WHA

Austedo (deutetrabenazine)

Indications for Prior Authorization

Austedo (deutetrabenazine)
  • For diagnosis of Chorea associated with Huntington’s disease
    Indicated for the treatment of chorea associated with Huntington’s disease in adults.

  • For diagnosis of Tardive Dyskinesia
    Indicated for tardive dyskinesia in adults.

Austedo XR (deutetrabenazine)
  • For diagnosis of Chorea associated with Huntington’s disease
    Indicated for the treatment of chorea associated with Huntington’s disease in adults.

  • For diagnosis of Tardive Dyskinesia
    Indicated for tardive dyskinesia in adults.

Criteria

Austedo, Austedo XR

Prior Authorization (Initial Authorization)

Length of Approval: 3 months [A]
For diagnosis of Chorea associated with Huntington’s disease

  • Diagnosis of chorea associated with Huntington’s disease [1, 3, 4]
    • AND
  • Prescribed by or in consultation with a neurologist [1, B]
Austedo, Austedo XR

Prior Authorization (Reauthorization)

Length of Approval: 12 Month(s)
For diagnosis of Chorea associated with Huntington’s disease

  • Patient demonstrates positive clinical response to therapy [1]
Austedo, Austedo XR

Prior Authorization (Initial Authorization)

Length of Approval: 3 months [A]
For diagnosis of Tardive Dyskinesia

  • Diagnosis of tardive dyskinesia [1, C]
    • AND
  • Disease severity is one of the following:
    • Moderate
    • Severe
    AND
  • One of the following [7, D]:
    • Patient has persistent symptoms of tardive dyskinesia despite a trial of dose reduction, tapering, or discontinuation of the offending medication
      • OR
    • Patient is not a candidate for a trial of dose reduction, tapering, or discontinuation of the offending medication
    AND
  • Prescribed by or in consultation with one of the following:
    • Neurologist
    • Psychiatrist
Austedo, Austedo XR

Prior Authorization (Reauthorization)

Length of Approval: 12 Month(s)
For diagnosis of Tardive Dyskinesia

  • Patient demonstrates positive clinical response to therapy [1]

  • Guideline ID
    GL-148721

  • Formulary
    premium

  • Effective date
    Sep 1, 2024

  • P&T approval date
    Jun 28, 2017

P & T Revisions

2024-07-24, 2023-09-29, 2023-07-21, 2023-05-03, 2023-02-08, 2022-07-18, 2021-07-28, 2020-07-14, 2020-05-19

  1. Austedo Prescribing Information. Teva Pharmaceuticals USA, Inc. Parsippany, PA. May 2024.
  2. Armstrong MJ, Miyasaki JM. Evidence-based guideline: Pharmacologic treatment of chorea in Huntington disease: Report of the Guideline Development Subcommittee of the American Academy of Neurology. Neurology. 2012 August.
  3. Claassen DO, Carroll B, De Boer LM, et al. Indirect tolerability comparison of deutetrabenazine and tetrabenazine for Huntington disease. J Clin Mov Disord. 2017. 4:3.
  4. Geschwind MD, Paras N. Deutetrabenazine for treatment of chorea in Huntington disease. JAMA. 2016;316(1):33-34.
  5. Huntington Study Group. Effect of deutetrabenazine on chorea among patients with Huntington disease. JAMA. 2016;316(1):40-50.
  6. Fernandez HH, Factor SA, Hauser RA, et al. Randomized controlled trial of deutetrabenazine for tardive dyskinesia: The ARM-TD study. Neurology. 2017;88(21):2003-10.
  7. Waln O, Jankovic J: An update on tardive dyskinesia: from phenomenology treatment. Tremor Other Hyperkinet Mov (N Y) 2013; 3: tre-03-161-4138-1.
  8. Per clinical consult with psychiatrist regarding Ingrezza (valbenazine), June 9, 2017.
  9. Austedo XR Prescribing Information. Teva Neuroscience, Inc. Parsippany, NJ. May 2024.
  1. Authorization period is based on the pivotal study duration of 12 weeks. [1, 5, 6]
  2. Ensures the requirement for proper diagnosing and quantifying an adequate chorea score (total maximal chorea score of greater than or equal to 10 (moderate to severe chorea) from the subscale of the Unified Huntington’s Disease Rating Scale (UHDRS). [1, 2]
  3. Patients were included in the pivotal randomized, double-blind, placebo-controlled trial of Austedo if they had moderate to severe tardive dyskinesia as determined by clinical observation (qualitative assessment). [6]
  4. Verified with consultant for a previous medication (Ingrezza [valbenazine]) that dose reduction, tapering, or discontinuation of the offending medication is considered first-line treatment for tardive dyskinesia. [8]
  • 2024-07-24: 2024 Annual Review
  • 2023-09-29: Program update to standard reauthorization language. No changes to clinical intent.
  • 2023-07-21: 2023 Annual Review
  • 2023-05-03: update guideline
  • 2023-02-08: Update Guideline
  • 2022-07-18: 2022 Annual Review
  • 2021-07-28: Annual Review
  • 2020-07-14: Annual review
  • 2020-05-19: Per PA feedback, separate disease severity for Tardive Dyskinesia into second criterion to ease PA operations.