Formulary step-therapy and prior authorization criteria for selected pharmacy products
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This document lists prior authorization/step therapy requirements and continuation rules for several outpatient prescription drugs on the Blue Cross Blue Shield - South Carolina formulary. It affects prescribers and pharmacy benefit administrators managing new starts and continuations for the listed products.
No material clinical or coverage changes in this revision.
Coverage Criteria — Product-specific Initial Therapy
inv-01: Diclofenac Sodium GEL 3% — Listing
Diclofenac Sodium GEL 3% is listed as an affected product.
Formulary entry; Criteria note: trial of either topical fluorouracil or topical imiquimod (see Formulary ID details)
inv-02: Antidepressant products — Initial Therapy
Covered when ALL of the following are met for new starts:
Approve for continuation of prior therapy
inv-03: Fanapt and related products — Initial Therapy
Covered when ALL of the following are met for new starts:
Approve for continuation of prior therapy
inv-04: Invega Hafyera — Initial Therapy
Covered when ALL of the following are met for new starts:
Step applies to new starts only; approve for continuation of prior therapy
inv-05: Relistor — Initial Therapy
Covered when ALL of the following are met:
Approve for continuation of prior therapy
inv-06: Rytary — Initial Therapy
Covered when ALL of the following are met for new starts:
Step applies to new starts only; approve for continuation of prior therapy
inv-07: Zonisade — Initial Therapy
Covered when ALL of the following are met for new starts:
Step applies to new starts only; approve for continuation of prior therapy
This section is an index listing and does not contain specific coverage criteria text. The document segment repeats drug names and topical headings (for example, Diclofenac Sodium and class headings such as Antidepressants and Atypical Antipsychotics) for navigation rather than presenting eligibility requirements.
This section is an index listing and does not define coverage criteria or exclusions. It lists product names used for navigation (for example, Emsam, Exxua, and Exxua Titration Pack) but does not include the policy criteria for those entries in this fragment.
Initial Therapy — Step and Trial Requirements
inv-84: Antidepressant initial therapy
Initial therapy requirements for antidepressant-class products.
Continuation approvable
inv-85: Atypical antipsychotic initial therapy
Initial therapy requirements for atypical antipsychotic-class products.
Continuation approvable
inv-86: Invega Hafyera initial therapy
Initial therapy requirement for Invega Hafyera.
Continuation approvable
inv-87: Relistor initial therapy
Initial therapy requirement for Relistor.
Continuation approvable
inv-88: Rytary initial therapy
Initial therapy requirement for Rytary.
Continuation approvable
inv-89: Zonisade initial therapy
Initial therapy requirement for Zonisade.
Step applies to new starts only; continuation approvable
Continuation of Prior Therapy
inv-90: Continuation of prior therapy — approvable when documented
Continuation of prior therapy is approvable for listed products when documented.
Appears repeatedly across entries
Step Therapy — Required Trials and Alternatives
| Drug/Class | Required prior trials (new starts) | Notes |
|---|---|---|
| Antidepressant-class products | Trial of two generics from: bupropion; mirtazapine; citalopram (tablet or solution); desvenlafaxine succinate ER; duloxetine; escitalopram; fluoxetine; fluvoxamine; paroxetine; sertraline; venlafaxine hydrochloride | Applies to new starts; approve continuation of prior therapy |
| Atypical antipsychotic-class products (e.g., Fanapt and titration packs) | Trial of two generics from: asenapine; aripiprazole; olanzapine; paliperidone; quetiapine; risperidone; ziprasidone | Applies to new starts; approve continuation of prior therapy |
| Invega Hafyera | Trial of one of: Invega Sustenna or Invega Trinza | Step applies to new starts only; approve continuation of prior therapy |
| Zonisade | Trial of a generic zonisamide capsule | Step applies to new starts only; approve continuation of prior therapy |
Provider Actions — Documentation, Denial Risks, and Operational Notes
Diclofenac Sodium GEL 3% listed (no PA text)
Diclofenac Sodium GEL 3% is listed as a product affected in this segment; no specific prior authorization or step requirements are provided in this fragment.
Antidepressant new-starts: trial of two generics required
For new starts, require documentation of a trial of two generic antidepressant agents from the listed options; continuation of prior antidepressant therapy should be approved when prior use is documented.
- Trial of two generics from: bupropion, mirtazapine, citalopram (tablet or solution), desvenlafaxine succinate ER, duloxetine, escitalopram, fluoxetine, fluvoxamine, paroxetine, sertraline, venlafaxine hydrochloride.
- Approve continuation when prior therapy is documented.
Fanapt new-starts: trial of two generic atypical antipsychotics
For Fanapt and its titration packs, require documentation of trials of two generic atypical antipsychotics from the listed options for new starts; continuation of prior Fanapt therapy should be approved when prior use is documented.
- Trial of two generics from: asenapine, aripiprazole, olanzapine, paliperidone, quetiapine, risperidone, ziprasidone.
- Approve continuation when prior therapy is documented.
Invega Hafyera new-start: trial of Sustenna or Trinza
For new starts of Invega Hafyera, require documentation of a trial of Invega Sustenna or Invega Trinza; the step requirement applies to new starts only and continuation of prior therapy should be approved when documented.
- Trial of one of: Invega Sustenna or Invega Trinza.
- Step applies to new starts only; approve continuation with documentation of prior use.
Index entry — no prior authorization specified
This index fragment does not specify any prior authorization requirements.
Index — no prior authorization rules
This index section lists drug names and navigation entries only and does not specify prior authorization rules.
Index only — no prior authorization specified
These index-only chunks do not contain prior authorization requirements; they are navigational listings referencing other policy pages.
Prior authorization — none in fragment
No prior authorization requirements are stated in this fragment; it is an index listing without authorization details.
Prior authorization not listed here (index excerpt)
No prior authorization requirements are specified in this index excerpt; it provides drug names and page references only.
Index — no PA specified
This index fragment is navigational only and does not specify prior authorization requirements.
Prior authorization — not specified in index
Index entries here do not specify prior authorization requirements; only drug names and titration pack references are listed.
Index-only: no prior authorization rules
No prior authorization requirements are listed in this index-only portion.
Prior authorization — none listed
This index portion does not list prior authorization requirements; it is for navigation to other sections.
Index — no prior auth details
No prior authorization requirements are provided in this index fragment.
Prior authorization (index) — no details
This index listing does not state any prior authorization requirements.
Prior authorization not specified in index
No prior authorization requirements are specified in this index excerpt; it lists drug and titration pack names only.
Prior authorization not specified
This fragment is an index/listing and does not include prior authorization requirements.
Prior authorization not listed here
No prior authorization requirements are specified in this index fragment.
Step therapy applies to new starts only; continuation approvable
Step therapy requirements described in the policy apply to new starts only; continuation of prior therapy should be approved when prior use is documented.
- Step requirements apply to new starts only.
- Approve continuation when prior therapy is documented.
Provider-action index fragment — no step rules present
This index fragment does not contain step therapy rules; it is for navigation only.
Provider-action index fragment — no step rules present
No step therapy rules are present in this index portion; consult the specific drug pages for requirements.
Provider-action index fragment — no step rules present
This index fragment contains no step therapy requirements and is navigational only.
Provider-action index fragment — no step rules present
No step therapy rules are present in this index fragment; it lists drugs and page references only.
Provider-action index fragment — no step rules present
This part of the index does not include step therapy requirements; it is for navigation.
Provider-action index fragment — no step rules present
No step therapy rules are provided in this index fragment.
Provider-action index fragment — no step rules present
This index fragment does not include any step therapy requirements; it is navigational only.
Provider-action index fragment — no step rules present
No step therapy rules are present in this index portion.
Provider-action index fragment — no step rules present
This index fragment contains no step therapy requirements; consult specific policy pages for details.
Provider-action index fragment — no step rules present
No step therapy rules are provided in this index fragment.
Provider-action index fragment — no step rules present
This index fragment does not include step therapy requirements; it serves navigation.
Provider-action index fragment — no step rules present
No step therapy rules are present in this index portion; consult the drug-specific sections.
Provider-action index fragment — no step rules present
This index fragment contains no step therapy rules; use the specific formulary entries for requirements.
Provider-action index fragment — no step rules present
No step therapy rules are provided in this index fragment.
Index entries for Fanapt/titration packs — navigation only
This index fragment does not specify step therapy requirements; it lists Fanapt titration packs for navigation only.
Index-only — no documentation requirements
No documentation requirements are specified in this index fragment.
Index-only — no documentation requirements
No documentation requirements are specified in this index fragment.
Index-only — no documentation requirements
No documentation or authorization requirements are provided in this index section; it lists drug names and page numbers only.
Index-only — no documentation requirements
This chunk contains only index entries and does not include documentation requirements.
Index-only — no documentation requirements
No documentation requirements are specified in these index pages.
Index-only — no documentation requirements
No documentation requirements are specified in this index fragment.
Index-only — no documentation requirements
No documentation requirements are specified in this index fragment.
Index-only — no documentation requirements
No documentation requirements are specified in the index pages included in these chunks.
Fanapt/titration pack index — no documentation requirements
Index entries for Fanapt and its titration packs are provided for navigation; no documentation requirements are specified in these chunks.
Document antidepressant trials (two generics)
Document trials of two generic antidepressant agents when required for new starts; include agent names and dates to support continuation or new-start approvals.
- Record the two generic agents tried and treatment dates.
- Include documentation of prior use to support continuation approvals.
Document atypical antipsychotic trials (two generics)
Document trials of two generic atypical antipsychotics for Fanapt and related products when required; include agent names and dates to support approval or continuation.
- Record the two generic atypical antipsychotics tried and treatment dates.
- Include documentation of prior use to support continuation approvals.
Denial risk: Rytary — document generic carbidopa/levodopa trial
For Rytary new starts, failure to document a trial of one generic carbidopa/levodopa formulation may trigger denial of coverage.
- Document the specific generic carbidopa/levodopa formulation tried, with dates.
Denial risk: Relistor — document trial of listed laxatives
For Relistor, failure to document a trial of one of the listed laxatives (lubiprostone, Constulose, Enulose, Generlac, or lactulose) may trigger denial.
- Document which laxative was tried and the treatment dates.
Index fragment — no authorization/denial criteria present
This index fragment does not include authorization or denial criteria; it is navigational only.
Index fragment — no authorization/denial criteria present
This index fragment lists drugs and topics for navigation and does not state authorization or denial triggers.
Index fragment — no authorization/denial criteria present
No authorization or denial criteria are present in these index pages; consult specific drug sections for requirements.
Index fragment — no authorization/denial criteria present
This index fragment contains no authorization or denial criteria and serves navigation only.
Index fragment — no authorization/denial criteria present
No authorization or denial criteria are present in this index fragment.
Index fragment — no authorization/denial criteria present
This index fragment is navigational and does not include authorization or denial criteria.
Index fragment — no authorization/denial criteria present
No authorization or denial criteria are provided in this index section; it lists drug names and page references only.
Index fragment — no authorization/denial criteria present
This index fragment contains no authorization or denial criteria; use the detailed product pages for requirements.
Index fragment — no authorization/denial criteria present
No authorization or denial criteria are present in this index fragment.
Index fragment — no authorization/denial criteria present
This index fragment is navigational only and does not include authorization or denial criteria.
Index fragment — no authorization/denial criteria present
No authorization or denial criteria are present in this index fragment.
Index fragment — no authorization/denial criteria present
This index fragment does not include authorization or denial criteria; it lists drug names for navigation.
Index fragment — no authorization/denial criteria present
No authorization or denial criteria are present in this index fragment.
Index entries for Fanapt and titration packs — navigation only
This index fragment lists Fanapt titration packs for navigation and does not specify documentation or authorization requirements.
Definitions and Index Terms
Background and Scope Notes
The provided fragment does not contain clinical background material. It is an index of drugs and topical policy sections that repeats product names and page references (for example, Diclofenac Sodium, class headings such as Antidepressants and Atypical Antipsychotics), and therefore no clinical background information is available in this segment.
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