Currentmedical mutual - ohioPolicy N/A

Austedo (deutetrabenazine) coverage

Defines prior authorization, clinical criteria, documentation, and approval durations for Austedo and Austedo XR for treatment of Huntington disease chorea and tardive dyskinesia for Medical Mutual - Ohio members.

Policy Summary

Payermedical mutual - ohio

PolicyAustedo (deutetrabenazine) coverage

Policy CodePolicy N/A

Change TypeAnnual review — no material changes

Effective DateN/A

Next Review DateJul 17, 2025

Key ActionObtain prior authorization and ensure the prescription is by or in consultation with a specialist; document trials of preferred agents and supporting records.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

2FDA-approved indications covered

1 yrInitial approval duration

≥6AIMS threshold

≥18Minimum age

Coverage Criteria for Austedo (deutetrabenazine)

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Chorea associated with Huntington disease (HD)

a) Diagnosis confirmation: Diagnosis of Huntington's disease is confirmed by genetic testing (for example, an expanded HTT CAG repeat sequence of at least 36).
b) Age: Patient is > 18 years of age.
c) Prescriber specialty: The medication is prescribed by or in consultation with a neurologist.
d) Step therapy exception to preferred agent: Patient has tried generic tetrabenazine tablets AND cannot continue to use the preferred medication due to a formulation difference in the inactive ingredient(s) (e.g., dyes, fillers, preservatives) which, per the prescriber, would result in a significant allergy or serious adverse reaction.
Prescriber must provide documentation of prior trial and intolerance/allergy; see Documentation Requirements for acceptable records.

Tardive Dyskinesia (TD)

a) Prescriber specialty: The medication is prescribed by or in consultation with a neurologist or psychiatrist.
b) Severity threshold: Patient has an Abnormal Involuntary Movement Scale (AIMS) score of 6 or greater.AIMS >= 6
c) Age: Patient is ≥ 18 years of age.
d) Clinical diagnosis: Patient has been clinically diagnosed with TD according to DSM‑V criteria: i) involuntary athetoid or choreiform movements; AND ii) history of treatment with a neuroleptic agent (antipsychotic); AND iii) symptoms lasting longer than 4–8 weeks.

The Company may determine that the drug provided was not medically necessary, investigational or experimental, or not within the scope of member benefits and deny reimbursement. The Company may also deny payment when a pattern of inappropriate or excessive billing/practice is identified; additional documentation (e.g., patient records, test results, provider credentials) may be requested to substantiate medical necessity.

Prescriber Requirements, Prior Authorization, and Documentation

Prior Authorization

Prior Authorization and Specialist Prescriber Requirement

Prior authorization is recommended for pharmacy benefit coverage of Austedo and Austedo XR. Initial approval requires the medication be prescribed by or in consultation with a physician who specializes in the condition being treated (e.g., neurologist for Huntington disease or neurologist/psychiatrist for tardive dyskinesia). All approvals for initial therapy are provided for the initial approval duration noted in the policy; reauthorization (if allowed) requires documentation of response to therapy.

Initial approval requires specialist prescriber or consultation (see policy criteria).
Prior authorization recommended for pharmacy benefit coverage.

Step Therapy

Step Therapy Requirement for Huntington Disease Chorea

For the FDA‑approved indication Chorea associated with Huntington disease (HD), the patient must have tried generic tetrabenazine tablets. Approval is contingent on documentation that the patient cannot continue the preferred medication due to a formulation difference in inactive ingredient(s) (e.g., dyes, fillers, preservatives) that the prescriber states would cause a significant allergy or serious adverse reaction.

HD chorea step therapy: trial of generic tetrabenazine required prior to Austedo/Austedo XR.
If the patient cannot continue the preferred medication, prescriber must document the specific formulation difference and clinically justify inability to use the preferred agent.

Documentation Required

Provider Documentation and Potential Denial Conditions

The prescriber must provide written documentation supporting trials of other agents or the requested medical information when noted in the criteria (indicated by an asterisk). Documentation should include, but is not limited to, chart notes, prescription claims records, and/or prescription receipts. The Company may request additional documentation as part of its coverage determination and may deny reimbursement if the drug is determined not medically necessary, investigational/experimental, outside the member’s benefits, or if inappropriate/excessive billing or practice patterns are found. Additional documentation that may be requested includes patient records, test results, and/or credentials of the provider ordering or performing the service.

Written documentation examples: chart notes; prescription claims records; prescription receipts.
The Company may request further records and may deny reimbursement when medical necessity is not met or for investigational/experimental uses.

Drug Background and Mechanism

Austedo (deutetrabenazine) and Austedo XR act by inhibiting vesicular monoamine transporter type 2 (VMAT2), reducing monoamine uptake into synaptic vesicles and depleting monoamine stores. This mechanism decreases involuntary movements and is the basis for use in chorea associated with Huntington disease (HD) and tardive dyskinesia (TD) in adults. These agents have been studied in other populations (for example, a small Phase Ib pediatric trial in Tourette syndrome), but the approved indications and the clinical criteria in this policy apply to adults with HD chorea and TD.

Mechanism / Definition Notes

inv-10: VMAT2 inhibition / mechanism — Austedo and its metabolites reversibly inhibit vesicular monoamine transporter type 2 (VMAT2), decreasing monoamine uptake into synaptic ...

Mechanism of actionAustedo and its major circulating metabolites reversibly inhibit vesicular monoamine transporter type 2 (VMAT2), resulting in decreased uptake of monoamines into synaptic vesicles and depletion of monoamine stores

Affected neurotransmittersDepletes monoamines such as dopamine, serotonin, norepinephrine, and histamine

Clinical effectReversible monoamine depletion from nerve terminals contributes to reduction of chorea in Huntington disease and treatment of tardive dyskinesia