Subject: Austedo 1746-A SGM P2022

Drug

AUSTEDO  (deutetrabenazine)

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
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: Documentation of score of items 1 to 7 of the Abnormal Involuntary Movement Scale (AIMS) for tardive dyskinesia. 

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:

1. Austedo [package insert]. North Wales, PA: Teva Pharmaceuticals USA, Inc. June 2021.
2. 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.
3. Fernandez HH, Factor SA, Hauser RA, et al. Randomized controlled trial of deutetrabenazine for tardive dyskinesia: The ARM-TD study. 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.

August 14, 2022