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    v1.0.31
    OpenPayerPolicy UpdatesPharmacy & Specialty DrugsAlign Sanford Step Therapy Coverage | OpenPayer
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    CurrentAlign Powered by Sanford Health PlanPolicy 26213

    ACTINIC KERATOSIS - SCORE

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    This policy governs step-therapy coverage for diclofenac sodium gel 3% used to treat actinic keratosis. Coverage requires a prior trial of either topical fluorouracil or topical imiquimod.

    Policy Summary
    PayerAlign Powered by Sanford Health Plan
    PolicyACTINIC KERATOSIS - SCORE
    Policy CodePolicy 26213
    Change TypeNo material clinical or coverage changes
    Effective DateNov 1, 2026
    Next Review DateN/A
    Key ActionDocument a trial of either topical fluorouracil or topical imiquimod before requesting diclofenac sodium gel 3%.
    SourceLink
    POLICY UPDATE CHANGES

    No material clinical or coverage changes in this revision.

    2Products affected
    2Products requiring a generic trial
    1 of 2Prior topical therapy options
    New startsZonisade applicability
    AllowedZonisade continuation

    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

    Diclofenac sodium gel 3% initial therapy

    Coverage requires the following step-therapy criterion.

    Required step therapy

    • Prior topical therapy

      • Trial of topical fluorouracil
      • Trial of topical imiquimod

    Rytary initial therapy

    Rytary requires the following step-therapy criterion:

    Rytary prerequisite: Trial of one generic carbidopa/levodopa-containing formulation

    Zonisade initial and continuation therapy

    Zonisade requires the following criterion for new starts:

    Zonisade prerequisite: Trial of generic zonisamide capsule

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

    Provider Documentation and Authorization Actions

    Prior Authorization

    Document Required Prior Topical Therapy

    Before requesting coverage for diclofenac sodium gel 3%, document a trial of either topical fluorouracil or topical imiquimod. Coverage may be denied when the required prior topical therapy is not documented.

    • Document a trial of topical fluorouracil or topical imiquimod.
    • Applies to authorization requests for diclofenac sodium gel 3%.
    Step Therapy

    Document Generic Carbidopa/Levodopa Trial

    Before requesting Rytary, document a trial of one generic carbidopa/levodopa-containing formulation. Rytary may be denied without one qualifying generic trial.

    • Document a trial of one generic carbidopa/levodopa-containing formulation.
    • The generic trial is required before Rytary.

    Policy Background

    This policy addresses actinic keratosis and coverage of topical diclofenac sodium gel 3%. Diclofenac sodium gel 3% is subject to step therapy; authorization requires documentation of a trial of either topical fluorouracil or topical imiquimod before coverage is considered.

    Initial Therapy Criteria

    Actinic keratosis step therapy

    Diclofenac sodium gel 3% is subject to step therapy for actinic keratosis.

    Required prior topical therapy: Trial of either topical fluorouracil or topical imiquimod1 of 2 agents

    Either topical agent satisfies the step requirement.

    Rytary initial therapy

    Rytary requires a prior generic trial.

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

    Zonisade initial therapy

    Zonisade requires a prior generic trial for new starts.

    Continuation Therapy Criteria

    Zonisade continuation therapy

    Continuation of prior therapy is approved for Zonisade.

    Continuation of Zonisade: Continuation of prior Zonisade therapy

    The step requirement applies to new starts only.

    Step-Therapy Requirements

    StepRequirement
    1Trial of either topical fluorouracil or topical imiquimod before diclofenac sodium gel 3%
    StepRequirement
    1Trial of one generic carbidopa/levodopa-containing formulation before Rytary
    StepRequirement
    1Trial of generic zonisamide capsule before Zonisade for new starts
    Policy Summary
    PayerAlign Powered by Sanford Health Plan
    PolicyACTINIC KERATOSIS - SCORE
    Policy CodePolicy 26213
    Change TypeNo material clinical or coverage changes
    Effective DateNov 1, 2026
    Next Review DateN/A
    Key ActionDocument a trial of either topical fluorouracil or topical imiquimod before requesting diclofenac sodium gel 3%.
    SourceLink
    On This Page
    Coverage CriteriaProvider Documentation and Authorization ActionsPolicy BackgroundInitial Therapy CriteriaContinuation Therapy CriteriaStep-Therapy Requirements
    Step Therapy

    Document Generic Zonisamide Trial for New Starts

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

    • For new starts, document a trial of generic zonisamide capsules.
    • Approve continuation of prior therapy; the step requirement applies to new starts only.
    Zonisade initial therapy: Trial of generic zonisamide capsule

    Step applies to new starts only.