DEUTETRABENAZINE TAB

Clinical Criteria Summary

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

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

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)

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

Dosage form: Oral tablets (6 mg, 9 mg, 12 mg); non-formulary status
Administer with food; swallow tablets whole (do not crush, chew, or break)
HD dosing: 6 mg once daily; may increase dose weekly based on response and tolerability in increments of 6 mg/day. If total daily dose is ≥12 mg, administer in two divided doses. Maximum recommended dose: 48 mg/day.
TD dosing: 6 mg twice daily; may increase dose weekly based on response and tolerability in increments of 6 mg/day. If total daily dose is ≥12 mg, administer in two divided doses. Maximum recommended dose: 48 mg/day.

HD: Demonstrated reduction in Total Chorea Score compared to placebo (p<0.0001) in a 12-week randomized, double-blind, placebo-controlled study.
TD: Demonstrated reduction in Abnormal Involuntary Movement Scale (AIMS) scores compared to placebo at week 12 in the AIM-TD and ARM-TD trials.

VMAT-2 inhibitor utilized for management of HD chorea and TD.
Indirect evidence suggests better tolerability compared to tetrabenazine, though VA ADERS data does not fully support this finding.
Sequencing of VMAT-2 inhibitors is not warranted based on current evidence and utilization data.