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

    Juxtapid (lomitapide) Coverage Criteria for Homozygous Familial Hypercholesterolemia

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    This policy governs North Carolina Medicaid outpatient pharmacy prior approval for Juxtapid (lomitapide) in eligible Medicaid beneficiaries. Coverage is limited to beneficiaries with homozygous familial hypercholesterolemia who meet age, REMS, concomitant therapy, pregnancy testing, and liver-monitoring requirements.

    Policy Summary
    PayerNorth Carolina Medicaid
    PolicyJuxtapid (lomitapide) Coverage Criteria
    Policy CodePolicy N/A
    Change TypeNo material changes
    Effective DateAugust 15, 2014
    Last ReviewJan 5, 2026
    Next Review DateN/A
    Key ActionSubmit prior approval requests demonstrating all coverage criteria; approval may be granted for up to 1 year at up to 60 mg once daily.
    SourceLink
    POLICY UPDATE CHANGES

    No material clinical or coverage changes in this revision.

    HoFHRequired diagnosis
    18+Minimum age
    60 mg/dayMaximum dose
    1 yearMaximum approval

    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.

    REMSSafety program
    No changesReview outcome

    Coverage Criteria

    Initial and ongoing coverage criteria

    Covered when all of the following requirements are met.

    Initial and ongoing coverage requirements

    • Diagnosis and program requirements

      • Diagnosis: The recipient has been diagnosed with homozygous familial hypercholesterolemia (HoFH).
      • REMS enrollment: The recipient is enrolled in the Juxtapid REMS program.

    • Age and lipid therapy

      • Age: The recipient is at least 18 years old or older.18 years or older

      • Concurrent lipid-lowering therapy

        • Receiving therapy: The beneficiary is receiving concurrent lipid-lowering therapy.
        • Unable to use therapy: The beneficiary is unable to use concurrent lipid-lowering therapy.

    • Pregnancy and liver safety requirements

      • Pregnancy testing: Females of reproductive potential obtain a negative pregnancy test.Negative pregnancy test
      • Baseline liver tests: ALT, AST, alkaline phosphatase, and total bilirubin are measured before initiating treatment.ALT, AST, alkaline phosphatase, and total bilirubin before initiation
      • Ongoing liver monitoring: During the first year, liver-related tests, including ALT and AST at a minimum, are measured before each dose increase or monthly, whichever occurs first. After the first year, these tests are performed at least every 3 months and before any dose increase.First year: before each dose increase or monthly, whichever occurs first; after first year: at least every 3 months and before dose increases

    EPSDT special provision

    EPSDT provisions may apply to beneficiaries under 21 years of age when medically necessary documentation supports the exception.

    EPSDT exception: For a beneficiary under 21 years of age, documentation must show that the requested product is medically necessary to correct or ameliorate a defect, physical or mental illness, or condition identified through a screening examination and meets EPSDT requirements. Service limitations on scope, amount, duration, frequency, location, or other criteria may be exceeded or may not apply when the documentation supports medical necessity under EPSDT.Under 21 years: medically necessary EPSDT documentation

    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 the product requires prior approval.

    For beneficiaries under 21 years of age, EPSDT may require coverage of medically necessary services, products, or procedures that correct or ameliorate a defect, physical or mental illness, or condition identified through a screening examination. However, 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.

    Initial Therapy Criteria

    Initial therapy

    Initial coverage requires all of the following.

    Initial therapy requirements: The recipient has homozygous familial hypercholesterolemia (HoFH), is enrolled in the Juxtapid REMS program, is at least 18 years old or older, is receiving concurrent lipid-lowering therapy or is unable to use concurrent lipid-lowering therapy, has a negative pregnancy test when a female of reproductive potential, and has baseline liver-related testing before treatment initiation.Age 18 years or older; negative pregnancy test when applicable; baseline ALT, AST, alkaline phosphatase, and total bilirubin

    Continuation Criteria

    Continuation therapy monitoring

    For treatment continuing beyond the first year, maintain required liver monitoring and dose-increase monitoring.

    Continuation monitoring: After the first year, perform ALT and AST testing at least every 3 months and before any increase in dose.At least every 3 months and before any dose increase

    Coding and Coverage Parameters

    Therapeutic Class Codemixed
    M4QAntihyperlipidimic-MTP Inhibitor and Antihyperlipidemic - Apolipoprotein B-100 Synthesis Inhibitor
    Minimum Age
    Minimum ageAt least 18 years old or older
    Applies toJuxtapid (lomitapide) coverage
    Coverage requirementThe beneficiary must meet the minimum age requirement as part of the coverage criteria
    Maximum Dose
    Maximum doseUp to 60 mg
    FrequencyOnce a day
    MedicationJuxtapid (lomitapide)

    Provider Requirements and Decision Risks

    Prior Authorization

    Juxtapid Prior Approval Required

    Prior approval is required for Juxtapid (lomitapide). When coverage criteria are met, approval may be granted for up to 1 year for a dose of up to 60 mg once daily.

    • Prior approval required.
    • Approval duration: up to 1 year.
    • Maximum approved dose: 60 mg once daily.
    Prior Authorization

    EPSDT Does Not Waive Prior Approval

    If a service, product, or procedure requires prior approval, a beneficiary’s being under 21 years of age does not eliminate the prior approval requirement.

    • Review the Basic Medicaid Billing Guide and EPSDT provider guidance for additional EPSDT and prior approval information.

    Unsupported block type: documentation

    Unsupported block type: documentation

    Background

    Juxtapid (lomitapide) is classified as an antihyperlipidemic microsomal triglyceride transfer protein (MTP) inhibitor and an apolipoprotein B-100 synthesis inhibitor. The policy addresses its use for beneficiaries diagnosed with homozygous familial hypercholesterolemia and requires enrollment in the Juxtapid REMS program, along with baseline and ongoing liver-related monitoring.

    Definitions

    Therapeutic Class
    MedicationJuxtapid (lomitapide)
    Therapeutic classAntihyperlipidemic microsomal triglyceride transfer protein (MTP) inhibitor
    Additional classificationAntihyperlipidemic apolipoprotein B-100 synthesis inhibitor
    EPSDT
    MeaningEarly and Periodic Screening, Diagnostic, and Treatment (EPSDT) is a federal Medicaid requirement
    BeneficiariesApplies to Medicaid beneficiaries under 21 years of age
    Medical necessityRequires coverage of medically necessary services, products, or procedures to correct or ameliorate a defect, physical or mental illness, or condition identified through a screening examination

    Quantity Limits

    Quantity Limit
    MedicationJuxtapid (lomitapide)
    Quantity limitUp to 60 mg
    FrequencyOnce a day
    Policy Summary
    PayerNorth Carolina Medicaid
    PolicyJuxtapid (lomitapide) Coverage Criteria
    Policy CodePolicy N/A
    Change TypeNo material changes
    Effective DateAugust 15, 2014
    Last ReviewJan 5, 2026
    Next Review DateN/A
    Key ActionSubmit prior approval requests demonstrating all coverage criteria; approval may be granted for up to 1 year at up to 60 mg once daily.
    SourceLink
    On This Page
    Coverage CriteriaInitial Therapy CriteriaContinuation CriteriaCoding and Coverage ParametersProvider Requirements and Decision RisksBackgroundDefinitionsQuantity Limits
    Maximum Approval Duration
    Maximum approval durationUp to 1 year
    Approved medicationJuxtapid (lomitapide)
    Approval parametersApproval may be for up to 1 year for up to 60 mg once a day
    Denial Risk

    Failure to Meet Coverage Criteria

    Coverage may be denied when required eligibility, safety, or monitoring criteria are not met or documented.

    • No documented HoFH diagnosis.
    • No enrollment in the Juxtapid REMS program.
    • Beneficiary is younger than 18 years.
    • No concurrent lipid-lowering therapy and no documented inability to use it.
    • Required negative pregnancy test is not obtained.
    • Required baseline or ongoing liver monitoring is not completed or documented.
    Billing Rule

    Eligibility and Service Restrictions

    Confirm eligibility and service restrictions before billing. The beneficiary must be enrolled in NC Medicaid on the date of service, and eligibility-category restrictions may make the beneficiary ineligible for the service.

    • Verify NC Medicaid enrollment on the date of service.
    • Check for restrictions associated with the beneficiary’s eligibility category.
    LimitationsEPSDT does not require coverage of services, products, or procedures that are unsafe, ineffective, experimental or investigational, not medical in nature, or not generally recognized as an accepted method of medical practice or treatment