CurrentFidelis CarePolicy N/A

Formulary step therapy for select antipsychotics and antidepressants

Defines Step 1 and Step 2 drug lists and step therapy criteria for coverage of specified antipsychotic and antidepressant products for Fidelis Care members in North Carolina.

Policy Summary

PayerFidelis Care

PolicyFormulary step therapy for select antipsychotics and antidepressants

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Next Review DateN/A

Key ActionProvide prior authorization with documented trials of required Step 1 agents (or applicable exceptions) to obtain coverage for Step 2 drugs.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

~70listed products across steps 1 and 2 (approximate count)

Step 1multiple oral antipsychotics and related products listed

Fanaptspecific Step 2 antipsychotic called out for approval after Step 1 trials

Auvelityspecific Step 2 antidepressant with special approval criteria

Coverage Criteria

Antipsychotic Step 2 Approval Criteria

Covered when the following criteria are met for certain Step 2 antipsychotics (e.g., Fanapt, Opipza):

Antipsychotic Step Therapy: If the patient has tried two Step 1 drugs (oral formulations of Aripiprazole, Asenapine Maleate, Brexpiprazole, Cariprazine HCl, Lumateperone Tosylate, Lurasidone HCl, Olanzapine, Paliperidone, Quetiapine Fumarate, Risperidone, Xanomeline/Trospium Chloride, or Ziprasidone HCl), approve the requested drug, Fanapt or Opipza.two distinct Step 1 agents

A trial of the brand name equivalent of a generic step 1 product will also count toward this requirement. Approve the requested drug if the patient is currently taking or has taken it in the past.

Auvelity Approval Criteria

Covered when the following criteria are met for Auvelity (depression agent listed in Step 2):

Auvelity approval: Approve if the patient has tried a generic SSRI OR SNRI AND separately tried bupropion.

Policy Summary

PayerFidelis Care

PolicyFormulary step therapy for select antipsychotics and antidepressants

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Next Review DateN/A

Key ActionProvide prior authorization with documented trials of required Step 1 agents (or applicable exceptions) to obtain coverage for Step 2 drugs.

SourceLink

On This Page

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Provider Actions and Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required and includes step therapy trials before certain Step 2 agents (e.g., Fanapt, Opipza, Auvelity) will be approved. Submit a prior authorization request documenting prior medication trials as described below. A current or past history of taking the requested Step 2 drug meets the requirement.

Prior authorization is required for Step 2 agents; do not submit without PA.
If the member is currently taking or has previously taken the requested Step 2 drug, approval may be granted without additional trials.

Step Therapy

Step Therapy Trial Requirement

Step therapy requires completion of Step 1 trials before Step 2 is approved unless an exception in the criteria applies. For antipsychotics: two different Step 1 oral agents are generally required (unless the member is currently or previously treated with the requested Step 2 agent). For antidepressants: a trial of a generic SSRI or SNRI plus a separate trial of bupropion is required before Auvelity, except when suicidal ideation is present (see exceptions).

Antipsychotics (Step 2 request such as Fanapt or Opipza): trial and failure of two different Step 1 oral antipsychotics (aripiprazole, asenapine, brexpiprazole, cariprazine, lumateperone, lurasidone, olanzapine, paliperidone, quetiapine, risperidone, xanomeline/trospium, ziprasidone) is required.
Antidepressants (Auvelity): trial of a generic SSRI OR SNRI AND a separate trial of bupropion is required prior to approval.
Exceptions: current or prior use of the requested Step 2 agent counts toward the requirement; Auvelity may be approved without Step 1 trial if the patient has suicidal ideation.

Documentation Required

Prior Trial Documentation

Document prior trials clearly in the PA submission. Acceptable documentation includes medication history from the medical record, pharmacy fill records, electronic prescribing or pharmacy benefit manager reports, or a provider attestation describing drug name, dose, duration, and reason for discontinuation. Brand-name use of a product that is equivalent to a listed generic Step 1 drug counts toward the trial requirement.

Include drug name, formulation, dose, dates of therapy, and reason for failure or intolerance.
Brand-name equivalent products count toward Step 1 trial requirements.
Acceptable records: medical chart notes, pharmacy fill history, e-prescribing records, PBM claims, or signed provider attestation.

Initial Therapy — Step 1

Step 1 Initial Therapy

Step 1 products — initial preferred agents

Step 1 list: Members should trial listed Step 1 oral agents prior to coverage of certain Step 2 agents.trial of Step 1 agent(s)

Full lists of Step 1 products are provided in the document (examples include aripiprazole, asenapine, lumateperone/Caplyta, lurasidone, olanzapine, paliperidone ER, quetiapine, brexpiprazole/Rexulti, risperidone, cariprazine/Vraylar, ziprasidone, and for antidepressants: bupropion, citalopram, desvenlafaxine, duloxetine, escitalopram, fluoxetine, among others).

Step Therapy Summary Table

Step	Requirement
Step 1	Member must have a documented trial of one or two Step 1 oral agents as specified by drug class prior to approval of a Step 2 agent (examples of Step 1 antipsychotics and antidepressants are listed in the policy). A trial of the brand‑name equivalent of a generic Step 1 product counts toward the requirement.
Step 2 (request)	Approve Step 2 agents (e.g., Fanapt, Opipza, Auvelity) only if Step 1 trial requirements are met, except where exceptions apply. For antipsychotic Step 2 requests (Fanapt/Opipza), approval requires trials of two distinct Step 1 oral antipsychotics or documentation that the patient is currently taking or has previously taken the requested Step 2 drug. For Auvelity, approval requires a trial of one generic SSRI or SNRI AND a separate trial of bupropion; Auvelity may be approved without Step 1 trials if the patient has suicidal ideation or is currently / previously taking Auvelity.

Step

Requirement

Step 1

Member must have a documented trial of one or two Step 1 oral agents as specified by drug class prior to approval of a Step 2 agent (examples of Step 1 antipsychotics and antidepressants are listed in the policy). A trial of the brand‑name equivalent of a generic Step 1 product counts toward the requirement.

Step 2 (request)

Approve Step 2 agents (e.g., Fanapt, Opipza, Auvelity) only if Step 1 trial requirements are met, except where exceptions apply. For antipsychotic Step 2 requests (Fanapt/Opipza), approval requires trials of two distinct Step 1 oral antipsychotics or documentation that the patient is currently taking or has previously taken the requested Step 2 drug. For Auvelity, approval requires a trial of one generic SSRI or SNRI AND a separate trial of bupropion; Auvelity may be approved without Step 1 trials if the patient has suicidal ideation or is currently / previously taking Auvelity.

Key Definitions

Step 1 trial (inv-10: definition)

DefinitionA Step 1 trial is a documented trial of an oral formulation of one of the listed Step 1 drugs (examples: aripiprazole, asenapine maleate, brexpiprazole, cariprazine HCl, lumateperone tosylate, lurasidone HCl, olanzapine, paliperidone, quetiapine fumarate, risperidone, xanomeline/trospium chloride, ziprasidone HCl).

Distinct drugs requirementFor certain Step 2 antipsychotic approvals (e.g., Fanapt, Opipza), the patient must have tried two distinct Step 1 oral agents to meet the trial requirement.

Brand-name equivalentA trial of the brand-name equivalent of a generic Step 1 product will count toward the Step 1 trial requirement.

Current or prior use countsApproval for the requested Step 2 antipsychotic may be granted if the patient is currently taking or has taken the requested drug (Fanapt or Opipza) in the past, which satisfies the requirement regardless of Step 1 trials.

Oral formulation requirementOnly oral formulations of the listed Step 1 drugs are counted as Step 1 trials (examples include ziprasidone capsules and Opipza oral film listed in the document).

Auvelity exception (inv-11)

Exception summaryAuvelity may be approved without completing Step 1 trials when the patient has suicidal ideation.

Current or prior Auvelity useApproval is allowed if the patient is currently taking Auvelity or has taken Auvelity in the past (counts as meeting requirement).

Standard Step 1 requirement otherwiseWhen the exception does not apply, Auvelity requires prior trials of a generic SSRI or SNRI and separately bupropion before approval.

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