Subject: tetrabenazine-Xenazine 2266-A SGM P2022

Drug

XENAZINE  (tetrabenazine)

tetrabenazine (generic)

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. 

A.   FDA-Approved Indication
      Treatment of chorea associated with Huntington’s disease 

B.   Compendial Uses
      1.   Tic disorders
      2.   Tardive dyskinesia
      3.   Hemiballismus
      4.   Chorea not associated with Huntington’s disease

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.   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 

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

C.   Tic disorders
       Authorization of 6 months may be granted for treatment of tic disorders.

D.   Tardive dyskinesia
       Authorization of 6 months may be granted for the treatment of tardive dyskinesia when the baseline AIMS
       score for items 1 to 7 is obtained.

E.   Hemiballismus
      Authorization of 6 months may be granted for the treatment of hemiballismus.

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.   Other indications
      Authorization of 12 months may be granted for treatment of all other indications listed in Section III when
      the member has experienced improvement or stabilization.

Place of Service:

Outpatient

The above policy is based on the following references:

1. Xenazine [package insert]. Deerfield, IL: Lundbeck Inc.; November 2019.
2. Micromedex® (electronic version). Truven Health Analytics, Greenwood Village, Colorado, USA. Available at: http://www.micromedexsolutions.com. Accessed March 3, 2022.
3. AHFS Drug Information. http://online.lexi.com/lco. Accessed March 3, 2022.
4. Guay DR. Tetrabenazine, a monoamine-depleting drug used in the treatment of hyperkinetic movement disorders. Am J Geriatr Pharmacother. 2010; 8:331-373.
5. Armstrong MJ, Miyasaki JM. Evidence-based guideline: pharmacologic treatment of chorea in Huntington disease: Report of the Guideline Development Subcommittee of the American Academy of Neurology. Neurology. 2012; 79(6):597-603.
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. Tetrabenazine [package insert]. Westin, FL: Apotex Corp.; September 2018.
8. 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