CurrentCignaPolicy Cigna National Formulary Coverage - Policy: Attention Deficit Hyperactivity Disorder Stimulant Medications Step Therapy Policy

Attention Deficit Hyperactivity Disorder Stimulant Medications Step Therapy Policy

Cigna national formulary step therapy policy that defines Step 1 and Step 2 long-acting stimulant products for ADHD (and related indications) and the coverage rule requiring trial of a Step 1 product prior to approval of Step 2 products; approvals are for 1 year.

Policy Summary

PayerCigna

PolicyAttention Deficit Hyperactivity Disorder Stimulant Medications Step Therapy Policy

Policy CodePolicy Cigna National Formulary Coverage - Policy: Attention Deficit Hyperactivity Disorder Stimulant Medications Step Therapy Policy

Change TypeSelected and annual revisions (additions/removals)

Effective DateApr 23, 2025

Next Review Date

Key ActionDocument prior trial of one Step 1 product to obtain approval for Step 2 stimulant products; approvals are for 1 year.

SourceLink

POLICY UPDATE CHANGES

Generic lisdexamfetamine capsules were added to Step 1.

Generic lisdexamfetamine chewable tablets were added to Step 2.

Criterion approving Vyvanse for binge eating disorder was removed.

Generic mixed salts of a single-entity amphetamine product extended-release capsules (generic to Mydayis) added to Step 1.

Adzenys ER removed from Step 2 Products (obsolete >3 years).

Adzenys XR-ODT authorized generic added to policy as a Step 2 Product.

Generic methylphenidate extended-release 72 mg tablets added to Step 2 Products.

Amphetamine ER ODT generic added to policy as a Step 2 Product.

Relexxii: removed reference to 'branded generic' and noted it is FDA-approved under NDA with an authorized generic; methylphenidate 72 mg tablets consolidated as authorized generic to Relexxii.

Step levels (Step 1 / Step 2)

multipleProducts listed

1 yearApproval duration

Policy snapshot & scope

This is the Cigna National Formulary Step Therapy policy titled Attention Deficit Hyperactivity Disorder Stimulant Medications Step Therapy Policy, current as of effective 2025-04-23 with the most recent review on 2026-01-14. It defines preferred Step 1 and Step 2 long-acting stimulant products and the coverage rule that generally requires trial of a Step 1 product before approving a Step 2 product.

The policy applies to Cigna-administered health benefit plans and is listed as CURRENT status; approvals under the policy are provided for 1 year duration. The subject is ADHD Stimulant Medications Step Therapy Policy and the payer is Cigna (national formulary).

Policy metadata

Policy NumberCigna National Formulary Coverage - Policy: Attention Deficit Hyperactivity Disorder Stimulant Medications Step Therapy Policy

PayerCigna Companies

Policy TitleADHD Stimulant Medications Step Therapy Policy

Effective Date2025-04-23

Last Review2026-01-14

Approval Duration1 year

Coverage Stancecovered_with_criteria

Material changes in this bulletin

04/05/2023revised

Relexxii: removed reference to 'branded generic'; Relexxii is FDA-approved under an NDA with an authorized generic; methylphenidate 72 mg extended-release tablets consolidated as authorized generic to Relexxii.

09/20/2023addedLatest

Generic lisdexamfetamine capsules were added to Step 1.

09/20/2023addedLatest

Step therapy requirement (coverage criteria)

Step Therapy Requirement

This program has been developed to encourage the use of a Step 1 Product prior to the use of a Step 2 Product. All approvals are provided for 1 year in duration.

Step Therapy Requirement: If the patient has tried one Step 1 Product, approve a Step 2 Product.

All approvals are provided for 1 year in duration.

Approvals under this step therapy program are provided for 1 year; coverage of Step 2 stimulant products requires prior trial of one Step 1 product and if the Step Therapy rule is not met at point of service, coverage will be determined by the step therapy criteria at that time.

Step 1 and Step 2 product groups

Step 1 Products (preferred first-step generics)mixedCovered

	generic amphetamine/dextroamphetamine extended-release capsules (generic to Adderall XR)
	generic dexmethylphenidate extended-release capsules (generic to Focalin XR)
	generic dextroamphetamine extended-release capsules (generic to Dexedrine Spansules)
	generic lisdexamfetamine capsules
	generic methylphenidate extended-release capsules (generic to Metadate CD and Ritalin LA)
	Metadate ER (generic according to First Data Bank [FDB])
	generic methylphenidate sustained-release tablets (generic to Ritalin SR)
	generic methylphenidate extended-release tablets (generic to Concerta)
	generic mixed salts of a single-entity amphetamine product extended-release capsules (generic to Mydayis)

Step 2 Products (require prior Step 1 trial)mixedCovered

	Adderall XR
	Adhansia XR
	Adzenys XR-ODT (brand, generic)
	Aptensio XR (brand and generic)
	Azstarys
	Concerta
	Cotempla XR-ODT
	Daytrana (brand and generic methylphenidate transdermal system)
	Dexedrine Spansules
	Dyanavel XR (tablets and oral solution)

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Definitions (quick reference)

Step 1 ProductPreferred first-step generic long-acting stimulant formulations listed in the policy (e.g., generic amphetamine/dextroamphetamine ER capsules, generic lisdexamfetamine capsules, generic methylphenidate ER formulations)

Step 2 ProductLong-acting stimulant products that require prior trial of a Step 1 product for coverage approval (e.g., brand and various extended-release products such as Adderall XR, Concerta, Vyvanse, Mydayis, etc.)

What providers must do

Step Therapy

Step therapy precondition

Coverage of Step 2 stimulant products requires prior trial of one Step 1 product; if the Step Therapy rule is not met at point of service coverage will be determined by the step therapy criteria.

Trial of one Step 1 product required prior to Step 2 coverage

Documentation Required

Approval duration and documentation

All approvals are provided for 1 year in duration; provider must document prior trial of one Step 1 product to obtain approval for Step 2 products.

Approvals = 1 year
Document prior trial of one Step 1 product

Clinical context and references

Background: Long‑acting stimulant medications are FDA‑approved for ADHD across various age ranges and, in some cases, other indications; all of these products have abuse potential and are Schedule II controlled substances. The American Academy of Pediatrics guideline supports stimulant medications as first‑line pharmacologic treatment for many pediatric patients with ADHD.

Evidence

AAP guideline citationWolraich ML et al., Pediatrics 2019;144(4):e20192528

Policy changes log

04/05/2023revised

Early Annual Revision (Review Date 04/05/2023): Relexxii—removed reference to 'branded generic'; Relexxii is FDA-approved under an NDA with an authorized generic; methylphenidate 72 mg tablets consolidated as authorized generic to Relexxii.

09/20/2023addedLatest

Selected Revision 09/20/2023: Generic lisdexamfetamine capsules were added to Step 1.

09/20/2023addedLatest

Policy Summary

PayerCigna

PolicyAttention Deficit Hyperactivity Disorder Stimulant Medications Step Therapy Policy

Policy CodePolicy Cigna National Formulary Coverage - Policy: Attention Deficit Hyperactivity Disorder Stimulant Medications Step Therapy Policy

Change TypeSelected and annual revisions (additions/removals)

Effective DateApr 23, 2025

Next Review Date

Key ActionDocument prior trial of one Step 1 product to obtain approval for Step 2 stimulant products; approvals are for 1 year.

SourceLink

On This Page

Generic lisdexamfetamine chewable tablets were added to Step 2.

09/20/2023removedLatest

Criterion approving Vyvanse for binge eating disorder was removed because generic lisdexamfetamine capsules are now available as a Step 1 product.

11/01/2023addedLatest

Generic mixed salts of a single-entity amphetamine product extended-release capsules (generic to Mydayis) added to Step 1.

04/23/2025removedLatest

Adzenys ER removed from Step 2 Products (obsolete >3 years).

09/17/2025addedLatest

Adzenys XR-ODT authorized generic added to policy as a Step 2 Product.

11/19/2025addedLatest

Generic methylphenidate extended-release 72 mg tablets added to Step 2 Products.

01/14/2026addedLatest

Amphetamine ER ODT generic added to policy as a Step 2 Product.

There is a material change: multiple Step-level updates were made — generic lisdexamfetamine capsules were added to Step 1 and generic lisdexamfetamine chewable tablets were added to Step 2, with other additions (eg, generic Mydayis-equivalent ER added to Step 1) and removals (eg, Vyvanse binge‑eating criterion removed). Because has_material_change is true, these revisions represent substantive changes to which prescribers and payers should attend.

Selected Revision 09/20/2023: Generic lisdexamfetamine chewable tablets were added to Step 2.

09/20/2023removedLatest

Selected Revision 09/20/2023: Criterion approving Vyvanse for binge eating disorder was removed because generic lisdexamfetamine capsules are now available as a Step 1 product.

11/01/2023addedLatest

Selected Revision 11/01/2023: Generic mixed salts of a single-entity amphetamine product extended-release capsules (generic to Mydayis) added to Step 1.

04/23/2025removedLatest

Annual Revision 04/23/2025: Adzenys ER removed from Step 2 Products (obsolete >3 years).

09/17/2025addedLatest

Selected Revision 09/17/2025: Adzenys XR-ODT authorized generic added to policy as a Step 2 Product.

11/19/2025addedLatest

Selected Revision 11/19/2025: Generic methylphenidate extended-release 72 mg tablets added to Step 2 Products.

01/14/2026addedLatest

Selected Revision 01/14/2026: Amphetamine ER ODT generic added to policy as a Step 2 Product.