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    v1.0.31
    OpenPayerPolicy UpdatesNeurology/NeurosurgeryAdvanced Health Myasthenia Gravis Coverage | OpenP…
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    CurrentAdvanced HealthPolicy N/A

    Myasthenia Gravis Agents Drug Use Criteria

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    This policy governs prior authorization for selected agents used to treat generalized myasthenia gravis in Advanced Health Medicaid members, including initial and renewal requirements for FDA-labeled use, adult age, specialist prescribing, disease severity, antibody status, prior therapy, laboratory thresholds, dosing, and clinical benefit.

    Policy Summary
    PayerAdvanced Health
    PolicyMyasthenia Gravis Agents Drug Use Criteria
    Policy CodePolicy N/A
    Change TypeNo material change
    Effective DateN/A
    Last ReviewFeb 12, 2025
    Next Review DateN/A
    Key ActionSubmit prior authorization documentation showing the OHP-funded condition, requested product and dose, member age, neurology specialist prescription, MG-ADL score, current MG therapy, MGFA class, antibody serology, applicable IgG level, and FDA-labeled dosing.
    SourceLink
    POLICY UPDATE CHANGES

    No material clinical or coverage changes in this revision.

    6 agentsAgents addressed
    ≥5Minimum MG-ADL score
    >18Minimum member age
    II-IVClinical classification

    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.

    2 cyclesInitial approval
    7 cyclesRenewal approval

    Coverage Criteria

    Initial Therapy

    Covered for initial therapy when ALL applicable common requirements and ONE product-specific pathway are met:

    ALL of the following

    • The member has an OHP-funded condition.
    • The prescribed medication and dose are supported by the FDA-approved package insert indications and dosing guidelines for the prescribed product.
    • The member is greater than 18 years old.
    • The prescription is written by a neurology specialist.
    • The member's MG-ADL total score is greater than or equal to 5.>= 5
    • The member is established on a current dose of myasthenia gravis therapy, such as pyridostigmine, corticosteroids, azathioprine, mycophenolate mofetil, cyclosporine, or tacrolimus.
    • Documentation supports MGFA clinical classification class II to IV.

    • ONE product-specific pathway

      • ALL of the following

        • The requested product is Zilbrysq (zilucoplan).
        • The member has a positive serological test for anti-AChR antibodies.
        • The member has had an adequate trial of, or has a contraindication to, one corticosteroid.

      • ALL of the following

        • The requested product is efgartigimod.
        • The member has a positive serological test for anti-AChR antibodies.

    Initial Dosing and Approval Duration

    Initial approval requires ALL of the following:

    ALL of the following

    • The requested dose corresponds to FDA labeling for the prescribed product.
    • Initial approval is limited to up to 2 treatment cycles.Up to 2 cycles

    Renewal Therapy

    Renewal is covered when the applicable renewal requirements and clinical benefit criteria are met:

    ALL of the following

    • ONE renewal pathway

      • ALL of the following

        • The renewal request is for efgartigimod.
        • At least 50 days have elapsed from the start of the previous efgartigimod treatment cycle.>= 50 days
      • The renewal request is not for efgartigimod.

    • Demonstrated clinical benefit

    Off-label use of medication is not a covered OHP benefit. Requests that do not meet the FDA-approved package insert indications and dosing guidelines are not covered under this criterion.

    The requested medication is not FDA-approved for use in pediatric patients under this criterion; coverage requires the member to be greater than 18 years old.

    Clinical Thresholds and Coding Reference

    MG-ADL total score
    ThresholdMG-ADL total score must be ≥5 for an initial request.
    ApplicationThe score is assessed during the initial request criteria review.
    Below thresholdA score below 5 does not meet criteria.
    MGFA clinical classification
    Eligible rangeMGFA clinical classification must be Class II to IV.
    DocumentationSubmitted documentation must support the applicable MGFA classification.
    Below rangeClassification outside Class II to IV does not meet criteria.

    Authorization and Documentation Requirements

    Prior Authorization

    Initial Prior Authorization Required

    Obtain prior authorization for an initial request before dispensing an MG agent. The member must meet the initial-request eligibility and clinical criteria in this policy.

    • Request is for an OHP-funded condition.
    • Prescribed product and dose are supported by the FDA-approved package insert.
    • Member is an adult older than 18 years and the prescription is written by a neurology specialist.
    • Additional clinical criteria and documentation requirements must be met before approval.
    Prior Authorization

    Renewal Prior Authorization

    Renewal authorization is required for continued treatment. Efgartigimod renewals must be separated from the prior treatment cycle by at least 50 days and may be approved for up to 7 cycles when clinical benefit is demonstrated.

    • For efgartigimod, at least 50 days must have elapsed from the start of the previous treatment cycle.

    Policy Background

    This policy addresses drug treatment of generalized myasthenia gravis in adults. Covered agents include Vyvgart, Vyvgart Hytrulo, Ultomiris, Soliris, Zilbrysq, and Rystiggo. Eligibility is based on the applicable antibody status: anti-acetylcholine receptor antibody-positive disease, or for rozanolixizumab-noli, anti-AChR- or anti-MuSK-antibody-positive disease. Ultomiris and Soliris have other FDA-approved indications, but these criteria apply when they are prescribed for myasthenia gravis.

    Clinical Definitions

    Generalized myasthenia gravis
    ConditionGeneralized myasthenia gravis is the condition addressed by these treatment criteria.
    Adult populationThe criteria apply to adult patients.
    Antibody statusPatients must be anti-acetylcholine receptor antibody positive or anti-muscle-specific tyrosine kinase antibody positive, as applicable to the requested agent.
    MG-ADL
    Full nameMG-ADL means Myasthenia Gravis Activities of Daily Living.
    MeasureThe policy uses the MG-ADL total score to assess symptom burden.
    Initial-request threshold
    Policy Summary
    PayerAdvanced Health
    PolicyMyasthenia Gravis Agents Drug Use Criteria
    Policy CodePolicy N/A
    Change TypeNo material change
    Effective DateN/A
    Last ReviewFeb 12, 2025
    Next Review DateN/A
    Key ActionSubmit prior authorization documentation showing the OHP-funded condition, requested product and dose, member age, neurology specialist prescription, MG-ADL score, current MG therapy, MGFA class, antibody serology, applicable IgG level, and FDA-labeled dosing.
    SourceLink
    On This Page
    Coverage CriteriaClinical Thresholds and Coding ReferenceAuthorization and Documentation RequirementsPolicy BackgroundClinical Definitions
    The member's IgG level is greater than or equal to 6.0 g/L.>= 6.0 g/L

  1. ALL of the following

    • The requested product is rozanolixizumab-noli.

    • At least one applicable antibody status

      • The member has a positive serological test for anti-AChR antibodies.

      • ALL of the following

        • The member has a negative anti-AChR antibody result.
        • The member has a positive serological test for anti-muscle-specific tyrosine kinase antibody (MuSK-Ab+).
    • The member's IgG level is greater than or equal to 5.5 g/L.>= 5.5 g/L
    2. Reduction in symptoms of at least 2 points from the MG-ADL total baseline score.>= 2-point reduction
  2. Reduced hospitalizations.
  3. Reduced steroid use.
  4. Renewal approval is limited to up to 7 cycles.Up to 7 cycles
    5. IgG level for rozanolixizumab
    Minimum IgG levelIgG must be ≥5.5 g/L for rozanolixizumab.
    Applicable productThis threshold applies to requests for rozanolixizumab-noli.
    Criteria reviewIf the required IgG level is not met, the request does not meet criteria.
    IgG level for efgartigimod
    Minimum IgG levelIgG must be ≥6.0 g/L for efgartigimod.
    Applicable productThis threshold applies to efgartigimod requests under the IgG pathway.
    Criteria reviewIf the required IgG level is not met, the request does not meet criteria.
    Interval between efgartigimod cycles
    Minimum intervalAt least 50 days must have elapsed from the start of the previous efgartigimod treatment cycle.
    Applies toThe interval requirement applies to efgartigimod renewal requests.
    If not metA renewal is denied when fewer than 50 days have elapsed.
    Clinical benefit by MG-ADL
    Required reductionClinical benefit includes a reduction in symptoms of at least 2 points from the MG-ADL total baseline score.
    Additional evidenceClinical benefit may also include reduced hospitalizations or reduced steroid use.
    Applies toThe clinical-benefit requirement applies to renewal requests.
  5. Renewal approval requires documented clinical benefit, including at least a 2-point reduction from the baseline MG-ADL total score, reduced hospitalizations, or reduced steroid use.
  6. Initial approval is for up to 2 cycles when FDA-labeled dosing criteria are met.
    7. Step Therapy

    Trial of First-Line Therapy

    Before requesting an MG agent, confirm that the member is established on a current dose of appropriate first-line MG therapy. If the member is not currently receiving MG therapy, the request does not meet criteria and first-line treatment must be trialed unless another policy criterion supports an applicable exception.

    • Current MG therapy may include pyridostigmine, corticosteroids, or another immunosuppressant such as azathioprine, mycophenolate mofetil, cyclosporine, or tacrolimus.
    • Document the current therapy, dose, duration or established use, and response or tolerance when submitting the request.
    • Requests for members who are not established on current MG therapy are denied for failure to trial first-line therapies.
    Documentation Required

    Initial Clinical Documentation

    For an initial request, submit clinical records supporting the member’s diagnosis and severity and documenting the required antibody and laboratory findings applicable to the requested product.

    • MG-ADL total score of at least 5.
    • MGFA clinical classification of class II to IV.
    • Current MG therapy and relevant treatment history.
    • Anti-AChR antibody results; for rozanolixizumab-noli when applicable, anti-MuSK antibody results.
    • IgG level when required for rozanolixizumab or efgartigimod.
    Documentation Required

    Product-Specific Documentation

    Product-specific documentation is required for certain initial requests. Zilucoplan requests must include an adequate corticosteroid trial or a documented contraindication, and rozanolixizumab-noli requests must include the required antibody and IgG documentation.

    • For Zilbrysq (zilucoplan), document an adequate trial of one corticosteroid or a contraindication to corticosteroid therapy.
    • For rozanolixizumab-noli, document a positive anti-MuSK antibody result when the member is not anti-AChR antibody positive.
    • Document IgG of at least 5.5 g/L for rozanolixizumab or at least 6.0 g/L for efgartigimod, as applicable.
    Documentation Required

    Renewal Documentation

    For renewal, submit details of the prior treatment cycle and objective evidence that the member continues to benefit from therapy.

    • Identify the product and document the start of the previous efgartigimod cycle when applicable.
    • Document the prior baseline MG-ADL total score and the current score, showing a reduction of at least 2 points.
    • Provide evidence of reduced hospitalizations and/or reduced steroid use as additional clinical-benefit support.
    Denial Risk

    Basic Eligibility and Prescribing Requirements

    Requests are denied when basic funding, product, dosing, age, or prescriber requirements are not met.

    • Deny as BTL when the condition is not OHP-funded.
    • Deny when the requested medication or dose is not supported by FDA labeling; off-label use is not covered under OHP.
    • Deny when the member is 18 years old or younger because the requested medication is not FDA-approved for pediatric use.
    • Deny when the prescription is not written by a neurology specialist; refer the patient to a neurologist for evaluation.
    Denial Risk

    Clinical Criteria Not Met

    Clinical criteria are not met when the member’s disease severity, established therapy, classification, antibody status, laboratory findings, or supporting records do not satisfy the applicable requirements.

    • Deny when the MG-ADL total score is less than 5.
    • Deny when the member is not established on a current dose of MG therapy; first-line therapy must be trialed.
    • Deny when documentation does not support MGFA class II to IV.
    • Deny when required anti-AChR or anti-MuSK antibody results, IgG levels, corticosteroid trial or contraindication, or FDA-labeled dosing documentation are absent or do not meet criteria.
    Denial Risk

    Renewal Criteria Not Met

    Renewal requests are denied when the required treatment-cycle interval or evidence of ongoing clinical benefit is not documented.

    • For efgartigimod, deny when fewer than 50 days have elapsed from the start of the previous treatment cycle.
    • Deny when the member has not demonstrated clinical benefit, including at least a 2-point reduction from baseline MG-ADL, reduced hospitalizations, or reduced steroid use.
    • Deny when renewal documentation does not substantiate the prior cycle and current response.
    The initial request requires an MG-ADL total score of at least 5.
    MGFA clinical classification
    Full nameMGFA means Myasthenia Gravis Foundation of America.
    ClassificationMGFA clinical classification describes the patient's clinical disease class.
    Applicable rangeInitial documentation must support Class II through Class IV.
    AChR-positive
    MeaningAChR-positive means positive serological testing for anti-acetylcholine receptor antibodies.
    Eligible agentsAChR-positive disease is included for Vyvgart, Vyvgart Hytrulo, Ultomiris, Soliris, and Zilbrysq.
    Product pathwayFor AChR-positive disease, Zilbrysq follows the corticosteroid pathway; other applicable requests proceed through the IgG pathway.
    MuSK-Ab-positive
    MeaningMuSK-Ab-positive means positive serological testing for anti-muscle-specific tyrosine kinase antibodies.
    Applicable agentFor anti-AChR antibody-negative disease, the request must be for rozanolixizumab-noli.
    Eligibility pathwayWhen anti-AChR testing is negative, positive MuSK antibody testing is required for rozanolixizumab-noli.