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    v1.0.30
    OpenPayerPolicy UpdatesPharmacy & Specialty DrugsNorth Carolina Medicaid Kevzara Prior Auth | OpenP…
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    CurrentNorth Carolina MedicaidPolicy N/A

    Kevzara coverage for rheumatoid arthritis

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    This policy governs NC Medicaid outpatient pharmacy prior approval for Kevzara, a systemic immunomodulator, in beneficiaries with rheumatoid arthritis. It establishes clinical prerequisites, preferred-product sequencing, concurrent biologic restrictions, and approval duration.

    Policy Summary
    PayerNorth Carolina Medicaid
    PolicyKevzara coverage for rheumatoid arthritis
    Policy CodePolicy N/A
    Change TypeCriteria separated by individual agentno material clinical or coverage change
    Effective DateJun 27, 2018
    Next Review DateN/A
    Key ActionObtain prior approval for Kevzara and document the required diagnosis, safety screening, treatment history or disease-severity pathway, and preferred-product requirements.
    SourceLink
    POLICY UPDATE CHANGES

    The criteria were separated out by individual agents.

    12 monthsMaximum approval duration
    1Injectable immunomodulators allowed at a time
    3Treatment-pathway alternatives
    Enbrel or HumiraPreferred biologic trial

    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

    Rheumatoid Arthritis Initial Coverage

    Covered for rheumatoid arthritis when all of the following are met:

    Rheumatoid arthritis coverage requirements

    • Diagnosis and safety screening: The beneficiary has rheumatoid arthritis; is not receiving another injectable biologic immunomodulator; has been considered and screened for latent tuberculosis infection; and has been tested with Hepatitis B surface antigen and core antibody.

    • Disease-modifying treatment or disease-severity pathway

      • Therapeutic failure or inadequate response: The beneficiary has experienced therapeutic failure or an inadequate response with methotrexate or at least one disease-modifying antirheumatic drug, such as leflunomide, hydroxychloroquine, minocycline, or sulfasalazine.
      • Contraindication or intolerance: The beneficiary is unable to receive methotrexate or a disease-modifying antirheumatic drug due to contraindications or intolerabilities.
      • Severe or rapidly progressing disease: The beneficiary has clinical evidence of severe or rapidly progressing disease.

    • Non-preferred medication requirement

      • Preferred biologic trial and failure: The beneficiary has tried and failed Enbrel or Humira.
      • Clinical inability to try preferred biologic: There is a clinical reason the beneficiary cannot try either Enbrel or Humira.

    Concurrent use of another injectable biologic immunomodulator is not allowed under the approval criteria. The beneficiary must not be receiving another injectable biologic immunomodulator when Kevzara coverage is requested.

    More than one injectable immunomodulator is not covered at the same time. Coverage is limited to one injectable immunomodulator during the treatment course.

    Provider Actions and Approval Rules

    Prior Authorization

    Prior Approval Required

    Prior approval is required for Kevzara under North Carolina Medicaid outpatient pharmacy criteria. Submit the request with the clinical information needed to establish approval eligibility.

    Billing Rule

    Approval Duration and Concurrent Therapy

    Approval may be granted for up to 12 months. Coverage is limited to one injectable immunomodulator at a time.

    • Maximum approval duration: 12 months.
    • Concurrent therapy limit: one injectable immunomodulator at a time.

    Policy Background

    Kevzara is reviewed under the systemic immunomodulator outpatient pharmacy criteria for treatment of rheumatoid arthritis. Coverage considerations include infection and Hepatitis B screening, prior response or intolerance to disease-modifying antirheumatic drugs, disease severity, and restrictions on concurrent injectable biologic immunomodulator use.

    Definitions and Special Provisions

    DMARD
    TermDisease-modifying antirheumatic drug (DMARD)
    DefinitionA medication used to modify the course of rheumatoid arthritis.
    ExamplesLeflunomide, hydroxychloroquine, minocycline, and sulfasalazine.
    EPSDT special provision
    Eligible beneficiariesMedicaid beneficiaries under 21 years of age.
    Coverage provisionMedically necessary services, products, or procedures may be covered to correct or ameliorate a defect, physical or mental illness, or condition identified through a screening examination, even when clinical policy limitations are exceeded or do not apply.

    Initial Therapy for Rheumatoid Arthritis

    Initial Therapy for Rheumatoid Arthritis

    Initial coverage is available when all required diagnosis, safety screening, treatment pathway, and applicable preferred-product requirements are met:

    Initial therapy requirements

    • Diagnosis and safety screening: The beneficiary has rheumatoid arthritis; is not receiving another injectable biologic immunomodulator; has been considered and screened for latent tuberculosis infection; and has been tested with Hepatitis B surface antigen and core antibody.

    • Qualifying treatment or disease-severity pathway

      • Therapeutic failure or inadequate response: The beneficiary has experienced therapeutic failure or an inadequate response with methotrexate or at least one disease-modifying antirheumatic drug, such as leflunomide, hydroxychloroquine, minocycline, or sulfasalazine.

    Preferred Product Sequence

    StepRequirementAlternative
    1For a non-preferred medication, the beneficiary must have a trial and failure of Enbrel or Humira.A clinical reason the beneficiary cannot try either Enbrel or Humira may satisfy the requirement.

    Approval and Concurrent-Use Limits

    Kevzara
    MedicationKevzara
    Approval durationUp to 12 months.
    Approval periodCoverage may be approved for a period of up to 12 months.
    Injectable immunomodulators
    Therapy typeInjectable immunomodulator therapy.
    Concurrent therapy limitOne injectable immunomodulator at a time.
    Coverage restrictionMore than one injectable immunomodulator is not covered at the same time.
    Policy Summary
    PayerNorth Carolina Medicaid
    PolicyKevzara coverage for rheumatoid arthritis
    Policy CodePolicy N/A
    Change TypeCriteria separated by individual agentno material clinical or coverage change
    Effective DateJun 27, 2018
    Next Review DateN/A
    Key ActionObtain prior approval for Kevzara and document the required diagnosis, safety screening, treatment history or disease-severity pathway, and preferred-product requirements.
    SourceLink
    On This Page
    Coverage CriteriaProvider Actions and Approval RulesPolicy BackgroundDefinitions and Special ProvisionsInitial Therapy for Rheumatoid ArthritisPreferred Product SequenceApproval and Concurrent-Use Limits
    Step Therapy

    Preferred Biologic Step Requirement

    Because Kevzara is non-preferred, document a trial and failure of Enbrel or Humira, unless there is a clinical reason the beneficiary cannot try either preferred medication.

    • Required step therapy: trial and failure of Enbrel or Humira.
    • A clinical exception must explain why the beneficiary cannot try Enbrel or Humira.
    Documentation Required

    Required Clinical Documentation

    Provide documentation supporting the diagnosis, absence of concurrent injectable biologic immunomodulator therapy, and the clinical criteria for treatment.

    • Rheumatoid arthritis diagnosis.
    • Confirmation that the beneficiary is not receiving another injectable biologic immunomodulator.
    • Screening for latent tuberculosis infection.
    • Hepatitis B surface antigen and core antibody testing.
    • Therapeutic failure or inadequate response to methotrexate or at least one disease-modifying antirheumatic drug; inability to receive these drugs because of contraindications or intolerability; or clinical evidence of severe or rapidly progressing disease.
    Documentation Required

    Preferred-Product Documentation

    For non-preferred Kevzara, document the preferred-product history or the clinical reason neither preferred product can be tried.

    • Document trial and failure of Enbrel or Humira.
    • If neither can be tried, document the specific contraindication, intolerance, or other clinical rationale.
    Denial Risk

    Clinical Criteria Not Met

    The request may be denied when the beneficiary does not meet the clinical criteria for rheumatoid arthritis treatment or when required safety and treatment information is absent.

    • No documented rheumatoid arthritis diagnosis.
    • Concurrent use of another injectable biologic immunomodulator.
    • No documentation of latent tuberculosis screening or hepatitis B surface antigen and core antibody testing.
    • No methotrexate or disease-modifying antirheumatic drug failure/inadequate response, qualifying contraindication or intolerance, or severe or rapidly progressing disease.
    Denial Risk

    Preferred Biologic Requirement Not Met

    Coverage of non-preferred Kevzara may be denied when Enbrel or Humira has not been tried and failed and no clinical exception is documented.

    • Document a trial and failure of Enbrel or Humira.
    • If the preferred biologics are inappropriate, provide the clinical reason the beneficiary cannot try either one.
    Denial Risk

    Concurrent Injectable Immunomodulator Therapy

    Coverage is restricted to one injectable immunomodulator at a time. Requests may be denied or require discontinuation of concurrent injectable immunomodulator therapy.

    • Verify that the beneficiary is not receiving another injectable biologic immunomodulator.
    • Do not bill or maintain concurrent therapy with more than one injectable immunomodulator.
    Prior approval
    Being under 21 years of age does not eliminate a prior approval requirement when the service, product, or procedure requires prior approval.
    Contraindication or intolerance:
    The beneficiary is unable to receive methotrexate or a disease-modifying antirheumatic drug due to contraindications or intolerabilities.
  1. Severe or rapidly progressing disease: The beneficiary has clinical evidence of severe or rapidly progressing disease.

  2. Non-preferred medication requirement

    • Preferred biologic trial and failure: The beneficiary has tried and failed Enbrel or Humira.
    • Clinical inability to try preferred biologic: There is a clinical reason the beneficiary cannot try either Enbrel or Humira.