CurrentUnitedHealthcarePolicy 2025 P 1236-10

Austedo (deutetrabenazine) prior authorization

Defines UnitedHealthcare prior authorization and reauthorization requirements for Austedo and Austedo XR for treatment of chorea in Huntington's disease and tardive dyskinesia in adults; applies to members whose benefits require pharmacy prior authorization.

Policy Summary

PayerUnitedHealthcare

PolicyAustedo (deutetrabenazine) prior authorization

Policy CodePolicy 2025 P 1236-10

Change TypeNo material change

Effective Date7/1/2025

Next Review Date

Key ActionObtain prior authorization and document diagnosis (or, for reauthorization, document positive clinical response); approvals issued for 12 months.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 monthsInitial auth period

12 monthsReauth period

2Indications covered

4/2025P&T approval through

Coverage Criteria

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Initial Therapy — Chorea (Huntington's disease)

Covered when ALL of the following are met

Chorea (Huntington's) initial: Diagnosis of chorea associated with Huntington's disease

Authorization will be issued for 12 months

Coverage criteria are subject to member-specific benefit plans and applicable law. State mandates, federal regulatory requirements, and the member’s benefit coverage may modify or supersede the criteria described in this policy. In addition, other utilization management programs (for example, Step Therapy or supply limits) and separate policies may apply and affect coverage determinations.

UnitedHealthcare may use program-specific automated approval or reauthorization processes that rely on claims history, medication history, diagnosis codes (ICD-10), or claim logic. As a result, approvals can be granted on that basis in some cases; conversely, lack of required documentation or failure to meet medical necessity, supply limits, or Step Therapy requirements may result in denial or non-approval.

Provider Actions & Requirements

Prior Authorization

Prior Authorization Required — Tardive dyskinesia

Prior authorization required for initial Austedo/Austedo XR therapy for tardive dyskinesia. Initial authorization will be issued for 12 months and requires documentation of the diagnosis of tardive dyskinesia.

Affected products: Austedo, Austedo XR
Approval duration: 12 months

Prior Authorization

Prior Authorization Required — Chorea (Huntington's disease)

Prior authorization required for initial Austedo/Austedo XR therapy for chorea associated with Huntington's disease. Initial authorization will be issued for 12 months and requires documentation of the diagnosis of chorea associated with Huntington's disease.

Affected products: Austedo, Austedo XR
Approval duration: 12 months

Documentation Required

Reauthorization Documentation Required

Documentation of positive clinical response is required for reauthorization. Reauthorizations are issued for 12 months when documentation shows clinical benefit from therapy.

Reauthorization applies to both tardive dyskinesia and chorea indications
Provide clinical notes documenting symptom improvement or stabilization

Denial Risk

Denial Risks and Automated Approvals

Denial risks and automated approval variability. If required documentation (diagnosis for initial authorization or evidence of positive clinical response for reauthorization) is missing or criteria are not met, the request may be denied. UnitedHealthcare programs may also use automated approval or re-approval processes based on prior claim/medication history, diagnosis codes (ICD-10), and claim logic; availability of automated approvals varies by program and therapeutic class.

Missing diagnosis documentation for initial requests increases denial risk
Missing clinical-response documentation for reauthorization increases denial risk
Automated approvals depend on program settings and may not apply to every request

Step Therapy

Supply Limits / Step Therapy / Medical Necessity

Supply limits, Step Therapy, and/or Medical Necessity programs may apply. Payor programs can impose quantity/supply limits or step therapy requirements independent of the coverage criteria above.

Step therapy or quantity limits may affect initial or refills
State mandates and member-specific benefit plans may further affect coverage

Initial Therapy Criteria

Initial Therapy — Initial authorization rules

Initial authorization rules

Initial indication: Diagnosis of tardive dyskinesia OR diagnosis of chorea associated with Huntington's disease

Authorization will be issued for 12 months

Program element	Details
Supply limits
Supply limits may be in place per program and may restrict quantity or day supply; approvals may be subject to these limits.

Background

Austedo (deutetrabenazine) and Austedo XR are members of the VMAT2 inhibitor drug class and are indicated for the treatment of chorea associated with Huntington’s disease and for treatment of tardive dyskinesia in adults. Coverage and authorization are based on the documented diagnosis corresponding to these indications and the policy’s medical necessity criteria.

Providers should note that prior authorization is required for Austedo/Austedo XR and that supply limits, Step Therapy, and other medical necessity reviews may be applied by the program. Automated approval processes that consider prior claims or diagnosis coding may be used in certain circumstances, but documentation supporting the diagnosis and clinical response is relied upon for initial authorizations and reauthorizations.

Definitions

Austedo / Austedo XR — Deutetrabenazine summary

Generic nameDeutetrabenazine

Drug classVesicular monoamine transporter 2 (VMAT2) inhibitor

Approved indications (adults)Chorea associated with Huntington's disease; Tardive dyskinesia

FormulationsAustedo; Austedo XR

Reference (label)Austedo - Austedo XR [package insert], Teva Pharmaceuticals, February 2025