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    v1.0.30
    OpenPayerPolicy UpdatesPharmacy & Specialty DrugsOklahoma Health Care Authority IG Coverage | OpenP…
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    ModifiedOklahoma Health Care AuthorityPolicy N/A

    Immune Globulin (IG) Intravenous (IV) and Subcutaneous (SC) Coverage Criteria

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    This policy governs Oklahoma Health Care Authority prior authorization requirements for specified intravenous and subcutaneous immune globulin products for SoonerCare members.

    Policy Summary
    PayerOklahoma Health Care Authority
    PolicyImmune Globulin (IG) Intravenous (IV) and Subcutaneous (SC) Coverage Criteria
    Policy CodePolicy N/A
    Change TypeModified
    Effective DateMay 1, 2026
    Next Review DateN/A
    Key ActionSubmit prior authorization requests for specified immune globulin products using Form PHARM-322.
    SourceLink
    POLICY UPDATE CHANGES

    Prior authorization is required for Alyglo, Asceniv, Bivigam, Cuvitru, Gammaplex, Hizentra, Octagam, Panzyga, and Xembify.

    9Products requiring prior authorization
    6 monthsMaximum initial approval
    Up to 1 yearMaximum subsequent approval
    3 monthsAge of weight documentation

    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.

    Immune Globulin Coverage Criteria

    Immune globulin initial and subsequent authorization

    Coverage requires one applicable clinical justification pathway, dosing documentation, and the applicable approval-duration requirement.

    Immune globulin prior authorization

    • Clinical justification pathway

      • Prior stabilization pathway: Document prior stabilization on the requested product with documented benefit from therapy, such as in recent office notes.
      • Alyglo or Asceniv pathway: For Alyglo or Asceniv, provide a patient-specific, clinically significant reason why the member cannot use all other available immunoglobulin therapy products.

        Applies only to Alyglo and Asceniv requests.

      • Route-appropriate alternative pathway: Provide a patient-specific, clinically significant reason why the member cannot use all available immunoglobulin therapy products appropriate for the requested route of administration.

        For IV requests, address Gammagard Liquid, Gammagard S/D, Gammaked, Gamunex-C, and Privigen. For SC requests, address Cutaquig, HyQvia, Gammagard Liquid, Gammaked, and Gamunex-C.

    • Dosing information: Provide the member's recent weight, taken within the last 3 months and identified as actual, ideal, or adjusted body weight as applicable, and provide the intended dosing frequency.Weight taken within the last 3 months

      The information is used to authorize the appropriate amount of product.

    • Approval duration: Initial approval may be for up to 6 months. Subsequent approval may be for up to 1 year when clinical effectiveness is documented.Initial: up to 6 months; subsequent: up to 1 year

    Dosing Documentation

    Recent member weight
    Documentation timingMember weight must be taken within the last 3 months.
    Dosing useThe recent weight must be used for dosing calculations.
    Weight typeIdentify the weight used as actual body weight, ideal body weight, or adjusted body weight, as applicable.

    Prior Authorization and Documentation

    Prior Authorization

    Prior Authorization Required for Specified Immune Globulin Products

    Prior authorization is required effective May 1, 2026 for the specified intravenous and subcutaneous immune globulin products. Submit the request using Form PHARM-322 through the OHCA website.

    • Affected products: Alyglo™ (IGIV, human-stwk), Asceniv™ (IGIV, human-slra), Bivigam® (IGIV, human), Cuvitru® (IGSC, human), Gammaplex® (IGIV, human), Hizentra® (IGSC, human), Octagam® (IGIV, human), Panzyga® (IGIV, human-ifas), and Xembify® (IGSC, human).
    • PA requirements are posted at www.oklahoma.gov/ohca/pa under the “Biologics” therapeutic category.
    • Form PHARM-322 is available at www.oklahoma.gov/ohca/rxforms and is used for IGIV/IGSC PA requests.
    Documentation Required

    Document the Clinical Rationale for Alternatives

    For the requested product, provide a patient-specific, clinically significant rationale explaining why the member cannot use the applicable alternatives available without prior authorization for the requested route of administration. For Alyglo™ and Asceniv™, the rationale must address why the member cannot use all other available immunoglobulin therapy products.

    Policy Background

    This policy governs human immune globulin administered intravenously (IGIV) or subcutaneously (IGSC) for SoonerCare members. Coverage decisions are product-specific and require an applicable clinical justification, consideration of route-appropriate alternatives, and dosing information based on the member’s recent weight.

    Administration Routes

    IGIV
    TermIGIV
    RouteIntravenous (IV)
    DefinitionImmune globulin administered through an intravenous route.
    IGSC
    TermIGSC
    RouteSubcutaneous (SC)
    DefinitionImmune globulin administered through a subcutaneous route.

    Initial Immune Globulin Therapy

    Initial immune globulin therapy

    Initial requests must satisfy one applicable clinical justification pathway and provide the required dosing information.

    Initial immune globulin authorization

    • Clinical justification

      • Stabilization and benefit: Document prior stabilization on the requested product with documented benefit from therapy, such as in recent office notes.
      • Alternative-product exception: Provide a patient-specific, clinically significant reason why the member cannot use all available immunoglobulin therapy products appropriate for the requested route of administration.

        For Alyglo and Asceniv, provide the reason the member cannot use all other available immunoglobulin therapy products.

    Subsequent Approval

    Subsequent approval

    Subsequent approval requires documentation of clinical effectiveness.

    Continuation approval: Document clinical effectiveness of the requested immune globulin therapy for subsequent approval.Approval may be granted for up to 1 year when clinical effectiveness is documented.

    Alternative Product Requirements

    StepRequirement
    1Provide a patient-specific, clinically significant reason why the member cannot use all available immunoglobulin therapy products appropriate for the requested route of administration. For Alyglo and Asceniv, provide a reason why the member cannot use all other available immunoglobulin therapy products.

    Approval Duration

    Approval duration
    Initial approvalUp to 6 months.
    Subsequent approvalUp to 1 year when clinical effectiveness is documented.
    Continuation documentationSubsequent approval requires documentation of clinical effectiveness.
    Policy Summary
    PayerOklahoma Health Care Authority
    PolicyImmune Globulin (IG) Intravenous (IV) and Subcutaneous (SC) Coverage Criteria
    Policy CodePolicy N/A
    Change TypeModified
    Effective DateMay 1, 2026
    Next Review DateN/A
    Key ActionSubmit prior authorization requests for specified immune globulin products using Form PHARM-322.
    SourceLink
    On This Page
    Immune Globulin Coverage CriteriaDosing DocumentationPrior Authorization and DocumentationPolicy BackgroundAdministration RoutesInitial Immune Globulin TherapySubsequent ApprovalAlternative Product RequirementsApproval Duration
    • IV alternatives: Gammagard Liquid® (IG infusion, human), Gammagard S/D® (IGIV, human), Gammaked™ (IG injection, human), Gamunex®-C (IG injection, human), and Privigen® (IGIV, human).
    • SC alternatives: Cutaquig® (IGSC, human), HyQvia® (IG infusion, human and recombinant human hyaluronidase), Gammagard Liquid® (IG infusion, human), Gamunex®-C (IG injection, human), and Gammaked™ (IG injection, human).
    • The rationale must be specific to the member and clinically significant; a general preference for the requested product is not sufficient.
    Documentation Required

    Submit Required Clinical Documentation

    Submit recent office notes documenting prior stabilization on the requested product and documented benefit from therapy. The PA request must also include the member’s recent weight, taken within the last 3 months, and the intended dosing frequency to support authorization of the appropriate quantity.

    • Recent weight may be actual body weight, ideal body weight, or adjusted body weight, as applicable to dosing calculations.
    • Initial approvals may be issued for up to 6 months.
    • Subsequent approval may be issued for up to 1 year when clinical effectiveness is documented.
    Denial Risk

    Missing Documentation May Result in Denial

    A request is at risk for denial when required clinical documentation is missing or does not establish medical necessity. Ensure the record includes stabilization, benefit, and a patient-specific clinically significant rationale for avoiding the applicable alternatives.

    • Missing recent office notes documenting prior stabilization on the requested product may result in denial.
    • Missing documentation of benefit or clinical effectiveness may prevent initial or subsequent approval.
    • Missing or non-specific rationale explaining why the member cannot use the applicable no-PA alternatives may result in denial, including the requirement for Alyglo™ and Asceniv™ to address all other available immunoglobulin therapy products.
    • Missing recent weight or intended dosing frequency may prevent authorization of the appropriate amount of product.
    Dosing documentation:
    Provide the member's recent weight used for dosing calculations and the intended dosing frequency.
    Weight taken within the last 3 months

    Weight may be actual body weight, ideal body weight, or adjusted body weight, as applicable.