CurrentUnitedHealthcarePolicy N/A

Step Therapy for Azstarys and Jornay PM (ADHD)

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This program requires members to try a specified generic stimulant prior to coverage of Azstarys (serdexmethylphenidate/dexmethylphenidate) or Jornay PM (methylphenidate ER) for treatment of ADHD in patients aged 6 and older; members already on these products per claims may continue therapy.

Policy Summary

PayerUnitedHealthcare

PolicyStep Therapy for Azstarys and Jornay PM (ADHD)

Policy CodePolicy N/A

Change TypeAdded generic Focalin XRannual review

Effective DateNov 16, 2025

Next Review DateSep 20, 2025

Key ActionObtain prior authorization and document prior trial and failure, contraindication, or intolerance to a listed generic stimulant before prescribing Azstarys or Jornay PM.

SourceLink

POLICY UPDATE CHANGES

Added generic Focalin XR as a step one option.

Annual review with no changes.

New program created for Step Therapy - ADHD for Azstarys and Jornay PM.

6+min age

3step options

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CurrentUnitedHealthcarePolicy N/A

Step Therapy for Azstarys and Jornay PM (ADHD)

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Sign up for all UnitedHealthcare policy alerts

Know when UnitedHealthcare releases new policies or updates existing guidance.

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Policy Summary

PayerUnitedHealthcare

PolicyStep Therapy for Azstarys and Jornay PM (ADHD)

Policy CodePolicy N/A

Change TypeAdded generic Focalin XRannual review

Effective DateNov 16, 2025

Next Review DateSep 20, 2025

Key ActionObtain prior authorization and document prior trial and failure, contraindication, or intolerance to a listed generic stimulant before prescribing Azstarys or Jornay PM.

SourceLink

POLICY UPDATE CHANGES

Added generic Focalin XR as a step one option.

Annual review with no changes.

New program created for Step Therapy - ADHD for Azstarys and Jornay PM.

6+min age

3step options

Coverage Criteria

Initial Therapy — Covered when ALL of the following are met

Covered when ALL of the following are met:

Initial approval: 1) Patient has a diagnosis of attention‑deficit/hyperactivity disorder (ADHD). 2) Patient is 6 years of age or older. 3) History of failure, contraindication, or intolerance to ONE of the following generic stimulants: (a) methylphenidate CD/ER/LA (e.g., generic Concerta, generic Ritalin LA); (b) amphetamine/dextroamphetamine extended‑release (generic Adderall XR); or (c) dexmethylphenidate ER (generic Focalin XR).

Patients currently on Azstarys or Jornay PM per claims may continue without meeting the step requirement.

Coverage determinations under this program may be affected by external requirements. State mandates, applicable federal regulatory requirements, and the specifics of a member’s benefit plan can modify or supersede the criteria described here. Other UnitedHealthcare policies and utilization management programs may also apply and influence authorization decisions.

Provider Actions and Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required for Azstarys or Jornay PM unless the member has a documented prior trial and failure, contraindication, or intolerance to a specified generic stimulant.

Applies to Azstarys and Jornay PM
Authorization issued for up to 12 months

Step Therapy

Step Therapy Requirement

Step therapy: member must have tried a listed generic stimulant (and had failure, contraindication, or intolerance) prior to coverage of Azstarys or Jornay PM. Patients currently on Azstarys or Jornay PM as shown in claims history may be allowed to continue therapy.

Required trial medications: methylphenidate CD/ER/LA (e.g., generic Concerta, generic Ritalin LA)
amphetamine/dextroamphetamine ER (generic Adderall XR)
dexmethylphenidate ER (generic Focalin XR)

Documentation Required

Providers must document prior trials including evidence of failure, contraindication, or intolerance to one of the specified generic stimulants when requesting authorization for Azstarys or Jornay PM.

Document medication name, dates used, and reason for discontinuation (failure, contraindication, or intolerance)
Clinical notes or prior claims supporting the trial may be used

Denial Risk

Step Requirement Not Met — Denial Risk

Coverage may be denied if there is no documented history of trial and failure, contraindication, or intolerance to one of the specified generic stimulants. UnitedHealthcare may also approve based on prior claims/medication history and diagnosis codes per program rules.

Denial risk if step requirement not met
Automated approvals/reauthorizations may occur based on claims and diagnosis history

Definitions

Azstarys — definition and program notes

DrugAzstarys (serdexmethylphenidate and dexmethylphenidate)

IndicationTreatment of Attention Deficit Hyperactivity Disorder (ADHD)

Minimum patient age6 years and older

Program statusIncluded in Step Therapy - ADHD program; requires trial of a listed generic stimulant prior to coverage

P&T approval history9/2023, 9/2024, 9/2025

Jornay PM — definition and program notes

DrugJornay PM (methylphenidate extended-release)

Initial Therapy Criteria

Initial Therapy - Step 1 — initial coverage requires prior trial

Initial coverage requires prior trial:

Step requirement: History of failure, contraindication, or intolerance to one of: methylphenidate CD/ER/LA (e.g., generic Concerta, generic Ritalin LA); amphetamine/dextroamphetamine ER (generic Adderall XR); or dexmethylphenidate ER (generic Focalin XR).

Continuation Therapy Criteria

Continuation Therapy — continuation allowed for members currently on therapy

Continuation allowed for members currently on therapy:

Continuation: Member has claims history documenting current use of Azstarys or Jornay PM; member may continue on their current therapy.

Authorization, when issued, will be for 12 months.

Step Therapy Options

Step	Required prior trial (must have history of failure, contraindication, or intolerance)	Notes
1	Methylphenidate CD/ER/LA (e.g., generic Concerta or generic Ritalin LA)	Member must have history of failure, contraindication, or intolerance to at least one listed option prior to coverage of Azstarys or Jornay PM; applies to patients age 6 and older.
1	Amphetamine/dextroamphetamine extended-release (generic Adderall XR)	Prior authorization required unless documented prior trial and failure/contraindication/intolerance to a listed generic stimulant; approvals issued for 12 months.
1	Dexmethylphenidate ER (generic Focalin XR)	Members currently on Azstarys or Jornay PM per claims may continue without meeting the step requirement.

Background

Azstarys (serdexmethylphenidate and dexmethylphenidate) and Jornay PM (methylphenidate extended‑release) are stimulant medications indicated for the treatment of Attention Deficit Hyperactivity Disorder in patients aged 6 years and older. This step therapy program requires a trial and documented failure, contraindication, or intolerance to a specified generic stimulant option before coverage of Azstarys or Jornay PM will be approved; however, members with claims evidence showing current use of Azstarys or Jornay PM may continue therapy. Prior authorization is required when the step requirement has not been met, and approvals are issued for 12 months.