WHA

AUSTEDO (deutetrabenazine)

Self-Administration - oral tablets

 

Diagnosis considered for coverage:

 

  • Chorea associated with Huntington's disease (HD): Treatment of chorea associated with Huntington's disease in adults.
  • Tardive dyskinesia (TD): Treatment of tardive dyskinesia in adults.

 

Coverage Criteria:

 

For diagnosis of chorea associated with Huntington's disease (HD):

  • Diagnosis of chorea associated with Huntington’s disease; AND
  • Prescribed by or in consultation with a neurologist.

 

For diagnosis of tardive dyskinesia (TD):

  • Diagnosis of tardive dyskinesia (TD); AND
  • TD disease severity is considered moderate or severe; AND
  • One of the following:
    • Patient has persistent symptoms of tardive dyskinesia despite a trial of dose reduction, tapering, or discontinuation of the offending medication
    • 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 a psychiatrist or a neurologist.

 

Reauthorization Criteria:

 

For diagnosis of chorea associated with Huntington's disease (HD) OR tardive dyskinesia (TD):

  • Documentation of positive clinical response to therapy

 

Dosing:

 

Chorea (assoc. w/ HD) or TD:

  • Austedo is dosed twice daily. Austedo XR is dosed once daily.
  • Recommended Starting Dose:
    • Austedo: 6 mg twice daily
    • Austedo XR: 12 mg once daily
  • Titrate at weekly intervals by 6 mg per day based on reduction of chorea or tardive dyskinesia, and tolerability, up to a maximum recommended daily dosage of 48 mg.

 

Coverage Duration:
 
  • Initial: 3 months
  • Reauthorization: 1 year

 

Authorization is not covered for the following:
  • The use of this drug for indications not listed in this policy does not meet the coverage criteria established by the Western Health Advantage (WHA) Pharmacy and Therapeutics (P&T) Committee.

 

Additional Information:
  • AUSTEDO XR and AUSTEDO can increase the risk of depression and suicidal thoughts and behavior (suicidality) in patients with Huntington’s disease.
  • The initial authorization period is based on the pivotal study duration of 12 weeks.
  • Consultation with a specialist 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).
  • Patients were included in the pivotal randomized, double-blind, placebo-controlled trial of Austedo if they had moderate to severe TD as determined by clinical observation (qualitative assessment).
  • Dose reduction, tapering, or discontinuation of the offending medication is considered first-line treatment for TD.

 

Policy Updates:
  • 07/16/2019 – Criteria review; no changes
  • 11/14/2023 – Remove quantitative diagnosis requirements, remove cautionary exclusion requirements, remove prerequisite drug requirements. (P&T, 11/14/2023)

 

References:
  1. Austedo Prescribing Information. Teva Pharmaceuticals USA, Inc. Parsippany, PA. May 2022.
  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. Austedo XR Prescribing Information. Teva Neuroscience, Inc. Parsippany, NJ. February 2023.

Last review date: November 14, 2023