ACTINIC KERATOSIS - SCORE (Step Therapy Criteria)
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This document lists step therapy requirements and affected products for several drug classes and specific medications for Blue Cross Blue Shield - South Carolina members. It governs prior authorization/step edits for drugs such as diclofenac gel, various antidepressants, atypical antipsychotics, Invega Hafyera, Relistor, and Rytary.
No material clinical or coverage changes in this revision.
Coverage Criteria
Diclofenac (Actinic keratosis) Initial Therapy
Diclofenac Sodium GEL 3% is covered when ALL of the following are met
from chunk 3
Antidepressants Initial Therapy
Listed antidepressant products are covered when ALL of the following are met
approve continuation of prior therapy
Atypical Antipsychotics Initial Therapy
Fanapt and related atypical antipsychotic products are covered when ALL of the following are met
approve continuation of prior therapy
Invega Hafyera Initial Therapy
Invega Hafyera is covered when ALL of the following are met for new starts
approve continuation of prior therapy; step applies to new starts only
Relistor Initial Therapy
Relistor is covered when ALL of the following are met
from chunk 16
Rytary Initial Therapy
Rytary is covered when ALL of the following are met
from chunk 19
Initial Step Therapy Criteria
Covered when ALL of the following are met for each product
from chunk 19
approve continuation of prior therapy per chunk 22
This section contains the coverage criteria applicable to the products listed in the policy. No explicit exclusions are specified in this portion of the document; coverage is governed by the individual step-therapy and prior‑authorization requirements described for each product (for example, the Diclofenac Sodium GEL 3% requirement listed below).
Initial Therapy Criteria (Step Therapy)
inv-38: Diclofenac initial therapy
Diclofenac Sodium GEL 3% is covered when ALL of the following are met
from chunk 3
inv-39: Antidepressant initial therapy
Listed antidepressant products are covered when ALL of the following are met
approve continuation of prior therapy
inv-40: Initial Therapy
Initial therapy requirements (step therapy)
chunk 19
chunk 22; step applies to new starts only; continuation approved
Step Therapy Requirements (Summary Table)
| Drug / Group | Step requirement |
|---|---|
| Diclofenac Sodium GEL 3% | |
| Trial of either topical fluorouracil OR topical imiquimod required prior to coverage |
| Drug / Group | Step requirement |
|---|---|
| Listed antidepressant products (e.g., Exxua Titration Pack, Fetzima, Fetzima Titration Pack) | |
| Trial of two generics from the formulary list (bupropion; mirtazapine; citalopram tablet or solution; desvenlafaxine succinate ER; duloxetine; escitalopram; fluoxetine; fluvoxamine; paroxetine; sertraline; venlafaxine HCl) required prior to coverage; approve continuation of prior therapy |
| Drug / Group | Step requirement |
|---|---|
| Atypical antipsychotic products (e.g., Fanapt, Fanapt titration packs, Lybalvi, Secuado) | |
| Trial of two oral generic formulary atypical antipsychotics (asenapine; aripiprazole; olanzapine; paliperidone; quetiapine; risperidone; ziprasidone) required prior to coverage; approve continuation of prior therapy |
| Drug / Group | Step requirement |
|---|---|
| Invega Hafyera (new starts) | |
| Trial of Invega Sustenna OR Invega Trinza required for new starts prior to coverage; continuation of prior therapy approved |
| Drug / Group | Step requirement |
|---|---|
| Relistor | |
| Trial of one of the following required prior to coverage: lubiprostone; Constulose; Enulose; Generlac; OR lactulose |
| Drug / Group | Step requirement |
|---|---|
| Rytary | |
| Trial of one generic carbidopa/levodopa containing formulation required prior to coverage |
| Drug / Group | Step requirement / notes |
|---|---|
| Branded products with step requirements (examples: Rytary; Zonisade) | |
| Trial of specified generic alternatives required prior to coverage. For Rytary: trial of one generic carbidopa/levodopa formulation. For Zonisade (new starts only): trial of generic zonisamide capsule required; continuation of prior therapy is approved. |
Provider Actions, Documentation & Prior Authorization
Diclofenac Prior Authorization: prior trial required
Require prior authorization for Diclofenac Sodium GEL 3% and document that the member has tried either topical fluorouracil or topical imiquimod before approval.
- Prior trial of either topical fluorouracil OR topical imiquimod is required.
Antidepressants Prior Authorization: two generic trials required
Require prior authorization for the listed antidepressant brands and document trials of two different generic formulary antidepressants from the enumerated list; continuation of previously established therapy is permitted.
- Trial of two generics from: bupropion, mirtazapine, citalopram (tablet or solution), desvenlafaxine succinate ER, duloxetine, escitalopram, fluoxetine, fluvoxamine, paroxetine, sertraline, venlafaxine hydrochloride.
- Approve continuation of prior therapy.
Atypical Antipsychotics Prior Authorization: two generic trials required
Require prior authorization for Fanapt and related atypical antipsychotic products and document trials of two oral generic formulary atypical antipsychotics from the specified list; continuation of prior therapy is allowed.
- Trial of two of: asenapine, aripiprazole, olanzapine, paliperidone, quetiapine, risperidone, ziprasidone.
- Approve continuation of prior therapy.
Invega Hafyera Prior Authorization: new-start trial required
Require prior authorization for new starts of Invega Hafyera and document a trial of Invega Sustenna or Invega Trinza; members already on Invega Hafyera may continue therapy without meeting the new-start step.
- For new starts, trial of Invega Sustenna OR Invega Trinza is required.
- Approve continuation of prior therapy.
Relistor Prior Authorization: trial of listed agents required
Require prior authorization for Relistor and document that the member has tried one of the listed bowel agents prior to approval.
- Trial of lubiprostone, Constulose, Enulose, Generlac, OR lactulose is required.
Rytary Prior Authorization: generic carbidopa/levodopa trial required
Require prior authorization for Rytary and document a prior trial of one generic carbidopa/levodopa formulation before approving Rytary.
- Trial of one generic carbidopa/levodopa containing formulation is required.
Zonisade Step Requirement: generic zonisamide trial for new starts
For new starts of Zonisade, require a trial of a generic zonisamide capsule; members already receiving Zonisade may continue without meeting the step requirement.
- Trial of generic zonisamide capsule is required for new starts.
- Approve continuation of prior therapy.
Diclofenac Step: topical agent trial required
Restate the step requirement for Diclofenac Sodium GEL 3%: prior trial of topical fluorouracil or topical imiquimod is required before coverage.
- Trial of either topical fluorouracil OR topical imiquimod required prior to Diclofenac Sodium GEL 3%.
Antidepressant Step: two generic trials required
Restate that for the listed antidepressant brands a step requiring trials of two generics from the enumerated formulary list must be documented; continuation of existing therapy is permitted.
- Trial of two generics from the enumerated antidepressant list is required.
- Approve continuation of prior therapy.
Atypical Antipsychotic Step: two generic trials required
Restate that Fanapt and related atypical antipsychotic products require trials of two oral generic formulary atypical antipsychotics from the specified list before approval; continuation of prior therapy is allowed.
- Trial of two of: asenapine, aripiprazole, olanzapine, paliperidone, quetiapine, risperidone, ziprasidone.
- Approve continuation of prior therapy.
Invega Hafyera Step: Sustenna or Trinza trial for new starts
Restate the Invega Hafyera new-start step: trial of Invega Sustenna or Invega Trinza is required for new initiations; members already on therapy may continue.
- For new starts, trial of Invega Sustenna OR Invega Trinza required.
- Approve continuation of prior therapy.
Relistor Step: trial of listed constipation agents required
Restate that Relistor requires a prior trial of one of the listed constipation agents (lubiprostone, Constulose, Enulose, Generlac, or lactulose) before approval.
- Trial of lubiprostone, Constulose, Enulose, Generlac, OR lactulose required.
Rytary Step: generic carbidopa/levodopa trial required
Restate that Rytary requires a prior trial of a generic carbidopa/levodopa formulation before Rytary will be covered.
- Trial of one generic carbidopa/levodopa containing formulation required prior to Rytary.
Generic Alternatives Step Summary
Summarize that step therapy requires documented trials of the specified generic alternatives prior to coverage of the branded products; this applies to new starts (Zonisade step applies to new starts only) while continuation of prior therapy is approved.
- Trial of specified generic alternatives is required prior to branded product coverage.
- Zonisade step applies to new starts only; continuation allowed for existing therapy.
Diclofenac Documentation: prior trial must be recorded
Document prior trial of either topical fluorouracil or topical imiquimod when requesting Diclofenac Sodium GEL 3%.
- Include evidence of trial with either topical fluorouracil OR topical imiquimod in the prior authorization documentation.
Antidepressant Documentation: record two generic trials
Document trials of two generic formulary antidepressants from the enumerated list when requesting coverage for the listed antidepressant brands; continuation of previously established therapy should be documented for approval.
- List the two generic agents tried from: bupropion, mirtazapine, citalopram (tablet or solution), desvenlafaxine succinate ER, duloxetine, escitalopram, fluoxetine, fluvoxamine, paroxetine, sertraline, venlafaxine hydrochloride.
- Document prior therapy for continuation approvals.
Atypical Antipsychotic Documentation: record two generic trials
Document trials of two oral generic formulary atypical antipsychotics from the specified list when requesting coverage for Fanapt and related products; document prior therapy for continuation approvals.
- Record trials of two of: asenapine, aripiprazole, olanzapine, paliperidone, quetiapine, risperidone, ziprasidone.
- Document prior therapy for continuation.
Invega Hafyera Documentation: new-start trial required
For new starts of Invega Hafyera, document a trial of Invega Sustenna or Invega Trinza in the prior authorization request; members already on Invega Hafyera may continue therapy with documentation of prior use.
- Document trial of Invega Sustenna OR Invega Trinza for new starts.
- Document prior therapy for continuation approvals.
Relistor Documentation: record trial of listed agents
Document prior trial of one of the listed constipation agents (lubiprostone, Constulose, Enulose, Generlac, or lactulose) before requesting Relistor.
- Include evidence of trial with one of the listed agents in the prior authorization documentation.
Rytary Documentation: generic carbidopa/levodopa trial must be shown
Document a prior trial of one generic carbidopa/levodopa formulation before approving Rytary; include the specific generic formulation used.
- Document which generic carbidopa/levodopa containing formulation was trialed.
Misc Documentation: Rytary and Zonisade trials must be recorded
Document prior trial of one generic carbidopa/levodopa formulation for Rytary requests and document trial of a generic zonisamide capsule for new starts of Zonisade; note that Zonisade step applies to new starts only and continuation of prior therapy is approved.
- Rytary: document one generic carbidopa/levodopa formulation trialed.
- Zonisade (new starts): document trial of a generic zonisamide capsule; document prior therapy for continuation.
Diclofenac Denial Risk: missing topical trial
Failure to document a required trial of topical fluorouracil or topical imiquimod may result in denial of coverage for Diclofenac Sodium GEL 3%.
- Denial risk if documentation of the required topical trial is not provided.
Antidepressant Denial Risk: missing two generic trials
Failure to document trials of two generic formulary antidepressants from the enumerated list may result in denial for the listed antidepressant products.
- Denial risk if two generic trials are not documented.
Atypical Antipsychotic Denial Risk: missing two generic trials
Failure to document trials of two listed generic atypical antipsychotics may result in denial for Fanapt and related products.
- Denial risk if two generic atypical antipsychotic trials are not documented.
Invega Hafyera Denial Risk: missing required Sustenna/Trinza trial
For Invega Hafyera new starts, lack of documentation showing a trial of Invega Sustenna or Invega Trinza may lead to denial.
- Denial risk if the required Sustenna or Trinza trial is not documented for new starts.
Relistor Denial Risk: missing trial of listed agents
Absence of documentation showing prior trial of lubiprostone, Constulose, Enulose, Generlac, or lactulose may lead to denial of Relistor requests.
- Denial risk if prior trial of one listed constipation agent is not documented.
Rytary Denial Risk: missing generic carbidopa/levodopa trial
Absence of documentation showing a required trial of one generic carbidopa/levodopa formulation may lead to denial for Rytary.
- Denial risk if the generic carbidopa/levodopa trial is not documented.
Misc Denial Risks: missing required generic trials
Failure to document required trials of specified generics (one generic carbidopa/levodopa for Rytary; generic zonisamide capsule for Zonisade new starts) may trigger a denial.
- Denial risk for Rytary if generic carbidopa/levodopa trial not shown.
- Denial risk for Zonisade new starts if generic zonisamide capsule trial not shown.
Continuation Therapy Criteria
inv-41: Antidepressant continuation
Continuation rule for antidepressants
from chunk 7
inv-42: Atypical antipsychotic continuation
Continuation rule for atypical antipsychotics
from chunk 10
inv-43: Invega Hafyera continuation
Continuation rule for Invega Hafyera
from chunk 13
inv-44: Continuation Therapy
Continuation allowed
chunk 22
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