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    v1.0.28
    OpenPayerPolicy UpdatesPharmacy & Specialty DrugsGeorgia DCH Immunomodulators Prior Auth Coverage |…
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    CurrentGeorgia Department of Community HealthPolicy N/A

    Georgia Medicaid Fee-for-Service Immunomodulators, Miscellaneous PA Summary

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    This document governs prior authorization (PA) requirements and medical necessity criteria for selected immunomodulator and miscellaneous specialty drugs for Georgia Medicaid Fee-for-Service members and providers.

    Policy Summary
    PayerGeorgia Department of Community Health
    PolicyImmunomodulators prior authorization summary (Besremi, Rhapsido, Vyvgart Hytrulo)
    Policy CodePolicy N/A
    Change TypeNo material changes
    Effective DateN/A
    Next Review DateN/A
    Key ActionObtain prior authorization from OptumRx (call 1-866-525-5827 or use the online PA request guides) before initiating therapy for listed products.
    SourceLink
    POLICY UPDATE CHANGES

    No material clinical or coverage changes in this revision.

    Initial: 6 moLength of authorization
    18+Minimum age
    RequiredPA requirement

    Coverage Criteria for Listed Drugs

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    Besremi (ropeginterferon alfa-2b-njft)

    Besremi — Covered when ALL of the following are met

    Besremi initial criteria: Member is >= 18 years of age
    Besremi initial criteria: Diagnosis of polycythemia vera with documented JAK2 V617F or JAK2 exon 12 mutation
    Besremi initial criteria: Hemoglobin > 16 g/dL OR hematocrit > 48%hemoglobin > 16 g/dL or hematocrit > 48%
    Besremi initial criteria: Documented inadequate response, allergy, contraindication, drug-drug interaction, or intolerable side effect to hydroxyurea

    Must be prescribed by or in consultation with a hematologist, oncologist, or other specialist.

    Rhapsido (remibrutinib)

    Rhapsido — Covered when ALL of the following are met

    Rhapsido initial criteria: Member is >= 18 years of age
    Rhapsido initial criteria: Diagnosis of chronic spontaneous urticaria (CSU) with symptoms (e.g., itching, hives) for >= 6 weekssymptoms >= 6 weeks
    Rhapsido initial criteria: Documented inadequate response, allergy, contraindication, drug-drug interaction, or intolerable side effects to at least 2 second-generation H1-antihistamines at maximum doses and to Dupixent or Xolairfailure of >= 2 second-generation H1-antihistamines
    Rhapsido initial criteria: If not a candidate for injectable therapy, submission of a written letter of medical necessity stating the reason the member is not a candidate for injectable therapy

    Vyvgart Hytrulo (efgartigimod alfa and hyaluronidase-qvfc)

    Vyvgart Hytrulo — Covered when ONE of the following indication-specific sets is met

    Vyvgart Hytrulo for generalized myasthenia gravis (gMG): Member is >= 18 years of age AND diagnosis of generalized myasthenia gravis who is anti-acetylcholine receptor (AChR) antibody positive AND MGFA class II, III, or IV AND IgG >= 6 g/L AND has tried two immunosuppressive therapies over the last 12 months and failed to achieve an adequate response OR has tried at least one immunosuppressive therapy and required four or more courses of plasmapheresis and/or IVIG over the last 12 months without symptom controlIgG >= 6 g/L; tried 2 immunosuppressive therapies over 12 months OR >=4 plasmapheresis/IVIG courses

    Must be prescribed by or in consultation with a neurologist or other specialist.

    Vyvgart Hytrulo for chronic inflammatory demyelinating polyneuropathy (CIDP): Member is >= 18 years of age AND diagnosis of CIDP confirmed by electrophysiologic diagnostic testing AND progressive symptoms for at least 2 months AND symptomatic polyradiculoneuropathy AND inadequate response, allergy, contraindication, drug-drug interaction, or intolerable side effects with glucocorticoids and immune globulin or plasma exchangeprogressive symptoms >= 2 months

    Must be prescribed by or in consultation with a neurologist or other specialist.

    The IV formulation of Vyvgart and Vyvgart Hytrulo vials are not covered under Pharmacy Service. When seeking coverage for administration of these products in a physician office or clinic, providers must request authorization through the Physician Services workflow on the Georgia Health Partnership website (Registered User portal at https://www.mmis.georgia.gov/portal).

    All other listed agents in this summary remain subject to the standard prior authorization process administered by OptumRx; site-specific coverage rules for IV/vial formulations of Vyvgart do not change the requirement to obtain PA for the drug itself.

    Initial therapy criteria

    Initial authorization criteria summarized per drug

    Besremi initial: See Besremi criteria: member >=18 years, polycythemia vera with JAK2 V617F or exon 12 mutation, hemoglobin >16 g/dL or hematocrit >48%, and inadequate response/intolerance to hydroxyurea; specialist involvement required

    Initial authorization length: 6 months

    Rhapsido initial: See Rhapsido criteria: member >=18 years, CSU >=6 weeks, failure of >=2 second-generation H1-antihistamines at maximum doses and Dupixent or Xolair; letter of medical necessity if not candidate for injectable therapy; specialist involvement required

    Initial authorization length: 6 months

    Vyvgart Hytrulo initial: See Vyvgart Hytrulo criteria for gMG (anti-AChR+, MGFA II–IV, IgG >=6 g/L, failed immunosuppressives or multiple plasmapheresis/IVIG courses) and for CIDP (electrophysiologic confirmation, >=2 months progressive symptoms, failed steroids and IVIG/plasma exchange); specialist involvement requiredIgG >= 6 g/L; progressive symptoms >= 2 months

    Initial authorization length: 6 months

    Provider Actions and Prior Authorization

    Prior Authorization

    Prior authorization required — initiate via OptumRx or online

    Prior authorization (PA) is required for the listed products. To initiate a PA, providers may call OptumRx at 1-866-525-5827 or follow the online PA request instructions on the Georgia Department of Community Health websites.

    Step Therapy

    Document prior therapy failures per drug-specific criteria

    Approval requires documented failure, intolerance, allergy, contraindication, or drug–drug interaction with the specified prior therapies for each drug: hydroxyurea for Besremi; at least 2 second‑generation H1‑antihistamines at maximum doses plus Dupixent or Xolair for Rhapsido; and appropriate immunosuppressants and IVIG/plasmapheresis criteria for Vyvgart Hytrulo.

    • Besremi: inadequate response/intolerance to hydroxyurea is required (Besremi criteria).
    • Rhapsido: inadequate response/intolerance to ≥2 second‑generation H1‑antihistamines at max doses and Dupixent or Xolair; letter of medical necessity if not candidate for injectable therapy (Rhapsido criteria).
    • Vyvgart Hytrulo: inadequate response/intolerance to specified immunosuppressive therapies or required multiple courses of plasmapheresis/IVIG per gMG/CIDP criteria (Vyvgart criteria).
    Documentation Required

    Request physician‑service authorization for Vyvgart IV/vial office administration

    If requesting coverage for IV or vial formulations of Vyvgart administered in a physician office or clinic, providers must request coverage through the Registered User (Physician Services) portion of the Georgia Health Partnership website at https://www.mmis.georgia.gov/portal.

    Denial Risk

    PA required — lack of PA may lead to denial; exceptions handled via PA

    Failure to obtain prior authorization through the OptumRx PA process may result in denial of coverage; exceptions to coverage conditions are considered only through the prior authorization process.

    Billing Rule

    Vyvgart IV/vial formulations require physician‑service authorization (not covered under Pharmacy Service)

    IV and vial formulations of Vyvgart are not covered under Pharmacy Service; administration in a physician office or clinic requires authorization via Physician Services on the Georgia Health Partnership website.

    • Do not bill these formulations through pharmacy benefit — request Physician Services authorization for office/infusion administration.

    Initial Therapy Criteria (per drug)

    Initial therapy criteria

    Initial authorization criteria summarized per drug

    Besremi initial: See Besremi criteria: member >=18 years, polycythemia vera with JAK2 V617F or exon 12 mutation, hemoglobin >16 g/dL or hematocrit >48%, and inadequate response/intolerance to hydroxyurea; specialist involvement required

    Initial authorization length: 6 months

    Rhapsido initial: See Rhapsido criteria: member >=18 years, CSU >=6 weeks, failure of >=2 second-generation H1-antihistamines at maximum doses and Dupixent or Xolair; letter of medical necessity if not candidate for injectable therapy; specialist involvement required

    Initial authorization length: 6 months

    Vyvgart Hytrulo initial: See Vyvgart Hytrulo criteria for gMG (anti-AChR+, MGFA II–IV, IgG >=6 g/L, failed immunosuppressives or multiple plasmapheresis/IVIG courses) and for CIDP (electrophysiologic confirmation, >=2 months progressive symptoms, failed steroids and IVIG/plasma exchange); specialist involvement requiredIgG >= 6 g/L; progressive symptoms >= 2 months

    Initial authorization length: 6 months

    ProductPrior therapy required before approval
    Besremi (ropeginterferon alfa-2b-njft)
    Member must have experienced an inadequate response, allergy, contraindication, drug-drug interaction, or intolerable side effect with hydroxyurea
    Rhapsido (remibrutinib)
    Member must have experienced an inadequate response, allergy, contraindication, drug-drug interaction, or intolerable side effects with at least 2 second-generation H1-antihistamines at maximum doses and with Dupixent or Xolair; if not a candidate for injectable therapy, a written letter of medical necessity is required
    Vyvgart Hytrulo (efgartigimod alfa and hyaluronidase-qvfc) — gMG indication
    Member must have tried two immunosuppressive therapies over the last 12 months and failed to achieve an adequate response OR have tried at least one immunosuppressive therapy and required four or more courses of plasmapheresis and/or IVIG over the last 12 months without symptom control
    Vyvgart Hytrulo (efgartigimod alfa and hyaluronidase-qvfc) — CIDP indication
    Member must have experienced inadequate response, allergies, contraindications, drug-drug interactions, or intolerable side effects with glucocorticoids and immune globulin or plasma exchange

    Renewal and Continuation Criteria

    Renewal

    Renewal authorization

    Renewals authorized for 1 year per policy length of authorization1 year

    Key Definitions

    MGFA class II-IV — definition and policy relevance
    DefinitionMyasthenia Gravis Foundation of America (MGFA) clinical classification specifying moderate to severe generalized myasthenia gravis (classes II–IV).
    Clinical implicationMGFA class II–IV indicates moderate to severe generalized MG and is required for Vyvgart Hytrulo coverage for anti‑AChR positive gMG patients.
    Age applicabilityApplies to members 18 years of age or older as specified in Vyvgart Hytrulo criteria.
    JAK2 mutation — Besremi approval requirement
    DefinitionPresence of JAK2 V617F or JAK2 exon 12 mutation required for Besremi approval in polycythemia vera.
    Associated criteriaMember must be ≥18 years old with PV and have hemoglobin >16 g/dL or hematocrit >48% in addition to JAK2 mutation for Besremi coverage.
    Therapy requirementDocumented inadequate response, allergy, contraindication, drug‑drug interaction, or intolerable side effect with hydroxyurea is required before approval.

    Quantity Limits and Related Guidance

    See current QLL list — Quantity Level Limits reference
    InstructionRefer to the online Quantity Level Limits (QLL) list for current quantity limitations: visit www.mmis.georgia.gov/portal → Pharmacy → Other Documents → select the most recent QLL list.
    LocationQLL list is available on the MMIS Georgia portal under Pharmacy → Other Documents.
    ScopeQLL provides the current, authoritative quantity limitations applicable to the drugs in this policy.

    Background

    This summary outlines the prior authorization clinical-entry requirements for selected immunomodulator and related specialty therapies covered under Georgia Medicaid Fee‑for‑Service. The document sets specific diagnostic, prior‑therapy, and specialist involvement criteria that must be met before approval and notes program-level rules such as length of authorization and site‑of‑care routing.

    Notably, certain products (e.g., Besremi and Vyvgart Hytrulo) are designated as preferred yet still require prior authorization. Providers should follow the PA initiation process and the site‑specific instruction for IV or vial administration of Vyvgart formulations described in the Physician Services portal when applicable.

    Policy Summary
    PayerGeorgia Department of Community Health
    PolicyImmunomodulators prior authorization summary (Besremi, Rhapsido, Vyvgart Hytrulo)
    Policy CodePolicy N/A
    Change TypeNo material changes
    Effective DateN/A
    Next Review DateN/A
    Key ActionObtain prior authorization from OptumRx (call 1-866-525-5827 or use the online PA request guides) before initiating therapy for listed products.
    SourceLink
    On This Page
    Coverage Criteria for Listed DrugsProvider Actions and Prior AuthorizationInitial Therapy Criteria (per drug)Renewal and Continuation CriteriaKey DefinitionsQuantity Limits and Related GuidanceBackground

    Must be prescribed by or in consultation with an allergist, immunologist, dermatologist, or other specialist.