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    v1.0.31
    OpenPayerPolicy UpdatesPharmacy & Specialty Drugseternalhealth Actinic Keratosis Coverage | OpenPay…
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    CurrenteternalhealthPolicy 26208

    ACTINIC KERATOSIS - SCORE

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

    Policy Summary
    Payereternalhealth
    PolicyACTINIC KERATOSIS - SCORE
    Policy CodePolicy 26208
    Change TypeNo material change
    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
    2Acceptable prerequisite therapies
    1 of 2Required trial structure
    2Generic formulations required
    New starts onlyZonisade step applicability

    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

    Initial Therapy Criteria

    Covered when the following prerequisite is met:

    Prerequisite topical therapy

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

    Rytary Initial Therapy Criteria

    Covered when the following prerequisite is met:

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

    Complete before Rytary

    Zonisade Initial Therapy Criteria

    Covered for new starts when the following prerequisite is met:

    Required prerequisite for new starts: Trial of generic zonisamide capsule

    The step requirement applies to new starts only; continuation of prior therapy is approved

    Provider Documentation and Action Items

    Step Therapy

    Topical Prerequisite Required

    Before diclofenac sodium gel 3% can be approved, document a trial of either topical fluorouracil or topical imiquimod.

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

    Rytary Prerequisite Trial

    Before Rytary approval, document a trial of one generic carbidopa/levodopa-containing formulation.

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

    Zonisade Prerequisite and Continuation

    For a new Zonisade start, document a trial of generic zonisamide capsules. The step requirement applies only to new starts; continuation of prior therapy may be approved.

    Initial Therapy Criteria

    Diclofenac Sodium Gel 3% Initial Therapy Criteria

    Initial coverage requires the following prerequisite:

    Prerequisite topical therapy

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

    Rytary Initial Therapy Criteria

    Rytary requires the following prerequisite:

    Step 1: Trial of one generic carbidopa/levodopa-containing formulation

    Continuation Therapy Criteria

    Zonisade Continuation Therapy Criteria

    Continuation of prior therapy is approved:

    Continuation: Prior Zonisade therapy

    Continuation is approved; the step requirement applies to new starts only

    Step Therapy Requirements

    StepRequirement
    1Trial of either topical fluorouracil or topical imiquimod
    StepRequirement
    1Trial of one generic carbidopa/levodopa-containing formulation before Rytary
    StepRequirement
    1Trial of generic zonisamide capsule before Zonisade. Step applies to new starts only; continuation of prior therapy is approved.
    Policy Summary
    Payereternalhealth
    PolicyACTINIC KERATOSIS - SCORE
    Policy CodePolicy 26208
    Change TypeNo material change
    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 Action ItemsInitial Therapy CriteriaContinuation Therapy CriteriaStep Therapy Requirements
    • New starts: trial of generic zonisamide capsules is required.
    • Continuation: approve for continuation of prior therapy.

    Unsupported block type: step_therapy

    Step Therapy

    Rytary Step Requirement

    Complete and document a trial of one generic carbidopa/levodopa-containing formulation before requesting Rytary.

    • One generic carbidopa/levodopa-containing formulation must be tried first.
    Step Therapy

    Zonisade Step Requirement

    For new Zonisade starts, complete and document a trial of generic zonisamide capsules. Continuation requests for prior therapy are handled separately and may be approved for continuation.

    • New starts require generic zonisamide capsule trial.
    • Continuation of prior therapy does not require repeating the new-start step.
    Documentation Required

    Document Prerequisite Topical Therapy

    Document whether the patient has tried either topical fluorouracil or topical imiquimod before submitting the diclofenac sodium gel 3% request.

    • Record the agent tried and relevant treatment history.
    Denial Risk

    Prerequisite Therapy Not Met

    Coverage for diclofenac sodium gel 3% may be denied when neither a topical fluorouracil nor a topical imiquimod trial is documented.

    • Denial risk: no documented trial of either required topical therapy.
    Denial Risk

    Rytary Trial Requirement

    A trial of one generic carbidopa/levodopa-containing formulation is required before Rytary approval.

    • If no qualifying generic trial is documented, the Rytary request may not meet the prerequisite.
    Denial Risk

    Zonisamide Trial Requirement

    For a new Zonisade start, a trial of generic zonisamide capsules is required before approval.

    • If no generic zonisamide capsule trial is documented, the new-start request may not meet the prerequisite.
    • Continuation of prior therapy is treated separately.

    Actinic keratosis is a condition addressed by this policy. The policy uses prerequisite therapy to guide coverage: for applicable new treatment requests, document the required generic or topical trial before the requested product is approved. Continuation of prior Zonisade therapy is treated separately from the new-start step requirement.

    Zonisade Initial Therapy Criteria

    Zonisade requires the following prerequisite for new starts:

    Step 1: Trial of generic zonisamide capsule

    The step requirement applies to new starts only