Subject: Austedo-Austedo XR 1746-A SGM P2023
|
AUSTEDO
(deutetrabenazine)
|
|
AUSTEDO XR
(deutetrabenazine extended release)
|
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 for both
initial approval and continuation of therapy prior authorization
reviews (where applicable): Documentation of score of items 1
to 7 of the Abnormal Involuntary Movement Scale (AIMS).
III. CRITERIA FOR INITIAL APPROVAL
A. Tardive dyskinesia
Authorization of 6 months may be granted for treatment of
tardive dyskinesia when the baseline AIMS score for items 1
to 7 is obtained.
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
A. Tardive dyskinesia
Authorization of 12 months may be granted for treatment of
tardive dyskinesia when the member’s tardive dyskinesia
symptoms have improved as indicated by a decreased AIMS
score (items 1 to 7) from baseline.
B. Chorea associated with Huntington’s disease
Authorization of 12 months may be granted for treatment of
chorea associated with Huntington’s disease when the
disease has improved or stabilized.
Place of Service:
Outpatient
The above policy is based on the following references:
- Austedo [package insert]. Parsippany, NJ: Teva Neuroscience, Inc. February 2023.
- Frank S, Testa CM, Stamler D, et al. Effect of deutetrabenazine on chorea among patients with Huntington disease: A randomized clinical trial. Huntington Study Group. 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.
August 13, 2023
