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    v1.0.31
    OpenPayerPolicy UpdatesPharmacy & Specialty DrugsAdvanced Health Stimulant Prior Auth | OpenPayer
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    CurrentAdvanced HealthPolicy N/A

    Long-Acting Stimulant Criteria for Patients 6-22 Years Old

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    This policy governs prior authorization and formulary exception coverage for extended-release stimulant medications in Advanced Health members ages 6 through 22. Coverage requires FDA-supported dosing and generally requires failure of formulary extended-release stimulant therapy or satisfaction of specified clinical exceptions.

    Policy Summary
    PayerAdvanced Health
    PolicyLong-Acting Stimulant Criteria for Patients 6-22 Years Old
    Policy CodePolicy N/A
    Change TypeNo material change
    Effective DateN/A
    Last ReviewMar 25, 2024
    Next Review DateN/A
    Key ActionDocument FDA-supported dosing and at least 2 weeks of formulary extended-release stimulant therapy at optimal dosing before requesting a non-formulary long-acting stimulant.
    SourceLink
    POLICY UPDATE CHANGES

    No material clinical or coverage changes in this revision.

    6-22 yearsMember age range
    12 monthsMaximum approval duration
    2 weeksMinimum formulary trial
    FDA-labeledDosing requirement

    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.

    Methylphenidate ERPreferred formulary option

    Coverage Criteria

    Initial therapy coverage criteria

    Covered when the prescribed dose is FDA-supported and at least one qualifying pathway is met.

    Core requirement: The prescribed dose is supported by the FDA-approved package insert dosing guideline for the prescribed product.FDA-approved package insert dose

    If not met, the request does not meet coverage criteria.

    Qualifying coverage pathway

    • Formulary failure pathway

      • Product-specific requirement: The request is not for lisdexamfetamine, or the member also trialed and failed dextroamphetamine extended-release.Additional dextroamphetamine ER failure when requesting lisdexamfetamine

        If the request is for lisdexamfetamine and this additional step was not completed, trial dextroamphetamine ER before approval.

    • Administration exception: The member is unable to swallow tablets and the requested product is able to be sprinkled.Unable to swallow tablets

      Approve for the requested duration of therapy up to 12 months.

    • Adverse-effect exception: The member experienced adverse side effects from methylphenidate or amphetamine/dextroamphetamine therapy, such as appetite suppression or weight loss, mood changes, tics, or insomnia.Documented adverse effects

      Approve for the requested duration of therapy up to 12 months.

    • Residential or CDRC exception: The member is in a residential treatment program or is a patient of the CDRC and is stable on a non-formulary agent.Qualifying program or CDRC status plus stability

      Approve for the requested duration of therapy up to 12 months.

    • New-member continuity exception: The member is new to Advanced Health and already established on a non-formulary agent.New member with established non-formulary therapy

      Approve for up to 12 months.

    Off-label medication use is not a covered benefit on OHP. Requests must therefore be based on an FDA-supported indication and meet the applicable coverage requirements.

    The prescribed dose must be supported by the product’s FDA-approved package insert dosing guideline. A dose that falls outside the labeled dosing does not meet coverage criteria.

    Provider Actions and Request Requirements

    Step Therapy

    FDA Dosing and Formulary Trial Required

    For an initial request, confirm that the prescribed dose is supported by the FDA-approved package insert dosing guideline for the prescribed product. If supported, document failure of the required formulary extended-release stimulant therapy before proceeding.

    • FDA-supported dosing is required.
    • The formulary failure pathway applies unless a qualifying clinical or transition exception is documented.
    Prior Authorization

    Clinical and Transition Exceptions

    A member who has not failed the required formulary therapy may qualify for an exception when the clinical or transition circumstances below are documented. Approve the requested duration, up to 12 months, when an exception is met.

    • Unable to swallow tablets: approve a product that can be sprinkled.
    • Experienced adverse effects with methylphenidate or amphetamine/dextroamphetamine therapy, such as appetite suppression or weight loss, mood changes, tics, or insomnia.

    Policy Background

    This policy addresses long-acting extended-release stimulant treatment for Advanced Health members ages 6 through 22, primarily in the treatment of attention-deficit/hyperactivity disorder. Coverage emphasizes formulary extended-release stimulant therapy, while allowing specified exceptions for administration limitations, adverse effects, care setting, and continuity of established therapy.

    Definitions

    Definitions
    TermTrial
    Minimum durationAt least 2 weeks
    Dosing standardTherapy must be provided at optimal dosing
    Definitions
    TermProdrug
    MedicationLisdexamfetamine
    Active drug relationshipLisdexamfetamine is a prodrug of dextroamphetamine

    Initial Therapy Criteria

    Initial request

    Initial requests require FDA-supported dosing and satisfaction of a qualifying coverage pathway.

    Initial request requirements: The prescribed dose follows the FDA-approved package insert dosing guideline, and at least one qualifying pathway is met: formulary extended-release stimulant failure, the additional product-specific requirement for lisdexamfetamine, inability to swallow tablets when the requested product can be sprinkled, clinically significant adverse effects, residential treatment or CDRC stability on a non-formulary agent, or established non-formulary therapy for a new Advanced Health member.All core requirements plus one qualifying pathway

    If the formulary failure pathway is not met and no qualifying exception applies, deny as not meeting criteria or as non-formulary.

    Continuation Criteria

    Approval duration

    Approved qualifying requests may be authorized for up to 12 months.

    Qualifying approval basis: The request was approved under the formulary-failure pathway or a qualifying exception pathway, including inability to swallow tablets when the product can be sprinkled, adverse effects from methylphenidate or amphetamine/dextroamphetamine therapy, residential treatment or CDRC stability on a non-formulary agent, or established non-formulary therapy for a new Advanced Health member.Up to 12 months

    The source document does not specify additional continuation criteria.

    Step Therapy Requirements

    StepTherapy requirementTrial durationOutcome
    1Trial methylphenidate extended-release 10 mg or 20 mg tablets (generic Methylin ER, Ritalin SR, or Metadate ER) or dextroamphetamine/amphetamine extended-release.At least 2 weeks at optimal dosingRequired before requesting a non-formulary long-acting stimulant.
    StepApplies toAdditional therapy requirementOutcome
    2Lisdexamfetamine requestsAfter the required formulary therapy failure, trial and fail dextroamphetamine extended-release.Required before approval; if not completed, deny as not meeting criteria.

    Quantity Limits by Product

    Quantity Limits
    MedicationAdderall XR (amphetamine/dextroamphetamine)
    Maximum daily dose30 mg/day
    Population qualifierADHD members age 6 years and older
    Quantity Limits
    MedicationFocalin XR (dexmethylphenidate)
    Maximum daily dose40 mg/day
    Population qualifierAdult maximum
    Policy Summary
    PayerAdvanced Health
    PolicyLong-Acting Stimulant Criteria for Patients 6-22 Years Old
    Policy CodePolicy N/A
    Change TypeNo material change
    Effective DateN/A
    Last ReviewMar 25, 2024
    Next Review DateN/A
    Key ActionDocument FDA-supported dosing and at least 2 weeks of formulary extended-release stimulant therapy at optimal dosing before requesting a non-formulary long-acting stimulant.
    SourceLink
    On This Page
    Coverage CriteriaProvider Actions and Request RequirementsPolicy BackgroundDefinitionsInitial Therapy CriteriaContinuation CriteriaStep Therapy RequirementsQuantity Limits by Product
  1. In a residential treatment program or a patient of the CDRC and stable on a non-formulary agent.
  2. New to Advanced Health and already established on a non-formulary agent.
    3. Step Therapy

    Formulary Extended-Release Stimulant Trial

    Document failure of a formulary extended-release stimulant before requesting a non-formulary long-acting stimulant. The trial must last at least 2 weeks at optimal dosing.

    • Methylphenidate extended-release 10 mg or 20 mg tablets, including generic Methylin ER, Ritalin SR, or Metadate ER; or
    • Dextroamphetamine/amphetamine extended-release.
    Step Therapy

    Additional Lisdexamfetamine Step

    For requests for lisdexamfetamine after failure of the formulary therapy, document an additional trial and failure of dextroamphetamine extended-release. Lisdexamfetamine requests may be approved for up to 12 months only after this additional step is completed.

    • Lisdexamfetamine is a prodrug of dextroamphetamine.
    • If the dextroamphetamine extended-release trial has not been completed and failed, direct the member to trial dextroamphetamine extended-release.
    Documentation Required

    Clinical History Supporting Criteria

    Submit clinical history sufficient to evaluate the request and any applicable exception. The record should identify the requested product and dose, prior formulary products and doses, trial duration, optimal dosing, outcomes or adverse effects, swallowing status, and relevant treatment or transition history.

    • Document whether the member is unable to swallow tablets and whether the requested product can be sprinkled.
    • Document adverse effects from methylphenidate or amphetamine/dextroamphetamine therapy.
    • When applicable, document residential treatment or CDRC status and stability on the non-formulary agent.
    • For transition requests, document that the member is new to Advanced Health and already established on the non-formulary agent.
    Denial Risk

    Non-FDA-Supported Dosing

    Do not request coverage for dosing that is not supported by the FDA-approved package insert for the prescribed product. Unsupported dosing and off-label use do not meet criteria; off-label medication use is not a covered benefit on OHP.

    • Requests with non-FDA-supported dosing are subject to denial.
    Denial Risk

    No Formulary Failure or Qualifying Exception

    Deny the request when the member has not failed the required formulary extended-release stimulant trial and no qualifying clinical or transition exception is documented.

    • The required trial is at least 2 weeks at optimal dosing.
    • Qualifying exceptions include inability to swallow tablets, clinically significant adverse effects, residential treatment or CDRC stability on a non-formulary agent, or established non-formulary therapy when new to Advanced Health.
    Denial Risk

    Required Dextroamphetamine ER Step Not Completed

    For a lisdexamfetamine request, deny or defer the request when the member has failed the initial formulary therapy but has not also trialed and failed dextroamphetamine extended-release.

    • Require a dextroamphetamine extended-release trial before approving lisdexamfetamine, unless another qualifying exception applies.
    Denial Risk

    Non-Formulary Request Without Exception

    When the requested product is non-formulary, deny the request if the member has neither failed the formulary alternative nor met a documented clinical or transition exception. Direct the member to trial the formulary alternative.

    • A qualifying exception may support approval for up to 12 months, including inability to swallow tablets, relevant adverse effects, residential treatment or CDRC stability, or established non-formulary therapy when new to Advanced Health.
    Definitions
    TermFDA-approved dosing
    BasisFDA-approved package insert
    ApplicationThe dosing guideline for the prescribed product
    Quantity Limits
    MedicationDexedrine ER Spansule (dextroamphetamine)
    Maximum daily dose40 mg/day
    Limit typeMaximum daily dose
    Quantity Limits
    MedicationVyvanse (lisdexamfetamine)
    Maximum daily dose70 mg/day
    Limit typeMaximum daily dose
    Quantity Limits
    MedicationRitalin LA (methylphenidate LA)
    Maximum daily dose60 mg/day
    Limit typeMaximum daily dose
    Quantity Limits
    MedicationMethylin ER/Ritalin SR/Metadate ER (methylphenidate)
    Maximum daily dose60 mg/day
    Dosage formTablet
    Quantity Limits
    MedicationMetadate CD (methylphenidate)
    Maximum daily dose60 mg/day
    Dosage formCapsule