CurrentBlue Cross Blue Shield - IowaPolicy 05.02.19

VMAT2 inhibitors (valbenazine, deutetrabenazine) — coverage and prior authorization criteria

Covers medical necessity and prior authorization criteria for VMAT2 inhibitor therapies (valbenazine/Ingrezza and deutetrabenazine/Austedo) for treatment of tardive dyskinesia and chorea associated with Huntington's disease for Wellmark/Blue Cross Blue Shield - Iowa members.

Policy Summary

PayerBlue Cross Blue Shield - Iowa

PolicyVMAT2 inhibitors (valbenazine, deutetrabenazine) — coverage and prior authorization criteria

Policy CodePolicy 05.02.19

Change TypeNo material change

Effective Date

Next Review DateJun 1, 2025

Key ActionObtain prior authorization and submit baseline AIMS score and documentation of prior Austedo trial or contraindication.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

3 moInitial: TD

6 moInitial: HD chorea

12 moContinuation

30/dayIngrezza limit

Coverage Criteria

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inv-01: Initial approval — Tardive Dyskinesia

Covered when ALL of the following are met for initial approval of valbenazine/deutetrabenazine for tardive dyskinesia:

Initial TD criteria: Member is 18 years of age or older; member has persistent symptoms of tardive dyskinesia despite a trial of dose reduction, tapering, or discontinuation of the offending medication OR member is not a candidate for such a trial; documentation of baseline Abnormal Involuntary Movement Scale (AIMS) score has been provided; and at least ONE of: inadequate response to a minimum of three months of therapy with Austedo (deutetrabenazine), intolerable adverse event attributed to Austedo, or at least one contraindication to Austedo (including Huntington's disease with suicidal ideation or untreated/ inadequately treated depression, hepatic impairment, concomitant use of a monoamine oxidase inhibitor [MAOI], use of reserpine, or use of tetrabenazine).

Authorization of 3 months may be granted.

inv-02: Initial approval — Chorea associated with Huntington's disease

Covered when ALL of the following are met for initial approval of valbenazine/deutetrabenazine for chorea in Huntington's disease:

Initial HD chorea criteria: Member demonstrates characteristic motor examination features; diagnosis confirmed by genetic testing with expanded HTT CAG repeat >= 36; member has had an inadequate response to a minimum of three months of therapy with Austedo (deutetrabenazine) OR has experienced an intolerable adverse event attributed to Austedo OR has at least one contraindication to Austedo (including Huntington's disease with suicidal ideation or untreated/inadequately treated depression, hepatic impairment, concomitant MAOI use, use of reserpine, or use of tetrabenazine).

Authorization of 6 months may be granted.

inv-03: Continuation therapy

Continuation approval criteria:

Continuation TD: Documentation of positive clinical response to therapy defined by improvement in member's Abnormal Involuntary Movement Scale (AIMS) score.

Authorization of 12 months may be granted.

Continuation HD chorea: Disease has improved or stabilized as documented by clinical assessment.

Authorization of 12 months may be granted.

This medical policy may not apply to the Federal Employee Program (FEP). Benefit determinations are based on the specific contract language in effect at the time services are rendered, and exclusions, limitations, or exceptions may apply. Individual member benefits must be verified; Wellmark only determines medical necessity when the benefit exists and no contract exclusions are applicable.

Use of valbenazine (Ingrezza) or deutetrabenazine (Austedo) is not supported when the member does not meet the specific diagnostic, age, or prior‑therapy criteria described for each indication or when required documentation is not provided. For both tardive dyskinesia and Huntington disease–associated chorea, the policy requires documentation of trials and/or contraindications to Austedo (deutetrabenazine) or a clear rationale why such a trial is not appropriate (for example, intolerable adverse event, contraindication, or member not a candidate for dose reduction/taper/discontinuation of an offending agent). Failure to submit required baseline and follow‑up documentation (including AIMS scores for initial and continuation requests) may result in denial.

Provider Actions and Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required for initial and continuation therapy. Initial approvals: up to 3 months for tardive dyskinesia and up to 6 months for chorea associated with Huntington's disease when criteria are met. Continuation approvals: up to 12 months when there is documented clinical benefit or stabilization as described below.

Initial approval durations: 3 months (tardive dyskinesia), 6 months (Huntington's chorea)
Continuation approval duration: 12 months when improvement or stabilization documented

Documentation Required

Required Documentation

For initial requests, submit baseline documentation and prior treatment history. For continuation requests, submit objective evidence of clinical benefit.

Initial requests: chart notes documenting baseline Abnormal Involuntary Movement Scale (AIMS) score; chart notes detailing outcomes of prior treatments, intolerable adverse events, or contraindications to Austedo (deutetrabenazine).
Continuation requests: chart notes documenting improvement in AIMS score and documentation of a positive clinical response (improvement in signs and symptoms of tardive dyskinesia).
Failure to submit required documentation may result in denial of the request.

Step Therapy

Step Therapy / Prior Medication Trial

Request must demonstrate trials of or contraindications to alternatives before Austedo is approved for tardive dyskinesia or Huntington's chorea when applicable.

Step therapy requirement: Member must have had an inadequate response to a minimum of three months of therapy with Austedo (deutetrabenazine) when applicable to the indication.
If member is not a candidate for dose reduction, tapering, or discontinuation of the offending medication, document reason(s).
Document any intolerable adverse events attributable to alternative agents (e.g., tetrabenazine, reserpine) or contraindications that preclude their use (e.g., hepatic impairment, concomitant MAOI use, Huntington's disease with active suicidal ideation or untreated/undertreated depression).

Background

VMAT2 inhibitors (valbenazine and deutetrabenazine) are FDA‑approved options for the treatment of adult tardive dyskinesia and for chorea associated with Huntington’s disease. For tardive dyskinesia, coverage is intended for adults with persistent symptoms despite dose reduction/taper/discontinuation of the offending agent or for those who are not candidates for such a trial; baseline Abnormal Involuntary Movement Scale (AIMS) documentation is required. For Huntington’s chorea, diagnosis must be confirmed by genetic testing (expanded HTT CAG repeat >= 36) and members must demonstrate characteristic motor features. Approvals are intended to align with FDA labeling and evidence‑based practice; dosing and quantity limits (for example, Ingrezza quantity limits) may apply.

Definitions

inv-13: AIMS — Abnormal Involuntary Movement Scale definition and use

AIMS definitionAbnormal Involuntary Movement Scale — standardized scale used to document severity of tardive dyskinesia and to monitor response to therapy

When to documentBaseline AIMS score required with initial authorization requests

Use for continuationFollow-up AIMS scores or documentation of improvement in AIMS required to support continuation/renewal

PurposeObjective measure to assess severity and treatment response for VMAT2 inhibitor therapy

VMAT2 Inhibitor Pharmacotherapy

inv-14: VMAT2 inhibitor pharmacotherapy — treatment options node

Dosage/administration limits: Approvals may be subject to dosing limits in accordance with FDA-approved labeling, accepted compendia, and/or evidence-based practice guidelines; quantity limits apply (Ingrezza 30 sprinkle capsules/30 days or Ingrezza 30 capsules/30 days).