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    v1.0.31
    OpenPayerPolicy UpdatesPharmacy & Specialty DrugsAdvanced Health Tecfidera Prior Auth | OpenPayer
    Ask Trek AI about this page
    ModifiedAdvanced HealthPolicy N/A

    Tecfidera (dimethyl fumarate) Coverage Criteria

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    This policy governs prior authorization and renewal coverage for oral dimethyl fumarate used to treat relapsing forms of multiple sclerosis in adult members. It establishes prescriber, indication, safety-monitoring, concurrent-therapy, dosing, and continuation requirements.

    Policy Summary
    PayerAdvanced Health
    PolicyTecfidera (dimethyl fumarate) Coverage Criteria
    Policy CodePolicy N/A
    Change TypeModified
    Effective DateN/A
    Next Review DateN/A
    Key ActionSubmit current CBC results, including lymphocyte count, and liver function test results before initial approval.
    SourceLink
    POLICY UPDATE CHANGES

    No material clinical or coverage changes in this revision.

    18+Minimum member age for initial coverage
    6 monthsMaximum initial approval period
    12 monthsMaximum renewal approval period
    >500/µLRequired baseline lymphocyte count
    240 mg twice daily

    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.

    Maintenance dose

    Coverage Criteria

    Initial Therapy

    Initial therapy is covered when all of the following are met:

    Initial therapy

    • Prescriber: Medication is prescribed by or in consultation with a neurologist
    • Indication and age: Medication is used to treat a relapsing form of multiple sclerosis, including clinically isolated syndrome, relapsing-remitting disease, or active secondary progressive disease, and the member is 18 years of age or olderAge >=18 years
    • No concurrent disease-modifying therapy: Member is not receiving concurrent treatment with another multiple sclerosis disease-modifying drug, including interferon beta-1b, glatiramer acetate, interferon beta-1a, natalizumab, ofatumumab, ocrelizumab, or mitoxantroneNo concurrent MS disease-modifying drug
    • Baseline safety testing: Baseline liver function tests and CBC have been completed, with a baseline lymphocyte count greater than 500/µLLymphocytes >500/µL

    Continuation Therapy

    Renewal therapy is covered when the prescribing physician documents and attests that the member's condition has improved.

    Renewal therapy: The prescribing physician assesses improvement in the member's condition and attests to that improvementDocumented clinical improvement

    Approve for up to 12 months when met; otherwise send to MD review.

    Concurrent use is not covered. Dimethyl fumarate must not be used with another multiple sclerosis disease-modifying drug, including interferon beta-1b, glatiramer acetate, interferon beta-1a, natalizumab, ofatumumab, ocrelizumab, or mitoxantrone.

    Dimethyl fumarate is contraindicated in members with known hypersensitivity to dimethyl fumarate or any component of the formulation, including anaphylaxis or angioedema.

    Use outside the covered indication is not covered. Dimethyl fumarate is covered for relapsing forms of multiple sclerosis—including clinically isolated syndrome, relapsing-remitting disease, or active secondary progressive disease—in members 18 years of age or older. Off-label use is not a covered OHP benefit.

    Safety Thresholds and Coding Rules

    Baseline Lymphocyte Count
    Required testBaseline CBC with lymphocyte count
    Minimum lymphocyte count>500/µL
    TimingMust be completed before initial approval
    Hold Therapy for Low WBC
    Hold thresholdWBC below 2 x 10^3 cells/mm3
    Required actionHold fumarate salt therapy
    Monitoring measureWhite blood cell count

    Authorization and Documentation Requirements

    Prior Authorization

    Prior Authorization Required

    Prior authorization is required for both initial and renewal requests for Tecfidera (dimethyl fumarate). Submit the applicable clinical documentation with each request.

    • Initial requests: submit documentation supporting the covered indication, age, neurology involvement, absence of concurrent disease-modifying therapy, and completed baseline safety assessments.
    • Renewal requests: submit the prescribing physician’s assessment and attestation that the member’s condition has improved.
    Denial Risk

    Neurology Involvement Required

    The medication must be prescribed by, or used in consultation with, a neurologist. Requests without neurologist involvement do not meet criteria and may be denied.

    • Resubmit the prior authorization request with a current neurology note or consultation when neurologist involvement is not documented.

    Clinical Background

    Dimethyl fumarate is an oral fumarate therapy used to treat relapsing forms of multiple sclerosis in adults. Covered relapsing forms include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease.

    Definitions

    Relapsing Forms of Multiple Sclerosis
    Clinically isolated syndromeIncluded as a relapsing form of multiple sclerosis
    Relapsing-remitting diseaseIncluded as a relapsing form of multiple sclerosis
    Active secondary progressive diseaseIncluded as a relapsing form of multiple sclerosis
    Monomethyl Fumarate
    TermMonomethyl fumarate
    Relationship to dimethyl fumarateActive metabolite of dimethyl fumarate
    Drug groupFumarate salt

    Initial Request

    Initial Request

    Initial approval requires all listed authorization criteria:

    Initial request

    • Prescriber: Medication is prescribed by or in consultation with a neurologist
    • Indication and age: Medication is used to treat a relapsing form of multiple sclerosis, including clinically isolated syndrome, relapsing-remitting disease, or active secondary progressive disease, and the member is 18 years of age or olderAge >=18 years
    • Concurrent therapy: Member is not receiving concurrent treatment with another multiple sclerosis disease-modifying drug, including interferon beta-1b, glatiramer acetate, interferon beta-1a, natalizumab, ofatumumab, ocrelizumab, or mitoxantrone

    Renewal Request

    Renewal Request

    Renewal approval is available when the member demonstrates clinical improvement:

    Renewal request

    • Clinical improvement: The prescribing physician assesses that the member's condition has improved and attests to the member's improvementDocumented clinical improvement

      Approve for up to 12 months if met; otherwise refer for MD review.

    Quantity Limits

    Initial Dosing Quantity Limit
    DrugDimethyl fumarate
    Dose120 mg
    Quantity limit14 capsules per 7-day supply for initial dosing
    Maintenance Dosing Quantity Limit
    DrugDimethyl fumarate
    Dose240 mg
    Quantity limit60 capsules per 30-day supply for maintenance dosing
    Policy Summary
    PayerAdvanced Health
    PolicyTecfidera (dimethyl fumarate) Coverage Criteria
    Policy CodePolicy N/A
    Change TypeModified
    Effective DateN/A
    Next Review DateN/A
    Key ActionSubmit current CBC results, including lymphocyte count, and liver function test results before initial approval.
    SourceLink
    On This Page
    Coverage CriteriaSafety Thresholds and Coding RulesAuthorization and Documentation RequirementsClinical BackgroundDefinitionsInitial RequestRenewal RequestQuantity Limits
    Hold Therapy for Low Lymphocyte Count
    Hold thresholdLymphocyte count below 0.5 x 10^3 cells/mm3
    Required actionHold fumarate salt therapy
    Monitoring measureLymphocyte count in cells/mm3 (cells/µL)
    Permanent Discontinuation After Withholding
    WBC recovery requirementWBC must increase to greater than 2 x 10^3 cells/mm3
    Lymphocyte recovery requirementLymphocyte count must increase to greater than 0.5 x 10^3 cells/mm3
    Timeframe and actionIf either count does not recover after 4 weeks of withholding therapy, permanently discontinue treatment
    Documentation Required

    Current Neurology Documentation

    Submit current neurology documentation supporting the prescription, including a neurology note or consultation. This documentation is required to establish neurologist involvement for the request.

    • A current neurology note or consult must accompany the prior authorization request when required to support the prescription.
    Denial Risk

    Covered Indication and Age Required

    Coverage is limited to members age 18 or older receiving Tecfidera for a covered relapsing form of multiple sclerosis. Requests for other indications or younger members do not meet criteria.

    • Covered indications include clinically isolated syndrome, relapsing-remitting multiple sclerosis, and active secondary progressive multiple sclerosis.
    • Off-label use is not a covered benefit on OHP and will be denied as criteria not met.
    Denial Risk

    No Concurrent Disease-Modifying Therapy

    Tecfidera must not be used concurrently with another disease-modifying drug for multiple sclerosis. Requests involving concurrent disease-modifying therapy will be denied as criteria not met.

    • Examples include interferon beta-1b, glatiramer acetate, interferon beta-1a, natalizumab, ofatumumab, ocrelizumab, and mitoxantrone.

    Unsupported block type: documentation

    Unsupported block type: documentation

    Denial Risk

    Physician Medical Director Review

    If the prescribing physician does not document and attest to improvement at renewal, the request must be escalated for physician medical director review.

    • Send the renewal request to MD review when the required improvement documentation or attestation is absent.
    No concurrent MS disease-modifying drug
  1. Baseline safety assessments: Documentation includes liver function tests and a baseline CBC with lymphocyte count greater than 500/µLLymphocytes >500/µL