VALBENAZINE CAP,ORAL

Clinical Criteria Summary

Active suicidality or untreated/inadequately treated depression
Congenital long QT interval or QTc >450 ms (men) / >470 ms (women)
History of cardiac arrhythmias (ventricular), cardiac conduction system disease (LBBB/RBBB), or presence of a cardiac device (requires cardiology evaluation for consideration)
Concurrent use of monoamine oxidase inhibitors (MAOIs)
Current or recent reserpine use within the past 20 days
Concurrent use of another VMAT2 inhibitor
History of neuroleptic malignant syndrome (NMS)
Current clinically significant hyperprolactinemia
Pregnancy or lactation
Concurrent use of strong CYP3A4 inducers

Documented diagnosis of Huntington disease in the medical record
Disabling or painful chorea that interferes with functional status (self-care, ambulation), quality of life, or causes social stigma/isolation/embarrassment
Documentation of specific movement(s) (facial, oral, extremity, trunk) and their impact on function, quality of life, or socialization
Verification by an attending psychiatrist or neurologist if the initial prescriber is a resident, fellow, or other trainee

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.

Patient is actively suicidal or has untreated/inadequately treated depression
Congenital long QT interval, or QTc >450 ms (men) / >470 ms (women)
History of cardiac arrhythmias (ventricular), cardiac conduction system disease (LBBB/RBBB), or cardiac device (candidates may be considered with cardiology evaluation)
Concurrent use of a monoamine oxidase inhibitor (MAOI)
Current or recent reserpine use within the past 20 days
Concurrent use of another VMAT2 inhibitor
History of neuroleptic malignant syndrome (NMS)
Current clinically significant hyperprolactinemia
Pregnant or lactating
Concurrent use of a strong CYP3A4 inducer

Diagnosis of tardive dyskinesia secondary to a dopaminergic blocking agent (e.g., antipsychotic or metoclopramide)
TD interferes with functional status (self-care, ambulation), quality of life, or causes social stigma/isolation/embarrassment
Prescriber has documented specific movement(s) (facial, oral, extremity, trunk) in medical record along with impact on function, quality of life, or socialization
Recent Abnormal Involuntary Movement Scale (AIMS) score recorded in medical record
ECG performed to confirm QTc <450 ms (men) / <470 ms (women)
If initial prescriber is a resident/fellow/trainee, attending psychiatrist or neurologist must verify diagnosis and need for valbenazine