VALBENAZINE CAP,SPRINKLE

Clinical Criteria Summary

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

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