ModifiedmhnPolicy CP.PCH.42

Deutetrabenazine (Austedo, Austedo XR) coverage

Medical necessity and prior authorization criteria for coverage of deutetrabenazine (Austedo/Austedo XR) for Huntington disease chorea and tardive dyskinesia, describing prescriber, age, diagnostic, dosing, and continuity requirements for affected commercial and HIM lines of business.

Policy Summary

Payermhn

PolicyDeutetrabenazine (Austedo, Austedo XR) coverage

Policy CodePolicy CP.PCH.42

Change TypeMaterial coverage updates and product additions

Effective DateJun 1, 2021

Next Review Date

Key ActionSubmit prior authorization with documentation of diagnosis, prescriber specialty, age ≥18, and dosing not exceeding 48 mg/day.

SourceLink

POLICY UPDATE CHANGES

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

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

Updated Appendix definitions per updated DSM-5-TR during 2Q 2025 annual review.

≥18minimum age for coverage

48 mgmax daily dose

36 mgreduced dose (CYP2D6 issues)

12 moCommercial approval dur.

Trek Health ingests and normalizes Transparency in Coverage data and payer policy updates to give provider organizations a clear view of how commercial reimbursement behaves across markets, payers, and services. Our platform transforms raw payer disclosures into structured intelligence that supports contract evaluation, payer negotiations, and service line strategy. By combining market benchmarks with ongoing policy visibility, Trek helps teams identify variability, risk, and opportunity in commercial reimbursement. The result is faster insight, stronger negotiating positions, and more informed financial decisions.

6 moHIM approval dur.

Coverage Criteria for Deutetrabenazine (Austedo / Austedo XR)

inv-01: Chorea Associated with Huntington Disease (Initial)

Covered when ALL of the following are met:

Chorea Associated with Huntington Disease - initial criteria: 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 supported by UHDRS score 1-4 on any one of chorea items 1 through 7; 6. Austedo/Austedo XR is not prescribed concurrently with tetrabenazine or Ingrezza; 7. Dose does not exceed 48 mg per day.

inv-02: Tardive Dyskinesia (Initial)

Covered when ALL of the following are met:

Tardive Dyskinesia - initial criteria: 1. Diagnosis of TD secondary to treatment with a centrally acting dopamine receptor blocking agent; 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; 5. Dose does not exceed 48 mg per day.

inv-03: All Indications — Continuation

Covered when ALL of the following are met:

Continuation criteria: 1. Member currently receiving medication via Centene benefit or previously met initial approval OR member receiving medication under continuity of care regulations; 2. For Huntington disease: member is responding to therapy evidenced by reduction since baseline in any one UHDRS chorea item; for TD: member is responding to therapy evidenced by reduction since baseline in any one AIMS item; 3. Austedo/Austedo XR is not prescribed concurrently with tetrabenazine or Ingrezza; 4. If request is for a dose increase, the new dose does not exceed 48 mg per day.

inv-04: Other Diagnoses/Indications

If use is not covered above, follow formulary/non-formulary and off-label policies:

Alternate handling for new label changes or unlisted uses: 1. If the drug had a recent label change (within the last 6 months) not yet reflected in this policy, refer to the applicable formulary/no-coverage or non-formulary policy for the relevant line of business (see CP.CPA.190, HIM.PA.33, HIM.PA.103 as applicable); 2. If the requested use (diagnosis, age, dosing) is not specifically listed and criterion 1 does not apply, refer to the off-label use policy for the relevant line of business (CP.CPA.09 or HIM.PA.154).

inv-05: Dosing and titration

Coverage and dosing guidance highlights

Dosing limits: Maximum recommended daily dose is 48 mg/day; reduce to 36 mg/day in poor CYP2D6 metabolizers or when combined with strong CYP2D6 inhibitors.48 mg/day; 36 mg/day for poor metabolizers/strong inhibitors

Titrate weekly by 6 mg/day for TD when using Austedo up to 48 mg/day; when switching between Austedo and Austedo XR, match total daily dose; product strengths include Austedo immediate-release (6, 9, 12 mg) and Austedo XR extended-release (6, 12, 18, 24, 30, 36, 42, 48 mg).

inv-06: Assessment (AIMS)

Assessment tools

AIMS usage: AIMS is a 12-item clinician-rated tool used to evaluate severity of involuntary movements in TD; items 1-10 are scored 0-4, items 11-12 are yes/no, and item 8 uses the highest score of items 1-7. A prior requirement for an AIMS score for initial TD authorization has been removed per policy history.AIMS items 1-10: 0-4

See Appendix H and Munetz 1988 for additional AIMS details.

Requests for deutetrabenazine (Austedo/Austedo XR) for indications that are not FDA‑approved and are not specifically addressed in this policy will not be authorized unless the provider submits sufficient documentation of efficacy and safety consistent with the applicable off‑label use policies (CP.CPA.09 for commercial and HIM.PA.154 for health insurance marketplace) or other evidence of coverage documents.

Contraindications for deutetrabenazine include: patients with Huntington disease who have suicidal ideation or untreated or inadequately treated depression; patients with hepatic impairment; and concurrent use with the following medications: reserpine, monoamine oxidase inhibitors (MAOIs), tetrabenazine, or valbenazine. The policy also notes a boxed warning for depression and suicidality in patients with Huntington disease.

Within the provided excerpt there are no additional explicit exclusion criteria listed beyond the contraindications and non‑FDA‑approved indication handling noted elsewhere in this policy.

The excerpt does not contain any explicit statements labeled "Not Medically Necessary"; coverage determinations are described through the policy's authorized indications, contraindications, and required supporting documentation.

Coding — Diagnosis and Scoring

Covered ICD-10 Diagnosis CodesICD-10Covered

G24.01

Tardive Dyskinesia (ICD-10)

Neutral ICD-10 Diagnosis CodesICD-10

G24.01

Tardive Dyskinesia (ICD-10)

HTT CAG repeats — Key threshold for Huntington disease

HTT CAG repeats thresholdTargeted mutation analysis demonstrates a CAG trinucleotide expansion of ≥ 36 repeats in the HTT gene.

Role in approvalRequired laboratory/genetic documentation to confirm Huntington disease chorea diagnosis prior to coverage.

Age applicabilityApplies to patients age ≥ 18 years as part of initial coverage criteria.

UHDRS chorea item score — Required threshold

Required UHDRS chorea scoreA Unified Huntington Disease Rating Scale (UHDRS) chorea item score of 1–4 on any one of chorea items 1 through 7 is required to support evidence of chorea.

UHDRS subscore description

Prior Authorization and Provider Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required. Provider must submit documentation (such as office chart notes, lab results or other clinical information) supporting that the member has met all approval criteria prior to authorization. Requests missing required documentation or for non‑FDA approved indications without adequate off‑label justification per CP.CPA.09 (commercial) or HIM.PA.154 (HIM/Marketplace) will be denied.

Submit office notes, labs, and other clinical information to demonstrate criteria are met
Non‑FDA uses require sufficient off‑label evidence per referenced policies

Note

Prior Authorization Criteria Modifications (historical)

Initial and continuation criteria have been modified over time. Notably, per May SDC and prior clinical guidance the AIMS score requirement for TD initial authorizations was removed. Authorization durations and other operational elements have also been revised in past updates.

Historical edits include removal of AIMS requirement for TD initial authorizations (05.20.22)

Background and Clinical Context

Deutetrabenazine is a vesicular monoamine transporter 2 (VMAT2) inhibitor approved for treatment of chorea associated with Huntington disease and for tardive dyskinesia in adults. For Huntington chorea, the policy references the Unified Huntington's Disease Rating Scale (UHDRS) chorea subscore to document chorea severity; the UHDRS chorea subscore rates seven body regions on a 0–4 scale. For tardive dyskinesia, the policy references the Abnormal Involuntary Movement Scale (AIMS), a clinician‑rated 12‑item assessment used to evaluate severity of involuntary movements where items 1–10 are scored 0–4, items 11–12 are yes/no, and item 8 uses the highest score of items 1–7. These assessment tools are used to document baseline severity and measure response to therapy per the authorization and continuation criteria.

Definitions and Assessment Tools

VMAT2 inhibitor / Indications — Drug mechanism and approvals

Mechanism of actionDeutetrabenazine is a vesicular monoamine transporter 2 (VMAT2) inhibitor.

FDA‑approved indicationsIndicated for chorea associated with Huntington disease and for tardive dyskinesia (TD) in adults.

Product namesMarketed as Austedo and Austedo XR (immediate‑release and extended‑release formulations).

UHDRS / AIMS — Rating scale descriptions

UHDRS descriptionUHDRS chorea subscore rates seven body regions on a five‑point scale (0–4) and is used to quantify chorea in Huntington disease.

AIMS descriptionAIMS is a 12‑item clinician‑rated tool to evaluate severity of involuntary movements in TD; items 1–10 scored 0–4; items 11–12 are yes/no; item 8 uses highest score of items 1–7.

Policy Revision History

2024-07-10added_strengthsLatest

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

2023-03-13added_formulation

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

2022-05-20criteria_revision

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

Policy Summary

Payermhn

PolicyDeutetrabenazine (Austedo, Austedo XR) coverage

Policy CodePolicy CP.PCH.42

Change TypeMaterial coverage updates and product additions

Effective DateJun 1, 2021

Next Review Date

Key ActionSubmit prior authorization with documentation of diagnosis, prescriber specialty, age ≥18, and dosing not exceeding 48 mg/day.

SourceLink

On This Page

Chorea subscore rates seven body regions on a five-point scale from 0 to 4, where 0 = no chorea.

Use in continuationFor continuation, a reduction since baseline in any one UHDRS chorea item demonstrates response to therapy.

AIMS scoring — Scoring details

AIMS item scoringAIMS items 1–10 are rated on a 5‑point scale (0 = none to 4 = severe).

Items 11–12Items 11 (dental) and 12 (dentures) are recorded as yes/no to help characterize lip, jaw, and tongue movements.

Item 8 scoring ruleItem 8 uses the highest score of any one of items 1–7 when assessing overall severity.

Approval durations revised for Commercial line of business (09.27.21; 02.22)

Austedo XR formulation added to policy (03.13.23)

Step Therapy

Continuation and Step Considerations

Continuation therapy requires documentation of clinical response compared to baseline: for Huntington disease, evidence of improvement in UHDRS chorea items 1–7; for tardive dyskinesia (TD), evidence of improvement in AIMS items 1–9. Concurrent prescribing with tetrabenazine or Ingrezza is not allowed for continuation. Dose increases are limited to a maximum of 48 mg/day and dose changes should follow prescribing information.

Continuation requires reduction since baseline in UHDRS (Huntington) or AIMS (TD) on at least one relevant item
Concurrent use with tetrabenazine or Ingrezza is prohibited for continued therapy
Dose increases must not exceed 48 mg/day

Documentation Required

Dosing and Product Documentation

Dosing and product information must be documented per the Prescribing Information. Use recommended starting, titration, maximum doses, and switching guidance when completing requests. Product strengths and formulations (Austedo immediate‑release tablets: 6, 9, 12 mg; Austedo XR extended‑release tablets: 6, 12, 18, 24, 30, 36, 42, 48 mg) should be included in the clinical rationale for dose and formulation selection.

Follow Prescribing Information for starting doses, titration, max dose (48 mg/day; reduced max for poor CYP2D6 metabolizers) and switching between Austedo and Austedo XR
List product strength/formulation when requesting a specific dose/formulation

Denial Risk

Requests Lacking Required Documentation

Requests that do not demonstrate the member meets all approval criteria (diagnosis, prescriber specialty, age, genetic testing for Huntington disease, baseline and follow‑up measures where required, and absence of concurrent contraindicated therapy) will be denied or returned for additional information.

Required elements include: diagnosis, prescriber specialty (neurologist for Huntington chorea; psychiatrist or neurologist for TD), age ≥18, CAG repeat result for Huntington (≥36), baseline UHDRS or AIMS as applicable, and documentation that Austedo/Austedo XR is not given concomitantly with tetrabenazine or Ingrezza
Insufficient documentation will result in denial or referral per policy

Clinical useBoth scales are commonly used in research and clinical practice to document baseline severity and response to therapy.

Tardive Dyskinesia (TD) — Definition and coding

Definition of TDTardive dyskinesia is a medication‑induced movement disorder characterized by abnormal, involuntary movements of the tongue, jaw, trunk, or extremities that develop in association with dopamine‑blocking agents.

ICD‑10 codeTardive dyskinesia: ICD‑10 G24.01.

Timing and exposure criteriaMovements present ≥ 4 weeks; typically develop during exposure to offending agent or within specified withdrawal timeframes; history of offending agent use ≥ 3 months (or ≥ 1 month if age ≥ 60 years) may be required for diagnosis.

Abnormal Involuntary Movement Scale (AIMS) — Assessment details

Tool overviewThe AIMS is a 12‑item clinician‑rated assessment developed by NIMH to evaluate severity of involuntary movements across multiple disorders including TD.

Scoring detailsItems 1–10 are rated 0–4 (0 = none; 4 = severe); items 1–7 assess body‑region dyskinesia; item 8 uses the highest score of items 1–7; items 11–12 are yes/no questions regarding dental status.

Clinical usageUsed in both research and clinical practice to establish baseline severity and measure response to treatment for TD.

2021-03-04policy_creation

Policy created (split from CP.PHAR.341) and removed redirection to tetrabenazine for chorea; P&T approval recorded 2021-05-21.