Subject: Austedo-Austedo XR 1746-A SGM P2024
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AUSTEDO
(deutetrabenazine)
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AUSTEDO XR
(deutetrabenazine extended release)
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Policy:
I. 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 Indications
A. Treatment of chorea associated with Huntington’s disease in adults
B. Treatment of tardive dyskinesia in adults
All other indications are considered experimental/investigational and not medically necessary.
II. DOCUMENTATION
Submission of the following information is necessary to initiate the prior authorization review for
initial requests:
A. Tardive dyskinesia: Chart notes or medical record documentation of clinical manifestations
of disease.
B. Chorea associated with Huntington’s disease: Chart notes or medical record documentation
of characteristic motor examination features.
III. CRITERIA FOR INITIAL APPROVAL
A. Tardive dyskinesia
Authorization of 6 months may be granted for treatment of tardive dyskinesia when both of
the following criteria are met:
1. Member exhibits clinical manifestations of disease.
2. 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]).
B. Chorea associated with Huntington’s disease
Authorization of 6 months may be granted for treatment of chorea associated with
Huntington’s disease when both of the following criteria are met:
1. Member demonstrates characteristic motor examination features.
2. Member meets one of the following conditions:
i. Laboratory results indicate an expanded HTT CAG repeat sequence of at least 36
ii. Member has a positive family history for Huntington’s disease
IV. CONTINUATION OF THERAPY
Authorization of 12 months may be granted for members with an indication listed in Section III
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:
- Austedo [package insert]. Parsippany, NJ: Teva Neuroscience, Inc. May 2024.
- Frank S, Testa CM, Stamler D, et al. Effect of deutetrabenazine on chorea among patients with Huntington disease: a randomized clinical trial. 2016;316(1):40-50.
- Fernandez HH, Factor SA, Hauser RA, et al. Randomized controlled trial of deutetrabenazine for tardive dyskinesia: the ARM-TD study. 2017;88:2003-10.
- 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.
- 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.
September 25, 2024
