CurrentAdvanced HealthPolicy N/A

Ingrezza (Valbenazine) Drug Use Criteria

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Prior authorization and renewal criteria for Ingrezza (valbenazine) in adults with tardive dyskinesia or chorea associated with Huntington's disease.

Policy Summary

PayerAdvanced Health

PolicyIngrezza (Valbenazine) Drug Use Criteria

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Last ReviewApr 9, 2025

Next Review DateN/A

Key ActionSubmit prior authorization documentation confirming eligibility, safety assessment, and required prerequisites for initial Ingrezza requests.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

18+Minimum age

Moderate+TD severity

≥3 moSymptom duration

≥8 wkTetrabenazine trial

3 moInitial approval

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CurrentAdvanced HealthPolicy N/A

Ingrezza (Valbenazine) Drug Use Criteria

Customize your policy alerts

Sign up for all advancedhealth policy alerts

Know when advancedhealth releases new policies or updates existing guidance.

Monitor payer policy activity

Receive email alerts as soon as relevant payer policies are published or updated.

Prior authorization and renewal criteria for Ingrezza (valbenazine) in adults with tardive dyskinesia or chorea associated with Huntington's disease.

Policy Summary

PayerAdvanced Health

PolicyIngrezza (Valbenazine) Drug Use Criteria

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Last ReviewApr 9, 2025

Next Review DateN/A

Key ActionSubmit prior authorization documentation confirming eligibility, safety assessment, and required prerequisites for initial Ingrezza requests.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

18+Minimum age

Moderate+TD severity

≥3 moSymptom duration

≥8 wkTetrabenazine trial

3 moInitial approval

6 moRenewal approval

Coverage Criteria

Initial Therapy

Covered for an initial request when all general requirements and one applicable disease-association pathway are satisfied.

General initial requirements

Disease-association pathway
- Dopamine receptor-blocking agent pathway: No other diagnosed movement disorder is present; the member is not currently taking monoamine oxidase inhibitors; laboratory data confirms adequate hepatic function without severe hepatic impairment; an attempt has been made to reduce or discontinue the causative dopamine-blocking agent; the member has had an adequate tetrabenazine trial for at least 8 weeks without clinical benefit or with documented intolerance; and assessment confirms no uncontrolled depression or risk of violent or suicidal behavior.Tetrabenazine trial ≥8 weeks
  Approve for 3 months when all criteria are met.
- Huntington's disease chorea pathway: The tardive dyskinesia is associated with chorea secondary to Huntington's disease, and assessment confirms absence of uncontrolled depression or risk of violent or suicidal behavior.

Continuation Therapy

Covered for renewal when all of the following are met.

Renewal criteria: The member has demonstrated clinical benefit, has no significant adverse effects or safety concerns, and has documented ongoing medical necessity for treatment.

Approve for 6 months; provide updated laboratory results and chart notes with the next request.

Coverage is not available when the member is currently taking a monoamine oxidase inhibitor (MAOI) or has severe hepatic impairment. For the applicable initial pathway, hepatic laboratory data must confirm adequate hepatic function.

Coverage is excluded when the member has another diagnosed movement disorder, such as Parkinson’s disease or acute dystonia, and the symptoms may be attributable to that disorder rather than tardive dyskinesia.

Initial treatment is not medically necessary when the member does not meet the required eligibility criteria, including age 18 years or older, moderate or severe tardive dyskinesia, symptoms present for at least 3 months, and a qualifying association with chronic dopamine receptor-blocking agent use or chorea secondary to Huntington’s disease. The applicable pathway requirements must also be met, including safety assessment, attempted reduction or discontinuation of the causative agent, and an adequate tetrabenazine trial of 8 or more weeks when required.

Continuation treatment is not medically necessary when there is no documented clinical benefit, significant adverse effects or safety concerns are present, or ongoing medical necessity is not documented.

Authorization and Documentation Requirements

Prior Authorization

Initial Prior Authorization Required

Prior authorization is required for initial Ingrezza (valbenazine) requests. Approval requires meeting the applicable initial clinical, prerequisite, and safety criteria; an approved initial request is authorized for 3 months.

Submit documentation supporting all applicable initial criteria and required safety prerequisites.
Ingrezza is FDA-approved for adults with tardive dyskinesia or chorea associated with Huntington's disease.

Prior Authorization

Renewal Prior Authorization

Renewal requests require evidence that treatment remains effective, safe, and medically necessary. An approved renewal is authorized for 6 months.

Document clinical benefit, such as reduced TD movements or improved function.
Confirm no significant adverse effects or safety concerns.
Document ongoing medical necessity and provide updated laboratory results and chart notes with the next request.

Clinical Background

Ingrezza (valbenazine) is a selective vesicular monoamine transporter 2 (VMAT2) inhibitor. By regulating dopamine release and decreasing monoamine uptake into synaptic vesicles, it reduces excessive dopamine signaling and involuntary movements. The policy addresses its FDA-approved use in adults with tardive dyskinesia and chorea associated with Huntington’s disease.

Key Definitions

Tardive Dyskinesia

DefinitionA movement disorder characterized by involuntary movements associated with chronic dopamine receptor-blocking agent use or chorea secondary to Huntington's disease.

Required severityModerate or severe tardive dyskinesia.

Required symptom durationSymptoms must have been present for at least 3 months.

VMAT2 Inhibitor

DefinitionA selective vesicular monoamine transporter 2 (VMAT2) inhibitor.

Primary mechanismRegulates dopamine release through inhibition of VMAT2.

Effect on monoamine uptake

Initial Ingrezza Therapy

Initial Ingrezza coverage requires all general requirements plus one applicable disease-association pathway.

General initial requirements

Qualifying disease-association pathway
- Dopamine receptor-blocking agent pathway: The member has no other diagnosed movement disorder; is not currently taking monoamine oxidase inhibitors; laboratory data confirms adequate hepatic function without severe hepatic impairment; an attempt has been made to reduce or discontinue the causative dopamine-blocking agent; the member has had an adequate tetrabenazine trial for at least 8 weeks without clinical benefit or with documented intolerance; and assessment confirms absence of uncontrolled depression or risk of violent or suicidal behavior.Tetrabenazine trial ≥8 weeks
  Approve for 3 months when all criteria are met.
- Huntington's disease chorea pathway:

Ingrezza Renewal

Renewal is covered when all of the following criteria are met.

Renewal: Clinical benefit is demonstrated; there are no significant adverse effects or safety concerns; and ongoing medical necessity is documented.

Approve for 6 months and provide updated laboratory results and chart notes with the next request.

Required Prior Therapy

Step	Prior therapy	Minimum trial	Requirement before Ingrezza
1	Tetrabenazine	8 or more weeks	For the dopamine receptor-blocking agent-associated pathway, the trial must show no clinical benefit or documented intolerance.

Policy Summary

PayerAdvanced Health

PolicyIngrezza (Valbenazine) Drug Use Criteria

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Last ReviewApr 9, 2025

Next Review DateN/A

Key ActionSubmit prior authorization documentation confirming eligibility, safety assessment, and required prerequisites for initial Ingrezza requests.

SourceLink

On This Page

Step Therapy

Tetrabenazine Trial Required

Before Ingrezza is approved under the applicable pathway, the member must have an adequate tetrabenazine trial of at least 8 weeks without clinical benefit or with documented intolerance.

Document the tetrabenazine dose, duration, outcome, and any intolerance.
Requests without an adequate 8-week tetrabenazine trial may be denied.

Documentation Required

Initial Clinical Documentation

For an initial request, submit clinical documentation establishing the member's age, diagnosis, severity, duration of symptoms, and the relevant causative-agent or disease association.

Document age 18 years or older.
Document moderate or severe tardive dyskinesia (TD).
Document that TD symptoms have been present for at least 3 months.
Document whether TD is associated with chronic dopamine receptor-blocking agent use or whether chorea is secondary to Huntington's disease.

Documentation Required

Prerequisite and Safety Documentation

Document completion of required treatment and safety prerequisites before requesting initial approval.

Document an attempt to reduce or discontinue the causative dopamine-blocking agent, when applicable.
Document an adequate tetrabenazine trial of at least 8 weeks without benefit or with intolerance.
Provide laboratory data confirming adequate hepatic function and no severe hepatic impairment.
Provide an assessment showing absence of uncontrolled depression and risk of violent or suicidal behavior.

Documentation Required

Renewal Documentation

Renewal documentation must demonstrate continued benefit, acceptable safety, and ongoing medical necessity for Ingrezza.

Provide updated evidence of reduced TD movements or improved function.
Document review of adverse effects and safety concerns, confirming that no significant concerns are present.
Include updated laboratory results and chart notes with the next request.

Denial Risk

Clinical Eligibility Denial Risks

An initial request may be denied when core clinical eligibility requirements are not met.

Member is younger than 18 years; Ingrezza is FDA-approved only for adults.
TD is not moderate or severe.
TD symptoms have been present for fewer than 3 months.
TD is not associated with chronic dopamine receptor-blocking agent use or chorea secondary to Huntington's disease.

Denial Risk

Safety and Prerequisite Denial Risks

An initial request may be denied for an exclusion, contraindication, or unmet prerequisite.

Another diagnosed movement disorder is present in addition to TD, such as Parkinson's disease or acute dystonia, and symptoms may be attributable to that disorder.
The member is currently taking a monoamine oxidase inhibitor (MAOI); concurrent use is contraindicated.
Laboratory data do not confirm adequate hepatic function or severe hepatic impairment is present.
The causative dopamine-blocking agent has not been reduced or discontinued when applicable.
The required tetrabenazine trial of at least 8 weeks has not been completed.
Assessment does not establish absence of uncontrolled depression or risk of violent or suicidal behavior.

Denial Risk

Renewal Failure Risks

A renewal request may be denied when continued treatment benefit, safety, medical necessity, or supporting documentation is not established.

No clinical benefit is demonstrated, such as reduced TD movements or improved function.
Significant adverse effects or safety concerns are present.
Ongoing medical necessity is not documented.
Required updated laboratory results, chart notes, or other renewal documentation are absent.

Inhibits the uptake of monoamines, such as dopamine, into synaptic vesicles.

The indication is chorea secondary to Huntington's disease, and assessment confirms absence of uncontrolled depression or risk of violent or suicidal behavior.