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DEUTETRABENAZINE TAB,SA,24HR (EXTENDED RELEASE)

Clinical Criteria Summary

Exclusion Criteria

  • Actively suicidal or has untreated or inadequately treated depression
  • Congenital long QT interval, or a QTc >450 ms for men or QTc >470 ms for women
  • History of cardiac arrhythmias (ventricular), cardiac conduction system disease (LBBB or RBBB), or cardiac device (can be considered candidates with cardiology evaluation)
  • Concurrent use of a monoamine oxidase inhibitor (MAOI) or within 14 days of discontinuing therapy with an MAOI
  • Current or use of reserpine within the past 20 days
  • Concurrent use of another VMAT2 inhibitor (i.e., tetrabenazine, valbenazine)
  • History of neuroleptic malignant syndrome (NMS)
  • Current clinically significant hyperprolactinemia
  • Pregnant or lactating
  • Hepatic impairment

Inclusion Criteria: Treatment of Huntington Disease

  • Initial prescriber is a resident, fellow, or other trainee: an attending psychiatrist or neurologist has verified the diagnosis and need for deutetrabenazine
  • Diagnosis of Huntington disease documented in the medical record
  • Chorea is disabling or painful and interferes with functional status (including self-care and ambulation), quality of life, or creates a social stigma sufficient to cause social isolation or embarrassment
  • Prescriber has documented specific movement(s) (e.g., facial, oral, extremity, or trunk) in the medical record along with how the chorea is affecting function, quality of life, or socialization

Inclusion Criteria: Treatment of Dystonia

  • Initial prescriber is a resident, fellow, or other trainee: an attending psychiatrist or neurologist has verified the diagnosis and need for deutetrabenazine
  • No response or intolerant to alternative agents (local botulinum toxin injections, anticholinergics, or benzodiazepines)

Inclusion Criteria: Treatment of Tardive Dyskinesia

  • Diagnosis of tardive dyskinesia (TD) secondary to a dopaminergic blocking agent (e.g., antipsychotic or metoclopramide)
  • TD interferes with functional status (including self-care and ambulation), quality of life, or creates a social stigma sufficient to cause social isolation or embarrassment
  • Prescriber has documented specific movement(s) (e.g., facial, oral, extremity, or trunk) in the medical record along with how TD is affecting function, quality of life, or socialization
  • Recent Abnormal Involuntary Movement Scale (AIMS) score is recorded in the medical record
  • ECG performed to confirm a QTc <450 ms for men or QTc <470 ms for women
  • Initial prescriber is a resident, fellow, or other trainee: an attending psychiatrist or neurologist has verified the diagnosis and need for deutetrabenazine

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