Subject: tetrabenazine-Xenazine SGM 2266-A P2026

Drug

XENAZINE  (tetrabenazine)

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 Indications^1,2

Treatment of chorea associated with Huntington’s disease.

Compendial Uses

·        Chorea not associated with Huntington’s disease^4,5

·        Hemiballismus^4,5

·        Tardive dyskinesia^3,4,7

·        Tic disorders^3-6

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.

·        Chorea not associated with Huntington’s disease: Neurologist or a specialist in the treatment of chorea not associated with Huntington’s disease.

·        Hemiballismus: Neurologist or a specialist in the treatment of hemiballismus.

·        Tic disorders: Neurologist or a specialist in the treatment of tic disorders.

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 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

Chorea Not Associated with Huntington’s Disease^4,5

Authorization of 6 months may be granted for treatment of chorea not associated with Huntington’s disease.

Hemiballismus^4,5

Authorization of 6 months may be granted for treatment of hemiballismus.

Tardive dyskinesia^3,4,7

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

·        Member exhibits clinical manifestations of disease.

·        Patient 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]).

Tic disorders^3-6

Authorization of 12 months may be granted for treatment of tic disorders.

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.      Xenazine [package insert]. Deerfield, IL: Lundbeck; November 2019.

2.     Tetrabenazine [package insert]. Weston, FL: Apotex Corp.; November 2021.

3.     Micromedex® (electronic version). Truven Health Analytics, Greenwood Village, Colorado, USA. Available at: http://www.micromedexsolutions.com. Accessed March 9, 2026.

4.     AHFS DI (Adult and Pediatric). Lexicomp. Last updated February 25, 2026. Accessed March 9, 2026. http://online.lexi.com/lco/action/home.

5.     Guay DRP. Tetrabenazine, a monoamine-depleting drug used in the treatment of hyperkinetic movement disorders. Am J Geriatr Pharmacother. 2010;8:331-373.

6.     Kenney C, Hunter C, Jankovic J. Long-term tolerability of tetrabenazine in the treatment of hyperkinetic movement disorders. Movement Disorders. 2007;22(2):193-7.

7.     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