Formulary step therapy and prior authorization criteria for selected psychiatric and related drugs
Customize your policy alerts
Sign up for all Blue Cross Blue Shield - South Carolina policy alerts
Know when Blue Cross Blue Shield - South Carolina releases new policies or updates existing guidance.
Monitor payer policy activity
This document governs step therapy and trial-of-therapy criteria for specific outpatient prescription products (primarily psychiatric medications and related agents) under the South Carolina PDP Basic plan; it affects prescribers and pharmacy benefit adjudication for plan members in South Carolina.
No material clinical or coverage changes in this revision.
Coverage Criteria and Product-Specific Requirements
Product-specific step therapy requirements
Covered when the following product-specific trial requirements are met (and continuation of prior therapy is approved):
From chunk 2
From chunk 4
From chunk 6
From chunk 8
From chunk 10
From chunk 12
Continuation of prior therapy is permitted for many listed products when documentation of prior therapy is provided. For new starts, specific step therapy requirements apply to selected products: for antidepressant products (Exxua, Fetzima and their titration packs) a trial of two generic formulary antidepressants is required from the following list: bupropion, mirtazapine, citalopram, desvenlafaxine succinate ER, duloxetine, escitalopram, fluoxetine, fluvoxamine, paroxetine, sertraline, or venlafaxine HCl; approval is granted for continuation of prior therapy. For atypical antipsychotics (Fanapt and related products) a trial of two oral generic formulary atypical antipsychotics is required (choose from asenapine, aripiprazole, olanzapine, paliperidone, quetiapine, risperidone, ziprasidone); continuation of prior therapy is approved. For Invega Hafyera new starts, a trial of Invega Sustenna or Invega Trinza is required; continuation of prior therapy is approved. For Zonisade new starts, a trial of a generic zonisamide capsule is required; continuation of prior therapy is approved.
Provider Actions, Documentation, and Denial Risks
Antidepressant prior authorization — trial of two generics
Prior authorization for certain branded antidepressant products (Exxua, Fetzima and related titration packs) requires documentation of trials of two generic formulary antidepressant agents from the enumerated list; continuation of prior therapy is approved without repeating steps.
- Required trial agents (generics): bupropion; mirtazapine; citalopram; desvenlafaxine succinate ER; duloxetine; escitalopram; fluoxetine; fluvoxamine; paroxetine; sertraline; venlafaxine HCl
Atypical antipsychotic prior authorization — two oral generics required
Prior authorization for Fanapt, Lybalvi, Secuado and related atypical antipsychotic products requires documentation of trials of two oral generic formulary atypical antipsychotics; continuation of prior therapy is approved.
- Required trial agents (generics): asenapine; aripiprazole; olanzapine; paliperidone; quetiapine; risperidone; ziprasidone
Invega Hafyera prior authorization — trial of Sustenna or Trinza
New starts of Invega Hafyera require prior trial of either Invega Sustenna or Invega Trinza for approval; continuation of prior therapy is approved when documented.
- Required trial for new starts: Invega Sustenna or Invega Trinza
Zonisade prior authorization — trial of generic zonisamide
New starts of Zonisade require trial of a generic zonisamide capsule prior to approval; continuation of prior therapy is approved when documented.
- Required trial for new starts: generic zonisamide capsule
Relistor prior authorization — trial of specified laxatives required
Prior authorization for Relistor requires documentation of a trial of specified constipation agents (laxatives) before approval.
- Required trial agents: lubiprostone; Constulose; Enulose; Generlac; lactulose
Diclofenac GEL prior authorization — topical agent trial required
Prior authorization for Diclofenac Sodium GEL 3% (actinic keratosis) requires documentation of trial of either topical fluorouracil or topical imiquimod before approval.
- Required trial agents: topical fluorouracil or topical imiquimod
Antidepressant step therapy — two generic trials required
Step therapy for Exxua and related antidepressant products requires documented trials of two generic formulary antidepressants from the enumerated list; continuation of prior therapy is approved.
- Acceptable trial agents include: bupropion; mirtazapine; citalopram; desvenlafaxine succinate ER; duloxetine; escitalopram; fluoxetine; fluvoxamine; paroxetine; sertraline; venlafaxine HCl
Atypical antipsychotic step therapy — two oral generic trials required
Step therapy for Fanapt and related atypical antipsychotics requires documented trials of two oral generic formulary atypical antipsychotics; continuation of prior therapy is approved.
- Acceptable trial agents: asenapine; aripiprazole; olanzapine; paliperidone; quetiapine; risperidone; ziprasidone
Invega Hafyera step therapy — Sustenna or Trinza required for new starts
Step therapy for new starts of Invega Hafyera requires trial of Invega Sustenna or Invega Trinza; continuation of prior therapy is approved.
- Required trial for new starts: Invega Sustenna or Invega Trinza
Zonisade step therapy — generic zonisamide required for new starts
Step therapy for new starts of Zonisade requires trial of a generic zonisamide capsule; continuation of prior therapy is approved.
- Required trial for new starts: generic zonisamide capsule
Relistor step therapy — trial of listed laxatives required
Step therapy for Relistor requires prior trial of one of the listed constipation agents before approval.
- Required trial agents: lubiprostone; Constulose; Enulose; Generlac; lactulose
Diclofenac GEL step therapy — topical fluorouracil or imiquimod required
Step therapy for Diclofenac Sodium GEL 3% (actinic keratosis) requires trial of topical fluorouracil or topical imiquimod prior to approval.
- Required trial agents: topical fluorouracil or topical imiquimod
Antidepressant documentation — record two generic trials or prior therapy
Document trials of two generic formulary antidepressant agents from the enumerated list for new-start approvals, or provide evidence of prior therapy for continuation approvals.
- Document the specific agents tried and dates of trial
- Continuation: provide evidence of member's prior therapy to avoid repeating steps
Atypical antipsychotic documentation — record two oral generic trials or prior therapy
Document trials of two oral generic formulary atypical antipsychotic agents from the enumerated list for new-start approvals, or provide evidence of prior therapy for continuation approvals.
- Document the specific agents tried and dates of trial
- Continuation: provide evidence of member's prior therapy to avoid repeating steps
Invega Hafyera documentation — trial of Sustenna or Trinza required for new starts
For Invega Hafyera new starts, document trial of Invega Sustenna or Invega Trinza; for continuation requests, provide evidence of prior therapy.
- Document which paliperidone LAI was used (Sustenna or Trinza) and trial dates
- Continuation: include prior therapy records
Relistor documentation — record prior laxative trials
Document a trial of a listed constipation agent(s) (lubiprostone, Constulose, Enulose, Generlac, or lactulose) before pursuing Relistor approval.
- Document agent(s) tried and duration of therapy
Zonisade documentation — record generic zonisamide trial or prior therapy
Document trial of a generic zonisamide capsule for Zonisade new starts; for continuation requests, provide evidence of prior therapy.
- Document the generic zonisamide product and dates of trial
- Continuation: include prior therapy records
Diclofenac GEL documentation — record topical agent trial
Document trial of topical fluorouracil or topical imiquimod for actinic keratosis-related Diclofenac GEL 3% requests before approval.
- Document which topical agent was used and treatment dates
Antidepressant denial risk — missing generic trials may trigger denial
Failure to document trials of two generic formulary antidepressants from the enumerated list may result in denial of approval for Exxua, Fetzima and related products; continuation of prior therapy is approved when documented.
- Ensure records show two distinct generic antidepressant trials or provide prior therapy evidence to avoid denial
Atypical antipsychotic denial risk — missing generic trials may trigger denial
Failure to document trials of two oral generic formulary atypical antipsychotics may result in denial for Fanapt and related products; continuation of prior therapy is approved when documented.
- Provide documentation of two distinct generic atypical antipsychotic trials to avoid denial
Invega Hafyera denial risk — missing Sustenna/Trinza trial may trigger denial
Failure to document trial of Invega Sustenna or Invega Trinza for new-start Invega Hafyera requests may result in denial; continuation of prior therapy is approved when documented.
- For new starts, include trial documentation of Sustenna or Trinza to avoid denial
Relistor denial risk — missing laxative trials may trigger denial
Failure to document trial of lubiprostone, Constulose, Enulose, Generlac, or lactulose may result in denial for Relistor.
- Document prior laxative therapy to support Relistor approval
Zonisade denial risk — missing generic zonisamide trial may trigger denial
Failure to trial a generic zonisamide capsule for Zonisade new starts may result in denial; continuation of prior therapy is approved when documented.
- For new starts, document generic zonisamide trial to avoid denial
Diclofenac GEL denial risk — missing topical trial may trigger denial
Failure to document trial of topical fluorouracil or topical imiquimod may result in denial for Diclofenac Sodium GEL 3% (actinic keratosis).
- Document prior topical therapy to support Diclofenac GEL approval
Pharmacotherapy Modalities
Antidepressant pharmacotherapy
From chunk 4
Antipsychotic pharmacotherapy
From chunk 6
Definitions and Key Terms
Background and Scope
This policy establishes formulary step requirements and prior authorization expectations for selected outpatient prescription products within the South Carolina PDP Basic plan. It is intended to guide pharmacy benefit adjudication and prescriber documentation by listing required alternative-agent trials for nonpreferred or brand products and by noting that documentation of prior therapy generally permits continuation without repeating step requirements. Where noted, step requirements apply to new starts only and continuation of previously established therapy is approved when prior treatment is documented.
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.