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.
No material clinical or coverage changes in this revision.
Coverage Criteria and Step Therapy Rules
Initial Therapy (Diclofenac Sodium Gel 3%)
Covered when ALL of the following are met
Required prior therapy before approval of diclofenac sodium gel 3%
Antidepressant Step Requirement
Covered when ALL of the following are met
Approve for continuation of prior therapy
Atypical Antipsychotic Step Requirement
Covered when ALL of the following are met
Approve for continuation of prior therapy
Invega Hafyera Step Requirement
Covered when ALL of the following are met
Step applies to new starts only; approve for continuation of prior therapy
Relistor Step Requirement
Covered when ALL of the following are met
Required prior therapy before Relistor approval
Rytary Step Requirement
Covered when ALL of the following are met
Required prior therapy before Rytary approval
Zonisade (zonisamide) — Initial and Continuation
Covered when the following condition is met for Zonisade:
Step applies to new starts only.
Products Affected and Codes
| Diclofenac Sodium GEL 3% | Product affected as listed in policy |
| Emsam | Product listed under Antidepressants |
| Exxua | Product listed under Antidepressants |
| Exxua Titration Pack | Product listed under Antidepressants |
| Fetzima | Product listed under Antidepressants |
| Fetzima Titration Pack | Product listed under Antidepressants |
| Fanapt | Product listed under Atypical Antipsychotics |
| Fanapt Titration Pack A | Product listed under Atypical Antipsychotics |
| Lybalvi | Product listed under Atypical Antipsychotics |
| Secuado | Product listed under Atypical Antipsychotics |
| Invega Hafyera | Product listed under Invega Hafyera Therapy |
| Relistor | Product listed under Relistor |
| Rytary | Product listed under Rytary |
| Zonisade | Product listed under Zonisade Suspension |
Prior Authorization, Documentation, and Denial Risks
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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 — 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 — 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 — 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.
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
Initial Therapy Requirements
Initial therapy for Actinic Keratosis
Required before diclofenac sodium gel 3%
Initial Therapy (New Starts)
Initial therapy requirements for Zonisade:
Step applies to new starts only.
Continuation of Therapy
Continuation approvals
Continuation of prior therapy is approved where specified.
Applies to several branded products as listed
Continuation of Prior Zonisade Therapy
Continuation rules for members already on Zonisade:
Continuation does not require repeating the step trial.
Step Therapy Trial Requirements
| Step | Requirement | Notes |
|---|---|---|
| {"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":""} |
| Step | Requirement | Notes |
|---|---|---|
| {"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":""} |
| Step | Requirement | Notes |
|---|---|---|
| {"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":""} |
| Step | Requirement | Notes |
|---|---|---|
| {"text":"1","status":""}|{"text":"Trial of lubiprostone, Constulose, Enulose, Generlac, lactulose, or Movantik","status":""}|{"text":"Required prior therapy before Relistor approval.","status":""} |
| Step | Requirement | Notes |
|---|---|---|
| {"text":"1","status":""}|{"text":"Trial of one generic carbidopa/levodopa containing formulation","status":""}|{"text":"Required prior therapy before Rytary approval.","status":""} |
| Step | Requirement | Notes |
|---|---|---|
| {"text":"1","status":""}|{"text":"Trial of generic zonisamide capsule","status":""}|{"text":"Step applies to new starts only; approve for continuation of prior therapy.","status":""} |
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