Subject: Austedo-Austedo XR SGM 1746-A P2026

Drug

AUSTEDO  (deutetrabenazine)

AUSTEDO XR  (deutetrabenazine extended-release)

Policy:

Indications

The indications below including FDA-approved indications and compendial uses are considered a covered benefit provided that all the approval criteria are met and the member has no exclusions to the prescribed therapy.

FDA-Approved Indications¹

·        Treatment of chorea associated with Huntington’s disease in adults

·        Treatment of tardive dyskinesia in adults

All other indications are considered experimental/investigational and not medically necessary.

Prescriber Specialties

This medication must be prescribed by or in consultation with one of the following:

·        Chorea associated with Huntington’s disease: Neurologist or a specialist in the treatment of chorea associated with Huntington’s disease.

·        Tardive dyskinesia: Neurologist, psychiatrist, or a specialist in the treatment of tardive dyskinesia.

Documentation

Submission of the following information is necessary to initiate the prior authorization review for initial requests:

·        Chorea associated with Huntington’s disease: Chart notes or medical record documentation of characteristic motor examination features.

·        Tardive dyskinesia: Chart notes or medical record documentation of clinical manifestations of disease.

Coverage Criteria

Chorea Associated with Huntington’s Disease^1,2

Authorization of 12 months may be granted for treatment of chorea associated with Huntington’s disease in adult members when both of the following criteria are met:

·        Member demonstrates characteristic motor examination features.

·        Member meets one of the following conditions:

§  Laboratory results indicate an expanded HTT CAG repeat sequence of at least 36

§  Member has a positive family history for Huntington’s disease

Tardive Dyskinesia^1,3-5

Authorization of 12 months may be granted for treatment of tardive dyskinesia in adult members when both of the following criteria are met:

·        Member exhibits clinical manifestations of disease.

·        Member has a history of treatment with a dopamine receptor antagonist.

·        Member’s tardive dyskinesia has been assessed through clinical examination or with a structured evaluative tool (e.g., Abnormal Involuntary Movement Scale [AIMS], Dyskinesia Identification System: Condensed User Scale [DISCUS]).

Continuation of Therapy

Authorization of 12 months may be granted for members with an indication listed in the coverage criteria who are experiencing benefit from therapy as evidenced by disease stability or disease improvement.

Place of Service:

Outpatient

The above policy is based on the following references:

1.      Austedo/Austedo XR [package insert]. Parsippany, NJ: Teva Neuroscience, Inc. February 2025.

2.     Frank S, Testa CM, Stamler D, et al. Effect of deutetrabenazine on chorea among patients with Huntington disease: a randomized clinical trial. JAMA. 2016;316(1):40-50.

3.     Fernandez HH, Factor SA, Hauser RA, et al. Randomized controlled trial of deutetrabenazine for tardive dyskinesia: the ARM-TD study. Neurology. 2017;88:2003-10.

4.     Anderson KE, Stamler D, Davis MD, et al. Deutetrabenazine for treatment of involuntary movements in patients with tardive dyskinesia (AIM-TD): a double-blind, randomized, placebo-controlled, phase 3 trial. Lancet Psychiatry. 2017;4:595-604.

5.     American Psychiatric Association. (2021). Practice Guideline for the Treatment of Patients With Schizophrenia, third edition. https://doi.org/10.1176/appi.books.9780890424841.

Copyright Aetna Inc. All rights reserved. Pharmacy Clinical Policy Bulletins are developed by Aetna to assist in administering plan benefits and constitute neither offers of coverage nor medical advice. This Clinical Policy Bulletin contains only a partial, general description of plan or program benefits and does not constitute a contract. Aetna does not provide health care services and, therefore, cannot guarantee any results or outcomes. Participating providers are independent contractors in private practice and are neither employees nor agents of Aetna or its affiliates. Treating providers are solely responsible for medical advice and treatment of members. This Clinical Policy Bulletin may be updated and therefore is subject to change.

October 03, 2026