CurrentCignaPolicy IP0079

Austedo

Defines prior authorization requirements and medical necessity criteria for Austedo and Austedo XR (deutetrabenazine) for Cigna-administered prescription benefit plans, affecting prescribers and payers for covered members.

Policy Summary

PayerCigna

PolicyAustedo coverage (deutetrabenazine)

Policy CodePolicy IP0079

Change TypeRevised (material and cosmetic updates)

Effective DateJun 15, 2025

Next Review DateJun 15, 2025

Key ActionObtain prior authorization; approvals are provided for 1 year when criteria are met.

SourceLink

POLICY UPDATE CHANGES

Updated wording to require 'Patient has a history of use of dopamine receptor blocking agent' with examples moved to a Note for the tardive dyskinesia indication.

Updated policy title from Deutetrabenazine to Austedo.

2FDA-approved indications listed

1 yrInitial approval duration

≥18Minimum age

Prior AuthAuthorization

Coverage Criteria for Austedo (deutetrabenazine)

FDA-Approved Indications

Austedo/Austedo XR are considered medically necessary when ONE of the following is met (1 or 2):

FDA-Approved Indications: 1. Chorea associated with Huntington's disease. Approve for 1 year if the patient meets ALL of the following (A, B, and C):

Chorea associated with Huntington's disease: A) Patient is >= 18 years of age; AND B) Diagnosis of Huntington's disease is confirmed by genetic testing (for example, an expanded HTT CAG repeat sequence of at least 36); AND C) The medication is prescribed by or in consultation with a neurologist.

Tardive dyskinesia: 2. Tardive dyskinesia. Approve for 1 year if the patient meets ALL of the following (A, B and C):

Tardive dyskinesia details:

Policy Summary

PayerCigna

PolicyAustedo coverage (deutetrabenazine)

Policy CodePolicy IP0079

Change TypeRevised (material and cosmetic updates)

Effective DateJun 15, 2025

Next Review DateJun 15, 2025

Key ActionObtain prior authorization; approvals are provided for 1 year when criteria are met.

SourceLink

On This Page

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Provider Actions, Documentation, and Prior Authorization

Prior Authorization

Prior Authorization Required

Prior authorization is required for prescription benefit coverage of Austedo/Austedo XR. Approvals are provided for 1 year when criteria are met. Because evaluation and monitoring require specialist expertise, Austedo/Austedo XR must be prescribed by or in consultation with a physician who specializes in the condition being treated.

Approvals valid for 1 year.
Required prescriber: specialist in the treated condition (see FDA-Indications criteria).

Documentation Required

Required Documentation and Prescriber Qualifications

Prescriptions must be provided by or in consultation with an appropriate specialist (e.g., neurologist for Huntington’s disease; neurologist or psychiatrist for tardive dyskinesia). Documentation should include age, diagnostic confirmation (genetic testing for Huntington’s disease), history of dopamine receptor blocking agent use for tardive dyskinesia, and any consultation notes supporting the specialist involvement.

Huntington’s disease: documentation of genetic testing (e.g., HTT CAG repeat ≥ 36).
Tardive dyskinesia: documentation of prior use of dopamine receptor blocking agent (examples: antipsychotics, metoclopramide, prochlorperazine; note that dopamine agonists such as pramipexole/ropinirole are examples).
Include prescription details, treatment rationale, and any relevant prior therapies or monitoring notes.

Denial Risk

Denial Triggers / Billing Risks

Claims submitted without covered diagnosis or procedure codes under this Coverage Policy will be denied as not covered. Requests submitted without prior authorization when required will be denied. Receipt of sample product does not satisfy criteria requirements for coverage.

Denial triggers include: missing prior authorization; absent or non-covered diagnosis codes; insufficient documentation of specialist prescription/consultation; lack of required diagnostic confirmation (e.g., genetic testing for Huntington’s disease).

Note

Provider Action

Provider action: ensure prior authorization is obtained before initiating Austedo/Austedo XR and that all required documentation and specialist involvement are included with the request.

Submit genetic test results for Huntington’s disease requests.
Document history of dopamine receptor blocking agent use for tardive dyskinesia requests.
Confirm prescriber specialty or include consultation note.
Verify prior authorization approval duration (1 year) and reauthorize as needed before expiration.

Initial Therapy / Medical Necessity Criteria

Initial Therapy Criteria

Initial approval for Chorea: Patient is >= 18 years; diagnosis of Huntington's disease confirmed by genetic testing (for example, an expanded HTT CAG repeat sequence of at least 36); prescribed by or in consultation with a neurologist.

Approve for 1 year.

Initial approval for Tardive Dyskinesia: Patient is >= 18 years; patient has a history of use of dopamine receptor blocking agent (examples provided as a note); prescribed by or in consultation with a neurologist or psychiatrist.

Approve for 1 year.

Requirement	Details
Prescriber specialty requirement
Must be prescribed by or in consultation with a specialist appropriate to the indication: neurologist for chorea; neurologist or psychiatrist for tardive dyskinesia.

Definitions

inv-11: Dopamine receptor blocking agent (history of use)

DefinitionHistory of prior exposure to dopamine receptor blocking agents (required for tardive dyskinesia criterion)

Examples (moved to policy Note)Dopamine agonists (e.g., pramipexole, ropinirole), antipsychotics, metoclopramide, prochlorperazine

DocumentationProvider must confirm history of use when requesting authorization

inv-12: Genetically confirmed Huntington's disease

DefinitionDiagnosis of Huntington's disease confirmed by genetic testing

Illustrative genetic criterionExpanded HTT CAG repeat sequence of at least 36 (>= 36)

Associated requirementPatient must be >= 18 years of age and medication prescribed by or in consultation with a neurologist

Background

Deutetrabenazine (Austedo/Austedo XR) is a vesicular monoamine transporter type 2 (VMAT2) inhibitor indicated in adults for treatment of chorea associated with Huntington's disease and for tardive dyskinesia. Coverage under this policy requires that patients meet the specific indication criteria (age ≥ 18 years, diagnostic confirmation for Huntington's disease, or history of use of a dopamine receptor blocking agent for tardive dyskinesia) and that the drug be prescribed by or in consultation with the appropriate specialist. Approvals are provided for 1 year when criteria are met; dosing, duration, and site of care should be reasonable and clinically appropriate.

OpenPayer

Austedo

Coverage Criteria for Austedo (deutetrabenazine)

Coding and Key Clinical Values

Provider Actions, Documentation, and Prior Authorization

Initial Therapy / Medical Necessity Criteria

Continuation Therapy and Approval Duration

Step Therapy and Prescriber Requirements

Site of Care Guidance

Definitions

Background