Formulary step therapy requirements for select prescription drugs
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This document lists product-specific prior authorization/step therapy criteria for Blue Cross Blue Shield - South Carolina Bronze 6T members, describing required trials of alternative agents for various branded and specialty drugs.
No material clinical or coverage changes in this revision.
Coverage Criteria and Requirements
Antidepressant initial therapy requirement
Covered when ALL of the following are met
Approve for continuation of prior therapy.
Atypical antipsychotic initial therapy requirement
Covered when ALL of the following are met
Approve for continuation of prior therapy.
Invega Hafyera initial therapy requirement
Covered when ALL of the following are met
Step applies to new starts only. Approve for continuation of prior therapy.
Relistor initial therapy requirement
Covered when ALL of the following are met
Rytary initial therapy requirement
Covered when ALL of the following are met
Approve for continuation of prior therapy.
Zonisade initial therapy requirement
Covered when ALL of the following are met
Step applies to new starts only. Approve for continuation of prior therapy.
Step therapy requirements in this formulary explicitly permit continuation of prior therapy for multiple listed products. Where the policy language states “Approve for continuation of prior therapy,” prior, stable use of the specified branded agent does not require repeating the step trials. Examples in this document include the antidepressant group (Exxua Titration Pack, Fetzima and Fetzima Titration Pack), atypical antipsychotic entries (Fanapt and related products), Invega Hafyera, Rytary, and Zonisade, all of which contain an explicit continuation provision.
Although continuation is approved, the step requirements remain in force for new starts — i.e., patients initiating therapy. For products where the source specifies that the step “applies to new starts only,” prescribers must document the required trial(s) of the listed alternative agents for new therapy requests; existing therapy may be authorized without re‑trial.
Provider Actions, Step Therapy and Documentation
Antidepressant Prior Authorization Required
Antidepressant prior authorization: Trial of two generics from the formulary list (bupropion, mirtazapine, citalopram [tablet or solution], desvenlafaxine succinate ER, duloxetine, escitalopram, fluoxetine, fluvoxamine, paroxetine, sertraline [tablet or solution], venlafaxine hydrochloride) is required for new starts. Requests for continuation of previously-authorized therapy are approved.
- Affected products: Exxua Titration Pack; Fetzima; Fetzima Titration Pack
Antidepressant Step Therapy
Antidepressant step therapy: For coverage of specified branded antidepressants, prescribers must document trials of two generics from the formulary list above prior to approval. Documentation that the request is for continuation of prior therapy supports approval.
- Step applies to new starts; continuation approved when previously authorized
Atypical Antipsychotic Step Therapy / Prior Authorization
Atypical antipsychotic prior authorization and step therapy: New starts for Fanapt, Lybalvi, Secuado and related products require documented trials of two oral generic atypical antipsychotics (asenapine, aripiprazole, olanzapine, paliperidone, quetiapine, risperidone, ziprasidone). Continuation of prior therapy is approved.
- Affected products: Fanapt Titration Pack C; Lybalvi; Secuado
- Trial of two oral generic atypical antipsychotics required for new starts; continuation approved
Invega Hafyera Step Therapy / Prior Authorization
Invega Hafyera prior authorization and step therapy: New starts require trial of Invega Sustenna or Invega Trinza prior to coverage of Invega Hafyera. The step applies to new starts only. Continuation of prior therapy is approved.
- Step applies to new starts only; Invega Sustenna or Invega Trinza must be tried first
- Continuation approved for existing patients
Relistor Prior Authorization / Step Therapy
Relistor prior authorization and step therapy: Trial of one of the following laxatives is required prior to approval: lubiprostone, Constulose, Enulose, Generlac, or lactulose. Prescribers must document the trial of these alternatives.
- Affected product: Relistor
- Trial of listed laxatives required prior to approval
Rytary / Zonisade Step Therapy
Rytary and Zonisade step therapy: New starts for Rytary require a trial of one generic carbidopa/levodopa containing formulation. New starts for Zonisade require a trial of a generic zonisamide capsule. Both steps apply to new starts only; continuation of prior therapy is approved.
- Rytary: trial of one generic carbidopa/levodopa formulation required
- Zonisade: trial of generic zonisamide capsule required; step applies to new starts only
- Continuation approved for existing patients
Required Documentation and Denial Risk
Documentation and denial risk: Prescribers must document prior trials of the specific alternative agents listed for each step requirement and indicate if the request is for continuation of prior therapy. Failure to document required trials may result in denial of the request (examples: antidepressant—lack of two generic trials; atypical antipsychotic—lack of two generic atypical antipsychotic trials; Invega Hafyera—no trial of Invega Sustenna or Trinza for new starts; Relistor—no trial of listed laxatives; Rytary/Zonisade—no trial of generic carbidopa/levodopa for Rytary or generic zonisamide capsule for Zonisade).
- Providers must document prior trials and whether request is for continuation
- Failure to document required trials may trigger denial
Initial Therapy Criteria (New Starts)
Antidepressant initial therapy
Atypical antipsychotic initial therapy
Invega Hafyera initial therapy
Continuation of Therapy Provisions
Continuation provisions
Continuation of prior therapy
Applies to multiple products listed (see source).
Step Therapy Table and Requirements
| Product / Product Group | Required prior trials (step) | Number of agents required | Continuation of prior therapy |
|---|---|---|---|
| Antidepressant products (Exxua Titration Pack, Fetzima, Fetzima Titration Pack and related branded antidepressants) | Trial of two generics from: 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. |
| Atypical antipsychotic products (Fanapt, Fanapt titration packs, Lybalvi, Secuado) | Trial of two oral generic atypical antipsychotics from: asenapine; aripiprazole; olanzapine; paliperidone; quetiapine; risperidone; ziprasidone. | 2 agents | Approve for continuation of prior therapy. |
| Invega Hafyera | Trial of one of: Invega Sustenna or Invega Trinza. | 1 agent | Step applies to new starts only. Approve for continuation of prior therapy. |
| Relistor | Trial of lubiprostone; Constulose; Enulose; Generlac; or lactulose. | 1 agent | |
| Rytary | Trial of one generic carbidopa/levodopa containing formulation. | 1 agent | Approve for continuation of prior therapy. |
| Zonisade | Trial of generic zonisamide capsule. | 1 agent | Step applies to new starts only. Approve for continuation of prior therapy. |
Definitions and Applicability
Background and Scope
This formulary document lists step therapy requirements that mandate documented trials of specified alternative agents — typically generic formulations — prior to coverage of certain branded or specialty medications. Examples include: a trial of two generic antidepressants from the enumerated list for several branded antidepressant products, and a trial of two oral generic atypical antipsychotics for Fanapt and related entries.
Where noted in the criteria, the policy requires one specified alternative trial for new starts (for example, Invega Hafyera requires trial of Invega Sustenna or Invega Trinza; Rytary requires trial of one generic carbidopa/levodopa formulation; Relistor requires trial of one of several listed laxatives; Zonisade requires trial of a generic zonisamide capsule). Prescribers must document the prior trials of the specific alternative agents listed when requesting authorization.
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