ModifiedCentenePolicy CP.PCH.42

Deutetrabenazine (Austedo, Austedo XR) coverage

This policy defines medical necessity criteria, prior authorization requirements, and coverage limitations for deutetrabenazine (Austedo and Austedo XR) for Centene-affiliated health plans, affecting prescribers and members (adults) under Commercial and HIM/ICHRA lines of business.

Policy Summary

PayerCentene

PolicyDeutetrabenazine (Austedo, Austedo XR) coverage

Policy CodePolicy CP.PCH.42

Change TypeMaterial updates — concurrent use exclusion expandedapproval durations extendedAIMS requirement removed

Effective DateJun 1, 2021

Next Review Date

Key ActionProvider must submit documentation (e.g., office chart notes, lab results) demonstrating the member meets specified diagnosis, prescriber specialty, age, and dosing criteria for prior authorization.

SourceLink

POLICY UPDATE CHANGES

Added Ingrezza Sprinkle to the concurrent use exclusion and revised initial approval durations from 6 to 12 months for HIM; added ICHRA line of business.

Added new extended-release dosage formulation Austedo XR and later added new XR strengths (18 mg, 30 mg, 36 mg, 42 mg, 48 mg).

Removed requirement for AIMS score for initial authorizations for tardive dyskinesia.

48 mg/daymax daily dose

≥18min age

12 monthstypical approval

Chorea; TD

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Coverage Criteria for Deutetrabenazine (Austedo, Austedo XR)

Initial Therapy - Chorea (Huntington Disease)

Covered when ALL of the following are met

Chorea Associated with Huntington Disease - Initial: 1. Diagnosis of chorea associated with Huntington disease; 2. Prescribed by or in consultation with a neurologist; 3. Age ≥ 18 years; 4. Targeted mutation analysis demonstrates a CAG trinucleotide expansion of ≥ 36 repeats in the HTT gene; 5. Evidence of chorea is supported by a UHDRS score of 1 to 4 on any one of chorea items 1 through 7; 6. Austedo/Austedo XR is not prescribed concurrently with tetrabenazine or Ingrezza/Ingrezza Sprinkle; 7. Dose does not exceed 48 mg per day.dose ≤ 48 mg/day

Approval duration: 12 months (HIM/ICHRA and Commercial)

Initial Therapy - Tardive Dyskinesia

Covered when ALL of the following are met

Tardive Dyskinesia - Initial: 1. Diagnosis of TD secondary to treatment with a centrally acting dopamine receptor blocking agent (DRBA); 2. Prescribed by or in consultation with a psychiatrist or neurologist; 3. Age ≥ 18 years; 4. Austedo/Austedo XR is not prescribed concurrently with tetrabenazine or Ingrezza/Ingrezza Sprinkle; 5. Dose does not exceed 48 mg per day.dose ≤ 48 mg/day

Approval duration: 12 months (HIM/ICHRA and Commercial)

Continued Therapy

Covered when ALL of the following are met

Continued Therapy - All Indications: 1. Member meets one of the following: a) currently receiving medication via Centene benefit or previously met initial approval criteria; or b) currently receiving medication with applicable continuity-of-care regulations; 2. Member is responding positively to therapy: for Huntington disease, reduction since baseline in any one UHDRS chorea item 1–7; for TD, reduction since baseline in any one AIMS item 1–9; 3. Austedo/Austedo XR is not prescribed concurrently with tetrabenazine or Ingrezza/Ingrezza Sprinkle; 4. If request is for a dose increase, new dose does not exceed 48 mg per day.

Approval duration: 12 months

Clinical criteria and dosing

Clinical diagnostic and dosing considerations noted in policy content

TD diagnostic requirements: Abnormal involuntary movements of the tongue, jaw, trunk, or extremities present ≥ 4 weeks AND history of exposure to a dopamine receptor blocking agent for ≥ 3 months (≥ 1 month if age ≥ 60 years), or onset during exposure or within 4 weeks of withdrawal from an oral agent (8 weeks after long-acting injectable).see text

From DSM-5-TR/policy appendix

Dosing limits: Maximum recommended daily dosage 48 mg/day (36 mg/day in poor CYP2D6 metabolizers or when used with strong CYP2D6 inhibitors). Austedo IR and Austedo XR dosing and titration guidance provided; when switching between formulations, use the same total daily dose.48 mg/day

See product dosing section

Non–FDA approved indications that are not specifically addressed by this policy are not authorized for coverage unless the provider submits sufficient documentation of efficacy and safety consistent with the applicable off‑label use policies: CP.CPA.09 for Commercial lines and HIM.PA.154 for Health Insurance Marketplace/ICHRA, or unless coverage is established in separate evidence of coverage documents.

Important safety considerations and contraindications include a boxed warning for depression and suicidality in patients with Huntington disease. The medication is contraindicated in patients with suicidal or untreated/inadequately treated depression, in those with significant hepatic impairment, and in patients taking interacting agents such as reserpine, monoamine oxidase inhibitors (MAOIs), tetrabenazine, or valbenazine.

Concurrent use with other VMAT2 agents is excluded. The policy's concurrent‑use exclusion has been updated to explicitly include Ingrezza Sprinkle (valbenazine sprinkle), and requests for therapy that involve simultaneous use with tetrabenazine or Ingrezza/Ingrezza Sprinkle are not permitted under this policy.

Requests for deutetrabenazine to treat indications that are not FDA‑approved and are not covered in this policy require submission of clinical evidence supporting efficacy and safety in accordance with the referenced off‑label use policies (CP.CPA.09 for Commercial or HIM.PA.154 for HIM/ICHRA). Without that supporting documentation, coverage is not authorized.

Within the excerpt provided there are no explicit statements framed using the phrase 'not medically necessary.' The policy instead identifies non‑authorized indications and refers off‑label requests to the applicable off‑label use policies for determination.

Coding and Diagnostic Codes

Tardive Dyskinesia ICD-10ICD-10

G24.01

Tardive Dyskinesia

Diagnosis CodesICD-10

G24.01

Tardive dyskinesia

UHDRS Chorea Item Score

UHDRS chorea item scoreScore of 1 to 4 on any one of the seven UHDRS chorea items (items 1–7)

Supporting useUsed to document presence and severity of chorea for Huntington disease coverage determination

Source appendixSee Appendix D: Unified Huntington Disease Rating Scale (UHDRS) for scoring details

HTT CAG Repeats

HTT CAG repeats thresholdCAG trinucleotide expansion of ≥ 36 repeats in the huntingtin (HTT) gene is required

Test typeTargeted mutation analysis for HTT CAG expansion

Provider Actions, Prior Authorization, and Documentation

Prior Authorization

Prior Authorization Required

Prior authorization is required. Providers must submit evidence that the member meets specified diagnosis, prescriber specialty, age, and dosing criteria for the requested indication. Prior authorization decisions require supporting clinical documentation (e.g., office chart notes, lab results, specialist consultation notes) demonstrating the member meets all applicable approval criteria.

Prior authorization required for Austedo/Austedo XR for covered indications
Documentation must show member meets all approval criteria (diagnosis, prescriber specialty, age, dosing limits)

Denial Risk

Prior Authorization Exclusions and Denial Triggers

Policy exclusions and prior-authorization-related restrictions that may trigger denial include: lack of submitted documentation supporting that the member has met approval criteria, prescribing without the required specialist consultation, and concurrent use with excluded agents. Specifically, Austedo/Austedo XR must not be prescribed concurrently with tetrabenazine or Ingrezza/Ingrezza Sprinkle; Ingrezza Sprinkle is listed in the concurrent use exclusion.

Background

Deutetrabenazine (Austedo and Austedo XR) is a vesicular monoamine transporter 2 (VMAT2) inhibitor approved for the treatment of chorea associated with Huntington disease and for tardive dyskinesia in adults. Huntington disease chorea severity is commonly assessed using the UHDRS chorea items, and tardive dyskinesia is assessed using the Abnormal Involuntary Movement Scale (AIMS).

Definitions and Assessment Tools

Deutetrabenazine Mechanism

Mechanism of actionVesicular monoamine transporter 2 (VMAT2) inhibitor

Approved productsDeutetrabenazine marketed as Austedo and Austedo XR

Therapeutic roleUsed to reduce hyperkinetic movements such as chorea and tardive dyskinesia

UHDRS Chorea

DefinitionUnified Huntington Disease Rating Scale (UHDRS) chorea subscore rates seven body regions on a 0–4 scale

Items coveredSeven body regions assessed (facial, bucco‑oral‑lingual, trunk, extremities) with 0 = no chorea and 4 = severe

Use in policy

Revision History and Change Log

2026-04-09policy_revisionLatest

Added Ingrezza Sprinkle to the concurrent use exclusion and revised initial approval durations from 6 to 12 months for HIM; added ICHRA line of business.

2024-07-10formulary_update

Added new strengths of Austedo XR extended‑release tablets (18 mg, 30 mg, 36 mg, 42 mg, 48 mg).

2023-03-13formulary_update

Policy Summary

PayerCentene

PolicyDeutetrabenazine (Austedo, Austedo XR) coverage

Policy CodePolicy CP.PCH.42

Change TypeMaterial updates — concurrent use exclusion expandedapproval durations extendedAIMS requirement removed

Effective DateJun 1, 2021

Next Review Date

SourceLink

On This Page

Indication linkRequired as part of initial approval criteria for chorea associated with Huntington disease

Minimum Exposure Duration for TD Diagnosis

Minimum exposure duration (general)>= 3 months of exposure to a dopamine receptor blocking agent for TD diagnosis

Exception for older adults>= 1 month if age ≥ 60 years

ContextPart of diagnostic criteria describing required history of exposure to offending agent

Movement Duration for TD Diagnosis

Movement duration requirement>= 4 weeks of abnormal involuntary movements to consider a diagnosis of tardive dyskinesia

Relation to withdrawalMovements may emerge during exposure or within 4 weeks of withdrawal from an oral agent (8 weeks for long‑acting injectable)

Role in diagnosisIf dyskinesia persists for ≥ 4 weeks, TD diagnosis may be warranted

Concurrent use exclusion: tetrabenazine and Ingrezza/Ingrezza Sprinkle
May be denied if required specialist consultation (e.g., neurologist or psychiatrist per indication) is not documented
May be denied for insufficient supporting clinical documentation

Documentation Required

AIMS Assessment

The Abnormal Involuntary Movement Scale (AIMS) is described in the policy as a clinician-rated 12‑item assessment tool commonly used to evaluate severity of involuntary movements including TD. However, per the policy change log, the requirement to submit an AIMS score for initial authorization for tardive dyskinesia (TD) was removed; AIMS may still be used in clinical assessment but is not required for initial prior authorization.

AIMS: clinician-rated 12-item tool (items 1-10 rated 0-4; items 11-12 yes/no)
Requirement for AIMS score for initial TD authorizations removed per policy update

Step Therapy

No explicit step therapy sequences are required in the provided policy text for initial authorization of Austedo/Austedo XR. The policy does require specific prescriber specialties (e.g., neurologist for Huntington chorea; psychiatrist or neurologist for TD) and other diagnosis-specific criteria rather than step therapy steps.

No step-therapy sequence specified in the policy excerpt
Provider must meet prescriber specialty and diagnosis-specific criteria instead of step therapy

UHDRS chorea score is used to support evidence of chorea for initial and continued coverage

AIMS (Abnormal Involuntary Movement Scale)

DefinitionAbnormal Involuntary Movement Scale (AIMS) assesses involuntary movements across multiple items and body regions

ScopeAIMS items 1–9 assess dyskinesia (items 1–7 by region, items 8–9 overall); items 11–12 are yes/no dental questions

Role in policyAIMS is referenced as a tool to document response for tardive dyskinesia, though requirement for initial AIMS score was removed per change log

Tardive Dyskinesia

DefinitionTardive dyskinesia: a medication‑induced movement disorder characterized by abnormal, involuntary movements (tongue, jaw, trunk, extremities) associated with dopamine receptor blocking agents

Typical causesOften occurs after exposure to first‑ or second‑generation antipsychotics and other DRBAs (e.g., metoclopramide)

Clinical featuresMovements may be choreiform, athetoid, or semirhythmic and are present over a period of ≥ 4 weeks

AIMS (Instrument Details)

AIMS instrument descriptionClinician‑rated 12‑item tool; items 1–10 rated 0–4 and items 11–12 are yes/no; items 1–7 assess regional dyskinesia

Scoring detailsItems 1–10 use a 5‑point scale (0 none to 4 severe); item 8 uses the highest score of any one of items 1–7

Use casesDeveloped by NIMH and used in research and clinical practice to evaluate severity of TD and treatment response

Added the extended‑release dosage formulation Austedo XR to the policy.

2022-05-20clinical_change

Removed requirement for AIMS score for initial authorizations for tardive dyskinesia per May SDC and prior clinical guidance.

2022-01-31annual_review

2Q 2022 annual review - no significant clinical changes; references reviewed and updated.

2022-09-29template_update

Applied template changes to other diagnoses/indications and the continued therapy section.

2025-02-23annual_review

2Q 2025 annual review - updated appendix definitions per DSM-5-TR; references reviewed and updated.