CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

deutetrabenazine (Austedo/Austedo XR) coverage

Policy governs authorization, continuation, and quantity limits for Austedo and Austedo XR for Neighborhood Health Plan of Rhode Island members for FDA‑approved indications (Huntington's chorea and tardive dyskinesia). Applies to providers requesting coverage for these medications.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

Policydeutetrabenazine (Austedo/Austedo XR) coverage

Policy CodePolicy N/A

Change TypeNo material change

Effective DateJun 1, 2021

Next Review DateN/A

Key ActionObtain prior authorization: initial approvals may be granted for 6 months when initial criteria are met and continuation approvals for 12 months when continuation criteria are met.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

6 moinitial authorization duration

12 mocontinuation authorization duration

48 mg/daymaximum daily dose

2 tabs/dayquantity limit example

Coverage Criteria

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Initial Therapy — Covered when ALL of the following are met for an FDA‑approved indication:

Covered when ALL of the following are met for an FDA‑approved indication:

Indication: Member has diagnosis of chorea associated with Huntington's disease OR tardive dyskinesia in adults (FDA‑approved indications).

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Prescriber: For Huntington's disease: prescribed by or in consultation with a neurologist. For tardive dyskinesia: prescribed by or in consultation with a neurologist or psychiatrist.

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Concomitant Medications: Member will not use Austedo or Austedo XR concomitantly with monoamine oxidase inhibitors (MAOIs), reserpine, or tetrabenazine, and is not using an additional vesicular monoamine transporter 2 (VMAT2) inhibitor concurrently.

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Dose Limit: Dose does not exceed 48 mg/day.<=48 mg/day

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Huntington's diagnostic specifics: Member demonstrates characteristic motor examination features AND (expanded HTT CAG repeat >=36 OR positive family history); member is not suicidal and does not have untreated or inadequately treated depression (HADS depression subscale <11).

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Tardive dyskinesia diagnostics: Documented diagnosis of tardive dyskinesia secondary to a centrally acting dopamine receptor‑blocking agent (DRBA); assessed via clinical exam or validated tool (e.g., AIMS, DISCUS).

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Continuation Therapy — Continued coverage for 12 months may be granted when ALL of the following are met:

Continued coverage for 12 months may be granted when ALL of the following are met:

Tolerability: Documentation that the member is tolerating treatment.

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Prior documentation: If member has not been approved previously by Neighborhood, clinician must submit documentation that initial criteria are met.

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Concomitant Medications: Member will not use Austedo or Austedo XR concomitantly with monoamine oxidase inhibitors (MAOIs), reserpine, or tetrabenazine and is not using another VMAT2 inhibitor concurrently.

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Response for Huntington's disease: For treatment of chorea associated with Huntington's disease: chorea symptoms have improved or stabilized from baseline AND member is not suicidal and does not have untreated or inadequately treated depression (HADS depression subscale <11).

Requests for deutetrabenazine (Austedo/Austedo XR) for indications other than the FDA‑approved uses — treatment of chorea associated with Huntington’s disease and treatment of tardive dyskinesia in adults — are considered experimental/investigational and not medically necessary. Coverage is limited to the FDA‑approved indications and will be denied for other uses.

This policy does not cover use of deutetrabenazine for non‑FDA indications such as isolated chorea presentations or other movement disorders outside the approved indications. Specifically, indications beyond Huntington’s chorea and tardive dyskinesia are considered experimental/investigational and not medically necessary, and such requests may be denied.

Provider Actions / Prior Authorization

Prior Authorization

Prior authorization durations

Prior authorization is required. Initial authorizations may be granted for 6 months when all initial criteria are met; continuation authorizations may be granted for 12 months when continuation criteria are met.

Step Therapy

Concomitant therapy restrictions

Documentation must show the member will not use Austedo/Austedo XR concomitantly with MAOIs, reserpine, or tetrabenazine and that the member is not using an additional VMAT2 inhibitor while taking Austedo/Austedo XR.

Documentation Required

Required clinical documentation

Provide clinical documentation that initial criteria are met, including confirmation of the covered diagnosis, prior treatment details, screening for depression/suicidality for Huntington's disease, and evidence that tardive dyskinesia is secondary to a centrally acting dopamine receptor‑blocking agent; for continuation, document tolerability and clinical response or submit initial criteria if not previously approved by Neighborhood.

Huntington's disease: documentation member is not suicidal or has untreated/inadequately treated depression (HADS depression subscale <11) and diagnostic confirmation (motor features plus HTT CAG repeat ≥36 or positive family history).
Tardive dyskinesia: documented diagnosis secondary to a DRBA and assessment with clinical exam or a validated tool (e.g., AIMS, DISCUS).
If seeking continuation: documentation of tolerability and evidence of improvement or stability; if no prior Neighborhood approval, submit initial criteria.

Denial Risk

Indications outside FDA‑approved uses are not covered

Requests for indications other than treatment of chorea associated with Huntington's disease and tardive dyskinesia in adults are considered experimental/investigational and are not medically necessary.

Definitions

Confirmed Huntington's disease — inv-12

Core diagnostic requirementCharacteristic motor examination features consistent with chorea associated with Huntington's disease.

Genetic confirmationLaboratory results indicating an expanded HTT CAG repeat sequence of at least 36.

Alternative to genetic testA positive family history for Huntington's disease satisfies the diagnostic requirement if genetic testing is not available.

Depression/suicide screeningMember must not be suicidal and must not have untreated or inadequately treated depression (HADS depression subscale <11 required).

Tardive dyskinesia — inv-13

DefinitionInvoluntary movements secondary to a centrally acting dopamine receptor‑blocking agent (DRBA).

Assessment methodsDiagnosis must be documented by clinical examination or with a structured evaluative tool (e.g., AIMS, DISCUS).

Prescriber requirementFor tardive dyskinesia, Austedo or Austedo XR must be prescribed by or in consultation with a neurologist or psychiatrist.

Austedo 6 mg	Austedo 6 mg tablet (quantity limits specified)
Austedo 9 mg	Austedo 9 mg tablet (quantity limits specified)
Austedo 12 mg	Austedo 12 mg tablet (quantity limits specified)
Austedo XR 6 mg	Austedo XR 6 mg tablet (quantity limits specified)
Austedo XR 48 mg	Austedo XR 48 mg tablet (quantity limits specified)
Austedo XR titration kits	XR titration kits with specified tablet combinations

OpenPayer

deutetrabenazine (Austedo/Austedo XR) coverage

Coverage Criteria

Products, Doses, and Coding

Provider Actions / Prior Authorization

Background

Definitions