CurrentCareSourcePolicy N/A

Step Therapy / Step Edit formulary listing for multiple psychotropic and other medications

Formulary step-therapy requirements listing Step 1 and Step 2 products for multiple therapeutic classes (antipsychotics, antidepressants, inhaled corticosteroids, GI agents, others) and criteria when step edits may be bypassed (age, specific diagnosis, palliative care, prior use). Governs prior authorization/approval decisions for listed products.

Policy Summary

PayerCareSource

PolicyStep Therapy / Step Edit formulary listing for multiple psychotropic and other medications

Policy CodePolicy N/A

Change TypeClarification / Exceptions enumerated

Effective Date

Next Review Date

Key ActionPrior authorization approval for Step 2 products requires documented trials of Step 1 products as specified (typically two Step 1 trials), except for enumerated exceptions (Opipza, Relistor in palliative care, Linzess pediatric, Auvelity suicidal ideation/prior use, fluticasone age/diagnosis exceptions).

POLICY UPDATE CHANGES

Specific exceptions where Step 1 trial may be bypassed are enumerated (Opipza, Relistor in palliative care, Linzess pediatric use, Auvelity suicidal ideation or prior/current use, fluticasone HFA age/diagnosis or device-use exceptions).

Brand name equivalent of a generic Step 1 product counts toward step requirement.

100+Products listed

MultipleTherapeutic classes covered

What is changing — high-level summary

This bulletin outlines the formulary Step 1 / Step 2 product groupings and approval criteria across multiple therapeutic classes (e.g., antipsychotics, antidepressants, inhaled corticosteroids, GI agents). Step therapy requires trials of lower-step (Step 1) agents before coverage of higher-step (Step 2) products, with specific exception rules enumerated for some products and patient circumstances.

Step therapy rules and approval criteria

General Step Therapy Rule

Approve Step 2 product only after trials of Step 1 products unless specific exceptions apply:

General Step Therapy

Step 1 trial requirement: Patient has tried two Step 1 products2 trials
A trial of the brand name equivalent of a generic Step 1 product will count towards this requirement.

Opipza (sulpiride/opiprazole) exception

Opipza-specific rule

Opipza exception: If the request is for Opipza, approve if the patient has tried one Step 1 product1 trial

Opipza requires only one Step 1 trial instead of two.

Relistor (methylnaltrexone) exception

Relistor injection for opioid-induced constipation

Relistor approval branches

Palliative care branch: Approve Relistor injection for opioid-induced constipation in an adult patient with advanced illness who is receiving palliative care without a trial of a Step 1 drugno Step 1 required
Palliative-care patients are exempt from Step 1 trial.
Non-palliative branch: Otherwise, approve requested Step 2 Relistor if the patient has tried a Step 1 product1 trial
Standard Step 1 trial required for non-palliative patients.

Linzess (linaclotide) pediatric exception

Pediatric functional constipation rule

Linzess pediatric exception: Approve Linzess (145 mcg or 290 mcg) without a trial of a Step 1 drug if being prescribed for functional constipation in a pediatric patient ages 6-17 yearsno Step 1 required

Applies specifically to Linzess 145 mcg and 290 mcg for ages 6-17.

Auvelity (dextromethorphan-bupropion) exception

Suicidal ideation / current use rule

Auvelity exceptions

Suicidal ideation: Approve Auvelity if the patient has suicidal ideation without a trial of a Step 1 drugno Step 1 required
Immediate approval permitted for suicidal ideation.
Current or prior Auvelity use: Approve Auvelity if the patient is currently receiving Auvelity or has taken Auvelity in the pastno Step 1 required
Prior or current use of Auvelity waives Step 1 requirement.

Fluticasone propionate HFA inhaler exceptions

Age and specific diagnosis exceptions for fluticasone HFA

Fluticasone HFA exceptions

Age 5-11 with device inability: If patient is 5 to 11 years old and unable to use BOTH a powder inhaler AND a breath-actuated MDI (e.g., QVAR Redihaler), approve fluticasone propionate HFA if the patient has tried Asmanex HFAtried Asmanex HFA
Device-use limitation must be documented.
Age 4 or younger: If the patient is 4 years of age or younger, approve fluticasone propionate HFA without a trial of a Step 1 drugno Step 1 required
Automatic approval for ages ≤4.
Specific diagnoses:

Antidepressant class rule

Approval criteria for Auvelity and other antidepressants

Antidepressant class rule: For non-Auvelity Step 2 antidepressants, approve if the patient has tried a generic SSRI OR SNRI AND has separately tried bupropiontried SSRI or SNRI plus bupropion

Auvelity has separate exceptions (suicidal ideation; prior/current use).

Step 1 and Step 2 product listings (examples)

Listed Step 1 products (examples)mixed

aripiprazole 10 mg disintegrating tablet	Step 1 antipsychotic product
aripiprazole 1 mg/ml oral solution	Step 1 antipsychotic product
asenapine 2.5 mg sublingual tablet	Step 1 antipsychotic product
olanzapine 5 mg tablet	Step 1 antipsychotic product
quetiapine 50 mg tablet	Step 1 antipsychotic product
risperidone 1 mg tablet	Step 1 antipsychotic product
bupropion hcl 100 mg tablet	Step 1 antidepressant example
citalopram 10 mg tablet	Step 1 SSRI example
ASMANEX HFA 100 MCG AEROSOL INHALER	Step 1 inhaled corticosteroid example
RELISTOR 8 MG/0.4 ML SUBCUTANEOUS SYRINGE	Listed Relistor formulation as Step 1 in index

Listed Step 2 products (examples)mixed

FANAPT 2-12 MG tablets	Step 2 antipsychotic (iloperidone) examples
OPIPZA 2/5/10 MG ORAL FILM	Step 2 antipsychotic (opiprazole) - special rule: one Step1 trial counts
AUVELITY 45 MG-105 MG TABLET, EXTENDED RELEASE	Step 2 antidepressant with exception for suicidal ideation or prior use
RELISTOR 12 MG/0.6 ML SUBCUTANEOUS SOLUTION	Step 2 Relistor formulation
LINZESS 145 MCG CAPSULE	Step 2 GI agent with pediatric exception
LINZESS 290 MCG CAPSULE	Step 2 GI agent with pediatric exception

Products specifically called out in index (representative)mixed

CAPLYTA 10.5 MG CAPSULE	antipsychotic listed in index as 1 = 1,2
REXULTI 0.25-4 MG TABLETS	listed across index entries
VRAYLAR 1.5-6 MG CAPSULES	listed Step assignments vary (often Step 2)
QVAR REDIHALER 40/80 MCG	breath-actuated MDI referenced in inhaler exceptions

What providers must do

Prior Authorization

Step Therapy prior authorization requirement

Prior authorization approval for Step 2 products requires documented trials of Step 1 products as specified (typically two Step 1 trials), except for the following enumerated exceptions:

Opipza (approve if patient has tried one Step 1 product rather than two)
Relistor injection for opioid‑induced constipation in an adult with advanced illness receiving palliative care (approve without a Step 1 trial)
Linzess (145 mcg or 290 mcg) for functional constipation in pediatric patients ages 6–17 (approve without a Step 1 trial)
Auvelity for patients with suicidal ideation or if the patient is currently receiving or has previously taken Auvelity (approve without a Step 1 trial)
Fluticasone propionate HFA: age and diagnosis/device exceptions (approve if patient 5–11 yrs unable to use both powder inhaler and breath‑actuated MDI after trying Asmanex HFA; approve without Step 1 trial if 4 yrs or younger; approve without Step 1 trial for eosinophilic esophagitis or chronic GVHD with bronchiolitis obliterans syndrome involvement)

Documentation Required

Document prior trials or exception rationale

Providers must document prior use of required Step 1 products (including brand name equivalents) or document that the patient meets exception criteria (for example: age, specific diagnosis, palliative care, inability to use alternative inhaler devices, suicidal ideation, or prior/current use of the requested Step 2 product).

Definitions and scope

Step 1 / Step 2: formulary tiers denoting preferred (Step 1) versus later‑line / non‑preferred (Step 2) agents where prior trials of Step 1 products are required before approving Step 2 products.

Scope: This bulletin covers multiple therapeutic classes including antipsychotics, antidepressants, inhaled corticosteroids, GI agents, and other listed products and governs prior authorization decisions and when step edits may be bypassed (age, specific diagnosis, palliative care, prior use).

Operational clarification: the bulletin specifies that a brand name equivalent of a generic Step 1 product counts toward the Step 1 trial requirement. This clarification is marked non‑material.

Policy update changes

clarifiedLatest

Brand name equivalent of a generic Step 1 product counts toward step requirement (operational note).

clarifiedLatest

Specific exceptions where Step 1 trial may be bypassed are enumerated: Opipza (approve after one Step 1 trial), Relistor injection may be approved without Step 1 trial for adult patients with advanced illness receiving palliative care, Linzess (145 or 290 mcg) may be approved without Step 1 trial for pediatric patients ages 6-17 for functional constipation, Auvelity may be approved without Step 1 trial for patients with suicidal ideation or for patients currently receiving or with prior use of Auvelity, and fluticasone propionate HFA has age/device/diagnosis exceptions (approve if age 5–11 unable to use both powder inhaler and breath-actuated MDI after Asmanex HFA trial; approve without Step 1 for age ≤4; approve without Step 1 for eosinophilic esophagitis or chronic GVHD with BOS involvement).