2026 Step Therapy Criteria — select CNS drugs (antidepressants, antipsychotics, dextromethorphan/bupropion, trazodone)
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Defines step therapy coverage rules for several classes of central nervous system medications (antidepressants, oral antipsychotics, dextromethorphan/bupropion products, and trazodone) for Fidelis Care members and specifies prerequisite drug trials required for coverage.
No material clinical or coverage changes in this revision.
Coverage Criteria
Antidepressants — Initial/Step 2
Covered when the Step trial requirements below are met
Approve Exxua without prerequisite for suicidal ideation or if currently/previously taking Exxua.
Antipsychotics (oral) — Initial/Step 2
Covered when the Step trial requirements below are met
Approve Fanapt if patient is currently taking Fanapt or has taken Fanapt in the past.
Dextromethorphan/bupropion — Initial/Step 2
Covered when the Step trial requirements below are met
Approve Auvelity for suicidal ideation without prerequisite trials or if currently/previously taking Auvelity.
Trazodone — Step listing
Step therapy product lists
No additional step criteria provided in this document portion.
Approval conditions for Raldesy
Coverage for Raldesy is provided when ANY of the following are met
Step 1 lists tablet strengths 50 mg, 100 mg, 150 mg; Step 2 is Raldesy 10 mg/mL oral solution
Special-case approvals allow bypass of the usual step requirements in defined circumstances. For antidepressant Step 2 products, Exxua may be approved without a prior Step 1 trial when the patient has documented suicidal ideation or is currently taking (or has previously taken) Exxua. Likewise, for oral antipsychotic Step 2 products, approval may be granted if the member is currently taking (or has previously taken) the Step 2 product (for example, Fanapt). For dextromethorphan/bupropion (Auvelity), Auvelity may be approved without prior trials when the patient has suicidal ideation or is currently/previously taking Auvelity. These exceptions are limited to the products and circumstances specified in the policy.
No explicit exclusions are listed in the cited portions of this policy. The trazodone/Raldesy sections provide step lists and approval conditions but do not identify additional drugs, diagnoses, or member groups that are excluded from coverage in these chunks.
Coverage for Raldesy (trazodone 10 mg/mL oral solution) requires documentation that one of the Step 1 tablet forms of generic trazodone was tried — defined as at least a 1-day supply within the prior 180 days. If there is no record of such a tablet trial, approval may still be granted only if the provider documents that the patient cannot swallow tablets or has difficulty swallowing tablets, or if the member is currently taking Raldesy or has taken Raldesy at any time in the past. Absent any of these conditions, use of Raldesy without a prior tablet trial may be considered not meeting the step therapy requirement.
| trazodone 100 mg tablet | Listed Step 1 agent |
| trazodone 150 mg tablet | Listed Step 1 agent |
| trazodone 50 mg tablet | Listed in details as a tablet strength |
| Raldesy 10 mg/mL oral solution | Step 2 agent (oral solution) |
Coding and Lookback
Provider Actions and Documentation Requirements
Antidepressants — Step 1 prerequisite
Step 2 antidepressant products require evidence that the member has tried ONE Step 1 antidepressant (at least a 1‑day supply within the prior 180 days). Exxua may be approved without a prior Step 1 trial if the patient has documented suicidal ideation or is currently/previously taking Exxua.
- Acceptable Step 1 agents include listed generics such as bupropion SR/XL, citalopram, duloxetine, escitalopram, fluoxetine, fluvoxamine, paroxetine, sertraline, or venlafaxine IR/ER.
- Document at least a 1‑day supply of the Step 1 agent within the prior 180 days to satisfy the prerequisite.
Antipsychotics (oral) — Step 1 prerequisite
Step 2 oral antipsychotic products require documentation that the member has tried TWO Step 1 oral antipsychotic drugs (each at least a 1‑day supply within the prior 180 days). Approve Fanapt if the patient is currently taking Fanapt or has taken Fanapt in the past.
- Step 1 oral antipsychotics include listed agents such as aripiprazole, asenapine, brexpiprazole, cariprazine, lumateperone, lurasidone, olanzapine, paliperidone, quetiapine, risperidone, xanomeline/trospium, ziprasidone, etc.
- Each Step 1 trial must be at least a 1‑day supply within the prior 180 days.
Dextromethorphan/bupropion — Step prerequisite
Coverage for Auvelity (dextromethorphan/bupropion) requires documentation that the patient tried a generic SSRI or SNRI AND bupropion (each at least a 1‑day supply in the prior 180 days). Auvelity may be approved without prerequisite trials for documented suicidal ideation or if the patient is currently/previously taking Auvelity.
- Acceptable Step 1 agents include listed SSRIs/SNRIs and bupropion formulations (see Step 1 list).
- Record at least a 1‑day supply of each required Step 1 agent within the prior 180 days to meet the prerequisite.
Step therapy prior authorization for Raldesy
Prior authorization for Raldesy requires evidence that step therapy criteria are met: a prior trial of a generic trazodone tablet (50, 100, or 150 mg) with at least a 1‑day supply in the prior 180 days, or documentation of inability to swallow tablets, or current/prior use of Raldesy.
- If a prior tablet trial cannot be documented, provide documentation of swallowing impairment or evidence the member is currently/previously taking Raldesy.
- Tablet strengths listed for Step 1 include 50 mg, 100 mg, and 150 mg.
Antidepressants — Step therapy rules
For antidepressant step therapy, ensure one Step 1 generic antidepressant from the listed agents has been tried (at least a 1‑day supply in the prior 180 days) before requesting Step 2 products. Exxua is an exception and may be approved without the prerequisite for suicidal ideation or documented current/prior Exxua use.
- Step 1 list includes bupropion SR/XL, citalopram, duloxetine, escitalopram, fluoxetine, fluvoxamine, paroxetine, sertraline, and venlafaxine IR/ER.
- Document the 1‑day supply within 180 days in the medical record or pharmacy history.
Antipsychotics (oral) — Step therapy rules
For oral antipsychotic step therapy, ensure two distinct Step 1 oral antipsychotic trials (each ≥1‑day supply within the prior 180 days) are documented before requesting Step 2 agents; Fanapt may be approved without Step 1 trials if current/prior Fanapt use is documented.
- Step 1 agents include oral formulations of aripiprazole, asenapine, brexpiprazole, cariprazine, lumateperone, lurasidone, olanzapine, paliperidone, quetiapine, risperidone, xanomeline/trospium, ziprasidone, and others listed.
- Each Step 1 trial must be verifiable as at least a 1‑day supply in the prior 180 days.
Dextromethorphan/bupropion — Step therapy rules
Auvelity Step 1 requires trials of both a generic SSRI or SNRI AND bupropion (each at least a 1‑day supply in the prior 180 days); Step 2 includes Auvelity and other listed agents. Approve Auvelity without prerequisites for suicidal ideation or documented current/prior Auvelity use.
- Confirm pharmacy fill records or provider documentation showing a 1‑day supply for each required agent within 180 days.
- If suicidal ideation is documented, note that prerequisite trials can be bypassed per policy.
Trazodone — Step therapy rules
Trazodone step therapy: Step 1 includes trazodone tablets (100 mg and 150 mg); Step 2 is Raldesy 10 mg/mL oral solution. A prior tablet trial (at least a 1‑day supply in the prior 180 days) is required unless swallowing impairment or prior/current Raldesy use is documented.
- Step 1 tablet strengths include 50 mg (also listed), 100 mg, and 150 mg.
- If unable to swallow tablets, document the clinical reason to support approval of Raldesy without a tablet trial.
Step therapy structure — Raldesy
Step therapy structure for Raldesy is two-tiered: Step 1 requires a trial of a generic trazodone tablet (50, 100, or 150 mg) with at least a 1‑day supply within the prior 180 days; Step 2 is Raldesy oral solution (10 mg/mL) which may be authorized if Step 1 is met or an exception applies (swallowing difficulty or current/prior Raldesy use).
- Record of the tablet trial (≥1‑day supply within 180 days) or documentation of swallowing impairment or prior Raldesy use must be provided for Step 2 approval.
- Tablet strengths enumerated for Step 1: 50 mg, 100 mg, 150 mg.
Antidepressants — documentation of trial
Documented trials must show at least a 1‑day supply of the listed Step 1 drug within the prior 180 days to satisfy prerequisites for Step 2 antidepressant approvals; absence of such documentation may result in denial.
- Record the date, medication name and strength, and evidence of fill or administration to demonstrate the 1‑day supply within 180 days.
Antipsychotics (oral) — documentation required
For Step 2 oral antipsychotic requests, provide documentation that two distinct Step 1 oral antipsychotic drugs were taken (each at least a 1‑day supply within the prior 180 days) or provide evidence of current/past use of the Step 2 product (Fanapt) to qualify for approval.
- Documentation can include pharmacy fill history, medication administration records, or provider notes specifying dates and quantities to demonstrate at least a 1‑day supply within 180 days.
Dextromethorphan/bupropion — documentation required
For Auvelity requests, document that the patient tried a generic SSRI or SNRI AND bupropion (each at least a 1‑day supply in the prior 180 days), or provide documentation of suicidal ideation or current/prior Auvelity use to allow bypass of prerequisites.
- Acceptable evidence includes pharmacy fills, provider chart notes, or medication lists showing the required agents and dates that satisfy the 180‑day lookback.
Required documentation for Raldesy
For Raldesy, provide a record of prior use of a trazodone tablet (at least a 1‑day supply in the last 180 days), or document inability to swallow tablets, or show prior/current use of Raldesy to support approval.
- If relying on swallowing impairment, include clinical notes describing the impairment or a swallow assessment.
- If relying on prior Raldesy use, include prior medication records showing Raldesy dispensing or administration.
Antidepressants — denial risk for missing Step trial
Failure to document that one Step 1 drug was tried (at least a 1‑day supply in the prior 180 days) for antidepressant Step 2 requests may result in denial of coverage.
- Ensure pharmacy fill data or chart notes are submitted with the prior authorization to avoid denial.
Antipsychotics (oral) — denial risk for missing Step trials
Lack of documentation that two Step 1 oral antipsychotic drugs were tried (each at least a 1‑day supply in the prior 180 days) may lead to denial of Step 2 oral antipsychotic coverage; documenting current or prior use of Fanapt is an alternative route to approval.
- Provide fill records or provider documentation for both Step 1 agents to mitigate denial risk.
Dextromethorphan/bupropion — denial risk for missing Step trials
Coverage for Auvelity requires prior trials of a generic SSRI or SNRI AND bupropion (each at least a 1‑day supply in the prior 180 days); absence of these documented trials may result in denial unless suicidal ideation or prior/current Auvelity use is documented.
- Submit documentation of both required trials or clinical justification to avoid denial.
Raldesy — denial risk for missing prior tablet trial
Coverage for Raldesy requires documentation of a prior trial of a tablet dosage form of generic trazodone (at least a 1‑day supply within the prior 180 days); absence of that trial and lack of documentation of an exception (swallowing impairment or prior Raldesy use) may trigger denial.
- Provide prior fill records or clinical documentation of tablet intolerance/swallowing difficulty or prior Raldesy exposure to support approval.
Background
This policy section defines the two-step structure used to authorize selected central nervous system drugs. It lists Step 1 (preferred/generic) agents and the Step 2 (brand/alternative) products, and specifies the prerequisite trial logic required for Step 2 coverage. A documented trial is defined as at least a 1-day supply within the prior 180 days. The document provides examples across classes: antidepressant Step 2 coverage is allowed if one Step 1 antidepressant was tried (or Exxua exceptions apply); oral antipsychotic Step 2 coverage requires two Step 1 oral antipsychotic trials (or current/prior Fanapt use); Auvelity requires trials of a generic SSRI or SNRI and bupropion (with exceptions for suicidal ideation or prior/current Auvelity use); and trazodone Step 1 tablet strengths (50 mg, 100 mg, 150 mg) are the prerequisite for Raldesy oral solution unless swallowing impairment or prior Raldesy use is documented.
Definitions
Initial Therapy (Step 1) Criteria
Step 1 (Initial therapy) products
Step 1 (preferred/generic) products
A single trial of these products counts toward Step 2 prerequisites.
Both an SSRI/SNRI and bupropion must be tried to allow Auvelity.
Initial therapy (Step 1)
Initial therapy requirement
Tablet strengths include 50 mg, 100 mg, 150 mg
Continuation Therapy Criteria
Continuation therapy
Continuation/maintenance use
Covers continuation without requiring additional tablet trial
Step Therapy Summary Tables
| Therapy | Step requirement | Exception / special-case approvals |
|---|---|---|
| Antidepressants (Step 2 products, e.g., branded or non-preferred formulations) | One Step 1 drug trial required (documented as at least a 1-day supply in the prior 180 days). | Exxua may be approved without prerequisite trials if the patient has suicidal ideation or is currently/previously taking Exxua. |
| Therapy | Step requirement | Exception / special-case approvals |
|---|---|---|
| Oral antipsychotics (Step 2 products, e.g., Fanapt) | Two Step 1 oral antipsychotic drug trials required (each documented as at least a 1-day supply in the prior 180 days). | Approve Fanapt if the patient is currently taking Fanapt or has taken Fanapt in the past. |
| Therapy | Step requirement | Exception / special-case approvals |
|---|---|---|
| Dextromethorphan/bupropion (Auvelity) | Patient must have tried both: (1) a generic SSRI or SNRI AND (2) bupropion (each at least a 1-day supply in the prior 180 days). | Approve Auvelity without prerequisite trials if the patient has suicidal ideation or is currently/previously taking Auvelity. |
| Therapy | Step 1 agents | Step 2 agent |
|---|---|---|
| Trazodone step listing | Trazodone 100 mg tablet; trazodone 150 mg tablet | Raldesy 10 mg/mL oral solution |
| Step | Required evidence | Alternate criteria / exceptions |
|---|---|---|
| Step 1 | Trial of a generic trazodone tablet (available strengths include 50 mg, 100 mg, or 150 mg) documented as at least a 1-day supply in the prior 180 days. | N/A |
| Step 2 | Raldesy 10 mg/mL oral solution may be approved after Step 1 is met. | Raldesy may be approved without a prior tablet trial if the patient has difficulty swallowing tablets or cannot swallow tablets, or if the patient is currently taking Raldesy or has taken Raldesy in the past. |
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