CurrentCignaPolicy N/A

Antidepressants - Raldesy Step Therapy Policy

Defines step therapy requirements for coverage of Raldesy (trazodone hydrochloride oral solution) under Cigna-administered health benefit plans; affects providers prescribing trazodone formulations and pharmacy prior authorization processes.

Policy Summary

PayerCigna

PolicyAntidepressants - Raldesy Step Therapy Policy

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateApr 23, 2025

Next Review DateApr 23, 2025

Key ActionSubmit supporting documentation and prior authorization requests showing trial of a generic trazodone tablet or documented inability to swallow tablets; approvals are for 1 year when criteria are met.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

2Step levels (Step 1, Step 2)

1 yearApproval duration

10 mg/mLRaldesy concentration

Coverage Criteria for Raldesy (trazodone HCl oral solution)

Step therapy criteria for Raldesy

Covered when ALL of the following are met

Policy Summary

PayerCigna

PolicyAntidepressants - Raldesy Step Therapy Policy

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateApr 23, 2025

Next Review DateApr 23, 2025

SourceLink

On This Page

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Step therapy requirement

One of the following must be true
- Trial of Step 1 Product: Patient has tried one Step 1 Product (generic trazodone HCl tablets).trial of one Step 1 product
  Appropriate trial documented by provider
- Swallowing impairment: Patient has difficulty swallowing tablets or cannot swallow tablets.documented swallowing impairment
  Alternative formulation justified

Use of Raldesy (trazodone hydrochloride oral solution) is subject to step therapy requirements. If neither a documented trial of one Step 1 Product (generic trazodone HCl tablets) nor a documented inability to swallow tablets is present, use of Raldesy is considered not medically necessary. The Step Therapy program requires that a patient either trial one Step 1 product or have a swallowing impairment that justifies an alternative formulation before a Step 2 product (Raldesy) will be approved.

Provider Requirements and Operational Guidance

Step Therapy

Step therapy required; approvals for 1 year

This program has been developed to encourage the use of a Step 1 Product prior to the use of a Step 2 Product. If the Step Therapy rule is not met for a Step 2 Product at the point of service, coverage will be determined by the Step Therapy criteria below. All approvals are provided for 1 year in duration.

Approvals: 1 year when criteria met

Note

Step definitions

Step definitions required for provider documentation and operational handling.

Step 1 = generic trazodone HCl tablets
Step 2 = Raldesy (oral solution)

Documentation Required

Supporting documentation and coding

Providers must submit supporting documentation consistent with the plan and clinical criteria. If the Step Therapy rule is not met at point of service for a Step 2 product, the determination will follow the Step Therapy criteria. Ensure claims include appropriate coding and documentation to support medical necessity.

Submit clinical documentation showing trial of Step 1 product or evidence of inability to swallow tablets
Include applicable diagnosis and procedure codes on claims; use most appropriate codes as of the date of service

Denial Risk

Step therapy enforcement and denial risk

Operational enforcement is at point of service; determinations for Step 2 products follow the step therapy criteria below. Providers should be aware of potential denial risk if criteria are not met and have documentation ready for appeals or exceptions.

Point-of-service enforcement for step therapy rules
If rule not met, coverage determination will follow the criteria in this policy

Product Definitions

Step 1 Product — generic trazodone HCl tablets (50, 100, 150, 300 mg strengths)

Step 1 ProductGeneric trazodone HCl tablets (available in 50 mg, 100 mg, 150 mg, and 300 mg strengths).

Dosage form guidanceTablets should be swallowed whole or broken in half along the score line; do not chew or crush.

Therapeutic classAntidepressant (trazodone hydrochloride).

Role in step therapyDesignated Step 1 option that must be tried prior to Step 2 (Raldesy) unless patient cannot swallow tablets.

Indication contextTrazodone HCl is indicated for treatment of major depressive disorder (MDD) in adults.

Step 2 Product — Raldesy (trazodone hydrochloride oral solution, 10 mg/mL)

Step 2 ProductRaldesy (trazodone hydrochloride oral solution, 10 mg/mL).

FormulationOral solution at a concentration of 10 mg/mL.

Step therapy placementDesignated Step 2 option to be authorized after trial of a Step 1 Product or when patient cannot swallow tablets.

Coverage stanceCovered as medically necessary when applicable step therapy criteria are met; other uses are considered not medically necessary.

Initial Authorization Criteria (Step 2 / Raldesy)

Initial therapy (Step 2) requirements

Initial authorization conditions for Raldesy

Initial approval (Step 2): Approve Raldesy if the patient has trialed one generic trazodone HCl tablet OR has documented difficulty/cannot swallow tablets.trial of one Step 1 product OR documented swallowing difficulty

Either condition suffices for initial authorization; document supporting clinical information

OpenPayer

Antidepressants - Raldesy Step Therapy Policy

Coverage Criteria for Raldesy (trazodone HCl oral solution)

Provider Requirements and Operational Guidance

Product Definitions

Initial Authorization Criteria (Step 2 / Raldesy)

Continuation and Approval Duration

Step Therapy Table

Background

Step	Product	Requirement / Criteria
Step 1	Generic trazodone HCl tablets	Patient must trial one Step 1 product prior to Step 2 (trial of one generic trazodone HCl tablet).
Step 2	Raldesy (trazodone hydrochloride oral solution, 10 mg/mL)	Approve Step 2 if patient has tried one Step 1 product OR if patient has difficulty swallowing or cannot swallow tablets.