CurrentCignaPolicy N/A

STEP THERAPY POLICY

Defines a step therapy program for antidepressant medications (Step 1 and Step 2 products) for Cigna-administered health benefit plans, including standard and high-impact criteria, exceptions, and product lists. Applies to approval determinations and prior-authorization-like enforcement at point of service with approvals provided for 1 year.

Policy Summary

PayerCigna

PolicySTEP THERAPY POLICY

Policy CodePolicy N/A

Change TypeSelected revisions and annual updates

Effective DateJul 1, 2024

Next Review Date

Key ActionProviders must document trial of required Step 1 product(s) (one for Standard Criteria, two for High Impact Criteria) prior to approval of Step 2 products; approvals are provided for 1 year.

SourceLink

POLICY UPDATE CHANGES

Escitalopram capsules: Brand escitalopram capsules added to the policy as a Step 2 product.

Exxua: Added to Step 2 of the policy and included in the standard and high impact exception criteria allowing prior users or those with suicidal ideation to receive the product.

Sertraline capsules: Removed '(brand)' descriptor after sertraline capsules in Step 2 list because sertraline capsules are now available as brand and generic.

Brisdelle: Brand Brisdelle removed from Step 2 of the policy as obsolete for ≥ 3 years.

New Policy established effective 07/01/2024.

2Step levels (Step 1, Step 2)

1 yearApproval duration

multipleProducts listed (Step 1 & Step 2)

Summary of material changes and key facts

Revision history notes material additions: brand escitalopram capsules and Exxua were added to Step 2 and exception criteria in later selected revisions; policy was initially established effective 2024-07-01. Review dates include last_review 2025-05-21 and subsequent selected revisions (08/27/2025, 10/15/2025, 11/12/2025) documenting the material changes.

Step levels2

Approval duration1 year

Policy effective2024-07-01

Last review2025-05-21

Step therapy criteria (who meets coverage)

Overall Program

This program-level requirement ensures Step 1 products are tried before Step 2 and approvals are time-limited.

Try Step 1 before Step 2: Step 1 products must be tried prior to Step 2 products (one try for Standard Criteria; two tries for High Impact Criteria).
Approvals are provided for 1 year in duration.
Point of service determination: If Step Therapy rule is not met at point of service, coverage determined by Step Therapy criteria below.

Standard Criteria

Covered when ALL of the following are met:

Step 1 trial: If the patient has tried one Step 1 Product, approve a Step 2 Product.
Prior Step 2 use exception: If the patient is currently taking or has taken Desvenlafaxine (brand), desvenlafaxine succinate extended‑release (Pristiq or generics), Exxua, Fetzima, Pexeva, vilazodone (Viibryd or generics), or Trintellix at any time in the past and discontinued its use, approve the Product that they have used.
Provider must document prior use to receive same product as an exception.
Swallowing impairment exception: If the patient cannot swallow or has difficulty swallowing tablets or capsules, approve generic escitalopram oral solution or generic paroxetine HCl oral suspension.
Provider must document swallowing difficulty to approve these formulations.

High Impact Criteria

Covered when ALL of the following are met (for high-impact products requiring two Step 1 trials):

Two Step 1 trials required: If the patient has tried two Step 1 Products, approve a Step 2 Product.
Prior Step 2 use exception: If the patient is currently taking or has taken Desvenlafaxine (brand), desvenlafaxine succinate extended‑release (Pristiq or generics), Exxua, Fetzima, Pexeva, vilazodone (Viibryd or generics), or Trintellix at any time in the past and discontinued its use, approve the Product that they have used.
Provider must document prior use to receive same product as an exception.
Swallowing impairment exception: If the patient cannot swallow or has difficulty swallowing tablets or capsules, approve generic escitalopram oral solution or generic paroxetine HCl oral suspension.
Provider must document swallowing difficulty to approve these formulations.

Step 1 and Step 2 product lists

Step 1 Products (required first-line products)mixedCovered

STEP1_LIST

generic bupropion extended-release tablets; generic bupropion sustained-release tablets; generic citalopram oral solution; generic citalopram tablets; generic duloxetine delayed-release (20 mg, 30 mg, 60 mg) capsules; generic escitalopram tablets; generic fluoxetine immediate-release capsules; generic fluoxetine oral solution; generic fluvoxamine immediate-release tablets; generic paroxetine HCl immediate-release tablets; generic sertraline oral solution; generic sertraline tablets; generic venlafaxine extended-release capsules; generic venlafaxine immediate-release tablets

Step 2 Products (subject to step therapy prior use requirement)mixedCovered

STEP2_LIST

Aplenzin; Auvelity; Bupropion XL tablets (authorized generics to Forfivo XL); Celexa; Citalopram capsules (brand); Cymbalta; Desvenlafaxine extended-release tablets (brand); generic desvenlafaxine succinate extended-release tablets; generic duloxetine 40 mg delayed-release capsules; Drizalma Sprinkle; Effexor XR; Escitalopram capsules (brand); generic escitalopram oral solution; Exxua; Fetzima; generic fluoxetine delayed-release 90 mg capsule; generic fluoxetine immediate-release tablets; generic fluvoxamine extended-release capsules; Forfivo XL; Lexapro; Paxil; Paxil CR; generic paroxetine HCl controlled-release (CR)/extended-release (ER) tablets; generic paroxetine HCl oral suspension; generic paroxetine mesylate capsules; Pexeva; Pristiq; Prozac; Sarafem; Savella; sertraline capsules; Trintellix; Venlafaxine besylate extended-release tablets (brand); generic venlafaxine HCl extended-release tablets; generic vilazodone hydrochloride tablets; Viibryd; Wellbutrin SR; Wellbutrin XL; Zoloft

Documentation and prior-auth requirements

Prior Authorization

Step therapy trials required

Providers must document trial of required Step 1 product(s) (one for Standard Criteria, two for High Impact Criteria) prior to approval of Step 2 products. Affected code groups: STEP1_LIST, STEP2_LIST. All approvals are provided for 1 year.

STEP1_LIST
STEP2_LIST
Approvals provided for 1 year

Documentation Required

Exception documentation for prior use or contraindication

If the patient previously used and discontinued any of the specified Step 2 products, the provider must document prior use to receive that same product as an exception. Specified products include Desvenlafaxine (brand), desvenlafaxine succinate extended‑release (Pristiq or generics), Exxua, Fetzima, Pexeva, vilazodone (Viibryd or generics), and Trintellix.

Definitions and clinical context

Antidepressant classes covered include bupropion-containing products (Aplenzin, Auvelity, Exxua, Forfivo XL, Wellbutrin SR/XL), SSRIs (citalopram, escitalopram, fluoxetine, fluvoxamine, paroxetine, sertraline, vilazodone, vortioxetine), and SNRIs (desvenlafaxine, duloxetine, venlafaxine, Fetzima). Products are available in multiple formulations (tablets, extended‑release/controlled‑release, oral solutions, and sprinkle/delayed‑release forms) and have product‑specific notes (for example, Auvelity combines dextromethorphan with bupropion and Exxua requires ECG/QTc considerations). These clinical and formulation distinctions inform step therapy placement and exceptions.

Term	Definition
Step 1 Product	Preferred first-line (generic) antidepressant products listed in the policy to be tried before Step 2 products.
Step 2 Product	Non-preferred or higher-impact antidepressant products that require prior trial(s) of Step 1 products unless an exception applies.

Policy changes and timeline

2024-07-01New Policy

New Policy established effective 07/01/2024.

2025-05-21Annual Revision

Annual Revision: Brand Brisdelle removed from Step 2 of the policy as obsolete for ≥ 3 years.

2025-08-27Selected Revision (material)

Selected Revision: Brand escitalopram capsules added to the policy as a Step 2 product.

Scope, effective dates, and status

PayerCigna

PolicyAntidepressants Step Therapy Policy (Cigna)

Policy NumberN/A

Effective Date2024-07-01

Last Review Date2025-05-21

StatusCURRENT

Defines a step therapy program for antidepressant medications for Cigna‑administered plans requiring Step 1 trials before Step 2 products, with standard and high‑impact criteria and approvals provided for 1 year.