Movement Disorder Agents: Valbenazine (Ingrezza)
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Prior authorization and medical-necessity coverage for valbenazine (Ingrezza) to treat Huntington disease chorea and tardive dyskinesia in Apple Health members, including clinical criteria, reauthorization, prescriber qualifications, exclusions, step therapy, and quantity limits.
Prescribing requirements were updated to allow nurse practitioners and physician assistants who specialize in mental health to prescribe or consult on valbenazine therapy.
Coverage Criteria Overview
Initial therapy: chorea associated with Huntington disease
Covered when ALL of the following are met:
Huntington disease chorea initial therapy
ALL of the following
- Patient is 18 years of age or older.Age >=18
- Valbenazine is prescribed by, or in consultation with, a provider who specializes in treating serious mental illness.
- The patient has a diagnosis of Huntington disease.
ONE baseline UHDRS section completed
- Baseline assessment using the Motor section of the Unified Huntington's Disease Rating Scale (UHDRS) has been completed.
- Baseline assessment using the Cognitive section of the UHDRS has been completed.
- Baseline assessment using the Behavioral section of the UHDRS has been completed.
- Baseline assessment using the Functional Assessment section of the UHDRS has been completed.
- Baseline assessment using the Independence Scale section of the UHDRS has been completed.
- Baseline assessment using the Total Functional Capacity section of the UHDRS has been completed.
- Valbenazine will not be used in combination with another VMAT2 inhibitor, such as tetrabenazine, or with a monoamine oxidase inhibitor, including isocarboxazid, phenelzine, tranylcypromine, or reserpine.
- Treatment with deutetrabenazine or deutetrabenazine ER is contraindicated, ineffective, or not tolerated.Minimum trial: 12 weeks
Initial therapy: tardive dyskinesia
Covered when ALL of the following are met:
Tardive dyskinesia initial therapy
ALL of the following
- Patient is 18 years of age or older.Age >=18
- Valbenazine is prescribed by, or in consultation with, a provider who specializes in treating serious mental illness.
- The patient has a diagnosis of tardive dyskinesia (TD).
ONE baseline assessment completed
- A baseline Abnormal Involuntary Movement Scale (AIMS) assessment has been completed.
- A baseline Clinical Global Impression of Change—Tardive Dyskinesia (CGI-TD) assessment has been completed.
- Valbenazine will not be used in combination with another VMAT2 inhibitor, such as tetrabenazine, or with a monoamine oxidase inhibitor, including isocarboxazid, phenelzine, tranylcypromine, or reserpine.
ALL of the following
ONE eligible treatment approach
- Switching from a first-generation to a second-generation antipsychotic.
- A trial of two second-generation antipsychotics.
- Discontinuation or dose modification of the offending medication, with continued symptoms.
Continuation and reauthorization
Covered when ALL of the following are met:
- The applicable ongoing treatment-exclusion criterion from the initial authorization criteria continues to be met; specifically, valbenazine is not used in combination with another VMAT2 inhibitor or a monoamine oxidase inhibitor.
- Documentation demonstrates disease stability or a positive clinical response.
Examples include reduced involuntary movements, decreased total maximal chorea score, improved AIMS score, or improved CGI-TD score.
Valbenazine must not be used in combination with another VMAT2 inhibitor, such as tetrabenazine, or with a monoamine oxidase inhibitor (MAOI), including isocarboxazid, phenelzine, tranylcypromine, or reserpine.
Authorization and Documentation Requirements
Prior Authorization Required
Prior authorization is required for valbenazine (Ingrezza). New-to-market drugs in this class are non-preferred under the Apple Health Preferred Drug List and require documentation of inadequate response or intolerance to preferred therapy.
- Non-preferred agents require inadequate response or documented intolerance due to severe adverse reaction or contraindication to at least two preferred agents.
- If only one preferred agent is available in the class, document inadequate response to that one preferred agent.
- If criteria are not met, a clinical reviewer may approve a medically necessary request on a case-by-case basis; new FDA indications are also reviewed case by case.
Deutetrabenazine Step Therapy
For Huntington disease–associated chorea, document that deutetrabenazine or deutetrabenazine ER is contraindicated, ineffective, or not tolerated before requesting valbenazine.
- An ineffective or not-tolerated trial requires a minimum of 12 weeks.
- The requirement applies unless deutetrabenazine or deutetrabenazine ER is contraindicated.
Prior Antipsychotic Management
For tardive dyskinesia, document persistent symptoms after at least one eligible antipsychotic-management approach, unless the approach is contraindicated, not tolerated, or would place psychiatric stability at risk.
- Switch from a first-generation to a second-generation antipsychotic.
- Trial of two second-generation antipsychotics.
- Discontinuation or dose modification of the offending medication with continued symptoms.
Huntington Disease Initial Documentation
For Huntington disease–associated chorea, submit documentation that the patient is at least 18 years old, has Huntington disease, and is prescribed by or in consultation with a provider specializing in serious mental illness. Include a baseline assessment using at least one applicable section of the Unified Huntington’s Disease Rating Scale (UHDRS).
- Acceptable UHDRS sections include Motor, Cognitive, Behavioral, Functional Assessment, Independence Scale, or Total Functional Capacity.
- Document that valbenazine will not be used with another VMAT2 inhibitor or a monoamine oxidase inhibitor (MAOI).
Tardive Dyskinesia Initial Documentation
For tardive dyskinesia, submit documentation that the patient is at least 18 years old, has a TD diagnosis, and is prescribed by or in consultation with a provider specializing in serious mental illness. Include a baseline assessment and documentation of persistent TD despite an eligible treatment approach.
- Acceptable baseline assessments are the Abnormal Involuntary Movement Scale (AIMS) or Clinical Global Impression of Change–Tardive Dyskinesia (CGI-TD).
- Document that valbenazine will not be used with another VMAT2 inhibitor or an MAOI.
- Document the applicable prior antipsychotic-management approach and any contraindication, intolerance, or psychiatric-stability exception.
Reauthorization Documentation
Reauthorization requests may be approved for 12 months when ongoing exclusion criteria remain satisfied and documentation demonstrates disease stability or a positive clinical response.
- Document continued nonuse with another VMAT2 inhibitor or MAOI.
- For Huntington disease, provide evidence such as reduced involuntary movements or a decreased total maximal chorea score.
- For tardive dyskinesia, provide evidence such as reduced involuntary movements, an improved AIMS score, or an improved CGI-TD score.
Failure to Meet Clinical Criteria
A request may be denied when required clinical criteria are not met or cannot be verified. This includes failure to satisfy age, diagnosis, prescriber-specialty, baseline-assessment, concomitant-medication, or treatment-history requirements.
- The patient is younger than 18 years of age.
- The required Huntington disease or tardive dyskinesia diagnosis is not documented.
- The prescriber is not a specialist in serious mental illness and there is no documented consultation with one.
- The required UHDRS, AIMS, or CGI-TD baseline assessment is absent.
- Valbenazine would be combined with another VMAT2 inhibitor or an MAOI.
- Required deutetrabenazine step therapy for Huntington disease, or required prior antipsychotic management for tardive dyskinesia, is not documented and no applicable exception is established.
Insufficient Reauthorization Documentation
Reauthorization may be denied when ongoing eligibility or treatment benefit is not documented. Requests require continued compliance with the applicable exclusion criteria and evidence of disease stability or positive clinical response.
- No documentation that valbenazine remains uncombined with another VMAT2 inhibitor or MAOI.
- No documented disease stability or positive clinical response.
- For Huntington disease, no evidence such as reduced involuntary movements or decreased total maximal chorea score.
- For tardive dyskinesia, no evidence such as reduced involuntary movements, improved AIMS score, or improved CGI-TD score.
Clinical Background
Huntington disease is an inherited, progressive neurodegenerative disorder associated with choreiform movements, psychiatric problems, and dementia. Treatment is symptomatic and supportive, with clinical assessment of motor and other functional effects used to guide care.
Tardive dyskinesia is a medication-induced hyperkinetic movement disorder caused by dopamine receptor-blocking agents, most often antipsychotic drugs, and may persist after the offending medication is discontinued. Valbenazine is a VMAT2 inhibitor used for chorea associated with Huntington disease and for tardive dyskinesia when the applicable coverage criteria are met.
Definitions
Initial Therapy Criteria
Initial therapy: Huntington disease chorea
Valbenazine may be approved for Huntington disease chorea when ALL clinical criteria are met:
Huntington disease chorea
- Patient is 18 years of age or older.Age >=18
- Treatment is prescribed by, or provided in consultation with, a provider who specializes in treating serious mental illness.
- Huntington disease is diagnosed.
ONE baseline UHDRS section completed
- Motor section
- Cognitive section
- Behavioral section
- Functional Assessment section
- Independence Scale section
- Total Functional Capacity section
- Valbenazine is not used in combination with another VMAT2 inhibitor, such as tetrabenazine, or a monoamine oxidase inhibitor, including isocarboxazid, phenelzine, tranylcypromine, or reserpine.
- Deutetrabenazine or deutetrabenazine ER is contraindicated, ineffective, or not tolerated after a minimum 12-week trial.Minimum prior trial: 12 weeks
Initial therapy: tardive dyskinesia
Valbenazine may be approved for tardive dyskinesia when ALL clinical criteria are met:
Tardive dyskinesia
- Patient is 18 years of age or older.Age >=18
- Treatment is prescribed by, or provided in consultation with, a provider who specializes in treating serious mental illness.
- Tardive dyskinesia (TD) is diagnosed.
ONE baseline assessment completed
- Abnormal Involuntary Movement Scale (AIMS) assessment
- Clinical Global Impression of Change—Tardive Dyskinesia (CGI-TD) assessment
- Valbenazine is not used in combination with another VMAT2 inhibitor, such as tetrabenazine, or a monoamine oxidase inhibitor, including isocarboxazid, phenelzine, tranylcypromine, or reserpine.
ALL of the following
ONE eligible approach
- Switch from a first-generation to a second-generation antipsychotic.
- Trial of two second-generation antipsychotics.
- Discontinuation or dose modification of the offending medication with continued symptoms.
Continuation and Reauthorization
Reauthorization
Valbenazine may be approved for reauthorization when ALL continuation criteria and documentation requirements are met:
- The applicable ongoing treatment-exclusion criterion from the initial authorization criteria continues to be met; specifically, valbenazine is not used in combination with another VMAT2 inhibitor or a monoamine oxidase inhibitor.
- Documentation demonstrates disease stability or a positive clinical response.
Examples include reduced involuntary movements, decreased total maximal chorea score, improved AIMS score, or improved CGI-TD score.
Required Prior Therapies
| Step | Required prior treatment | Duration / outcome |
|---|---|---|
| 1 | Trial of deutetrabenazine or deutetrabenazine ER for Huntington disease chorea | Minimum 12-week trial when attempted; treatment must be contraindicated, ineffective, or not tolerated. The requirement does not apply when contraindicated. |
| Step | Eligible treatment approach for tardive dyskinesia | Required outcome / exceptions |
|---|---|---|
| 1 | Switch from a first-generation to a second-generation antipsychotic | Persistent TD symptoms after the approach, unless contraindicated, not tolerated, or likely to put psychiatric stability at risk. |
| 1 | Trial of two second-generation antipsychotics | Persistent TD symptoms after the approach, unless contraindicated, not tolerated, or likely to put psychiatric stability at risk. |
| 1 | Discontinue or modify the dose of the offending medication | Continued TD symptoms after the approach, unless contraindicated, not tolerated, or likely to put psychiatric stability at risk. |
Quantity Limits
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