CurrentCareSourcePolicy N/A

Step therapy lists for outpatient psychotropic and related drugs

This document defines step-therapy groupings (Step 1 vs Step 2), approval rules, and special criteria for multiple CNS, respiratory, and related drugs affecting prior authorization decisions for CareSource members.

Policy Summary

PayerCareSource

PolicyStep therapy lists for outpatient psychotropic and related drugs

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

Key ActionObtain and document a trial of one Step 1 agent before authorizing a Step 2 drug unless an exception (prior/current use, suicidal ideation, swallowing difficulty, pregnancy, palliative care, or device inability) applies.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

20+distinct step-therapy group sections in this part

Step 1 → Step 2common approval pathway

Waivedsuicidal ideation exception

Allowedprior/current use exception

~80+drug formulations indexed

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Coverage Criteria and Approval Rules

Antidepressant Step therapy rules

Conditions under which Step 2 antidepressants are approved

Standard approval: If the patient has tried one Step 1 product, approve a Step 2 product.trial=1

From antidepressant section; chunk 2

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 the requested Step 2 product without a trial of a Step 1 product.prior_use OR suicidal_ideation

From antidepressant section; chunk 2

Auvelity (novel antidepressant) specific rules

Approval conditions for AUVELITY

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

Chunk 12

Exceptions: Approve Auvelity without a Step 1 trial if the patient has suicidal ideation OR is currently receiving or has taken Auvelity in the past.suicidal_ideation OR prior_current_Auvelity

Chunk 12

Relistor for opioid-induced constipation

Approval conditions for subcutaneous Relistor

Standard approval: If the patient has tried a Step 1 drug, approve the requested Step 2 drug.trial=1

Chunk 9

Palliative care exception: Approve Relistor injection if prescribed for treatment of opioid-induced constipation in an adult patient with advanced illness who is receiving palliative care without a trial of a Step 1 drug.palliative_care_condition

Chunk 9

Inhaled corticosteroid rules

Approval conditions and exceptions for Step 2 inhaled corticosteroids

Standard approval: If the patient has tried two Step 1 drugs, approve the requested Step 2 drug.trial=2

Chunk 15

Age/device exceptions: If patient is 5-11 and unable to use BOTH a dry powder inhaler AND a breath-actuated metered-dose inhaler, approve fluticasone propionate HFA if the patient has tried Asmanex HFA.age_5_to_11 AND device_inability

Chunk 15

Young child exception: If patient is 4 years of age or younger, approve fluticasone propionate HFA without a trial of a Step 1 drug.age<=4

Raldesy (trazodone oral solution) rules

Approval conditions for Raldesy oral solution

Standard approval: If the patient has tried one Step 1 drug, authorization for a Step 2 drug will be given.trial=1

Chunk 18

Swallowing exception: Approve Raldesy if the patient has difficulty swallowing tablets or cannot swallow tablets.dysphagia

Chunk 18

Prior/current use exception: Approve if the patient is currently taking Raldesy or has taken Raldesy at any time in the past.prior_current_Raldesy

Chunk 18

Step Therapy

Covered when the Step therapy condition is met

Step therapy requirement: Authorization for Step 2 drugs is allowed if the patient has tried one Step 1 drug.trial of one Step 1 drug

From policy text: 'If the patient has tried one Step 1 drug, then authorization for a Step 2 drug will be given.'

Raldesy (oral solution) approval

Covered when any of the following are met

Raldesy approval: Approve Raldesy if the patient has difficulty swallowing tablets or cannot swallow tablets; approve if the patient is currently taking Raldesy or has taken Raldesy at any time in the past.difficulty swallowing OR current/prior Raldesy use

Specifically names Raldesy 10 mg/mL oral solution.

This section does not list any explicit product exclusions by name. Instead, the policy relies on step-therapy requirements to determine authorization: failure to meet the required Step 1 trial(s) or to document an applicable exception is the operational basis for denying a Step 2 request. Reviewers should therefore treat noncompliance with the Step 1 trial rules (including missing documentation of prior/current use or other listed exceptions) as the primary reason a request for a Step 2 agent may be declined.

The policy does not present a separate list labeled “not medically necessary” in this section. Instead, requests for Step 2 medications that lack documentation of the required Step 1 trial(s) — and for which no documented exception applies (for example, prior or current use of the Step 2 agent or clinical exceptions such as suicidal ideation, pregnancy, palliative care, age/device inability, or swallowing difficulty where specified) — are at risk of denial. In practical terms, absence of the required Step 1 trial functions as the grounds for non-approval when exceptions are not met.

Step therapy requirement	Details / exceptions
Trial of one or more specified Step 1 agents is required prior to approval of Step 2 agents	If the patient has tried one Step 1 product, approve a Step 2 product. Exceptions: prior or current use of the requested Step 2 product; documented suicidal ideation; other listed exceptions (e.g., pregnancy, age/device inability, palliative care).
Inhaled corticosteroid groups may require two Step 1 trials before Step 2	For certain inhaled corticosteroids, criteria state: if the patient has tried two Step 1 drugs, approve the requested Step 2 drug; specific age/device, pregnancy, and diagnosis exceptions may allow bypassing Step 1 trials (see policy).

Coverage label	Rule
Covered	Patient must have tried one Step 1 drug before authorization of a Step 2 drug (authorization is allowed once one Step 1 drug has been tried).
Covered	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 (prior/current use exception).
Covered	If the patient has suicidal ideation, approve the requested Step 2 product without a trial of a Step 1 product (suicidal ideation exception).

Provider Actions, Prior Authorization & Documentation

Step Therapy

Step therapy rule

Step therapy prior authorization — A trial of one required Step 1 drug is generally required before authorization of a Step 2 drug. Once documentation shows the patient has tried at least one Step 1 drug, a Step 2 product may be approved. Exceptions: prior or current use of the requested Step 2 product, suicidal ideation, or other specific clinical exceptions noted below (e.g., age-based or swallowing difficulty exceptions for certain products).

If the patient has tried one Step 1 product, approve a Step 2 product.
If the patient is currently taking or has taken the requested Step 2 product at any time in the past, approve without a Step 1 trial.
If the patient has suicidal ideation, approve the requested Step 2 product without a Step 1 trial.

Documentation Required

Required supporting documentation

Required supporting documentation — Provider must submit clinical documentation showing prior trials and any applicable exceptions. Documentation should include medication names, doses, dates of trial, reason for discontinuation (lack of efficacy or adverse effects), and any special clinical circumstances (e.g., pregnancy, age-based limitations, eosinophilic esophagitis, graft-versus-host disease with lung involvement).

List of Step 1 agents tried (agent name, dose, start/stop dates).
Reason for failure or intolerance for each Step 1 agent (ineffectiveness, adverse event, contraindication).
Documentation of current or prior use of the requested Step 2 product (if applicable).
Clinical justification for exceptions (e.g., suicidal ideation, inability to swallow tablets, age-specific device limitations, pregnancy, specific diagnoses).

Step Therapy

Antidepressant step therapy summary

Antidepressant step therapy summary — Step 1 includes common generic SSRIs/SNRIs and bupropion (examples: bupropion formulations, citalopram, duloxetine, escitalopram, fluoxetine). Step 2 contains certain branded or less-preferred agents (examples: EXXUA products, AUVELITY and other listed Step 2 agents). Approve Step 2 if one Step 1 has been tried or if the patient meets an exception (prior use of the Step 2 agent, suicidal ideation).

Step 1 examples: bupropion (SR, XL), citalopram, duloxetine, escitalopram, fluoxetine (including oral solution).
Step 2 examples: EXXUA formulations, AUVELITY, vilazodone, nefazodone, certain paroxetine/sertraline/venlafaxine formulations listed as Step 2 in appendix.
Special criteria for AUVELITY: Approve if patient tried a generic SSRI OR SNRI AND separately tried bupropion; approve without Step 1 if suicidal ideation or current/past AUVELITY use.

Step Therapy

Antipsychotic step therapy summary

Antipsychotic step therapy summary — Multiple oral antipsychotics and formulations are categorized as Step 1 (examples include aripiprazole, asenapine, caplyta, lurasidone, olanzapine, paliperidone ER, quetiapine and certain risperidone/vraylar formulations). Step 2 includes less-preferred or branded agents (examples include FANAPT products). Approve Step 2 when at least one Step 1 agent has been tried or when exceptions apply (prior/current use of the requested Step 2 agent, documented clinical need).

Step 1 examples: aripiprazole (tablets, disintegrating, oral solution), asenapine sublingual tablets, CAPLYTA, lurasidone (various strengths), olanzapine (various forms), paliperidone ER, quetiapine (IR and ER), many risperidone formulations, VRAYLAR low-dose capsules.
Step 2 examples: FANAPT (various strengths and titration packs).
Notes: Some agents are listed with pending CMS review or special handling; consider formulary status and documented prior trials when authorizing.

Step Therapy

Inhaled corticosteroid step therapy summary

Inhaled corticosteroid step therapy summary — Step 1 lists several inhaled corticosteroid products (examples: Alvesco, Asmanex HFA and Twisthaler). Step 2 includes fluticasone propionate HFA, QVAR RediHaler, Pulmicort Flexhaler and other listed inhalers. Age and device-use exceptions apply: some products may be approved without Step 1 trials for young children or when the patient cannot use specific device types.

Step 1 examples: ALVESCO (80 and 160 mcg), ASMANEX HFA (50/100/200 mcg), ASMANEX TWISTHALER (110/220 mcg).
Step 2 examples: FLUTICASONE PROPIONATE HFA (44/110/220 mcg), PULMICORT FLEXHALER (90/180 mcg), QVAR REDIHALER (40/80 mcg), ASMANEX TWISTHALER 220 mcg (alternate pack sizes).
Approval rules: If the patient has tried two Step 1 drugs, approve Step 2. For ages 5–11 unable to use both a dry powder inhaler AND a breath-actuated MDI, approve fluticasone HFA if patient tried Asmanex HFA. For patients ≤4 years, approve fluticasone HFA without a Step 1 trial. Pregnancy and certain diagnoses (eosinophilic esophagitis, chronic GVHD with lung involvement) may permit approval without Step 1 trial if currently receiving therapy or clinical indication exists.

Prior Authorization

Raldesy approval conditions

Raldesy approval conditions — Raldesy (10 mg/mL oral solution) is approved when the patient has difficulty swallowing tablets or cannot swallow tablets, or when the patient is currently taking or has taken Raldesy in the past. Include documentation of swallowing difficulty or prior use in the prior authorization submission.

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

Denial Risk

Inhaler and antidepressant trial requirement

Inhaler and antidepressant trial requirement — Requests for certain Step 2 inhalers or antidepressants may be denied if required Step 1 trials (one or two drugs depending on drug class and age) are not documented. Ensure the submission documents the number and identity of Step 1 trials or a documented exception.

Antidepressants: at least one Step 1 trial is required before Step 2 unless exception applies (prior Step 2 use or suicidal ideation).
Inhaled corticosteroids: generally two Step 1 trials are required before Step 2 unless age/device/diagnosis-based exceptions apply; some inhalers allow approval after one Step 1 trial per specific criteria.

Definitions and Background

Step 1 / Step 2 definitions

Step 1 (definition)Preferred or first-line agents to be tried before Step 2; a trial of one Step 1 drug is generally required prior to Step 2.

Step 2 (definition)Agents requiring prior trial of Step 1 products for approval unless an exception applies (e.g., prior/current use of the Step 2 product, suicidal ideation, age/device inability, pregnancy, palliative care).

Prior/current use exceptionIf the member is currently taking or has taken the requested Step 2 product at any time in the past, approve without a Step 1 trial.

Suicidal ideation exceptionApprove Step 2 agents without a Step 1 trial when the patient has suicidal ideation.

Age/device and clinical exceptionsCertain clinical situations (e.g., young children unable to use required inhaler devices, eosinophilic esophagitis, chronic GVHD with lung involvement, pregnancy) allow bypassing Step 1 per the specific drug group rules.

Authorization standardFor most classes, once one Step 1 drug has been tried, authorization for a Step 2 drug will be given (some classes require two Step 1 trials as specified).

For operational clarity, outpatient medications in this portion of the policy are grouped into Step 1 (preferred or first-line agents, typically generics or lower-tier products) and Step 2 (higher-tier or branded agents that generally require prior trial of a Step 1 product). The standard pathway authorizes a Step 2 drug when the patient has tried one Step 1 drug unless a listed exception applies (examples and additional step counts vary by therapeutic group; inhaled corticosteroids commonly require two Step 1 trials or have specific age/device exceptions).

bupropion hcl sr 100 mg	12 hr sustained-release
bupropion hcl sr 150 mg	12 hr sustained-release
bupropion hcl sr 200 mg	12 hr sustained-release
bupropion hcl xl 150 mg	24 hr extended release
bupropion hcl xl 300 mg	24 hr extended release
citalopram 10 mg	tablet
duloxetine 30 mg	capsule, delayed release
EXXUA 18.2 MG	tablet, ER 24 hr dose pack
aripiprazole 10 mg	tablet
RELISTOR 12 MG/0.6 ML	subcutaneous solution/syringe

RALDESY 10 MG/ML ORAL SOLUTION	RALDESY 10 MG/ML ORAL SOLUTION (listed under index)
trazodone 300 mg tablet	trazodone 300 mg tablet
trazodone 50 mg tablet	trazodone 50 mg tablet
aripiprazole (multiple formulations)	aripiprazole oral solution, tablets, disintegrating tablets (various strengths)
lurasidone (20/40/60/80/120 mg tablets)	lurasidone multiple strengths
quetiapine (IR and ER multiple strengths)	quetiapine immediate and extended release products
REXULTI (0.5–4 mg tablets)	Rexulti tablets listed
RELSTIOR / RELISTOR products	RELISTOR 12 MG/0.6 ML and 8 MG/0.4 ML subcutaneous
Various SSRIs/SNRIs (sertraline, citalopram, paroxetine, venlafaxine, duloxetine, etc.)	Multiple antidepressant formulations and strengths
VRAYLAR (0.5, 0.75, 1.5 mg capsules)	cariprazine strengths listed

OpenPayer

Step therapy lists for outpatient psychotropic and related drugs

Coverage Criteria and Approval Rules

Step 1 — Initial (Preferred) Therapy Lists

Step Therapy Requirements and Tables

Provider Actions, Prior Authorization & Documentation

Product and Code Indexes

Definitions and Background