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    v1.0.30
    OpenPayerPolicy UpdatesPharmacy & Specialty DrugsAHCA Benlysta Prior Auth Coverage | OpenPayer
    Ask Trek AI about this page
    CurrentAgency for Health Care AdministrationPolicy N/A

    Benlysta (belimumab) Prior Authorization Criteria

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    This policy governs prior authorization for Benlysta (belimumab) for active, autoantibody-positive systemic lupus erythematosus and active lupus nephritis, and applies to providers requesting coverage through the Agency for Health Care Administration.

    Policy Summary
    PayerAgency for Health Care Administration
    PolicyBenlysta (belimumab) Prior Authorization Criteria
    Policy CodePolicy N/A
    Change TypeNo material change
    Effective DateN/A
    Next Review DateN/A
    Key ActionSubmit prior authorization documentation showing that the patient meets the applicable initial or continuation coverage criteria.
    SourceLink
    POLICY UPDATE CHANGES

    No material clinical or coverage changes in this revision.

    6 monthsMaximum authorization length
    ≥5 yearsSLE minimum age
    ≥18 yearsLupus nephritis minimum age
    2Covered indications
    3

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    Dosage forms

    Coverage Criteria

    Initial Therapy: General Criteria

    Covered when ALL of the following general initial review criteria are met:

    ALL of the following

    • Patient does not have a diagnosis of severe active central nervous system (CNS) disease.
    • Patient is not being treated for a chronic infection.
    • Patient has not been vaccinated with a live vaccine within the last 30 days.
    • Other biologic agents will not be used in combination with Benlysta (belimumab).

    • Patient is receiving standard therapy with at least ONE of the following:

      • NSAIDs.
      • Antimalarials, including hydroxychloroquine.
      • Systemic glucocorticoids.
      • Immunosuppressive agents, including cyclophosphamide, methotrexate (MTX), azathioprine, or mycophenolate.

    Initial Therapy: Systemic Lupus Erythematosus

    For diagnosis of systemic lupus erythematosus (SLE), the following criteria must be met in addition to the general initial review criteria:

    ALL of the following

    • Patient is at least 5 years of age.>= 5 years
    • Patient has a documented diagnosis of active, autoantibody-positive systemic lupus erythematosus (SLE).

    Initial Therapy: Active Lupus Nephritis

    For diagnosis of active lupus nephritis, the following criteria must be met in addition to the general initial review criteria:

    ALL of the following

    • Patient is at least 18 years of age.>= 18 years
    • Patient has a documented diagnosis of active lupus nephritis.

    Continuation Therapy

    Continuation of therapy is covered when ALL of the following criteria are met:

    ALL of the following

    • Patient met the initial review criteria.
    • Documentation demonstrates an improved clinical response.
    • Dosing is appropriate according to labeling or is supported by compendia.

    Coverage is subject to the following additional exclusions and restrictions:

    Benlysta is not covered for patients with severe active central nervous system (CNS) disease, patients being treated for a chronic infection, or patients who received a live vaccine within the last 30 days. Benlysta must not be used in combination with other biologic agents.

    Provider Actions and Review Requirements

    Prior Authorization

    Prior Authorization Required

    Prior authorization is required for Benlysta (belimumab) for all indications. Authorization may be issued for up to 6 months.

    Documentation Required

    Systemic Lupus Erythematosus Documentation

    For systemic lupus erythematosus (SLE), document an active, autoantibody-positive diagnosis and confirm that the patient is at least 5 years of age.

    • Documented diagnosis of active, autoantibody-positive SLE.
    • Patient age: ≥ 5 years.
    Documentation Required

    Lupus Nephritis Documentation

    Policy Background

    Benlysta (belimumab) is authorized under this policy for active, autoantibody-positive systemic lupus erythematosus in patients 5 years of age or older and for active lupus nephritis in patients 18 years of age or older. Treatment must be used with specified standard therapies and must not be combined with another biologic agent.

    Initial Therapy Criteria

    Initial Therapy for Systemic Lupus Erythematosus

    Initial therapy requires all general initial review criteria plus all systemic lupus erythematosus-specific criteria.

    Systemic lupus erythematosus initial therapy

    • General initial review criteria

      • Patient does not have severe active CNS disease.
      • Patient is not being treated for a chronic infection.
      • Patient has not received a live vaccine within the last 30 days.
      • Other biologic agents will not be used in combination with Benlysta.

      • Standard therapy

    Continuation Therapy

    Benlysta Continuation Therapy

    Continuation therapy is covered when all of the following are met.

    Continuation criteria

    • Patient met initial review criteria.
    • Documentation shows improved clinical response.
    • Dosing is appropriate according to labeling or is supported by compendia.

    Authorization Duration

    Quantity limits
    MedicationBenlysta (belimumab)
    Maximum authorization lengthUp to 6 months
    Authorization periodPer course

    Administration Setting

    Billing Rule

    Administer IV Benlysta in an equipped setting

    For intravenous use, administer Benlysta through healthcare providers prepared to manage anaphylaxis.

    Policy Summary
    PayerAgency for Health Care Administration
    PolicyBenlysta (belimumab) Prior Authorization Criteria
    Policy CodePolicy N/A
    Change TypeNo material change
    Effective DateN/A
    Next Review DateN/A
    Key ActionSubmit prior authorization documentation showing that the patient meets the applicable initial or continuation coverage criteria.
    SourceLink
    On This Page
    Coverage CriteriaProvider Actions and Review RequirementsPolicy BackgroundInitial Therapy CriteriaContinuation TherapyAuthorization DurationAdministration Setting

    For active lupus nephritis, document the active diagnosis and confirm that the patient is at least 18 years of age.

    • Documented diagnosis of active lupus nephritis.
    • Patient age: ≥ 18 years.
    Documentation Required

    Continuation Documentation Required

    For continuation of therapy, submit documentation showing an improved clinical response and confirm that dosing is appropriate according to labeling or supported by compendia.

    • Patient met the initial review criteria.
    • Documentation of improved clinical response.
    • Dosing is appropriate per labeling or supported by compendia.
    Denial Risk

    Clinical Safety Exclusions

    Authorization may be denied when clinical safety exclusions apply, including severe active central nervous system disease, treatment for a chronic infection, recent live vaccination, or combination use with another biologic agent.

    • No diagnosis of severe active CNS disease.
    • Patient is not being treated for a chronic infection.
    • No live vaccine in the last 30 days.
    • Other biologic agents will not be used in combination with Benlysta.
    Denial Risk

    Required Standard Therapy

    Authorization may be denied if the patient is not receiving standard therapy with an accepted concomitant treatment.

    • NSAIDs.
    • Antimalarials, including hydroxychloroquine.
    • Systemic glucocorticoids.
    • Immunosuppressive agents, including cyclophosphamide, methotrexate, azathioprine, or mycophenolate.
    Denial Risk

    Indication-Specific Eligibility

    Indication-specific eligibility must be met for the requested use: SLE requires a patient age of at least 5 years, while active lupus nephritis requires a patient age of at least 18 years. The applicable active diagnosis and supporting documentation must also be present.

    • Systemic lupus erythematosus: patient is ≥ 5 years and has active, autoantibody-positive SLE.
    • Active lupus nephritis: patient is ≥ 18 years and has active lupus nephritis.
    Denial Risk

    Continuation Requirements

    Continuation authorization may be denied without documentation of improved clinical response or when dosing is not compliant with labeling or compendia-supported guidance.

    • Improved clinical response must be documented.
    • Dosing must be appropriate per labeling or supported by compendia.
    • Patient is receiving an NSAID.
    • Patient is receiving an antimalarial, including hydroxychloroquine.
    • Patient is receiving a systemic glucocorticoid.
    • Patient is receiving an immunosuppressive agent: cyclophosphamide, methotrexate, azathioprine, or mycophenolate.

  1. Systemic lupus erythematosus-specific criteria

    • Patient is at least 5 years of age.Age ≥5 years
    • Patient has a documented diagnosis of active, autoantibody-positive systemic lupus erythematosus.

    2. Initial Therapy for Active Lupus Nephritis

    Initial therapy requires all general initial review criteria plus all active lupus nephritis-specific criteria.

    Active lupus nephritis initial therapy

    • General initial review criteria

      • Patient does not have severe active CNS disease.
      • Patient is not being treated for a chronic infection.
      • Patient has not received a live vaccine within the last 30 days.
      • Other biologic agents will not be used in combination with Benlysta.

      • Standard therapy

        • Patient is receiving an NSAID.
        • Patient is receiving an antimalarial, including hydroxychloroquine.
        • Patient is receiving a systemic glucocorticoid.
        • Patient is receiving an immunosuppressive agent: cyclophosphamide, methotrexate, azathioprine, or mycophenolate.

    • Active lupus nephritis-specific criteria

      • Patient is at least 18 years of age.Age ≥18 years
      • Patient has a documented diagnosis of active lupus nephritis.