Pharmacy Prior Authorization Criteria

Xenazine (tetrabenazine)

Indications for Prior Authorization

Xenazine (tetrabenazine)

• For diagnosis of Chorea associated with Huntington's disease
  Indicated for the treatment of chorea associated with Huntington's disease.

• For diagnosis of Hyperkinetic movement disorders in tardive dyskinesia and Tourette's syndrome [2-5]
  Has shown effectiveness in the treatment of hyperkinetic movement disorders (hyperkinesias) characterized by abnormal involuntary movements seen in tardive dyskinesia (TD), or issues such as tics (eye blink, shouting obscenities or profanities, etc.) observed in Tourette's syndrome (TS).

Criteria

Brand Xenazine

Prior Authorization (Initial Authorization)

Length of Approval: 3 months [B]
For diagnosis of Chorea associated with Huntington's disease

• Diagnosis of chorea in patients with Huntington's disease
AND
• Prescribed by or in consultation with a neurologist [C]
AND
• Trial and failure or intolerance to a minimum 30 day supply of generic tetrabenazine

Generic tetrabenazine

Prior Authorization (Initial Authorization)

Length of Approval: 3 months [B]
For diagnosis of Chorea associated with Huntington's disease

• Diagnosis of chorea in patients with Huntington's disease
AND
• Prescribed by or in consultation with a neurologist [C]

Brand Xenazine, Generic tetrabenazine

Prior Authorization (Reauthorization)

Length of Approval: 12 Month(s)
For diagnosis of Chorea associated with Huntington's disease

• Patient demonstrates positive clinical response to therapy

Brand Xenazine

Prior Authorization (Initial Authorization)

Length of Approval: 3 Months [B]
For diagnosis of Tourette's syndrome (Off-label)

• Patient has tics associated with Tourette's syndrome [2, 4]
AND
• Trial and failure, contraindication, or intolerance to a minimum 30 day supply of Haldol (haloperidol)
AND
• Prescribed by or in consultation with one of the following:
• Neurologist
• Psychiatrist
AND
• Trial and failure or intolerance to a minimum 30 day supply of generic tetrabenazine

Generic tetrabenazine

Prior Authorization (Initial Authorization)

Length of Approval: 3 Months [B]
For diagnosis of Tourette's syndrome (Off-label)

• Patient has tics associated with Tourette's syndrome [2, 4]
AND
• Trial and failure, contraindication, or intolerance to a minimum 30 day supply of Haldol (haloperidol)
AND
• Prescribed by or in consultation with one of the following:
• Neurologist
• Psychiatrist

Brand Xenazine, Generic tetrabenazine

Prior Authorization (Reauthorization)

Length of Approval: 12 Month(s)
For diagnosis of Tourette's syndrome (Off-label)

• Patient demonstrates positive clinical response to therapy

Brand Xenazine

Prior Authorization (Initial Authorization)

Length of Approval: 3 months [B]
For diagnosis of Tardive dyskinesia (Off-label)

• Diagnosis of tardive dyskinesia [3, 4]
AND
• One of the following [A, 5]:
• Patient has persistent symptoms of tardive dyskinesia despite a trial of dose reduction, tapering, or discontinuation of the offending medication
OR
• Patient is not a candidate for a trial of dose reduction, tapering or discontinuation of the offending medication
AND
• Prescribed by or in consultation with one of the following:
• Neurologist
• Psychiatrist
AND
• Trial and failure or intolerance to a minimum 30 day supply of generic tetrabenazine

Generic tetrabenazine

Prior Authorization (Initial Authorization)

Length of Approval: 3 months [B]
For diagnosis of Tardive dyskinesia (Off-label)

• Diagnosis of tardive dyskinesia [3, 4]
AND
• One of the following [A, 5]:
• Patient has persistent symptoms of tardive dyskinesia despite a trial of dose reduction, tapering, or discontinuation of the offending medication
OR
• Patient is not a candidate for a trial of dose reduction, tapering or discontinuation of the offending medication
AND
• Prescribed by or in consultation with one of the following:
• Neurologist
• Psychiatrist

Brand Xenazine, Generic tetrabenazine

Prior Authorization (Reauthorization)

Length of Approval: 12 Month(s)
For diagnosis of Tardive dyskinesia (Off-label)

• Patient demonstrates positive clinical response to therapy

P & T Revisions

2024-04-15, 2023-12-01, 2023-04-21, 2022-04-18, 2021-09-27, 2021-05-10, 2020-04-20

References

1. Xenazine Prescribing Information. Lundbeck. Deerfield, IL. November 2019.
2. Sweet RD, Brauun R, Shapiro E, Shapiro AK. Presynaptic catecholamine antagonists as treatment for Tourette syndrome. Effects of alpha methyl para tyrosine and tetrabenazine. Arch Gen Psych. 1974;31:857-861.
3. Kazamatsuri H, Chien C-P, Cole J. Treatment of Tardive Dyskinesia: clinical efficacy of a dopamine-depleting agent, tetrabenazine. Arch Gen Psychiat. 1972;27:95-99.
4. Micromedex® (electronic version). IBM Watson Health, Greenwood Village, Colorado. Available at: https://www.micromedexsolutions.com. Accessed April 1, 2021.
5. Per clinical consult with psychiatrist regarding Ingrezza (valbenazine), June 9, 2017.

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End Notes

1. Verified with consultant for a previous medication (Ingrezza [valbenazine]) that dose reduction, tapering, or discontinuation of the offending medication is considered first-line treatment for tardive dyskinesia. [5]
2. Authorization period is based on the pivotal study duration of 12 weeks. [1]
3. Ensures the requirement for proper diagnosing and quantifying an adequate chorea score (total maximal chorea score of greater than or equal to 10 (moderate to severe chorea) from the subscale of the Unified Huntington's Disease Rating Scale (UHDRS). Note that the pivotal trial that established efficacy of tetrabenazine included patients with a total maximal chorea of greater than or equal to 10. [1]

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Revision History

• 2024-04-15: 2024 Annual Review
• 2023-12-01: Program update to standard reauthorization language. No changes to clinical intent.
• 2023-04-21: 2023 Annual Review.
• 2022-04-18: 2022 Annual Review
• 2021-09-27: Annual Review
• 2021-05-10: Annual Review
• 2020-04-20: 2020 Annual Review - Updated References

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