Deutetrabenazine (Austedo, Austedo XR) coverage
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Defines medical necessity, prior authorization, and continuation criteria for deutetrabenazine (Austedo/Austedo XR) for Delaware First Health (Medicaid line of business). Applies to providers requesting coverage for members under the referenced plan.
Ingrezza Sprinkle was added to the concurrent use exclusion.
Initial approval durations were revised from 6 months to 12 months.
Austedo XR extended-release formulation and multiple new strengths were added.
Coverage Criteria
Initial Therapy — Chorea Associated with Huntington Disease
Covered when ALL of the following are met:
See Appendix D for UHDRS details.
Initial Therapy — Tardive Dyskinesia
Covered when ALL of the following are met:
See Appendix H for AIMS details.
Continued Therapy — All Indications
Continued coverage requires ALL of the following:
Approval duration 12 months.
Other Diagnoses/Indications
Coverage options when indication is not specified in primary sections:
Approval duration 12 months.
Dosing/Titration
Dosing and titration guidance (clinical) and administrative duration notes:
Approval duration 12 months; see Prescribing Information for full switching chart.
Non‑FDA approved indications that are not specifically addressed in this policy are not authorized for coverage unless there is sufficient documentation of efficacy and safety consistent with the plan's off‑label use policy CP.PMN.53 or other applicable evidence‑of‑coverage documents. Providers seeking coverage for an off‑label use must submit clinical rationale and supporting documentation per the referenced off‑label policy to demonstrate medical necessity.
Concurrent administration of deutetrabenazine with valbenazine in the form of Ingrezza Sprinkle is expressly excluded by this policy. Prescriptions that would result in concurrent use may be denied in accordance with the concurrent‑use exclusion.
This clinical policy is a medical necessity guide to assist coverage determinations and benefit administration; it does not replace plan contract language. Coverage remains subject to all applicable plan terms, conditions, exclusions, and limitations contained in the member's evidence of coverage or certificate of coverage. The Health Plan may amend or withdraw this policy at any time and makes no guarantee of payment; in any conflict, legal or regulatory requirements and the coverage document govern.
Initial Therapy Criteria
Initial Therapy — high‑level requirements
Initial authorization requires meeting all of the following high‑level requirements:
Prior authorization required; submit supporting documentation such as chart notes and rating scale scores.
Initial Therapy Dosing — recommendations and availability
Initial dosing recommendations and product availability:
Maximum 48 mg/day (36 mg/day for CYP2D6 poor metabolizers or with strong inhibitors).
Continuation Therapy Criteria
Continuation Therapy — members already receiving deutetrabenazine
Continuation criteria for members already receiving deutetrabenazine:
Approval duration 12 months.
Continuation Therapy Duration — administrative rules
Administrative continuation and duration rules:
Refer to full policy for additional monitoring criteria and continuity‑of‑care provisions.
Provider Actions and Prior Authorization
Prior authorization required with supporting documentation
Prior authorization is required. Submit documentation that supports the diagnosis, specialty prescriber/consultation, age, any required diagnostic testing, prior tetrabenazine trial (unless contraindicated), and dosing within policy limits.
- Diagnosis documentation (e.g., HTT CAG repeat ≥36 for Huntington chorea).
- Specialty prescriber or consultation note (neurologist for Huntington; psychiatrist or neurologist for TD).
- Age verification (member ≥ 18 years).
- Documentation of prior tetrabenazine trial and outcome unless contraindicated.
- Dose does not exceed 48 mg/day (36 mg/day for CYP2D6 considerations).
Prior authorization implied; initial approval duration set to 12 months
Prior authorization is implied by this clinical policy for coverage decisions. Initial approvals (and continuation) are granted for a 12‑month duration per the policy updates.
- Approval duration: 12 months (revised from 6 months as of 2Q 2026).
- Concurrent use exclusions continue to apply when evaluating PA requests.
Therapeutic alternative required: tetrabenazine trial
A trial and failure of tetrabenazine is required prior to approval unless tetrabenazine is contraindicated or causes clinically significant adverse effects.
- Huntington chorea: failure of tetrabenazine at up to 100 mg/day (no improvement on UHDRS chorea items).
- Tardive dyskinesia: failure of tetrabenazine at up to 200 mg/day (no improvement on AIMS items).
- Appendix B provides tetrabenazine dosing guidance.
Step therapy template changes — see full policy for details
Step therapy template changes were applied; refer to the full policy for the specific step sequence and criteria used in each indication and continuation section.
- Details of step requirements (including how tetrabenazine failure is documented) are contained in the full policy step therapy sections and appendices.
Required documentation to support PA
Provider must submit office chart notes, laboratory results, or other clinical records that demonstrate the member has met all approval criteria.
- Examples: baseline and follow‑up UHDRS or AIMS scores, specialist consultation notes, prior medication trials and outcomes, and relevant lab results.
Use and documentation of AIMS assessment
Document clinician-rated movement assessments where applicable; the AIMS is referenced as the assessment tool for tardive dyskinesia and may be expected in submitted records.
- AIMS items 1–10 are rated 0–4; an AIMS score of 3 or 4 on any one item supports moderate to severe TD per the policy.
Denial risk for insufficient documentation or non‑covered indications
Requests lacking required clinical documentation or for indications not covered by the policy (without sufficient off‑label justification) may be denied.
- Denials may result if the PA request does not include evidence that the member meets the indication‑specific criteria (e.g., UHDRS or AIMS scores, prior tetrabenazine failure).
- Non‑FDA indications require documentation per off‑label policy CP.PMN.53 to avoid denial.
Concurrent use with Ingrezza Sprinkle excluded
Concurrent prescribing with Ingrezza Sprinkle is explicitly excluded by the policy and may lead to denial of coverage when both agents are prescribed concurrently.
- Policy states Austedo/Austedo XR must not be prescribed concurrently with Ingrezza/Ingrezza Sprinkle.
- Ensure medication history confirms no concurrent valbenazine (Ingrezza) sprinkle use before approval.
Coding
| G24.01 | Tardive dyskinesia |
| G24.01 | Tardive dyskinesia |
Step Therapy
| Step | Requirement | Operational details / Appendix |
|---|---|---|
| 1 | ||
| Failure of tetrabenazine is required prior to approval unless tetrabenazine is contraindicated or causes clinically significant adverse effects (policy specifies up to 100 mg/day for Huntington chorea; up to 200 mg/day for tardive dyskinesia). | ||
| See Appendix B for tetrabenazine dosing guidance (therapeutic alternatives). Documentation of prior trial (chart notes or other clinical records) must be submitted with prior authorization request per policy requirements. |
| Template note | Effect on policy sections | Reference / Next steps |
|---|---|---|
| Step therapy template changes were applied during prior reviews. | ||
| These template updates affect wording in other diagnoses/indications and continued therapy sections; specific step requirements (e.g., tetrabenazine trial) are detailed in the respective indication sections rather than in the template note. | ||
| Refer to the full policy sections for each indication for exact step requirements and to the Reviews/Revisions log for the history of template changes (see 2Q 2022–2024 entries). |
Quantity Limits
Definitions
Site of Care
Oral therapy — outpatient/home administration
Deutetrabenazine is oral therapy intended for outpatient/home administration per the prescribing information.
- Site of care is home/outpatient; administer orally as directed in the dosing and administration section.
Background
Deutetrabenazine is a vesicular monoamine transporter 2 (VMAT2) inhibitor available as Austedo (immediate‑release) and Austedo XR (extended‑release). It is FDA‑approved in adults for the treatment of chorea associated with Huntington disease and for tardive dyskinesia. Dosing varies by formulation and clinical scenario, with a clinical maximum daily dose of 48 mg/day (reduced to 36 mg/day for poor CYP2D6 metabolizers or when combined with strong CYP2D6 inhibitors).
Revision History
Added Ingrezza Sprinkle to the concurrent use exclusion and revised initial approval durations from 6 to 12 months (2Q 2026 annual review).
Updated Appendix definitions per DSM-5-TR and reviewed/updated references (2Q 2025 annual review).
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