CurrentFidelis CarePolicy N/A

Step therapy requirements for select oral antidepressant and antipsychotic products

This document defines step therapy (prior authorization) requirements for multiple oral antidepressant and antipsychotic products (including branded specialty agents) and lists which drugs are Step 1 vs Step 2 for coverage decisions. It applies to Fidelis Care pharmacy benefits and prescribers seeking coverage for the listed products.

Policy Summary

PayerFidelis Care

PolicyStep therapy requirements for select oral antidepressant and antipsychotic products

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Next Review DateN/A

Key ActionDocument prior Step 1 trials (each = ≥1-day supply within prior 180 days) or record an approved exception (suicidal ideation or current/prior use) when requesting Step 2 product coverage.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

multipleStep 1 and Step 2 drug lists across several product groups

≥1-day/180dMinimum prior trial requirement

allowedSuicidal ideation exception

allowedCurrent/prior use exception

Coverage Criteria for Step 2 Products

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Exxua coverage (antidepressant group)

Covered when ONE of the following is met

Exxua approval criteria: The patient has tried at least one Step 1 antidepressant (Bupropion SR/XL, Citalopram, Duloxetine, Escitalopram, Fluoxetine, Fluvoxamine, Paroxetine, Sertraline, or Venlafaxine IR/ER) with at least a 1-day supply in the prior 180 days.1 trial in 180 days

Approve without Step 1 trials if patient has suicidal ideation; approve if patient is currently taking or has taken Exxua previously.

Fanapt coverage (antipsychotic group)

Covered when ALL of the following are met

Fanapt approval criteria: The patient has tried two different Step 1 oral antipsychotic agents (examples: Aripiprazole, Asenapine, Brexpiprazole, Cariprazine, Lumateperone, Lurasidone, Olanzapine, Paliperidone, Quetiapine, Risperidone, Xanomeline/Trospium, or Ziprasidone), each with at least a 1-day supply in the prior 180 days.2 trials in 180 days

A trial of the brand-name equivalent of a generic Step 1 product also counts; approve if patient is currently taking or has taken Fanapt previously.

Auvelity coverage (antidepressant group)

Covered when ALL of the following are met

Auvelity approval criteria: The patient has tried (1) a generic SSRI or SNRI AND (2) bupropion, with each trial representing at least a 1-day supply in the prior 180 days.SSRI/SNRI + bupropion in 180 days

Approve without prerequisite trials if patient has suicidal ideation; approve if patient is currently taking or has taken Auvelity previously.

Raldesy coverage (trazodone oral solution)

Covered when ONE of the following is met

Raldesy approval criteria: The patient has tried a tablet dosage form of generic trazodone (e.g., trazodone 100 mg or 150 mg) with at least a 1-day supply in the prior 180 days.1 trazodone tablet trial in 180 days

Approve if the patient has difficulty swallowing tablets or cannot swallow tablets; approve if patient is currently taking or has taken Raldesy previously.

This policy implements step therapy requirements for selected oral antidepressant and antipsychotic products. Coverage for the listed Step 2 (brand/specialty) agents is granted only when the product-specific criteria are met or when an approved exception applies. There are no additional exclusions beyond failure to meet the required step therapy trials; product-specific exceptions (for example, suicidal ideation, current or prior use, or documented inability to swallow tablets) are described within each product’s criteria and supersede the trial requirement when applicable. Prior trial lookback: a qualifying Step 1 trial is defined as at least a 1-day supply in the prior 180 days and must be documented to satisfy the step requirement.

Providers must follow the drug-specific rules: Exxua and Auvelity may be approved without Step 1 trials for patients with documented suicidal ideation, and any Step 2 product may be approved if the patient is currently taking or has previously taken that Step 2 product. Raldesy additionally permits approval when the patient has a documented inability to swallow tablets. Failure to document the required Step 1 trials (each trial = ≥1-day supply within 180 days) will result in denial of coverage unless a qualifying exception is met.

Step Therapy Rules and Trial Requirements

Step 2 product	Required Step 1 trials / exceptions
Exxua (extended‑release tablets)	One Step 1 antidepressant trial required (at least a 1‑day supply in the prior 180 days) from Bupropion SR/XL, Citalopram, Duloxetine, Escitalopram, Fluoxetine, Fluvoxamine, Paroxetine, Sertraline, or Venlafaxine IR/ER; OR approve without Step 1 trial if patient has suicidal ideation; OR approve if patient is currently taking or has previously taken Exxua.
Fanapt (tablets)	Two different Step 1 oral antipsychotic trials required (each at least a 1‑day supply in the prior 180 days) from aripiprazole, asenapine, brexpiprazole, cariprazine, lumateperone, lurasidone, olanzapine, paliperidone, quetiapine, risperidone, xanomeline/trospium, or ziprasidone; OR approve if patient is currently taking or has previously taken Fanapt.
Auvelity (extended‑release tablet)	Two-part requirement: (1) a generic SSRI or SNRI trial AND (2) a bupropion trial (each at least a 1‑day supply in the prior 180 days); OR approve without Step 1 trials if patient has suicidal ideation; OR approve if patient is currently taking or has previously taken Auvelity.
Raldesy (10 mg/mL oral solution)	One trial of a tablet dosage form of generic trazodone required (at least a 1‑day supply in the prior 180 days); OR approve if patient has difficulty swallowing tablets (cannot swallow tablets); OR approve if patient is currently taking or has previously taken Raldesy.

inv-06: Prior trial lookback — at least a 1-day supply in the prior 180 days

Lookback periodPrior trial must be at least a 1-day supply within the prior 180 days

What counts as a trialReceipt of a Step 1 drug with ≥1-day supply during the 180-day lookback

PurposeCounts toward meeting step therapy requirement to approve Step 2 products (e.g., Exxua)

ApplicabilityReferenced across antidepressant and antipsychotic Step 2 criteria where Step 1 trials are required

Documentation requirementProvider must document the prior trial (≥1-day supply in prior 180 days) or an applicable exception (suicidal ideation or current/prior use)

Step 1 (Initial) Therapy Lists

Step 1 (initial) therapy lists

Lists of Step 1 (initial) agents per product group

Step 1 antidepressants (examples): Bupropion SR/XL (multiple SR/XL strengths and XL formulations), Citalopram (tablet and oral solution), Duloxetine, Escitalopram, Fluoxetine (capsule and oral solution), Fluvoxamine, Paroxetine, Sertraline (tablets and oral concentrations), Venlafaxine IR/ER, Desvenlafaxine, Vilazodone; tablet and oral solution formulations as listed.

See product lists for specific strengths and formulations.

Step 1 antipsychotics (examples): Aripiprazole, Asenapine, Brexpiprazole, Cariprazine, Lumateperone, Lurasidone, Olanzapine, Paliperidone, Quetiapine, Risperidone, Ziprasidone, and others listed in Step 1 antipsychotic product lists.

See product lists for specific strengths and formulations.

Prior Authorization, Documentation, and Denial Conditions

Step Therapy

General step therapy rule — Step therapy and documentation required

Step therapy requires use of listed Step 1 agents before covering Step 2 products. Providers must document trials of the required Step 1 drugs (each trial = at least a 1-day supply within the prior 180 days) or document a qualifying exception. Coverage for a Step 2 product will be denied if required Step 1 trials are not documented.

Step 1 drugs include the listed generic agents for each product class (e.g., SSRIs, SNRIs, bupropion, or specified oral antipsychotics) and count if filled for ≥1 day within the prior 180 days.
Each documented trial may be satisfied by the brand-name equivalent of a generic Step 1 product where noted.

Prior Authorization

Exxua prior authorization

Coverage for Exxua will be provided only after documentation that the member has tried one Step 1 antidepressant (at least a 1-day supply in the prior 180 days). Approve without a Step 1 trial if the member has suicidal ideation or if the member is currently taking or has previously taken Exxua.

Step 1 antidepressants: bupropion SR/XL, citalopram, duloxetine, escitalopram, fluoxetine, fluvoxamine, paroxetine, sertraline, or venlafaxine IR/ER.
Required trial = at least a 1-day supply within the prior 180 days.

Prior Authorization

Fanapt prior authorization

Coverage for Fanapt requires documentation of trials of two Step 1 oral antipsychotic agents (each trial = at least a 1-day supply in the prior 180 days). Approve if the member is currently taking Fanapt or has taken Fanapt in the past.

Step 1 antipsychotics include oral aripiprazole, asenapine, brexpiprazole, cariprazine, lumateperone, lurasidone, olanzapine, paliperidone, quetiapine, risperidone, xanomeline/trospium, or ziprasidone.
A trial of the brand-name equivalent of a generic Step 1 product will count toward this requirement.

Prior Authorization

Auvelity prior authorization

Coverage for Auvelity requires prior trials of both 1) a generic SSRI or SNRI and 2) bupropion (each trial = at least a 1-day supply in the prior 180 days). Approve Auvelity without prerequisite trials if the member has suicidal ideation or is currently taking / has previously taken Auvelity.

Acceptable Step 1 agents include listed generic SSRIs/SNRIs and bupropion formulations.
Each required trial must be documented as ≥1 day supply in the prior 180 days.

Prior Authorization

Raldesy prior authorization

Coverage for Raldesy oral solution requires documentation that the member has tried a tablet dosage form of generic trazodone (at least a 1-day supply in the prior 180 days). Approve Raldesy if the member has difficulty swallowing tablets or if the member is currently taking or has previously taken Raldesy.

Affected Step 1 products: generic trazodone tablets (e.g., 50 mg, 100 mg, 150 mg).
Required trial = at least a 1-day supply within the prior 180 days.

Denial Risk

Failure to meet step therapy trials — denial conditions

If required Step 1 trials (each = ≥1 day supply within the prior 180 days) are not documented, coverage for the Step 2 product will be denied. Providers must include documentation of prior trials or a qualifying exception with the prior authorization request to avoid denial.

Qualifying exceptions that allow approval without Step 1 trials include documented suicidal ideation, clinical inability to take Step 1 formulation (e.g., swallowing difficulty for tablets), or current/prior use of the Step 2 product.
Documentation of prior use of the Step 2 product (current or past) satisfies the requirement.

Definitions and Exceptions

inv-15: Step 1 trial — A trial of a Step 1 drug defined as at least a 1-day supply within the prior 180 days

Definition of Step 1 trialA trial of a Step 1 drug defined as at least a 1-day supply within the prior 180 days that counts toward meeting step therapy requirements

How it is applied to approvalsCounts as the required trial when evaluating Step 2 antidepressants (e.g., Exxua, Auvelity) or antipsychotics when listed Step 1 agents were dispensed

Multiple-trial requirementsSome products require more than one Step 1 trial (e.g., Fanapt requires two separate Step 1 antipsychotic trials; each must meet the ≥1-day/180-day rule)

DocumentationProviders must document prior trials as fills of Step 1 agents with at least a 1-day supply within 180 days or document qualifying exceptions

inv-16: Suicidal ideation exception — An exception permitting initiation of certain Step 2 drugs (e.g., Exxua, Auvelity) without prior Step 1 trials when the patient has suicidal ideation

Suicidal ideation exception — scopePermits initiation of certain Step 2 antidepressants (e.g., Auvelity, Exxua) without prior Step 1 trials when the patient has suicidal ideation

Products explicitly covered by exceptionAuvelity and Exxua are named as examples where suicidal ideation allows approval without prerequisite trials

Documentation neededProvider must document the presence of suicidal ideation to waive Step 1 trial requirements

Interaction with other exceptionsException is independent of the current/prior use exception; either condition allows approval without Step 1 trials

Background

For operational clarity the policy groups oral antidepressant and antipsychotic agents into Step 1 (first-line generics and formulary agents) and Step 2 (branded or specialty products). Step 1 lists vary by product group: antidepressant Step 1 examples include agents such as bupropion SR/XL, citalopram, duloxetine, escitalopram, fluoxetine, fluvoxamine, paroxetine, sertraline, and venlafaxine IR/ER; antipsychotic Step 1 examples include oral aripiprazole, asenapine, brexpiprazole, cariprazine, lumateperone, lurasidone, olanzapine, paliperidone, quetiapine, risperidone, and ziprasidone.

Rationale: requiring documented trials of Step 1 agents (each trial defined as at least a 1-day supply in the prior 180 days) ensures use of established, lower-cost or formulary-preferred therapies before coverage of higher-cost Step 2 products. The policy preserves clinical judgment by allowing exceptions—most notably for patients with suicidal ideation (permitting initiation of certain Step 2 antidepressants without Step 1 trials) and for patients who are currently taking or have previously taken the Step 2 product.

OpenPayer

Step therapy requirements for select oral antidepressant and antipsychotic products

Coverage Criteria for Step 2 Products

Step Therapy Rules and Trial Requirements

Step 1 (Initial) Therapy Lists

Continuation and Re-approval Criteria

Prior Authorization, Documentation, and Denial Conditions

Coding and Lookback Definitions

Definitions and Exceptions

Background

Revision History