CurrentBlue Cross Blue Shield - South CarolinaPolicy N/A

Formulary step therapy and prior authorization criteria for selected outpatient drugs

Defines step-therapy and trial-of-therapy requirements for specific outpatient pharmacy products (Formulary ID 25385); affects pharmacy providers and prescribers requesting coverage for the listed drugs and titration packs.

Policy Summary

PayerBlue Cross Blue Shield - South Carolina

PolicyFormulary step therapy and prior authorization criteria for selected outpatient drugs

Policy CodePolicy N/A

Change TypeNo material change

Effective DateNov 1, 2025

Next Review DateN/A

Key ActionObtain and document required trials of specified generic comparators (two generics for Exxua and Fanapt; specific comparator trials for Invega Hafyera, Relistor, and Zonisade) when submitting prior authorization.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

11+drugs or titration packs listed

25385formulary identifier

11/01/2025effective date

10/01/2025last updated

Coverage Criteria for Formulary Products

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Exxua / Exxua Titration Pack

Covered when ALL of the following are met

Exxua initial: Trial of two generics from the listed antidepressant agents (bupropion; mirtazapine; citalopram [tablet or solution]; desvenlafaxine succinate ER; duloxetine; escitalopram; fluoxetine; fluvoxamine; paroxetine; sertraline [tablet or solution]; venlafaxine hydrochloride)2 agents

Approve for continuation of prior therapy

Fanapt and Titration Packs A/B/C

Covered when ALL of the following are met

Fanapt initial: Trial of two of the following oral generic formulary atypical antipsychotic agents: asenapine; aripiprazole; olanzapine; paliperidone; quetiapine; risperidone; ziprasidone2 agents

Approve for continuation of prior therapy

Invega Hafyera

Covered when ALL of the following are met (new starts only)

Invega Hafyera initial: Trial of one of the following: Invega Sustenna or Invega Trinza1 agent

Step applies to new starts only. Approve for continuation of prior therapy

Relistor

Covered when ALL of the following are met

Relistor initial: Trial of lubiprostone, Constulose, Enulose, Generlac, or lactulose1 agent

Zonisade

Covered when ALL of the following are met (new starts only)

Zonisade initial: Trial of generic zonisamide capsule1 agent

Step applies to new starts only. Approve for continuation of prior therapy

The source document contains an entry for Diclofenac Sodium GEL 3% but does not list any explicit exclusion conditions for the products included in this formulary. No product-specific exclusion language or patient-population exclusions are provided in the document.

The document does not include any statements labeling treatments as not medically necessary. There are no explicit 'not medically necessary' determinations or language present for the listed products.

Prior Authorization, Documentation, and Denial Risks

Prior Authorization

Exxua / Exxua Titration Pack — Prior Authorization

Prior Authorization requires documentation of trials (and lack of response or intolerance) of two generics from the listed antidepressant agents for Exxua or its titration pack. Approve for continuation of prior therapy.

Affected products: Exxua, Exxua Titration Pack
Required generics: bupropion, mirtazapine, citalopram (tablet or solution), desvenlafaxine succinate ER, duloxetine, escitalopram, fluoxetine, fluvoxamine, paroxetine, sertraline (tablet or solution), venlafaxine hydrochloride

Prior Authorization

Fanapt and Titration Packs — Prior Authorization

Prior Authorization requires trial of two of the listed oral generic atypical antipsychotics. Approve for continuation of prior therapy.

Affected products: Fanapt, Fanapt Titration Pack, Lybalvi, Secuado
Required generics: asenapine, aripiprazole, olanzapine, paliperidone, quetiapine, risperidone, ziprasidone

Step Therapy

Invega Hafyera — Prior Authorization and Step Therapy

Prior Authorization requires trial of Invega Sustenna or Invega Trinza for new starts of Invega Hafyera; this step applies to new starts only. Continuation of prior therapy is approved. Failure to document a trial of Invega Sustenna or Invega Trinza for a new start may result in denial.

Applies to new starts of Invega Hafyera only
Continuation of prior therapy is permitted without the step

Prior Authorization

Relistor — Prior Authorization

Prior Authorization requires documentation of a trial of lubiprostone, Constulose, Enulose, Generlac, or lactulose prior to approval of Relistor. Failure to document such a trial may trigger denial.

Affected product: Relistor
Required trial agents: lubiprostone, Constulose, Enulose, Generlac, lactulose

Step Therapy

Zonisade — Prior Authorization and Step Therapy

Prior Authorization requires trial of a generic zonisamide capsule for new starts of Zonisade; this step applies to new starts only. Continuation of prior therapy is approved. Failure to document a trial of generic zonisamide capsule for a new start may trigger denial.

Applies to new starts of Zonisade only
Continuation of prior therapy is permitted without the step

Documentation Required

Documentation Requirement — Trials and Rationale

Documentation requirement: For all applicable step or prior authorization rules above, provide records showing trials and lack of response or intolerance (or other clinical rationale) for the required prior agents. Failure to provide required documentation may result in denial of the request.

Include dates, agent names, doses, duration, and reason for discontinuation (lack of efficacy or intolerance)

Denial Risk

Denial Risk — Missing Required Documentation

Denial risk: Failure to document required prior trials as specified for Exxua, Fanapt (and titration packs), Invega Hafyera (new starts), Relistor, or Zonisade (new starts) may result in denial of authorization.

Exxua/Exxua Titration Pack — missing documentation of two generic antidepressant trials
Fanapt/Fanapt Titration Pack — missing documentation of two generic atypical antipsychotic trials
Invega Hafyera (new starts) — missing documentation of trial of Invega Sustenna or Invega Trinza
Relistor — missing documentation of trial of lubiprostone, Constulose, Enulose, Generlac, or lactulose
Zonisade (new starts) — missing documentation of trial of generic zonisamide capsule

Definitions and Key Terms

Exxua / Exxua Titration Pack — Required trials

RequirementTrial and documented failure or intolerance of two generic antidepressant agents from the listed formulary products (bupropion; mirtazapine; citalopram tablet or solution; desvenlafaxine succinate ER; duloxetine; escitalopram; fluoxetine; fluvoxamine; paroxetine; sertraline tablet or solution; venlafaxine hydrochloride).

Approval for continuationContinuation of prior Exxua or Exxua Titration Pack therapy is approved without requiring the two-agent trial.

Threshold2 agents must be trialed and documented as failed or not tolerated.

Documentation requiredClinical records must document trials and lack of response or intolerance for the two generic agents listed.

Fanapt and Titration Packs — Required trials

RequirementTrial and documented failure or intolerance of two oral generic formulary atypical antipsychotics from the following: asenapine; aripiprazole; olanzapine; paliperidone; quetiapine; risperidone; ziprasidone.

Approval for continuationContinuation of prior Fanapt or Fanapt titration pack therapy is approved without requiring the two-agent trial.

Threshold2 agents must be trialed and documented as failed or not tolerated.

Documentation requiredClinical records must document trials and lack of response or intolerance for the two generic atypical antipsychotics listed.

Initial Therapy Requirements

Exxua initial therapy

Fanapt initial therapy

Fanapt initial: Trial of two listed oral generic atypical antipsychotics (asenapine; aripiprazole; olanzapine; paliperidone; quetiapine; risperidone; ziprasidone)2 agents

Invega Hafyera initial therapy

Invega Hafyera initial: Trial of Invega Sustenna or Invega Trinza (new starts only)1 agent

Relistor initial therapy

Relistor initial: Trial of lubiprostone, Constulose, Enulose, Generlac, or lactulose1 agent

Zonisade initial therapy

Zonisade initial: Trial of generic zonisamide capsule (new starts only)1 agent

Step Therapy Rules

Step therapy requirement	Applicability
Trial of one of the following: Invega Sustenna or Invega Trinza	Step applies to new starts only
Approve for continuation of prior therapy

Step therapy requirement	Applicability
Trial of generic zonisamide capsule	Step applies to new starts only
Approve for continuation of prior therapy

Product	Required trial(s) prior to approval
Exxua / Exxua Titration Pack	Trial of two generics from the following formulary antidepressant agents: bupropion; mirtazapine; citalopram (tablet or solution); desvenlafaxine succinate ER; duloxetine; escitalopram; fluoxetine; fluvoxamine; paroxetine; sertraline (tablet or solution); venlafaxine hydrochloride
Fanapt and Titration Packs	Trial of two of the following oral generic formulary atypical antipsychotic agents: asenapine; aripiprazole; olanzapine; paliperidone; quetiapine; risperidone; ziprasidone

OpenPayer

Formulary step therapy and prior authorization criteria for selected outpatient drugs

Coverage Criteria for Formulary Products

Product Coding and Identifiers

Prior Authorization, Documentation, and Denial Risks

Background and Scope

Definitions and Key Terms

Initial Therapy Requirements

Continuation Therapy Requirements

Step Therapy Rules