CareSource step therapy Coverage Update

Coverage Criteria and Step Therapy Groups

Antidepressant Step Therapy

Covered when ALL of the following are met:

Step 2 approval rules: (1) If the patient has tried one Step 1 product, approve a Step 2 product. (2) 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. (3) If the patient has suicidal ideation, approve the requested Step 2 product without a trial of a Step 1 product.

Applies to antidepressant Step 1/Step 2 lists in chunks 0-2

Antipsychotic Step Therapy

Covered when the following conditions are met:

Standard requirement: Patient has tried two Step 1 drugs (a brand-name equivalent of a generic Step 1 product counts as a trial).2 trials

If request is for Opipza, only one Step 1 drug is required.

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

Also applies to several listed agents.

Relistor Step Therapy

Opioid‑induced constipation agent step therapy:

Standard requirement: If the patient has tried a Step 1 drug (SYMPROIC), approve the requested Step 2 (RELISTOR).1 trial

Relistor injection may be approved without a Step 1 trial when prescribed for opioid‑induced constipation in an adult patient with advanced illness receiving palliative care.

AUVELITY specific criteria

AUVELITY and related antidepressant group:

AUVELITY requirement: Approve if the patient has tried a generic SSRI OR SNRI AND has separately tried bupropion.2 distinct prior agents/classes

AUVELITY may be approved without prior Step 1 trials if the patient has suicidal ideation or is currently receiving / has previously received AUVELITY.

Fluticasone / inhaled steroid Step Therapy

Inhaled corticosteroid step therapy:

Standard requirement: If the patient has tried two Step 1 inhaled corticosteroid drugs, approve the requested Step 2 drug.2 trials

Exceptions: age/device inability (e.g., ages 5–11 unable to use both a dry powder inhaler and a breath‑actuated MDI), children ≤4 years of age, eosinophilic esophagitis or bronchiolitis obliterans, and pregnant patients currently receiving therapy — these can bypass Step 1 trials as specified in the policy.

Trazodone Step Therapy

Trazodone formulation step therapy:

Oral solution approval: If the patient has tried one Step 1 trazodone product (e.g., trazodone tablets), authorize the Step 2 product (Raldesy oral solution).1 trial

Approve Raldesy without a Step 1 trial if the patient has difficulty swallowing tablets, cannot swallow tablets, or is currently/previously taking Raldesy.

Step therapy and Raldesy authorization

Covered when the following step‑therapy conditions are met or an exception applies:

Primary step rule: Patient has tried one Step 1 drug.

If met, authorize the requested Step 2 drug.

Raldesy exceptions: Patient has difficulty swallowing tablets OR cannot swallow tablets OR is currently or has previously taken Raldesy.

If any condition is true, approve Raldesy without requiring a Step 1 trial.

Relistor injection (subcutaneous formulation) is an exception to the usual step-therapy requirement when prescribed for opioid-induced constipation in an adult patient with advanced illness receiving palliative care. In that clinical situation the policy allows approval of the Relistor injection without a trial of a Step 1 drug.

The cited portion of the document does not list any explicit exclusions for the step-therapy groups covered in these chunks. No exclusion statements appear in the referenced text.

The referenced chunks do not contain language declaring any therapies or indications as "not medically necessary." No explicit not-medically-necessary statements are present in these portions of the document.

Indexed Drugs and Coding

Indexed Psychotropic Drugs - Antipsychotics/Antidepressants/Relatedmixed

trazodone 300 mg tablet	trazodone 300 mg tablet (indexed strength to be included)
trazodone 50 mg tablet	trazodone 50 mg tablet
trazodone 100 mg tablet	trazodone 100 mg tablet
trazodone 150 mg tablet	trazodone 150 mg tablet
aripiprazole 1 mg/ml oral solution	aripiprazole oral solution 1 mg/mL
aripiprazole 2 mg tablet	aripiprazole 2 mg tablet
aripiprazole 5 mg tablet	aripiprazole 5 mg tablet
aripiprazole 10 mg tablet	aripiprazole 10 mg tablet
aripiprazole 10 mg disintegrating tablet	aripiprazole 10 mg orally disintegrating tablet
aripiprazole 15 mg tablet	aripiprazole 15 mg tablet

1–10 of 70

1/7

Prior Authorization, Documentation, and Provider Requirements

Step Therapy

General step therapy structure

Step therapy: A Step 1 trial is required before authorizing Step 2 products, except as noted below. If the patient has tried one Step 1 drug, approve a Step 2 drug. Providers must document the prior Step 1 trial or evidence of prior/current use of the requested Step 2 product.

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

Step Therapy

Antipsychotic Step therapy requirements

For antipsychotics requiring Step 2, a trial of two Step 1 antipsychotic drugs is required before approving most Step 2 antipsychotics. Exceptions: approve if the patient is currently taking the requested drug or has taken it in the past; Opipza requires only one Step 1 trial.

Two Step 1 trials required for Step 2 antipsychotics (brand-name equivalent counts).
Opipza (oral film) — only one Step 1 trial required.

Step 1 (Initial Therapy) Requirements

Step 1 (initial therapy)

Step 1 (initial therapy) — preferred / first‑line products (examples):

Step 1 products: See source Step 1 lists for full enumerations. Examples include generic SSRIs/SNRIs and first‑line antipsychotics and inhaled corticosteroids: bupropion formulations, citalopram, duloxetine, escitalopram, fluoxetine, fluvoxamine, sertraline oral forms; aripiprazole formulations, asenapine, lurasidone, quetiapine; ALVESCO and ASMANEX inhalers; trazodone 100 mg and 150 mg tablets.

Full step 1 enumerations are in chunks 0, 3, 10, 13, 16.

Initial therapy step

Initial therapy requirement for Step 2 drugs:

Initial requirement: Patient must have tried one Step 1 drug to qualify for Step 2 drug authorization (unless a specific exception applies).

Applies generally to drugs governed by this step rule; see product‑specific exceptions (e.g., Raldesy, AUVELITY, Relistor palliative‑care) in the policy.

Continuation and Prior-Use Rules

Continuation / prior-use

Continuation / prior‑use rules — approval when current or prior use documented:

Current or previous use: Approve the requested Step 2 product if the patient is currently taking it or has taken it at any time in the past.

This continuation/prior‑use allowance appears for antidepressants, antipsychotics, AUVELITY, and Raldesy as described in the policy.

Step-Specific Trial Requirements and Tables

Therapeutic group / product examples	Required number of Step 1 trials before Step 2	Product-specific exceptions / notes
Antidepressants (selected groups) — examples: multiple generic SSRIs/SNRIs listed in Step 1 (e.g., citalopram, escitalopram, fluoxetine, sertraline, venlafaxine) and Step 2 examples including EXXUA and higher-dose venlafaxine formulations.	One Step 1 trial	Approve Step 2 if patient has tried one Step 1 product; approve without trial if patient is currently taking or has previously taken the requested Step 2 product, or has suicidal ideation.
Antipsychotics — Step 1: various generics/first-line agents (e.g., aripiprazole, quetiapine, lurasidone, olanzapine); Step 2: branded agents such as FANAPT and others listed.	Two Step 1 trials (standard)	A trial of the brand-name equivalent of a generic Step 1 product counts. If the request is for OPIPZA, only one Step 1 trial is required. Approve if patient is currently taking or has taken the requested drug in the past.
AUVELITY and related antidepressant group — Step 1: generic SSRI or SNRI and bupropion listed as Step 1 agents; Step 2 includes AUVELITY.	Two distinct prior agents/classes: a generic SSRI or SNRI AND bupropion	Approve Auvelity without Step 1 trial if patient has suicidal ideation or is currently receiving/previously received AUVELITY.
Inhaled corticosteroids — Step 1: products such as ALVESCO, ASMANEX; Step 2: fluticasone propionate HFA and other listed devices.	Two Step 1 trials (standard)	Exceptions bypassing Step 1: children ≤4 years; ages 5–11 unable to use required devices; eosinophilic esophagitis or bronchiolitis obliterans; pregnant patients currently receiving therapy; other device/age-specific notes.
Trazodone formulation group — Step 1: trazodone tablets (100 mg, 150 mg); Step 2: Raldesy 10 mg/mL oral solution.	One Step 1 trial	Raldesy may be approved without a Step 1 trial if the patient has difficulty swallowing tablets, cannot swallow tablets, or is currently/has previously taken Raldesy.
Opioid-induced constipation agents — Step 1: SYMPROIC 0.2 mg tablet; Step 2: RELISTOR (subcutaneous formulations listed).	One Step 1 trial	Relistor injection may be approved without a Step 1 trial when prescribed for opioid‑induced constipation in an adult patient with advanced illness receiving palliative care.

Policy statement	Required Step 1 trial	Raldesy (10 mg/mL oral solution) exception / swallow-impairment or prior-use rule
Prior authorization for Step 2 drugs requires documentation that the patient has tried a Step 1 drug before approving a Step 2 agent.	One Step 1 drug trial is required (documented prior trial of a Step 1 product).	Raldesy may be approved without a Step 1 trial if the patient has difficulty swallowing tablets or cannot swallow tablets, or if the patient is currently taking or has previously taken Raldesy (prior/current use).
If the requested Step 2 product is already being taken or was taken previously, authorize without a Step 1 trial.	Not applicable (prior/current use replaces Step 1 trial requirement).	This continuation/prior‑use criterion also applies to Raldesy: prior or current Raldesy use qualifies for approval without an additional Step 1 trial.
Clinical exception: for AUVELITY and some other agents, suicidal ideation is an immediate exception to Step 1 trial requirements; similar exception logic is noted for other groups.	Not applicable to Raldesy-specific swallow impairment rule.	Separate from swallow-impairment rule: AUVELITY may be approved without Step 1 trial for suicidal ideation, per policy details.

Background and Scope

This policy defines step-therapy requirements that apply across several therapeutic areas including antidepressants, antipsychotics, inhaled corticosteroids, trazodone formulations, and agents for opioid-induced constipation. Generally, authorization for a Step 2 (non-preferred or later-line) agent requires documentation that the member has tried a specified number of Step 1 (preferred/generic) agents — typically one trial for many groups and two trials for selected classes such as inhaled corticosteroids or antipsychotics where noted. The policy also includes product-specific continuation and exception rules: for example, Relistor injection may be approved without a Step 1 trial for adults with advanced illness receiving palliative care, Raldesy oral solution may be approved without a Step 1 trial for patients who cannot swallow tablets or who are current/former Raldesy users, and certain pediatric, pregnancy, and specific-disease scenarios permit bypassing Step 1 for inhaled corticosteroid agents.

Definitions and Product Notes

Step 1 / Step 2 definitions

DefinitionStep 1 = preferred or first-line products (often generics); Step 2 = non-preferred or later-line products that generally require prior trials of Step 1 therapies.

Standard requirementPatient must have tried one Step 1 drug before authorization of a Step 2 drug (some groups require two Step 1 trials; see specific group rules).

Antipsychotic exceptionFor certain antipsychotic requests (e.g., OPIPZA), only one Step 1 trial is required instead of two.

Current/prior useApproval of a Step 2 drug is allowed if the patient is currently taking or has previously taken the requested Step 2 product.

DocumentationProviders must document prior trials of required Step 1 drug(s) or evidence of current/previous use of the requested Step 2 drug to support authorization.

OpenPayer

Step therapy lists for select CNS and respiratory drugs