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    v1.0.31
    OpenPayerPolicy UpdatesPharmacy & Specialty Drugseternalhealth diclofenac gel Coverage Prior Auth |…
    Ask Trek AI about this page
    CurrenteternalhealthPolicy N/A

    ACTINIC KERATOSIS - SCORE

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    Defines product-specific coverage and step/step-therapy details for diclofenac sodium gel 3% for actinic keratosis and contains multiple unrelated drug score entries with their trial/step requirements. Affects providers seeking prior authorization for listed products under eternalHealth.

    Policy Summary
    Payereternalhealth
    PolicyACTINIC KERATOSIS - SCORE
    Policy CodePolicy N/A
    Change TypeMinor — no material changes
    Effective DateAug 1, 2026
    Last ReviewJul 2, 2026
    Next Review DateJul 2, 2026
    Key ActionPrior authorization requires documented trial of either topical fluorouracil or topical imiquimod for diclofenac sodium gel 3%.
    SourceLink
    POLICY UPDATE CHANGES

    No material clinical or coverage changes in this revision.

    1Primary criterion listed for diclofenac sodium gel 3%
    1Product listed under Actinic Keratosis
    8Other drug score entries present
    1Zonisade step 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.

    1Products Affected

    Coverage Criteria and Step Therapy Rules

    Initial Therapy (Diclofenac Sodium Gel 3%)

    Covered when ALL of the following are met

    Prior topical therapy: Trial of either topical fluorouracil or topical imiquimod

    Required prior therapy before approval of diclofenac sodium gel 3%

    Antidepressant Step Requirement

    Covered when ALL of the following are met

    Trial of generics: Trial of two generics from specified formulary antidepressants (bupropion, mirtazapine, citalopram, desvenlafaxine succinate ER, duloxetine, escitalopram, fluoxetine, fluvoxamine, paroxetine, sertraline, venlafaxine hydrochloride)2 agents

    Approve for continuation of prior therapy

    Atypical Antipsychotic Step Requirement

    Covered when ALL of the following are met

    Trial of generics: Trial of two oral generic formulary atypical antipsychotic agents (asenapine, aripiprazole, olanzapine, paliperidone, quetiapine, risperidone, ziprasidone)2 agents

    Approve for continuation of prior therapy

    Invega Hafyera Step Requirement

    Covered when ALL of the following are met

    Prior LAI trial: Trial of Invega Sustenna or Invega Trinza for new starts1 agent

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

    Relistor Step Requirement

    Covered when ALL of the following are met

    Prior laxative trial: Trial of lubiprostone, Constulose, Enulose, Generlac, lactulose, or Movantik1 agent

    Required prior therapy before Relistor approval

    Rytary Step Requirement

    Covered when ALL of the following are met

    Prior carbidopa/levodopa trial: Trial of one generic carbidopa/levodopa containing formulation1 agent

    Required prior therapy before Rytary approval

    Zonisade (zonisamide) — Initial and Continuation

    Covered when the following condition is met for Zonisade:

    Step and continuation: For new starts, a trial of generic zonisamide capsule is required. Approve for continuation of prior therapy.

    Step applies to new starts only.

    Products Affected and Codes

    Products Affected - Actinic KeratosismixedCovered
    Diclofenac Sodium GEL 3%Product affected as listed in policy
    Products Affected - Antidepressantsmixed
    EmsamProduct listed under Antidepressants
    ExxuaProduct listed under Antidepressants
    Exxua Titration PackProduct listed under Antidepressants
    FetzimaProduct listed under Antidepressants
    Fetzima Titration PackProduct listed under Antidepressants
    Products Affected - Atypical Antipsychoticsmixed
    FanaptProduct listed under Atypical Antipsychotics
    Fanapt Titration Pack AProduct listed under Atypical Antipsychotics
    LybalviProduct listed under Atypical Antipsychotics
    SecuadoProduct listed under Atypical Antipsychotics
    Products Affected - Invega Hafyeramixed
    Invega HafyeraProduct listed under Invega Hafyera Therapy
    Products Affected - Relistormixed
    RelistorProduct listed under Relistor
    Products Affected - Rytarymixed
    RytaryProduct listed under Rytary
    Products Affected - Zonisademixed
    ZonisadeProduct listed under Zonisade Suspension

    Prior Authorization, Documentation, and Denial Risks

    Prior Authorization

    Prior topical therapy required for Diclofenac Sodium GEL 3%

    Prior authorization requires documentation that the member has tried either topical fluorouracil or topical imiquimod before approval of Diclofenac Sodium GEL 3%.

    • Required prior topical therapy: trial of either topical fluorouracil or topical imiquimod.
    Step Therapy

    Zonisade step (new starts) and allow continuation

    For new starts, prescribers must document a trial of a generic zonisamide capsule before Zonisade (zonisamide suspension) will be approved. Members already receiving Zonisade may be approved for continuation without repeating the step trial.

    • Step applies to new starts only: trial of generic zonisamide capsule.
    • Approve for continuation of prior Zonisade therapy.

    Policy Background

    This document provides product-specific administrative coverage criteria within the Actinic Keratosis - SCORE policy. It lists the topical product Diclofenac Sodium GEL 3% for the indication Actinic keratosis and requires documentation of a prior topical therapy: a trial of either topical fluorouracil or topical imiquimod before diclofenac will be approved.

    The policy also includes a separate, product-specific step requirement for Zonisade (zonisamide suspension): for new starts a trial of a generic zonisamide capsule is required, while continuation of prior Zonisade therapy is approvable without repeating the step.

    Providers seeking prior authorization should document the required prior therapies as specified above; failure to document the indicated trials may result in denial of coverage for the affected product(s).

    Definitions and Key Terms

    Zonisade — definition and step requirements
    Defined termZonisade refers to the zonisamide suspension product listed under Products Affected.
    Product listedZonisade (zonisamide) is the sole product affected under the Zonisade entry.
    Initial step requirementFor new starts, a trial of a generic zonisamide capsule is required prior to approval.
    Continuation policyApprove for continuation of prior Zonisade therapy without repeating the step requirement.
    ScopeApplies to Zonisade as listed in the Actinic Keratosis - SCORE policy (Effective 2026-08-01).

    Initial Therapy Requirements

    Initial therapy for Actinic Keratosis

    Prior topical therapy: Trial of either topical fluorouracil or topical imiquimod

    Required before diclofenac sodium gel 3%

    Initial Therapy (New Starts)

    Initial therapy requirements for Zonisade:

    Initial step: Trial of generic zonisamide capsule required for new starts.

    Step applies to new starts only.

    Continuation of Therapy

    Continuation approvals

    Continuation of prior therapy is approved where specified.

    Continuation: Approve for continuation of prior therapy when member is already receiving the medication

    Applies to several branded products as listed

    Continuation of Prior Zonisade Therapy

    Continuation rules for members already on Zonisade:

    Continuation: Approve for continuation of prior therapy.

    Continuation does not require repeating the step trial.

    Step Therapy Trial Requirements

    StepRequirementNotes
    {"text":"1","status":""}|{"text":"Trial of one of the following: Invega Sustenna or Invega Trinza","status":""}|{"text":"Step applies to new starts only; approve for continuation of prior therapy.","status":""}
    StepRequirementNotes
    {"text":"1","status":""}|{"text":"Trial of two generics from the following formulary products: bupropion, mirtazapine, citalopram, desvenlafaxine succinate ER, duloxetine, escitalopram, fluoxetine, fluvoxamine, paroxetine, sertraline, venlafaxine hydrochloride","status":""}|{"text":"Approve for continuation of prior therapy.","status":""}
    StepRequirementNotes
    {"text":"1","status":""}|{"text":"Trial of two of the following oral generic formulary atypical antipsychotic agents: asenapine, aripiprazole, olanzapine, paliperidone, quetiapine, risperidone, ziprasidone","status":""}|{"text":"Approve for continuation of prior therapy.","status":""}
    StepRequirementNotes
    {"text":"1","status":""}|{"text":"Trial of lubiprostone, Constulose, Enulose, Generlac, lactulose, or Movantik","status":""}|{"text":"Required prior therapy before Relistor approval.","status":""}
    StepRequirementNotes
    {"text":"1","status":""}|{"text":"Trial of one generic carbidopa/levodopa containing formulation","status":""}|{"text":"Required prior therapy before Rytary approval.","status":""}
    StepRequirementNotes
    {"text":"1","status":""}|{"text":"Trial of generic zonisamide capsule","status":""}|{"text":"Step applies to new starts only; approve for continuation of prior therapy.","status":""}
    Policy Summary
    Payereternalhealth
    PolicyACTINIC KERATOSIS - SCORE
    Policy CodePolicy N/A
    Change TypeMinor — no material changes
    Effective DateAug 1, 2026
    Last ReviewJul 2, 2026
    Next Review DateJul 2, 2026
    Key ActionPrior authorization requires documented trial of either topical fluorouracil or topical imiquimod for diclofenac sodium gel 3%.
    SourceLink
    On This Page
    Coverage Criteria and Step Therapy RulesProducts Affected and CodesPrior Authorization, Documentation, and Denial RisksPolicy BackgroundDefinitions and Key TermsInitial Therapy RequirementsContinuation of TherapyStep Therapy Trial Requirements
    Step Therapy

    Invega Hafyera — prior LAI trial required for new starts

    New starts of Invega Hafyera require documentation of a trial of Invega Sustenna or Invega Trinza; continuation of prior Invega Hafyera therapy is approvable.

    • Required prior long‑acting injectable trial: Invega Sustenna or Invega Trinza.
    • Step applies to new starts; approve for continuation of prior therapy.
    Step Therapy

    Antidepressant step — two generic trials required

    Branded antidepressant products require documentation of trials of two generic formulary antidepressants from the listed set prior to approval; members already on therapy may be approved for continuation.

    • Trial of two generics from: bupropion, mirtazapine, citalopram, desvenlafaxine succinate ER, duloxetine, escitalopram, fluoxetine, fluvoxamine, paroxetine, sertraline, venlafaxine HCl.
    • Approve for continuation of prior therapy.
    Step Therapy

    Atypical antipsychotic step — two generic oral trials required

    Approval for the listed atypical antipsychotics requires documentation of trials of two oral generic formulary atypical antipsychotics; continuation of prior therapy is approvable.

    • Trial of two oral generic atypical antipsychotics from: asenapine, aripiprazole, olanzapine, paliperidone, quetiapine, risperidone, ziprasidone.
    • Approve for continuation of prior therapy.
    Step Therapy

    Relistor — prior laxative or Movantik trial required

    Relistor requires documentation of a trial of specified laxatives or Movantik prior to approval.

    • Trial of lubiprostone, Constulose, Enulose, Generlac, lactulose, or Movantik is required before Relistor approval.
    Step Therapy

    Rytary — prior carbidopa/levodopa trial required

    Rytary requires documentation of a trial of one generic carbidopa/levodopa containing formulation prior to approval.

    • Trial of one generic carbidopa/levodopa formulation is required before Rytary approval.
    Denial Risk

    Zonisade step applies to new starts; continuation allowed

    The step requirement applies to new starts only: lack of a documented trial of a generic zonisamide capsule for new starts may result in denial; prior therapy may be continued without repeating the step.

    • Step applies to new starts only: trial of generic zonisamide capsule required prior to approval of Zonisade.
    • Continuation of prior Zonisade therapy is approvable without repeating the step.
    Documentation Required

    Document prior topical therapy for actinic keratosis

    Documentation submitted for actinic keratosis treatment must show a trial of either topical fluorouracil or topical imiquimod to support approval of Diclofenac Sodium GEL 3%.

    • Required documentation: trial of topical fluorouracil or topical imiquimod.
    Documentation Required

    Document antidepressant trials or prior therapy

    For branded antidepressant requests, include documentation of trials of two generic formulary antidepressants or documentation that the member is already receiving the requested agent to support continuation approval.

    • Document trials of two generics from the specified formulary list.
    • If requesting continuation, document prior therapy on the requested agent.
    Documentation Required

    Required documentation for Zonisade new starts and continuation

    New starts for Zonisade must include documentation demonstrating a trial of a generic zonisamide capsule; if approving continuation, document prior use so the step does not need repeating.

    • Documentation should demonstrate trial of a generic zonisamide capsule for new starts.
    • For continuation approvals, document prior therapy on Zonisade.
    Denial Risk

    Denial risk — missing prior topical therapy for Diclofenac

    If the provider does not document a prior trial of either topical fluorouracil or topical imiquimod, the request for Diclofenac Sodium GEL 3% may be denied.

    • Lack of documented trial of topical fluorouracil or topical imiquimod may trigger denial.
    Denial Risk

    Denial risk — missing step trials for multiple products

    Failure to document required trial(s) of specified alternative agents (e.g., two generic antidepressants, two oral generic atypical antipsychotics, Invega Sustenna/Trinza, specified laxatives/Movantik, one generic carbidopa/levodopa) may trigger denial for the corresponding branded products.

    • Antidepressants: trial of two generics required.
    • Atypical antipsychotics: trial of two oral generics required.
    • Invega Hafyera: trial of Invega Sustenna or Invega Trinza required for new starts.
    • Relistor: trial of specified laxatives or Movantik required.
    • Rytary: trial of one generic carbidopa/levodopa formulation required.
    Denial Risk

    Denial risk — missing zonisamide capsule trial for Zonisade

    Failure to document a trial of a generic zonisamide capsule for new starts may result in denial of coverage for Zonisade.

    • Denial risk for Zonisade new starts without documented generic zonisamide capsule trial.