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    • Trek Health
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    v1.0.31
    OpenPayerPolicy UpdatesPharmacy & Specialty Drugseternalhealth Step Therapy Coverage | OpenPayer
    Ask Trek AI about this page
    CurrenteternalhealthPolicy N/A

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    This document establishes step-therapy requirements for affected prescription products, including diclofenac sodium gel 3% for actinic keratosis and additional products in antidepressant, atypical antipsychotic, long-acting antipsychotic, Lybalvi, and SGLT2 categories. Providers must document required trials of formulary alternatives before authorization, with continuation-therapy exceptions where specified.

    Policy Summary
    Payereternalhealth
    PolicyACTINIC KERATOSIS - SCORE
    Policy CodePolicy N/A
    Change TypeNo material change
    Effective DateJan 1, 202747d
    Next Review DateN/A
    Key ActionDocument the required prior formulary-product trials and identify whether the request is a continuation of prior therapy when applicable.
    SourceLink
    POLICY UPDATE CHANGES

    No material clinical or coverage changes in this revision.

    1Actinic keratosis product affected
    5Additional step-therapy sections
    2Required generic antidepressant trials
    7Generic atypical antipsychotic alternatives

    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.

    1
    Required generic dapagliflozin trial
    ApprovedZonisade continuation

    Product Coverage Criteria

    Actinic keratosis initial therapy

    Diclofenac sodium gel 3% is subject to the following step criterion.

    Required topical alternative trial

    • Topical fluorouracil trial: Trial of topical fluorouracil
    • Topical imiquimod trial: Trial of topical imiquimod

    Antidepressant initial and continuation therapy

    The following affected antidepressant products require the criterion below: Emsam, Exxua, Exxua Titration Pack, Fetzima, and Fetzima Titration Pack.

    Antidepressant step therapy: Trial of two generic formulary products selected from bupropion, mirtazapine, citalopram, desvenlafaxine succinate ER, duloxetine, escitalopram, fluoxetine, fluvoxamine, paroxetine, sertraline, or venlafaxine hydrochloride2 generic trials

    Approve for continuation of prior therapy.

    Atypical antipsychotic initial and continuation therapy

    The following affected atypical antipsychotic products require the criterion below: Bysanti, Bysanti Titration Pack A, Bysanti Titration Pack B, Bysanti Titration Pack C, Fanapt, Fanapt Titration Pack A, Fanapt Titration Pack B, Fanapt Titration Pack C, and Secuado.

    Atypical antipsychotic step therapy: Trial of two listed oral generic formulary atypical antipsychotic agents selected from asenapine, aripiprazole, olanzapine, paliperidone, quetiapine, risperidone, or ziprasidone2 generic trials

    Approve for continuation of prior therapy.

    Invega Hafyera therapy

    Invega Hafyera requires the following criterion for new starts.

    Prior Invega long-acting therapy

    • Invega Sustenna trial: Trial of Invega Sustenna
    • Invega Trinza trial: Trial of Invega Trinza

    Lybalvi therapy

    Lybalvi requires the following criterion.

    Generic olanzapine trial: Trial of one oral generic formulary olanzapine1 generic trial

    Approve for continuation of prior therapy.

    SGLT2 therapy

    Farxiga requires the following criterion.

    Generic dapagliflozin trial: Trial of generic dapagliflozin1 generic trial

    Zonisade suspension

    Zonisade suspension is subject to a new-start step requirement.

    New-start requirement: Trial of generic zonisamide capsule

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

    Generic dapagliflozin criterion

    Step criterion 1: Trial of generic dapagliflozin

    Provider Documentation and Authorization Actions

    Step Therapy

    Actinic Keratosis Topical Step Therapy

    For diclofenac sodium gel 3% authorization, document a trial of an appropriate topical alternative before requesting coverage.

    • Trial of either topical fluorouracil or topical imiquimod is required.
    Step Therapy

    Antidepressant Step Therapy

    For Emsam, Exxua, Exxua Titration Pack, Fetzima, and Fetzima Titration Pack, document two generic formulary antidepressant trials before requesting coverage.

    • Required trials may include bupropion, mirtazapine, citalopram, desvenlafaxine succinate ER, duloxetine, escitalopram, fluoxetine, fluvoxamine, paroxetine, sertraline, or venlafaxine hydrochloride.
    • Continuation of prior therapy may be approved.
    Step Therapy

    Atypical Antipsychotic Step Therapy

    Clinical Background

    Actinic keratosis is a precancerous skin lesion commonly treated with topical therapies. For diclofenac sodium gel 3%, coverage requires a trial of either topical fluorouracil or topical imiquimod before treatment is authorized.

    Initial Therapy Requirements

    Diclofenac sodium gel 3% — alternative topical therapy

    Diclofenac sodium gel 3% requires a trial of an alternative topical therapy.

    Topical alternative trial: Trial of either topical fluorouracil or topical imiquimod1 of 2 alternatives

    Antidepressants — formulary alternative trial requirements

    Affected antidepressant products require trials of formulary alternatives.

    Generic antidepressant trials: Trial of two generic formulary antidepressants selected from bupropion, mirtazapine, citalopram, desvenlafaxine succinate ER, duloxetine, escitalopram, fluoxetine, fluvoxamine, paroxetine, sertraline, or venlafaxine hydrochloride2 trials

    Continuation of Prior Therapy

    Antidepressant continuation

    Continuation of prior therapy is approved for the affected antidepressant products.

    Continuation approval: Approve for continuation of prior therapy

    Atypical antipsychotic continuation

    Continuation of prior therapy is approved for the affected atypical antipsychotic products.

    Continuation approval: Approve for continuation of prior therapy

    Invega Hafyera continuation

    Continuation of prior therapy is approved for Invega Hafyera.

    Continuation approval:

    Required Formulary Trials

    StepRequired trialApplies to
    1Trial either topical fluorouracil or topical imiquimodDiclofenac sodium gel 3%
    StepRequired trialListed alternatives
    1Trial two generic formulary antidepressantsBupropion, mirtazapine, citalopram, desvenlafaxine succinate ER, duloxetine, escitalopram, fluoxetine, fluvoxamine, paroxetine, sertraline, or venlafaxine hydrochloride
    StepRequired trialListed alternatives
    1Trial two listed oral generic formulary atypical antipsychotic agentsAsenapine, aripiprazole, olanzapine, paliperidone, quetiapine, risperidone, or ziprasidone
    StepRequired trialApplies to
    1For new starts, trial Invega Sustenna or Invega TrinzaInvega Hafyera; continuation of prior therapy is approved
    StepRequired trialApplies to
    1Trial one oral generic formulary olanzapineLybalvi; continuation of prior therapy is approved
    StepRequired trialApplies to
    1Trial generic dapagliflozinFarxiga
    StepRequired trialApplies to
    1Trial generic zonisamide capsuleZonisade new starts only; continuation of prior therapy may be approved
    StepRequired trialApplies to
    1Trial generic dapagliflozinFarxiga
    Policy Summary
    Payereternalhealth
    PolicyACTINIC KERATOSIS - SCORE
    Policy CodePolicy N/A
    Change TypeNo material change
    Effective DateJan 1, 202747d
    Next Review DateN/A
    Key ActionDocument the required prior formulary-product trials and identify whether the request is a continuation of prior therapy when applicable.
    SourceLink
    On This Page
    Product Coverage CriteriaProvider Documentation and Authorization ActionsClinical BackgroundInitial Therapy RequirementsContinuation of Prior TherapyRequired Formulary Trials

    For Bysanti, Bysanti Titration Packs A-C, Fanapt, Fanapt Titration Packs A-C, and Secuado, document trials of two listed oral generic formulary atypical antipsychotics.

    • Eligible agents include asenapine, aripiprazole, olanzapine, paliperidone, quetiapine, risperidone, and ziprasidone.
    • Continuation of prior therapy may be approved.
    Step Therapy

    Invega Hafyera Step Therapy

    For Invega Hafyera, document prior therapy with one of the specified Invega long-acting products for new starts. The step requirement does not apply to continuation therapy.

    • Required prior therapy: Invega Sustenna or Invega Trinza.
    • Continuation of prior therapy may be approved.
    Step Therapy

    Lybalvi Step Therapy

    For Lybalvi, document a trial of one oral generic formulary olanzapine product before requesting coverage. Continuation of prior therapy may be approved.

    • One oral generic formulary olanzapine trial is required.
    Step Therapy

    Farxiga Step Therapy

    For Farxiga, document a trial of generic dapagliflozin before requesting coverage.

    • Generic dapagliflozin is the required formulary alternative.
    Step Therapy

    Zonisade New-Start Step Requirement

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

    • Continuation of prior therapy may be approved.
    Step Therapy

    Generic Dapagliflozin Trial

    Before requesting Farxiga, document the required trial of generic dapagliflozin.

    • Generic dapagliflozin trial is the listed step criterion.
    Step Therapy

    Actinic Keratosis Alternative Trial

    Before requesting diclofenac sodium gel 3% for actinic keratosis, document a trial of topical fluorouracil or topical imiquimod.

    • At least one of the two topical alternatives must be tried.
    Step Therapy

    Two Antidepressant Generic Trials

    Before requesting the affected antidepressant products, document trials of two generic formulary antidepressants. Continuation of prior therapy may be approved when documented.

    • Eligible generics include bupropion, mirtazapine, citalopram, desvenlafaxine succinate ER, duloxetine, escitalopram, fluoxetine, fluvoxamine, paroxetine, sertraline, and venlafaxine hydrochloride.
    Step Therapy

    Two Atypical Antipsychotic Generic Trials

    Before requesting the affected atypical antipsychotic products, document trials of two oral generic formulary atypical antipsychotics. Continuation of prior therapy may be approved when documented.

    • Eligible agents include asenapine, aripiprazole, olanzapine, paliperidone, quetiapine, risperidone, and ziprasidone.
    Documentation Required

    Prior Invega Long-Acting Therapy

    For Invega Hafyera new starts, document prior treatment with Invega Sustenna or Invega Trinza. Continuation therapy is handled as an exception to the new-start step.

    • One of the two specified Invega long-acting therapies must be documented.
    Step Therapy

    Generic Olanzapine Trial

    For Lybalvi, document one trial of an oral generic formulary olanzapine product before authorization.

    • Continuation of prior therapy may be approved.
    Step Therapy

    Generic Dapagliflozin Trial

    For Farxiga, document a trial of generic dapagliflozin before authorization.

    • This is the required formulary step.
    Step Therapy

    Zonisade Step Therapy

    For Zonisade new starts, document a trial of generic zonisamide capsules before authorization. Continuation of prior therapy may be approved.

    • The step requirement applies to new starts only.
    Documentation Required

    Document Prior Therapy and Continuation Status

    Document the applicable formulary trials and whether the request is for a new start or continuation therapy.

    • Actinic keratosis: topical fluorouracil or imiquimod trial.
    • Antidepressants: two listed generic formulary antidepressant trials.
    • Atypical antipsychotics: two listed oral generic formulary trials.
    • Invega Hafyera: Invega Sustenna or Invega Trinza for new starts.
    • Lybalvi: one oral generic formulary olanzapine trial.
    • Farxiga: generic dapagliflozin trial.
    • Zonisade: generic zonisamide capsule trial for new starts.
    Denial Risk

    No Required Topical Trial

    Authorization may be denied when no trial of topical fluorouracil or topical imiquimod is documented for diclofenac sodium gel 3%.

    • Document at least one required topical alternative trial.
    Denial Risk

    Insufficient Antidepressant Trials

    Authorization may be denied when fewer than two eligible generic formulary antidepressant trials are documented for the affected products.

    • Document two qualifying generic antidepressant trials, unless continuation of prior therapy applies.
    Denial Risk

    Insufficient Atypical Antipsychotic Trials

    Authorization may be denied when fewer than two eligible oral generic formulary atypical antipsychotic trials are documented.

    • Document two qualifying generic trials, unless continuation of prior therapy applies.
    Denial Risk

    No Prior Invega Long-Acting Therapy

    For an Invega Hafyera new start, authorization may be denied when prior therapy with Invega Sustenna or Invega Trinza is not documented.

    • The step requirement applies to new starts only; continuation of prior therapy may be approved.
    Denial Risk

    No Generic Olanzapine Trial

    Authorization may be denied when no trial of an oral generic formulary olanzapine product is documented for Lybalvi.

    • Continuation of prior therapy may be approved when documented.
    Denial Risk

    No Generic Dapagliflozin Trial

    Authorization may be denied when no trial of generic dapagliflozin is documented for Farxiga.

    • Document the required generic dapagliflozin trial.
    Denial Risk

    Required Generic Zonisamide Trial

    For a Zonisade new start, authorization may be denied when the required trial of generic zonisamide capsules is not documented.

    • The step requirement applies to new starts only; continuation of prior therapy may be approved.

    Atypical antipsychotics — formulary alternative trial requirements

    Affected atypical antipsychotic products require trials of formulary alternatives.

    Generic atypical antipsychotic trials: Trial of two listed oral generic formulary atypical antipsychotic agents selected from asenapine, aripiprazole, olanzapine, paliperidone, quetiapine, risperidone, or ziprasidone2 trials

    Invega Hafyera — prior long-acting paliperidone therapy for new starts

    For new starts, Invega Hafyera requires a prior long-acting paliperidone therapy trial.

    Prior Invega product trial: Trial of Invega Sustenna or Invega Trinza1 trial

    Step applies to new starts only.

    Lybalvi — formulary generic olanzapine trial

    Lybalvi requires a formulary generic olanzapine trial.

    Generic olanzapine trial: Trial of one oral generic formulary olanzapine1 trial

    Farxiga — generic dapagliflozin trial

    Farxiga requires a generic dapagliflozin trial.

    Generic dapagliflozin trial: Trial of generic dapagliflozin1 trial

    Zonisade initial therapy — step-therapy requirement

    Initial Zonisade therapy requires step therapy.

    Required prior therapy: Trial of generic zonisamide capsule

    Requirement applies to new starts only.

    Approve for continuation of prior therapy

    The step applies to new starts only.

    Lybalvi continuation

    Continuation of prior therapy is approved for Lybalvi.

    Continuation approval: Approve for continuation of prior therapy

    Zonisade continuation therapy

    Continuation of prior therapy may be approved.

    Continuation of prior therapy: Patient is continuing prior Zonisade therapy

    The generic zonisamide capsule step applies to new starts only.