrastim-cbqv) are covered as a medical-only benefit without prior authorization.

    Provider Actions

    Prior Authorization

    Prior Authorization Required for Nyvepria

    Nyvepria (pegfilgrastim-apgf) requires prior authorization effective June 15, 2026. Submit requests through the Oklahoma Health Care Authority (OHCA) prior authorization process. PA requirements are available at www.oklahoma.gov/ohca/pa under the “Oncologic Therapies” therapeutic category.

    • Products that do not require PA include Fulphila (pegfilgrastim-jmdb), Fylnetra (pegfilgrastim-pbbk), Neulasta (pegfilgrastim), Ziextenzo (pegfilgrastim-bmez), and Neulasta Onpro and Udenyca as medical-only benefits.
    Documentation Required

    Approval Criteria

    Requests for Nyvepria and Stimufend (pegfilgrastim-fpgk) must establish that the requested product is medically appropriate for the member.

    • The member must have an FDA-approved diagnosis.
    • A patient-specific, clinically significant reason must be provided for use of the requested product.
    Step Therapy

    Preferred Pegfilgrastim Products

    Preferred biosimilar and reference products must be considered before requesting Nyvepria or Stimufend.

    • Explain why the member cannot use Fulphila, Fylnetra, Neulasta, Neulasta Onpro as a medical-only benefit, Udenyca as a medical-only benefit, or Ziextenzo.
    • Biosimilars and reference products are preferred based on the lowest-net-cost product(s); preferred status may change if comparative net costs change.
    Documentation Required

    Clinical Justification and Diagnosis

    Include documentation supporting both the diagnosis and the clinical need for the requested pegfilgrastim product.

    • Document the member’s FDA-approved diagnosis.
    • Provide a patient-specific, clinically significant explanation of why the member cannot use each applicable preferred product.
    • Identify any applicable medical-only benefit limitation for Neulasta Onpro or Udenyca.
    Prior Authorization

    Required Request Form: PHARM-208

    Use Form PHARM-208 for Granulocyte Colony-Stimulating Factor (G-CSF) requests.

    • The form is available at www.oklahoma.gov/ohca/rxforms.
    • Submit the completed form and supporting clinical documentation through the OHCA prior authorization process.
    Denial Risk

    Failure to Meet Approval Criteria

    A request may be denied when the approval criteria are not met.

    • Denial applies when an FDA-approved diagnosis is not documented.
    • Denial applies when a patient-specific, clinically significant justification for inability to use the preferred pegfilgrastim products is not provided.

    Policy Background

    This policy addresses pegfilgrastim, a granulocyte colony-stimulating factor (G-CSF) therapy, including Nyvepria (pegfilgrastim-apgf) and Stimufend (pegfilgrastim-fpgk). Coverage applies when these products are used for an FDA-approved diagnosis and the required clinical justification is provided. The policy also identifies preferred pegfilgrastim products and specifies that Neulasta Onpro and Udenyca are covered as medical-only benefits without prior authorization.

    Initial Therapy

    Initial Therapy

    Initial approval requires all of the following:

    Initial therapy requirements

    • FDA-approved diagnosis: The member has an FDA-approved diagnosis.
    • Clinical reason for nonpreferred product: A patient-specific, clinically significant reason is provided why the member cannot use Fulphila (pegfilgrastim-jmdb), Fylnetra (pegfilgrastim-pbbk), Neulasta (pegfilgrastim), Neulasta Onpro (pegfilgrastim) as a medical-only benefit, Udenyca (pegfilgrastim-cbqv) as a medical-only benefit, or Ziextenzo (pegfilgrastim-bmez).

      Preferred products are selected based on the lowest net cost product or products.

    Preferred Product Step Therapy

    StepRequirement
    1Provide a patient-specific, clinically significant reason why the member cannot use Fulphila (pegfilgrastim-jmdb), Fylnetra (pegfilgrastim-pbbk), Neulasta (pegfilgrastim), Neulasta Onpro (pegfilgrastim) as a medical-only benefit, Udenyca (pegfilgrastim-cbqv) as a medical-only benefit, or Ziextenzo (pegfilgrastim-bmez).

    Medical-Only Benefits

    Note

    Use the medical-only benefit pathway

    Neulasta Onpro and Udenyca are covered as medical-only benefits without prior authorization.

    • Neulasta Onpro: medical-only benefit
    • Udenyca: medical-only benefit

    Preferred Biosimilar Product Selection

    Billing Rule

    Verify current preferred product status

    Preferred pegfilgrastim products are selected based on the lowest net cost product or products. Products may be moved between preferred and non-preferred status if net cost changes.

    • Check current preferred status before selecting the product.
    • Preferred status is based on comparative net cost.
    Billing Rule

    Account for changing preferred status

    Preferred pegfilgrastim products are selected based on the lowest net cost product or products, and preferred status may change when net cost changes in comparison with the reference product or other available biosimilars.

    • Product status may change over time.
    • Use the product currently designated as preferred.
    Policy Summary
    PayerOklahoma Health Care Authority
    PolicyNyvepria and Stimufend Approval Criteria
    Policy CodePolicy N/A
    Change TypeNo material clinical or coverage change
    Effective DateJune 15, 2026
    Next Review DateN/A
    Key ActionSubmit Form PHARM-208 with an FDA-approved diagnosis and a patient-specific, clinically significant reason the member cannot use preferred pegfilgrastim products.
    SourceLink
    On This Page
    Coverage CriteriaProvider ActionsPolicy BackgroundInitial TherapyPreferred Product Step TherapyMedical-Only BenefitsPreferred Biosimilar Product Selection
    Billing Rule

    Apply Udenyca’s medical-only benefit rule

    Select preferred products based on the lowest net cost product or products. Udenyca is covered as a medical-only benefit without prior authorization.

    • Udenyca is not subject to PA when covered through the medical-only benefit.
    • Confirm the applicable benefit pathway before submitting the request.
    Billing Rule

    Review status before billing

    Preferred pegfilgrastim products may be moved to preferred or non-preferred status if the net cost changes in comparison with the reference product or other available biosimilar products.

    • Review current product status before billing or requesting a non-preferred product.
    • For non-preferred products, provide the required patient-specific clinical justification.