CurrentCignaPolicy N/A

Attention Deficit Hyperactivity Disorder Non-Stimulant Medications Step Therapy Policy

A Cigna coverage policy defining step therapy requirements for non-stimulant medications used to treat ADHD, specifying Step 1 and Step 2 products and approval criteria for members under Cigna-administered health benefit plans.

Policy Summary

PayerCigna

PolicyAttention Deficit Hyperactivity Disorder Non-Stimulant Medications Step Therapy Policy

Policy CodePolicy N/A

Change TypeStep 2 additionStep 1 additionsclarification

Effective DateN/A

Next Review DateN/A

Key ActionRequest prior authorization demonstrating Step Therapy criteria are met to approve Step 2 products for 1 year.

SourceLink

POLICY UPDATE CHANGES

Onyda XR was added to Step 2.

Generic lisdexamfetamine capsules and chewable tablets were added to Step 1.

Generic guanfacine ER and generic clonidine ER tablets are not included in Step 1 or Step 2.

Step 1 & Step 2coverage tiers defined

1 yearapproval duration

2 criteriaapproval rules

5 namedexample Step 2 drugs

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Coverage Criteria for ADHD Non-stimulant Medications

Step Therapy Approval Criteria

Covered when the following step therapy criteria are met

Step therapy main rules: 1. If the patient has tried one Step 1 Product, approve a Step 2 Product. 2. If the patient is unable to take a stimulant medication and unable to swallow whole capsules and tablets according to the prescriber, approve Qelbree or Onyda XR.

Approvals provided for 1 year.

Note: generic guanfacine extended‑release tablets and generic clonidine extended‑release tablets are explicitly not included in either Step 1 or Step 2 of this Step Therapy program.

Any request that does not meet one of the specified Step Therapy criteria or exceptions listed in this policy is considered not medically necessary and will be denied.

Named Products and Coding / Approval Duration

Named products and stimulant listsmixed

Intuniv	guanfacine extended-release tablets (brand)
Kapvay	clonidine hydrochloride extended-release tablets (brand, discontinued 12/2023)
Onyda XR	clonidine hydrochloride extended-release oral suspension
Strattera	atomoxetine capsules (brand, generic available)
Qelbree	viloxazine extended-release capsules
Amphetamine products	various amphetamine formulations listed (Evekeo, Adzenys XR-ODT, Dyanavel XR, Adzenys ER, Adderall, Dexedrine, Vyvanse, etc.)
Methylphenidate/dexmethylphenidate products	various methylphenidate/dexmethylphenidate formulations listed (Adhansia XR, Aptensio XR, Concerta, Ritalin, Daytrana, Quillivant XR, etc.)

inv-05: Approval duration — 1 year

Approval durationApprovals for Step 2 products are provided for 1 year when Step Therapy criteria are met.

Applies toAll Step 2 product approvals under this program

Effective actionAuthorization length set at 12 months from approval date

Renewal considerationContinued coverage requires meeting applicable criteria at time of renewal

Provider Prior Authorization, Step Therapy & Billing Requirements

Prior Authorization

Prior Authorization Required

This program requires Step Therapy prior authorization for Step 2 products. Approvals are provided for 1 year when the Step Therapy rule is met.

Approvals valid for 1 year

Step Therapy

Step Therapy Rule

Step Therapy rule: Step 1 products must be used prior to Step 2 products. Step 1 includes generic atomoxetine capsules and stimulant medications (amphetamine and methylphenidate/dexmethylphenidate products). Step 2 includes Strattera (brand), Intuniv (brand), Kapvay (brand), Onyda XR, and Qelbree. Generic guanfacine ER and generic clonidine ER are excluded from both steps.

Step 1: generic atomoxetine; stimulant medications (amphetamine and methylphenidate/dexmethylphenidate)
Step 2: Strattera (brand), Intuniv (brand), Kapvay (brand), Onyda XR, Qelbree
Generic guanfacine ER and generic clonidine ER are not included in either Step 1 or Step 2

Documentation Required

Billing Documentation

Billing documentation: Providers must bill using the most appropriate diagnosis and procedure codes as of the submission date/effective date. Claims submitted without covered code(s) under the applicable coverage policy will be denied as not covered.

Use most appropriate codes as of the submission date
Claims without covered diagnosis/procedure codes will be denied

Denial Risk

Denial Triggers

Denial triggers: Coverage will be denied when Step Therapy requirements are not met for Step 2 products at point of service and when services or products are billed without covered diagnosis or procedure codes under the applicable coverage policy.

Noncompliance with Step Therapy requirements for Step 2 products
Services billed without covered diagnosis/procedure codes

Pharmacotherapy Modalities

Pharmacotherapy (ADHD non-stimulant and stimulant medications)

Step 1 products: Generic atomoxetine capsules and stimulant medications (amphetamine and methylphenidate/dexmethylphenidate products) are Step 1 products.

Generic guanfacine ER and generic clonidine ER tablets are not included in Step 1.

Pharmacotherapy (Step 2 non-stimulant medications)

Step 2 products: Strattera (brand), Intuniv (brand), Kapvay (brand), Onyda XR, Qelbree are Step 2 products; covered when criteria are met.

Approvals provided for 1 year when Step Therapy rule is met. Generic guanfacine ER and generic clonidine ER tablets are not included in Step 2.

Background

Non‑stimulant medications are alternative pharmacologic options for attention‑deficit/hyperactivity disorder (ADHD). This policy addresses Step Therapy for non‑stimulant agents, with Step 1 defined as generic atomoxetine capsules and stimulant medications (amphetamine and methylphenidate/dexmethylphenidate products) and Step 2 including Strattera, Intuniv, Kapvay, Onyda XR, and Qelbree. The program encourages use of a Step 1 Product prior to a Step 2 Product; if the Step Therapy rule is not met at point of service, coverage is determined by the Step Therapy criteria. When criteria are met, approvals are provided for 1 year.