CurrentCareSourcePolicy N/A

Step Therapy and Prior Authorization Rules for Select Medications (Pharmacy)

Defines Step Therapy sequencing and approval criteria across multiple drug classes (antidepressants, antipsychotics, inhaled corticosteroids, opioid‑induced constipation agents, trazodone formulations) affecting prescribing providers and pharmacy prior‑authorization processes.

Policy Summary

PayerCareSource

PolicyStep Therapy and Prior Authorization Rules for Select Medications (Pharmacy)

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

Key ActionProvide documentation of required Step 1 trial(s) or evidence of an exception (current/prior use, swallowing impairment, suicidal ideation, palliative care) when requesting prior authorization.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

>=1Step 2 agent named (Raldesy)

Step 1 → Step 2Common approval pathway

includes specific exceptionsExceptions permitting approval

NCApplicable state

coveredAge/setting exceptions

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Coverage Criteria and Step Therapy Rules

Antidepressant SSRI/SNRI/bupropion — general step therapy

Covered when the following Step Therapy rules are met:

Primary rule: If the patient has tried one Step 1 product, approve a Step 2 product.1 Step 1 trial

From antidepressant section; exceptions below.

Exceptions: If the patient is currently taking or has taken the requested Step 2 product at any time in the past; OR if the patient has suicidal ideation; approve without a Step 1 trial.

Exceptions allow bypassing Step 1.

Antipsychotic and related agents — step therapy

Covered when ALL of the following are met:

Primary rule: If the patient has tried two Step 1 drugs, approve the requested Step 2 drug.2 Step 1 trials

Brand equivalent of a generic Step 1 counts toward requirement.

Exceptions: Approve if the patient is currently taking the requested drug or has taken it at any time in the past.

Current or prior use waives the Step 1 requirement.

Methylnaltrexone (Relistor) — step therapy and palliative exception

Primary rule: If the patient has tried a Step 1 drug (Symproic), approve the requested Step 2 drug (Relistor).1 Step 1 trial

Standard requirement.

Palliative exception: If being prescribed for opioid-induced constipation in an adult patient with advanced illness receiving palliative care, approve Relistor injection without a trial of a Step 1 drug.advanced illness + palliative care

Explicit exception for palliative care.

Auvelity and other antidepressants — step therapy and exceptions

Primary rule: Approve if the patient has tried a generic SSRI OR SNRI AND separately tried bupropion.trial of SSRI/SNRI + bupropion

Specifically called out for Auvelity.

Exceptions: Approve Auvelity without Step 1 trial if the patient has suicidal ideation, or if the patient is currently receiving Auvelity or has taken it in the past.

Current/prior use or suicidal ideation allow bypassing Step 1.

Inhaled corticosteroids — step therapy and special population exceptions

Primary rule: If the patient has tried two Step 1 drugs, approve the requested Step 2 drug.2 Step 1 trials

General rule for inhaled corticosteroids.

Device-use and age exceptions: If patient ages 5-11 is unable to use BOTH a dry powder inhaler AND a breath‑activated metered‑dose inhaler, approve fluticasone HFA if the patient has tried Asmanex HFA; if the patient is 4 years of age or younger, approve fluticasone propionate HFA without a trial of a Step 1 drug.age/device criteria

Addresses pediatric device-use and young children.

Disease and pregnancy exceptions: If being treated for eosinophilic esophagitis or chronic graft versus host disease with lung involvement (bronchiolitis obliterans syndrome), approve fluticasone propionate HFA without a trial of a Step 1 drug; if pregnant and currently receiving the requested drug, approve without a trial of a Step 1 drug.

Trazodone oral solution (Raldesy) — step therapy

Primary rule: If the patient has tried one Step 1 trazodone product, authorize a Step 2 drug (Raldesy).1 Step 1 trial

Standard requirement for trazodone oral solution.

Exceptions: Approve Raldesy if patient has difficulty swallowing tablets or cannot swallow tablets; or if currently taking or previously took Raldesy.swallowing difficulty or prior/current use

Specific functional and prior-use exceptions.

Authorization for Raldesy (Step 2)

Covered when ALL of the following are met or exceptions exist:

Approval conditions: Approval is granted if ANY of: patient has tried one Step 1 drug; patient has difficulty swallowing tablets or cannot swallow tablets; patient is currently taking or has taken Raldesy in the past.

Derived from Step 2 criteria

This policy does not list formal exclusions for the classes covered. Instead, it defines exceptions under which a Step 2 agent may be approved without completing Step 1 trials. Examples of such exceptions include age- or device-use limitations (e.g., children unable to use certain inhaler types), specific disease states (e.g., eosinophilic esophagitis or bronchiolitis obliterans syndrome), pregnancy when the member is currently receiving the requested drug, and other clinically justified situations described in each therapeutic-class section.

Requests that do not document the required prior Step 1 trial(s) and do not meet any of the stated exceptions are not consistent with the Step Therapy criteria and therefore would not meet coverage. For example, many Step 2 approvals require evidence of 1 or 2 Step 1 trials (as specified per drug class); absent documented trials or an applicable exception (current use, prior use, suicidal ideation, etc.), approval is not supported by the policy.

Drug and Billing Codes

Listed antidepressant and related productsmixed

AUVELITY 45 MG-105 MG	AUVELITY extended release tablet
EXXUA 18.2 MG	EXXUA extended release tablets (various strengths)
fluoxetine 20 mg	fluoxetine capsule
bupropion hcl sr 150 mg	bupropion sustained release tablet

Antipsychotic and related agentsmixed

CAPLYTA 10.5 MG	CAPLYTA capsule
OPIPZA 2 MG	OPIPZA oral film
FANAPT 1 MG	FANAPT tablet
VRAYLAR 0.5 MG	VRAYLAR capsule

Opioid-induced constipation agentsmixed

SYMPROIC 0.2 MG	SYMPROIC tablet (Step 1)
RELISTOR 12 MG/0.6 ML	RELISTOR subcutaneous solution/syringe
RELISTOR 8 MG/0.4 ML	RELISTOR subcutaneous syringe (alternate strength)

Inhaled corticosteroidsmixed

ALVESCO 80 MCG/ACTUATION	ALVESCO aerosol inhaler
FLUTICASONE PROPIONATE 110 MCG/ACTUATION	Fluticasone HFA aerosol inhaler
ASMANEX TWISTHALER 220 MCG	ASMANEX breath activated inhaler

Trazodone oral solution and tabletsmixed

trazodone 100 mg	trazodone tablet
RALDESY 10 MG/ML	RALDESY oral solution

Indexed drug list (no billing codes provided)mixed

No codes listed

Prior Authorization, Documentation, and Provider Requirements

Prior Authorization

Prior Authorization Required — Step Therapy Applies

Step therapy prior authorization is required for certain products. Prior trials of lower-step agents must be documented; requests may be approved without step trials when the member is currently taking the requested product, has taken it in the past, has documented inability to swallow required formulations, or presents clinical circumstances listed below. Failure to meet step-therapy requirements or provide required documentation may result in denial.

Step therapy applies to listed Step 2 products across therapeutic classes (antidepressants, antipsychotics, inhaled corticosteroids, opioid-induced constipation agents, etc.).
Exceptions: current use of the requested product, prior use of the requested product, suicidal ideation (for antidepressants/Auvelity rules), inability to swallow tablets (e.g., Raldesy), palliative care for advanced illness (Relistor injection), pediatric or pregnancy exceptions where specified.
Required documentation: medical records or pharmacy claims supporting prior trials, current use, or exception reason.

Step Therapy

Raldesy (Step 2) Prior Authorization Criteria

Step 1 (Preferred) Initial Therapy Lists

Initial therapy (Step 1) — Step 1 product lists per therapeutic area

Step 1 (preferred) product lists per therapeutic area

Antidepressant Step 1 list: Includes multiple SSRIs, SNRIs, and bupropion formulations as enumerated in the Step 1 lists (e.g., bupropion, citalopram, escitalopram, fluoxetine, duloxetine).

Refer to enumerated product lists in policy.

Antipsychotic Step 1 list: Includes multiple antipsychotics and formulations (e.g., aripiprazole, asenapine, lurasidone, olanzapine, paliperidone ER, quetiapine IR/ER).

Refer to enumerated product lists in policy.

Inhaled corticosteroid Step 1 list: Includes Alvesco and Asmanex formulations.

Refer to enumerated product lists.

Continuation, Prior-Use, and Renewal Exceptions

Continuation / prior-use exceptions

Continuation/renewal exceptions

Current therapy: If the patient is currently receiving the requested Step 2 drug, approve continuation without further Step 1 trials.current use

Applies across multiple sections where stated.

Prior therapy: If the patient has taken the requested Step 2 product at any time in the past, approve without Step 1 trial.prior use

Applies across multiple sections.

Step Therapy Sequencing Summary

Rule	Description
Follow Step 1 → Step 2 sequencing per drug group
Requirement: trial the number of Step 1 products specified by drug class (typically 1 for antidepressants/trazodone/Relistor; 2 for antipsychotics and inhaled corticosteroids) before authorizing a Step 2 product
Continuation / prior-use exception
If the patient is currently receiving the requested Step 2 drug or has taken it previously, approve without a Step 1 trial
Clinical exceptions
Allow bypass of Step 1 when documented conditions apply (examples: suicidal ideation for certain antidepressants/Auvelity; advanced illness receiving palliative care for Relistor injection; age, device-use inability, pregnancy, or specific diseases for inhaled corticosteroids)
Drug-group specific sequencing examples
Antidepressants (SSRI/SNRI/bupropion): 1 Step 1 trial required. Antipsychotics: 2 Step 1 trials required. Inhaled corticosteroids: 2 Step 1 trials required. Opioid-induced constipation agents (Relistor): 1 Step 1 trial required. Trazodone oral solution (Raldesy): 1 Step 1 trial required.
Documentation requirements
Documentation must show prior trials of required Step 1 products, or documentation that the member is currently or previously taking the requested Step 2 product, or documentation supporting exception criteria (e.g., swallowing difficulty, suicidal ideation, advanced illness/palliative care, age/device-use limitations)
Denial risk
Failure to meet Step Therapy requirements (no documented trial of required Step 1 drug(s)) and absence of an exception may result in denial of a Step 2 product request

Coverage condition	Requirement / allowable exception
Standard prior-trial requirement for Raldesy (Step 2)
Patient must have tried one Step 1 trazodone product (e.g., trazodone 100 mg or 150 mg tablet) before authorization of Raldesy oral solution
Swallowing-difficulty exception
If the patient has difficulty swallowing tablets or cannot swallow tablets, Raldesy may be approved without a prior Step 1 trial
Prior or current use exception
If the patient is currently taking Raldesy or has taken Raldesy at any time in the past, approve without a Step 1 trial
Documentation to support approval
Provider must document prior Step 1 trial when required, or document swallowing impairment or prior/current use of Raldesy to qualify for an exception
Denial risk
Failure to document the required prior trial or a permitted exception may prevent approval of the Step 2 agent

Definitions and Key Terms

Step 1 / Step 2 definitions

Step 1Preferred or first-line products that should be tried before higher-tier agents; a trial of the required Step 1 product(s) must be documented to meet Step Therapy unless an exception applies.

Step 2Non-preferred or higher-tier products that generally require prior documented trial(s) of Step 1 agent(s) before authorization.

Common approval pathwayStandard rule: approve a Step 2 product if the patient has tried the required number of Step 1 products (typically 1 or 2 trials depending on drug class).

Exceptions that bypass Step 1Current use or prior use of the requested Step 2 product, suicidal ideation (for certain antidepressants/Auvelity), specific age/device or clinical-condition criteria (inhaled steroids), palliative care for advanced illness (Relistor), or documented inability to swallow tablets (Raldesy).

Documentation requirementPrior trials of required Step 1 products or evidence supporting an exception (e.g., current/prior use, suicidal ideation, advanced illness/palliative care, age/device inability, swallowing impairment) must be provided with the request.

Background and Purpose

The intent of this policy is to implement step therapy (fail‑first) sequencing across multiple therapeutic classes to encourage use of preferred Step 1 agents before higher‑tier Step 2 products while preserving clinically appropriate exceptions. The policy specifies that Step 2 agents are generally authorized only after documented trials of the required number of Step 1 products (commonly 1 or 2 trials depending on class), but allows bypass when clinical circumstances apply (for example, active suicidal ideation, current or prior use of the requested Step 2 drug, pediatric or device‑use limitations, pregnancy, or specific disease or palliative‑care situations).

Policy Summary

PayerCareSource

PolicyStep Therapy and Prior Authorization Rules for Select Medications (Pharmacy)

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

SourceLink

On This Page

disease or pregnancy

Clinical condition exceptions.

Raldesy (trazodone oral solution) is a Step 2 product that requires documentation of a trial of one Step 1 trazodone product unless an exception applies. Approve when criteria below are met or when exception documentation is provided.

Step requirement: patient must have tried one Step 1 trazodone product (e.g., trazodone 100 mg or 150 mg tablet) prior to approval of Raldesy 10 mg/mL oral solution.
Exceptions that allow approval without trial: documented difficulty or inability to swallow tablets; current or prior use of Raldesy at any time; presence of clinical need (e.g., swallowing impairment) documented in the medical record.

Step Therapy

Antidepressant Step Therapy Rules (Provider Summary)

Antidepressant step therapy rules — provider-facing summary.

Step structure: Step 1 includes multiple generic SSRIs/SNRIs and bupropion formulations; Step 2 includes selected branded/generic agents (e.g., Auvelity, vilazodone) and higher-step agents.
Approval criteria: Approve a Step 2 antidepressant if the member has tried one Step 1 product (some Auvelity criteria require a generic SSRI or SNRI AND separate trial of bupropion).
Allowances: Approve Step 2 without Step 1 trial if member is currently taking the Step 2 product, has taken it previously, or has suicidal ideation (for Auvelity and some Step 2 antidepressants).

Step Therapy

Antipsychotic Step Therapy Rules (Provider Summary)

Antipsychotic step therapy rules — provider-facing summary.

Step structure: Antipsychotics are organized into Step 1 (many generics and some branded agents) and Step 2 (selected products such as Fanapt).
Approval criteria: Approve Step 2 antipsychotic if the member has tried two Step 1 drugs (a brand-name equivalent of a generic Step 1 counts).
Allowances: Approve without required Step 1 trials if member is currently taking the requested Step 2 drug or has taken it previously.

Step Therapy

Opioid-Induced Constipation Agents (Provider Summary)

Opioid-induced constipation agents — provider-facing summary.

Step structure: Symproic (naldemedine) listed as Step 1; Relistor (methylnaltrexone) injectable formulations listed as Step 2.
Approval criteria: If the member has tried a Step 1 agent, approve the requested Step 2 agent. Relistor injection may be approved without a Step 1 trial when prescribed for opioid-induced constipation in an adult with advanced illness receiving palliative care.
Documentation: Provide prior trial evidence or documentation of palliative-care status as applicable.

Step Therapy

Auvelity-Specific Criteria (Provider Summary)

Auvelity-specific criteria — provider-facing summary.

Approval requires prior trials: Approve Auvelity (dextromethorphan-bupropion) if the member has tried a generic SSRI OR SNRI AND separately tried bupropion.
Exceptions: Approve Auvelity without Step 1 trial when the member has suicidal ideation or is currently receiving/have previously received Auvelity.
Documentation: Medical record evidence of prior trials or exception (suicidal ideation, current/prior use).

Step Therapy

Inhaled Corticosteroid Step Therapy Rules (Provider Summary)

Inhaled corticosteroid step therapy rules — provider-facing summary.

Step structure: Step 1 includes Asmanex and other inhaled corticosteroids; Step 2 includes fluticasone propionate HFA and other devices/strengths.
Approval criteria: Approve Step 2 inhaled corticosteroid if the member has tried two Step 1 drugs.
Special allowances: For ages 5–11 who cannot use both a dry powder inhaler and breath-actuated MDI, approve fluticasone HFA if the member has tried Asmanex HFA. For children ≤4 years, approve fluticasone HFA without Step 1 trial. Approve without trial for eosinophilic esophagitis, chronic GVHD with lung involvement, or if pregnant and currently receiving the requested drug.

Step Therapy

Trazodone Oral Solution Criteria (Provider Summary)

Trazodone oral solution (Raldesy) — provider-facing summary.

Step structure: Trazodone tablets (50 mg, 100 mg, 150 mg, 300 mg) are Step 1; Raldesy oral solution is Step 2.
Approval criteria: Approve Raldesy if the member has tried one Step 1 trazodone product.
Exceptions: Approve Raldesy without Step 1 trial if member has difficulty swallowing tablets, is currently taking Raldesy, or has taken it in the past; documentation must support the exception.

Step Therapy

Step 2 Rules (General — includes Raldesy example)

General Step 2 rules (applies across classes): A documented trial of required Step 1 products is required before a Step 2 product will be authorized, except where explicit exceptions exist (current/prior use, swallowing impairment, suicidal ideation, palliative care, pediatric/pregnancy rules).

Documentation of prior trials should include drug name, dose, duration, and reason for discontinuation when applicable.
If the required trial(s) are not documented, the request may be denied.

Documentation Required

Required Documentation (General)

Required documentation (general) — providers must submit evidence supporting prior trials or exceptions when requesting Step 2 products. Lack of required documentation increases risk of denial.

Acceptable evidence: medical records, chart notes, and pharmacy claims showing prior medication name, dose, dates of therapy, and reason for discontinuation or intolerance.
Exception documentation: notes supporting current use, prior use, swallowing impairment, suicidal ideation, palliative-care status, pregnancy status, or age-related device limitations.
Operational note: A trial of the brand-name equivalent of a generic Step 1 product counts toward trial requirements.

Documentation Required

Required Documentation for Raldesy Requests

Required documentation for Raldesy requests — specific evidence needed when requesting trazodone oral solution.

If seeking approval based on prior Step 1 trial: provide documentation of trial of at least one trazodone tablet (name, dose, dates).
If seeking approval based on swallowing impairment: provide clinical documentation describing the swallowing difficulty or diagnosis that prevents tablet use.
If seeking approval based on current or prior use: provide records or claims showing prior Raldesy therapy dates.

Denial Risk

Step Therapy Noncompliance — Denial Risk

Step therapy noncompliance — denial risk if requirements are not met.

Requests lacking documented prior trials or valid exceptions may be denied; ensure complete supporting documentation accompanies the prior authorization request.
Providers may be contacted for additional information; unresolved missing documentation at time of review may result in denial.

Step Therapy

Step Therapy Trial Requirement — Documentation Needed

Step therapy trial requirement — failure to document prior trial may prevent approval.

For most Step 2 approvals, at least one (or two for antipsychotics/inhaled corticosteroids where specified) Step 1 trials must be documented unless an exception applies.
Document trials clearly (drug, dose, duration, outcome) to avoid delays or denials.

Trazodone Step 1 list: Includes trazodone 100 mg and 150 mg tablets.

Refer to enumerated product lists.

Initial therapy criteria — step therapy initial requirement for Step 2 agents

Step therapy initial requirement for Step 2 agents

Initial requirement for Step 2: Patient must have trialed one Step 1 drug to authorize Step 2 medication unless swallowing impairment or prior/current use of the Step 2 agent is documented.1 Step 1 trial (unless exception)

Applies to Step 2 agents (example: Raldesy).

Step 2 definition and example agent

Step 2 (definition)A formulary tier indicating agents that require prior trial of a Step 1 drug before authorization; example Step 2 agent: RALDESY 10 mg/mL oral solution.

Typical Step 1 trial requiredAuthorization for a Step 2 drug (e.g., Raldesy) is given if the patient has tried one Step 1 drug, unless an exception applies.

Swallowing impairment exceptionApprove Raldesy if the patient has difficulty swallowing tablets or cannot swallow tablets without requiring a Step 1 trial.

Continuation/prior-use exceptionApprove Step 2 if the patient is currently taking or has taken the Step 2 product at any time in the past without requiring Step 1 trials.