Subject: tetrabenazine-Xenazine 2266-A SGM P2023

Drug

XENAZINE  (tetrabenazine)

tetrabenazine

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 (where applicable): Documentation of score of items 1
          to 7 of the Abnormal Involuntary Movement Scale (AIMS).


  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 7, 2023.
3. AHFS Drug Information. http://online.lexi.com/lco. Accessed March 7, 2023.
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]. Weston, FL: Apotex Corp.; October 2021.
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 13, 2023