CurrentCignaPolicy IP0208

Vesicular Monoamine Transporter Type 2 Inhibitors - Tetrabenazine

Defines Cigna's prior authorization and medical necessity criteria for tetrabenazine (Xenazine and generics) for treatment of chorea in Huntington's disease and selected other hyperkinetic movement disorders for adult members.

Policy Summary

PayerCigna

PolicyVesicular Monoamine Transporter Type 2 Inhibitors - Tetrabenazine

Policy CodePolicy IP0208

Change TypeTitle updateclarification of tardive dyskinesia phrasing

Effective Date

Next Review Date

Key ActionObtain prior authorization and document specialist prescriber and required genetic confirmation when requesting tetrabenazine.

SourceLink

POLICY UPDATE CHANGES

The wording for the tardive dyskinesia requirement was changed from 'Individual has a history of treatment with a dopamine receptor blocking agent (for example, ...)' to 'Patient has a history of use of dopamine receptor blocking agent' and examples were moved to a note.

Updated the policy title from 'Tetrabenazine' to 'Vesicular Monoamine Transporter Type 2 Inhibitors - Tetrabenazine.'

The 'Conditions Not Covered' statement was reworded.

1 yearstandard approval duration

≥18minimum age

4covered indications

Prior Auth

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Coverage and Medical Necessity Criteria

FDA-Approved Indication — Huntington's chorea

Covered when ALL of the following are met (FDA-approved indication):

Chorea associated with Huntington's disease (FDA) - approval for 1 year: A) Patient is >= 18 years of age; AND B) Diagnosis of Huntington's disease is confirmed by genetic testing (for example, an expanded HTT CAG repeat sequence of at least 36); AND C) The medication is prescribed by or in consultation with a neurologist; AND D) Preferred product criteria is met for the product(s) as listed in the below table(s)

Other supported indications

Covered when ALL of the following are met (Other uses with supportive evidence):

Hyperkinetic dystonia - approval for 1 year: A) Patient is >= 18 years of age; AND B) The medication is prescribed by or in consultation with a neurologist; AND C) Preferred product criteria is met for the product(s) as listed in the below table(s)

Tardive dyskinesia - approval for 1 year: A) Patient is >= 18 years of age; AND B) Patient has a history of use of dopamine receptor blocking agent; AND C) The medication is prescribed by or in consultation with a neurologist or psychiatrist; AND D) Preferred product criteria is met for the product(s) as listed in the below table(s)

Examples of dopamine receptor blocking agents include dopamine agonists (e.g., pramipexole, ropinirole), antipsychotics, metoclopramide, prochlorperazine.

Tourette syndrome and related tic disorders - approval for 1 year: A) Patient is >= 18 years of age; AND B) The medication is prescribed by or in consultation with a neurologist; AND C) Preferred product criteria is met for the product(s) as listed in the below table(s)

Brand vs generic product criteria

Brand-specific criteria for Xenazine when coverage is available under certain plans:

Employer and Individual/Family plans - Xenazine brand criteria: A) Patient meets the above medical necessity criteria; AND B) Patient tried generic tetrabenazine tablets; AND ii) Patient cannot continue to use generic tetrabenazine tablets due to a formulation difference in inactive ingredients which would result in a significant allergy or serious adverse reaction per the prescribing physician.

Applies to Employer Plans and Individual and Family Plans as specified.

Tetrabenazine (Xenazine and generic tetrabenazine) for any use not specifically listed as a covered indication in this policy is considered not medically necessary.

Use of tetrabenazine for indications not enumerated in this policy is considered not medically necessary; the policy's "Conditions Not Covered" language has been reworded in recent revisions and will be updated as new published data become available.

Coding and Identifiers

Referenced drug identifiersNDC

NDC	Not specified in document; policy references Xenazine (tetrabenazine tablets) and generics

HTT CAG repeat — threshold

HTT CAG repeat lengthExpanded HTT CAG repeat sequence of at least 36

ContextRequired for genetic confirmation of Huntington's disease when seeking tetrabenazine for chorea

Related approval detailUsed as part of criteria for 1-year approval for chorea associated with Huntington's disease (patient must also be ≥ 18 years and prescribed by/with a neurologist)

Prescriber Requirements, Authorization, and Billing

Prior Authorization

Prior Authorization Required

Prior Authorization is required for prescription benefit coverage of tetrabenazine. Approvals are typically provided for 1 year per indication. Because of the specialized skills required for evaluation and diagnosis of patients treated with tetrabenazine and the monitoring required for adverse events and long-term efficacy, tetrabenazine must be prescribed by or in consultation with a physician who specializes in the condition being treated.

Prior authorization required for tetrabenazine
Typical approval duration: 1 year per indication
Prescriber requirement: prescribed by or in consultation with a specialist (e.g., neurologist or psychiatrist as indicated)

Step Therapy

Brand vs Generic Step Therapy

When coverage is available and medically necessary, the prescriber must document that the patient tried generic tetrabenazine tablets before a request for brand Xenazine will be approved for employer and individual/family plans. The prescriber must also document the clinical justification that the patient cannot continue generic tetrabenazine due to a formulation-related significant allergy or serious adverse reaction attributable to inactive ingredient differences (e.g., dyes, fillers, preservatives).

Background and Clinical Context

Tetrabenazine is a vesicular monoamine transporter type 2 (VMAT2) inhibitor. It is FDA‑indicated for treatment of chorea associated with Huntington's disease in adults and is approved under that indication when specified criteria are met. Tetrabenazine has also been studied for other hyperkinetic movement disorders, including tardive dyskinesia and tic disorders, though those uses are generally off‑label and supported by varying levels of evidence; policy revisions note changes in wording regarding history of use of dopamine receptor blocking agents and relocation of example agents to a note.

Definitions and Terms

Tetrabenazine — key facts

Drug classVesicular monoamine transporter type 2 (VMAT2) inhibitor

FDA-indicationIndicated for treatment of chorea associated with Huntington's disease in adults

Typical approval durationApprovals for indicated use are provided for 1 year per policy when criteria are met

Common name/brandTetrabenazine (Xenazine and generics)

Dopamine receptor blocking agent — definition and examples

DefinitionAgents that can cause tardive dyskinesia (disease linked to prior exposure to dopamine receptor blocking agents)

Examples (policy note)

Policy Summary

PayerCigna

PolicyVesicular Monoamine Transporter Type 2 Inhibitors - Tetrabenazine

Policy CodePolicy IP0208

Change TypeTitle updateclarification of tardive dyskinesia phrasing

Effective Date

Next Review Date

Key ActionObtain prior authorization and document specialist prescriber and required genetic confirmation when requesting tetrabenazine.

SourceLink

On This Page

Applies to Brand Xenazine for Employer Plans and Individual and Family Plans
Requirement: trial of generic tetrabenazine tablets documented
Requirement: documentation of inability to use generic due to inactive-ingredient formulation difference causing significant allergy or serious adverse reaction, per prescribing physician

Documentation Required

Prescriber and Documentation Requirements

Tetrabenazine approval requires that the medication be prescribed by or in consultation with a physician who specializes in the condition being treated (for example, a neurologist for chorea, hyperkinetic dystonia, Tourette syndrome; a neurologist or psychiatrist for tardive dyskinesia). Documentation in the prior authorization request should include confirmation of specialist involvement/consultation and the clinical information supporting the diagnosis and indication (e.g., genetic test confirming Huntington's disease when applicable, history of dopamine receptor blocking agent use for tardive dyskinesia, age confirmation, and any prior medication trials).

Prescriber requirement: specialist or consultation (neurologist or psychiatrist as appropriate)
Required documentation: diagnosis confirmation (e.g., genetic testing for Huntington's disease), age, prior medication trials, and rationale for brand use if applicable
Clinical documentation must support the selected indication and length of therapy (typical approval duration: 1 year)

Billing Rule

Billing / Code Mismatch — Denial Risk

Claims submitted without covered diagnosis or procedure codes supporting the medical necessity of tetrabenazine will be denied. When billing, providers must use the most appropriate and current codes as of the date of service. Receipt of sample product does not satisfy any criteria requirements for coverage.

Claims lacking a covered diagnosis or applicable procedure code will be denied
Use the most appropriate codes current on the date of service
Receipt of sample product does not fulfill coverage criteria

Examples include antipsychotics, metoclopramide, and prochlorperazine (examples were moved to a note in the policy)

Relevance to coverageHistory of use of a dopamine receptor blocking agent is required for tetrabenazine coverage for tardive dyskinesia