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.
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.
Coverage Criteria
Initial Therapy — Covered when ALL of the following are met
Covered when ALL of the following are met:
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 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 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
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
Initial Therapy Criteria
Initial Therapy - Step 1 — initial coverage requires prior trial
Initial coverage requires prior trial:
Continuation Therapy Criteria
Continuation Therapy — continuation allowed for members currently on therapy
Continuation allowed for members currently on 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.
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