CurrentCareSourcePolicy N/A

Outpatient Step Therapy Coverage Criteria for Select Psychotropic, Respiratory, and Related Medications

Defines step-therapy groupings (Step 1 and Step 2), approval criteria, and special exceptions for multiple drug classes (antidepressants, antipsychotics, opioid-induced constipation agents, inhaled corticosteroids, trazodone/Raldesy) affecting CareSource members and prescribing providers.

Policy Summary

PayerCareSource

PolicyOutpatient Step Therapy Coverage Criteria for Select Psychotropic, Respiratory, and Related Medications

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

Key ActionProviders must document prior Step 1 trials (number/type per drug group) or an applicable exception (current/prior use, suicidal ideation, palliative care, age/device limitations) to obtain approval for Step 2 agents.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

10+distinct step-therapy drug groups present

Step 1 / Step 2common approval pathway structure

Exceptionsuicidal ideation override

Age-basedpediatric/device inhaler exception

RALDESY

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Coverage and Step-Therapy Criteria

Antidepressant Step Therapy (including Auvelity)

Antidepressant step-therapy groups and Raldesy (trazodone oral solution) approval rules.

{"text":"If the patient has tried one Step 1 product, approve a Step 2 product.","note":"Counts: a trial of a brand-name equivalent of a generic Step 1 product counts toward the requirement."},

{"text":"If the patient is currently taking or has taken the requested Step 2 product at any time in the past, approve the requested product without a trial of a Step 1 product."},

{"text":"If the patient has suicidal ideation, approve the requested Step 2 product without a trial of a Step 1 product."},

Trazodone (Raldesy) Step Therapy

Trazodone (Raldesy) step-therapy and approval exceptions.

ALL of the following

Step 1 trazodone products
- trazodone 100 mg tablet
- trazodone 150 mg tablet
- trazodone 50 mg tablet
- trazodone 300 mg tablet
Step 2 trazodone product
- RALDESY 10 MG/ML ORAL SOLUTION
If the patient has tried one Step 1 drug, then authorization for a Step 2 drug will be given.
Approve Raldesy if the patient has difficulty swallowing tablets or cannot swallow tablets.
Approve Raldesy if the patient is currently taking Raldesy or has taken Raldesy at any time in the past.

Provider Requirements and Prior Authorization Guidance

Prior Authorization

Relistor Prior Authorization

Relistor (Step 2) requires prior authorization when requested without documentation of a Step 1 trial. Exception: Relistor injection (8 mg/0.4 mL subcutaneous) may be approved without a Step 1 trial when prescribed for opioid‑induced constipation in an adult with advanced illness who is receiving palliative care.

Prior authorization required for Relistor when no Step 1 trial documented
Palliative-care / advanced-illness adult patients receiving palliative care: Relistor injection approvable without Step 1 trial

Prior Authorization

Auvelity Prior Authorization

Auvelity (Step 2) requires prior authorization. Approve only if the patient has tried BOTH: 1) a generic SSRI OR SNRI, AND 2) bupropion. Exceptions: approve without Step 1 trials if the patient has suicidal ideation, or if the patient is currently receiving Auvelity or has taken it in the past.

Required prior trials: generic SSRI OR SNRI AND separately bupropion
Approve without Step 1 trial for patients with suicidal ideation

Step Therapy Tables and Quick Rules

Requirement	Details
Approve Step 2 antidepressant if the patient has tried one Step 1 product.
Approve without Step 1 trial if the patient is currently taking or has taken the requested Step 2 product in the past.
Approve Auvelity without a Step 1 trial if the patient has suicidal ideation.
Approve Auvelity only after documentation of a trial of a generic SSRI OR SNRI AND a separate trial of bupropion, unless an exception applies (suicidal ideation or current/prior Auvelity use).

Requirement	Details
Approve Step 2 antipsychotic if the patient has tried two Step 1 drugs.
Approve the requested Step 2 antipsychotic if the patient is currently taking or has taken the requested drug in the past without requiring two Step 1 trials.
A trial of the brand-name equivalent of a generic Step 1 product counts toward the two-trial requirement.

Requirement	Details
Approve Relistor (Step 2) if the patient has tried the Step 1 agent Symproic.
Approve Relistor injection without a Symproic trial when prescribed for opioid-induced constipation in an adult patient with advanced illness receiving palliative care.
Policy lists multiple Relistor formulations (subcutaneous solution and syringe products) as Step 2 options.

Requirement	Details
If the patient has tried one Step 1 drug, authorization for a Step 2 drug will be given; evidence of a Step 1 trial is required unless a specific exception applies (e.g., prior/current use, formulation/swallowing issues, palliative care, suicidal ideation where noted).

Initial/Step 1 therapy

Initial Step 1 agents to be tried prior to Step 2 products:

Antidepressant Step 1 agents: Includes bupropion formulations, citalopram, duloxetine, escitalopram, fluoxetine and other listed SSRIs/SNRIs (see Step 1 listing).

Providers should trial these Step 1 agents prior to Step 2 antidepressants.

Antipsychotic Step 1 agents: Includes aripiprazole (various formulations), asenapine, Caplyta, lurasidone, olanzapine, quetiapine IR/ER and other listed antipsychotics (see Step 1 listing).

Providers should trial these Step 1 agents prior to Step 2 antipsychotics.

Inhaled corticosteroid Step 1 agents: Includes Alvesco, Asmanex HFA/Twisthaler and other listed Step 1 inhaled corticosteroids (see Step 1 listing).

Formulary and Drug Index Coding

Formulary drug listings (selected)NDC|mixedCovered

RALDESY 10 MG/ML ORAL SOLUTION	RALDESY 10 MG/ML ORAL SOLUTION (formulary listing)
trazodone 50 mg tablet	trazodone 50 mg tablet (listed)
trazodone 100 mg tablet	trazodone 100 mg tablet (listed)
trazodone 150 mg tablet	trazodone 150 mg tablet (listed)
trazodone 300 mg tablet	trazodone 300 mg tablet (listed)

Indexed psychotropic drugsmixed

aripiprazole (various strengths and formulations)	listed in index (tablets, disintegrating tablets, oral solution)
asenapine (sublingual tablets)	listed in index
auvelity 45 mg-105 mg tablet ER	listed in index
bupropion (various formulations)	listed in index
caplyta (various strengths)	listed in index
quetiapine (IR and ER various strengths)	listed in index
risperidone (tablets, disintegrating, solution)	listed in index
vilazodone (10,20,40 mg)	listed in index
vraylar (various strengths)	listed in index

Continuation and Renewal Rules

Prior or current therapy exceptions

Continuation is permitted when evidence of prior or current use of the requested product is documented:

Prior or current use: Patient is currently taking or has taken the requested Step 2 product in the past — approve for continuation without new Step 1 trials.

Applies to antidepressants, antipsychotics, Auvelity and trazodone solution; documentation of prior/current use required.

Raldesy continuation

Raldesy continuation and renewal guidance:

Raldesy continuation: Approve renewal/continuation if the patient is currently taking Raldesy or has taken Raldesy at any time in the past.

Supports continuity of therapy for Raldesy oral solution; document prior/current use or swallowing impairment as applicable.

Definitions

Step 1 / Step 2 definitions and trial expectations

Definition - Step 1Step 1 drugs are the preferred or first-line agents that must generally be tried before a Step 2 product is approved.

Definition - Step 2Step 2 drugs are alternative or brand agents that require prior trial(s) of Step 1 agent(s) for coverage unless an exception applies.

Primary trial expectationApprove a Step 2 product if the patient has tried one Step 1 product (evidence of trial required).

Prior/current use exceptionApprove Step 2 without Step 1 trial if the patient is currently taking or has taken the requested Step 2 product in the past.

Clinical exception - suicidal ideationFor patients with suicidal ideation, approve the requested Step 2 product without a trial of a Step 1 product.

Background

The policy is organized around a uniform step-therapy approach across outpatient medication classes: each therapeutic group lists Step 1 (preferred/first-line) agents and Step 2 (alternative/brand) agents, with explicit trial and exception rules. In general, a patient must try the specified number of Step 1 agents (commonly one for antidepressants and two for many antipsychotics and selected inhaled corticosteroids) before a Step 2 product will be authorized. The document also nests drug-specific rules — for example, Auvelity requires trials of an SSRI or SNRI plus bupropion unless suicidal ideation or prior/current Auvelity use applies — and includes formulation-based exceptions such as approval of Raldesy oral solution when swallowing tablets is not feasible or for continuity of therapy.