Subject: tetrabenazine-Xenazine 2266-A SGM P2024

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 to initiate the prior authorization review for
          initial requests:
          A.  Tardive dyskinesia: Chart notes or medical record documentation of clinical manifestations
               of disease.
          B.  Chorea associated with Huntington’s disease: Chart notes or medical record documentation
               of characteristic motor examination features.


   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 treatment of tardive dyskinesia when both of
               the following criteria are met:
               1.  Member exhibits clinical manifestations of disease.
               2.  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]).

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


   IV.  CONTINUATION OF THERAPY

          Authorization of 12 months may be granted for members with an indication listed in Section III
          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 Inc.; November 2019.
2. Tetrabenazine [package insert]. Weston, FL: Apotex Corp.; October 2021.
3. Micromedex® (electronic version). Truven Health Analytics, Greenwood Village, Colorado, USA. Available at: http://www.micromedexsolutions.com. Accessed March 14, 2024.
4. AHFS DI (Adult and Pediatric). Lexicomp. Last updated March 11, 2024. Accessed March 14, 2024. http://online.lexi.com/lco
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.

September 25, 2024