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    v1.0.30
    OpenPayerPolicy UpdatesPharmacy & Specialty DrugsNorth Carolina Medicaid GLP-1 Prior Auth | OpenPay…
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    CurrentNorth Carolina MedicaidPolicy N/A

    Medicaid Outpatient Pharmacy Prior Approval Criteria: GLP-1 Receptor Agonists and Combinations

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    This policy governs North Carolina Medicaid outpatient pharmacy prior approval, coverage criteria, continuation requirements, and quantity limits for GLP-1 receptor agonists and combination products for eligible beneficiaries, including EPSDT provisions for beneficiaries under 21.

    Policy Summary
    PayerNorth Carolina Medicaid
    PolicyGLP-1 Receptor Agonists and Combinations
    Policy CodePolicy N/A
    Change TypeNo material change
    Effective DateMarch 1, 2024
    Next Review DateN/A
    Key ActionSubmit prior approval requests for GLP-1 receptor agonists and combinations when required, including requests exceeding product-specific quantity limits.
    SourceLink
    POLICY UPDATE CHANGES

    No material clinical or coverage changes in this revision.

    10Listed GLP-1 products
    Type 2 diabetesRequired diagnosis
    34 daysStandard dispensing period
    2Preferred products required for non-preferred therapy

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    Under 21EPSDT exception consideration

    Coverage Criteria

    Initial Therapy

    Covered for both preferred and non-preferred products when all applicable criteria are met.

    Initial coverage

    • Diagnosis and qualifying pathway

      • Qualifying pathway

        • Metformin treatment failure: Trial and failure or insufficient response to metformin-containing products.
        • Metformin intolerance: Contraindication or adverse event to metformin.
        • ASCVD or CKD: Established ASCVD or chronic kidney disease.
        • High-risk ASCVD: Age 55 years or older with at least two additional risk factors: smoking, obesity, hypertension, dyslipidemia, or albuminuria.≥55 years and ≥2 additional risk factors

    • Additional non-preferred requirement

      • Preferred product trials: Tried and failed or had an insufficient response to at least two preferred products.At least two products
      • Clinical exception: A clinical reason exists that preferred products cannot be tried.

    Continuation Therapy

    Continuation of coverage requires all applicable renewal criteria.

    Continuation therapy

    • Clinical improvement: Beneficiary has improved while on the medication.

    • Treatment goal progress

      • Goals met: Individual clinical goals set by the provider are being met.
      • Adequate progress: Beneficiary is continuing to make adequate progress toward treatment goals.

    EPSDT Exception to Policy Limitations

    For beneficiaries under 21, specified service limitations may be exceeded or may not apply when medical necessity is documented.

    EPSDT exception: The beneficiary is under 21 years of age, AND provider documentation shows that the requested product is medically necessary to correct or ameliorate a defect, physical or mental illness, or condition identified through a screening examination, including the need to improve or maintain health, compensate for a health problem, prevent worsening, or prevent additional health problems.Under 21 years of age

    EPSDT does not require coverage of a service, product, or procedure that is unsafe, ineffective, experimental or investigational, not medical in nature, or not generally recognized as an accepted method of medical practice or treatment. Prior approval remains required when applicable.

    For beneficiaries under 21 years of age, EPSDT may allow stated policy limitations on scope, amount, duration, frequency, location, or other criteria to be exceeded or not apply when provider documentation establishes that the requested service, product, or procedure is medically necessary to correct or ameliorate an identified defect, illness, or condition. EPSDT does not require coverage of a service, product, or procedure that is unsafe, ineffective, experimental or investigational, not medical in nature, or not generally recognized as an accepted method of medical practice or treatment.

    Therapeutic Class Coding

    Therapeutic Class Codesmixed
    C4IANTIHYPERGLY,INSULIN,LONG ACT-GLP-1 RECEPT.AGONIST and Combinations
    C4XANTIHYPERGLY,INSULIN,LONG ACT-GLP-1 RECEPT.AGONIST and Combinations
    High-Risk ASCVD Age Threshold
    Age threshold≥ 55 years of age
    Applies toHigh-risk ASCVD status
    Additional requirementAt least 2 additional risk factors are also required
    High-Risk ASCVD Additional Risk Factors
    Required number≥ 2 additional risk factors
    Risk-factor pathwayUsed to establish high-risk ASCVD status
    Examples of risk factorsSmoking, obesity, hypertension, dyslipidemia, or albuminuria

    Prior Approval and Documentation

    Prior Authorization

    Outpatient Pharmacy Prior Approval Required

    Prior approval is required for covered GLP-1 receptor agonists and combinations dispensed through outpatient pharmacy. Beneficiaries under age 21 remain subject to prior approval requirements; EPSDT eligibility does not eliminate prior approval.

    • Apply the applicable prior approval process before dispensing the requested product.
    • Under-21 status does not eliminate the prior approval requirement.
    Prior Authorization

    Quantity-Limit Override Requires Prior Approval

    Prior approval is required to exceed a product-specific quantity limit. The request must explain why the beneficiary needs more medication for the course of therapy and include supporting medical information.

    • Victoza: 4 pens per 34 days
    • Trulicity: 5 pens/syringes per 34 days
    • Bydureon/Bydureon BCise: 5 pens per 34 days
    • Byetta: 2 pens per 34 days

    Policy Scope

    This policy addresses GLP-1 receptor agonists and combination products dispensed through the North Carolina Medicaid outpatient pharmacy benefit for beneficiaries with Type 2 diabetes. Initial coverage requires the diagnosis and a qualifying metformin-related, cardiovascular, renal, or high-risk ASCVD pathway; non-preferred products also require trials of at least two preferred products unless a clinical reason prevents their use. Continuation requires documentation of improvement on therapy and that individual treatment goals are being met or that the beneficiary is making adequate progress toward those goals.

    Policy Definitions

    ASCVD
    TermASCVD
    DefinitionEstablished atherosclerotic cardiovascular disease
    Coverage pathwayEstablished ASCVD is a qualifying pathway for initial coverage when the beneficiary has Type 2 diabetes
    CKD
    TermCKD
    DefinitionChronic kidney disease
    Coverage pathwayChronic kidney disease is a qualifying pathway for initial coverage when the beneficiary has Type 2 diabetes

    Initial Coverage

    Initial Coverage

    Initial coverage applies to preferred and non-preferred products when all applicable criteria are met.

    Initial product coverage

    • Qualifying clinical pathway

      • Trial and failure or insufficient response to metformin-containing products.
      • Contraindication or adverse event to metformin.
      • Established ASCVD or chronic kidney disease.
      • Age 55 years or older with at least two additional risk factors: smoking, obesity, hypertension, dyslipidemia, or albuminuria.≥55 years and ≥2 additional risk factors

    Continuation of Coverage

    Continuation of Coverage

    Continuation of coverage applies to preferred and non-preferred products when documented clinical benefit and progress toward treatment goals are demonstrated.

    Renewal criteria

    • Clinical improvement: Medical documentation shows improvement while on the medication.

    • Goals or progress

      • Goals met: Individual clinical goals set by the provider are being met.
      • Adequate progress: Beneficiary is continuing to make adequate progress toward treatment goals.

    Preferred Product Requirements

    StepRequirementException
    1For a non-preferred product, the beneficiary must have tried and failed or experienced an insufficient response to at least two preferred products.A clinical reason exists that preferred products cannot be tried.

    Product-Specific Quantity Limits

    Victoza Quantity Limit
    Quantity limit4 pens
    Dispensing periodPer 34 days
    ProductVictoza
    Trulicity Quantity Limit
    Quantity limit5 pens/syringes
    Dispensing periodPer 34 days
    ProductTrulicity
    Policy Summary
    PayerNorth Carolina Medicaid
    PolicyGLP-1 Receptor Agonists and Combinations
    Policy CodePolicy N/A
    Change TypeNo material change
    Effective DateMarch 1, 2024
    Next Review DateN/A
    Key ActionSubmit prior approval requests for GLP-1 receptor agonists and combinations when required, including requests exceeding product-specific quantity limits.
    SourceLink
    On This Page
    Coverage CriteriaTherapeutic Class CodingPrior Approval and DocumentationPolicy ScopePolicy DefinitionsInitial CoverageContinuation of CoveragePreferred Product RequirementsProduct-Specific Quantity Limits
  1. Ozempic 0.25 mg or 0.5 mg/dose: 2 pens per 34 days
  2. Ozempic 1 mg/dose: 2 mg prefilled pen, 3 pens per 34 days
  3. Ozempic 4 mg prefilled pen: 2 pens per 34 days
  4. Ozempic 2 mg/dose: 2 pens per 34 days
  5. Xultophy: 6 pens per 34 days
  6. Soliqua: 7 pens per 34 days
  7. Rybelsus tablets: 34/34 days
    8. Step Therapy

    Non-Preferred Products Require Step Therapy

    For a non-preferred product, document trials of at least two preferred products. Each trial must demonstrate failure or an insufficient response, unless there is a clinical reason the preferred products cannot be tried.

    • At least two preferred-product trials are required for non-preferred products.
    • A clinical reason that preferred products cannot be tried may satisfy the requirement.
    Documentation Required

    Initial Clinical Documentation

    For initial coverage, submit documentation confirming Type 2 diabetes and the applicable metformin pathway. The beneficiary must have failed or had an insufficient response to metformin-containing products, or documentation must support an applicable metformin exception or qualifying cardiovascular or kidney risk.

    • Diagnosis of Type 2 diabetes is required.
    • Document a trial and failure or insufficient response to metformin-containing products, or a contraindication or adverse event to metformin.
    • Alternatively, document established ASCVD, chronic kidney disease, or high ASCVD risk defined as age 55 or older plus at least two additional risk factors.
    Documentation Required

    Non-Preferred Product Documentation

    For a non-preferred product, submit documentation of the required preferred-product trials and their outcomes, or the clinical rationale that preferred products cannot be tried.

    • Document trials of at least two preferred products.
    • Document failure or insufficient response to the preferred products.
    • If trials cannot be performed, document the clinical reason preferred products cannot be tried.
    Documentation Required

    Continuation Documentation Required

    For renewal, provide medical documentation that the beneficiary has improved while taking the medication and that individual clinical goals are being met or the beneficiary is continuing to make adequate progress toward treatment goals.

    • Document improvement on the medication.
    • Document that provider-set clinical goals are being met or that adequate progress toward treatment goals continues.
    Documentation Required

    Quantity-Limit Exception Documentation

    To request quantities above the product-specific limits, provide information supporting the medical necessity of the additional quantity for the beneficiary's course of therapy.

    • Explain why the beneficiary needs more medication than the listed limit.
    • Include medical and other supporting information with the prior approval request.
    Documentation Required

    EPSDT Exception Documentation

    For an EPSDT exception, submit provider documentation establishing that the requested product or quantity is medically necessary to correct or ameliorate an identified defect, physical or mental illness, or condition.

    • Describe the identified health problem and how the requested service, product, or procedure will correct, improve, or maintain the beneficiary's health.
    • Explain how it will compensate for the health problem, prevent worsening, or prevent additional health problems.
    • Show that the requested care meets EPSDT criteria; applicable scope, amount, duration, frequency, location, or other limitations may be exceeded when adequately supported.
    Denial Risk

    Initial Clinical Criteria Not Met

    Initial coverage is at risk of denial when the Type 2 diabetes requirement or the applicable metformin-related pathway is not satisfied and documented.

    • Diagnosis of Type 2 diabetes must be established.
    • Document metformin failure or insufficient response, or a qualifying contraindication, adverse event, ASCVD, chronic kidney disease, or high-risk ASCVD pathway.
    Denial Risk

    Preferred Product Requirement Not Met

    A non-preferred product is at risk of denial when the beneficiary has not tried and failed or had an insufficient response to at least two preferred products and no clinical rationale supports bypassing preferred products.

    • Document the required trials of at least two preferred products.
    • If preferred products cannot be tried, provide the clinical reason.
    Denial Risk

    Continuation Criteria Not Met

    A renewal request is at risk of denial when medical documentation does not show improvement on the medication and does not establish that individual clinical goals are being met or that adequate progress toward treatment goals continues.

    • Renewal documentation must address improvement and progress toward treatment goals.
    Denial Risk

    Quantity Limit Exceeded Without Support

    A quantity request above the product-specific limit is at risk of denial when prior approval is not obtained or the request lacks information explaining why the beneficiary needs the additional quantity for the course of therapy.

    • Submit the required medical and other supporting information.
    • Requests exceeding the listed limits require prior approval.
    High Risk for ASCVD
    Age requirement55 years of age or older
    Risk-factor requirementAt least 2 additional risk factors
    Qualifying risk factorsSmoking, obesity, hypertension, dyslipidemia, or albuminuria
    EPSDT
    MeaningEarly and Periodic Screening, Diagnostic, and Treatment provisions require coverage for medically necessary health care for Medicaid beneficiaries under 21
    Medical necessityThe service, product, or procedure must correct or ameliorate a defect, physical or mental illness, or condition identified through a screening examination
    Prior approvalBeing under 21 does not eliminate prior approval when the service, product, or procedure requires it

  8. Additional requirement for non-preferred products

    • Tried and failed or experienced an insufficient response to at least two preferred products.
    • A clinical reason exists that preferred products cannot be tried.
    9. Bydureon / Bydureon BCise Quantity Limit
    Quantity limit5 pens
    Dispensing periodPer 34 days
    ProductsBydureon and Bydureon BCise
    Byetta Quantity Limit
    Quantity limit2 pens
    Dispensing periodPer 34 days
    ProductByetta
    Ozempic 0.25 mg/dose or 0.5 mg/dose Quantity Limit
    Quantity limit2 pens
    Dispensing periodPer 34 days
    Strengths0.25 mg/dose or 0.5 mg/dose
    Ozempic 1 mg/dose Quantity Limit
    Quantity limit3 2 mg prefilled pens
    Dispensing periodPer 34 days
    Dose1 mg/dose
    Ozempic 4 mg Prefilled Pen Quantity Limit
    Quantity limit2 pens
    Dispensing periodPer 34 days
    ProductOzempic 4 mg prefilled pen
    Ozempic 2 mg/dose Quantity Limit
    Quantity limit2 pens
    Dispensing periodPer 34 days
    Dose2 mg/dose
    Xultophy Quantity Limit
    Quantity limit6 pens
    Dispensing periodPer 34 days
    ProductXultophy
    Soliqua Quantity Limit
    Quantity limit7 pens
    Dispensing periodPer 34 days
    ProductSoliqua
    Rybelsus Tablet Quantity Limit
    Quantity limit34 tablets
    Dispensing periodPer 34 days
    ProductRybelsus Tablet