Formulary step therapy and prior authorization criteria for selected outpatient drugs
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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.
No material clinical or coverage changes in this revision.
Coverage Criteria for Formulary Products
Exxua / Exxua Titration Pack
Covered when ALL of the following are met
Approve for continuation of prior therapy
Fanapt and Titration Packs A/B/C
Covered when ALL of the following are met
Approve for continuation of prior therapy
Invega Hafyera
Covered when ALL of the following are met (new starts only)
Step applies to new starts only. Approve for continuation of prior therapy
Relistor
Covered when ALL of the following are met
Zonisade
Covered when ALL of the following are met (new starts only)
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.
Product Coding and Identifiers
| NDC/HCPCS not specified | Diclofenac Sodium GEL 3% listed as product affected; no explicit codes in document |
| N/A | Auvelity, Emsam, Exxua, Fanapt, Fanapt Titration Packs A/B, Invega Hafyera, Relistor, Zonisade and associated titration packs are listed; no billing codes provided in document |
Prior Authorization, Documentation, and Denial Risks
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
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
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
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
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 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 — 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
Background and Scope
This formulary organizes step-therapy and trial requirements for several outpatient medications, including neuropsychiatric agents. It specifies required trials of lower-cost or generic alternatives before certain branded or specialty products are approved, and generally permits continuation of prior therapy where indicated.
Definitions and Key Terms
Initial Therapy Requirements
Exxua initial therapy
Fanapt initial therapy
Invega Hafyera initial therapy
Relistor initial therapy
Zonisade initial therapy
Continuation Therapy Requirements
Exxua continuation
Fanapt continuation
Invega Hafyera continuation
Zonisade continuation
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 |
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