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    v1.0.31
    OpenPayerPolicy UpdatesPharmacy & Specialty Drugseternalhealth Step Therapy Coverage | OpenPayer
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    CurrenteternalhealthPolicy 26208

    Formulary Step Therapy Criteria for Selected Prescription Drugs

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    This policy governs step therapy requirements for selected products, including diclofenac sodium gel 3%, antidepressants, atypical antipsychotics, Invega Hafyera, Relistor, Rytary, and Zonisade. Coverage generally requires trial of specified formulary alternatives, with continuation of prior therapy allowed where stated.

    Policy Summary
    Payereternalhealth
    PolicyFormulary Step Therapy Criteria for Selected Prescription Drugs
    Policy CodePolicy 26208
    Change TypeNo material change
    Effective DateOct 1, 2026
    Next Review DateN/A
    Key ActionDocument a trial of the required formulary alternative before coverage of the requested product.
    SourceLink
    POLICY UPDATE CHANGES

    No material clinical or coverage changes in this revision.

    7Drug or therapeutic-product sections
    7Product groups with step requirements
    2Generic trials required
    AllowedContinuation of prior therapy

    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

    Actinic Keratosis

    Coverage requires the following step:

    Diclofenac sodium gel 3% step therapy: Trial of either topical fluorouracil or topical imiquimod

    Antidepressants

    Coverage requires the following step:

    Antidepressant step therapy: Trial of two generics among bupropion, mirtazapine, citalopram, desvenlafaxine succinate ER, duloxetine, escitalopram, fluoxetine, fluvoxamine, paroxetine, sertraline, and venlafaxine hydrochloridetwo generic formulary products

    Approve for continuation of prior therapy.

    Atypical Antipsychotics

    Coverage requires the following step:

    Atypical antipsychotic step therapy: Trial of two oral generic formulary atypical antipsychotic agents among asenapine, aripiprazole, olanzapine, paliperidone, quetiapine, risperidone, and ziprasidonetwo oral generic agents

    Approve for continuation of prior therapy.

    Invega Hafyera Therapy

    Coverage requires the following step for new starts:

    Invega Hafyera step therapy: Trial of Invega Sustenna or Invega Trinzaone alternative product

    Step applies to new starts only. Approve for continuation of prior therapy.

    Relistor

    Coverage requires the following step:

    Relistor step therapy: Trial of lubiprostone, Constulose, Enulose, Generlac, lactulose, or Movantikone listed alternative

    Rytary

    Coverage requires the following step:

    Rytary step therapy: Trial of one generic carbidopa/levodopa-containing formulationone generic formulation

    Initial and continuation therapy

    Covered for new starts after the required generic trial; continuation of prior therapy may be approved.

    Therapy pathway

    • Initial therapy: Patient has trialed generic zonisamide capsules.

      Applies to new starts only.

    • Continuation therapy: Patient is continuing prior therapy.

      Approve for continuation of prior therapy.

    Provider Documentation Actions

    Step Therapy

    Actinic Keratosis Step Requirement

    Document a trial of either topical fluorouracil or topical imiquimod before approval of the applicable therapy for actinic keratosis.

    • Required trial: topical fluorouracil or topical imiquimod.
    Step Therapy

    Antidepressant Step Requirement

    Document trials of two generic formulary antidepressants. Continuation of prior therapy may be approved when continuation status is documented.

    • Formulary options include bupropion, mirtazapine, citalopram, desvenlafaxine succinate ER, duloxetine, escitalopram, fluoxetine, fluvoxamine, paroxetine, sertraline, and venlafaxine hydrochloride.
    • Document the two products tried and whether the request is for continuation of prior therapy.
    Step Therapy

    Atypical Antipsychotic Step Requirement

    Policy Background

    This policy establishes formulary step therapy requirements for selected prescription products across dermatology, psychiatry, gastroenterology, and neurology. Depending on the medication and whether treatment is being initiated or continued, coverage may require documented use of specified topical, generic, or alternative therapies before the requested product is covered. A continuation of prior therapy may be approved where the policy expressly allows it, including for certain antidepressants, atypical antipsychotics, Invega Hafyera, and Zonisade.

    Initial Therapy Criteria

    Diclofenac Sodium Gel 3%

    Initial coverage requires:

    Diclofenac sodium gel 3% initial therapy: Trial of either topical fluorouracil or topical imiquimod

    Antidepressants

    Initial coverage requires:

    Antidepressant initial therapy: Trial of two generic formulary products from the specified antidepressant listtwo generics

    Atypical Antipsychotics

    Initial coverage requires:

    Continuation Therapy Criteria

    Antidepressants

    Continuation of prior therapy may be approved.

    Antidepressant continuation: Continuation of prior therapy

    Atypical Antipsychotics

    Continuation of prior therapy may be approved.

    Atypical antipsychotic continuation: Continuation of prior therapy

    Invega Hafyera Therapy

    Continuation of prior therapy may be approved.

    Invega Hafyera continuation:

    Required Step Therapy by Product

    Product or therapyRequired stepCoverage notes
    Diclofenac sodium gel 3%Trial of either topical fluorouracil or topical imiquimodRequired before coverage
    Product or therapyRequired stepCoverage notes
    AntidepressantsTrial of two generic formulary products: bupropion, mirtazapine, citalopram, desvenlafaxine succinate ER, duloxetine, escitalopram, fluoxetine, fluvoxamine, paroxetine, sertraline, or venlafaxine hydrochlorideContinuation of prior therapy may be approved
    Product or therapyRequired stepCoverage notes
    Atypical antipsychoticsTrial of two oral generic formulary agents: asenapine, aripiprazole, olanzapine, paliperidone, quetiapine, risperidone, or ziprasidoneContinuation of prior therapy may be approved
    Product or therapyRequired stepCoverage notes
    Invega HafyeraTrial of Invega Sustenna or Invega TrinzaApplies to new starts only; continuation of prior therapy may be approved
    Product or therapyRequired stepCoverage notes
    RelistorTrial of lubiprostone, Constulose, Enulose, Generlac, lactulose, or MovantikRequired before coverage
    Product or therapyRequired stepCoverage notes
    RytaryTrial of one generic carbidopa/levodopa-containing formulationRequired before coverage
    Product or therapyRequired stepCoverage notes
    ZonisadeTrial of generic zonisamide capsuleApplies to new starts only; continuation of prior therapy may be approved
    Policy Summary
    Payereternalhealth
    PolicyFormulary Step Therapy Criteria for Selected Prescription Drugs
    Policy CodePolicy 26208
    Change TypeNo material change
    Effective DateOct 1, 2026
    Next Review DateN/A
    Key ActionDocument a trial of the required formulary alternative before coverage of the requested product.
    SourceLink
    On This Page
    Coverage CriteriaProvider Documentation ActionsPolicy BackgroundInitial Therapy CriteriaContinuation Therapy CriteriaRequired Step Therapy by Product

    Document trials of two oral generic formulary atypical antipsychotic agents. Continuation of prior therapy may be approved when continuation status is documented.

    • Formulary options include asenapine, aripiprazole, olanzapine, paliperidone, quetiapine, risperidone, and ziprasidone.
    • Document the two products tried and whether the request is for continuation of prior therapy.
    Step Therapy

    Invega Hafyera Step Requirement

    For new starts, document a trial of Invega Sustenna or Invega Trinza. The step requirement does not apply to continuation of prior therapy.

    • New starts require a trial of Invega Sustenna or Invega Trinza.
    • Continuation of prior therapy may be approved; document continuation status.
    Step Therapy

    Relistor Step Requirement

    Document a trial of at least one specified alternative product before approval of Relistor.

    • Acceptable alternatives: lubiprostone, Constulose, Enulose, Generlac, lactulose, or Movantik.
    Step Therapy

    Rytary Step Requirement

    Document a trial of one generic carbidopa/levodopa-containing formulation before approval of Rytary.

    • Required trial: one generic carbidopa/levodopa-containing formulation.
    Step Therapy

    Generic Zonisamide Step Requirement

    For new starts of Zonisade, document a trial of generic zonisamide capsules. The step requirement does not apply to continuation of prior therapy.

    • New starts require a generic zonisamide capsule trial before Zonisade.
    • Continuation of prior therapy may be approved; document continuation status.
    • A new Zonisade start without the required generic zonisamide trial may be denied.
    Atypical antipsychotic initial therapy: Trial of two oral generic formulary atypical antipsychotic agents from the specified listtwo generic agents

    Invega Hafyera Therapy

    For new starts, initial coverage requires:

    Invega Hafyera initial therapy: Trial of Invega Sustenna or Invega Trinzaone alternative product

    Step applies to new starts only.

    Relistor

    Initial coverage requires:

    Relistor initial therapy: Trial of lubiprostone, Constulose, Enulose, Generlac, lactulose, or Movantikone listed alternative

    Rytary

    Initial coverage requires:

    Rytary initial therapy: Trial of one generic carbidopa/levodopa-containing formulationone generic formulation

    Initial therapy

    New starts require a trial of generic zonisamide capsules.

    Generic zonisamide trial: Patient has trialed generic zonisamide capsules before starting Zonisade.

    Step applies to new starts only.

    Continuation of prior therapy

    Step applies to new starts only.

    Continuation therapy

    Continuation of prior therapy may be approved.

    Continuation of prior therapy: Patient is continuing prior therapy with Zonisade.

    Approve for continuation of prior therapy.