Deutetrabenazine (Austedo)

ORAL ADMINISTRATION

Indications for Prior Authorization:

  • Treatment of chorea associated with Huntington's disease

Patients must meet the following criteria for the indication(s) above:

  • Prescribed by or in collaboration with a specialist (neurologist), AND
  • 18 years or older, AND
  • Diagnosis of chorea associated with Huntinton's disease, as indicated by characteristic motor examination features and genetic testing (i.e., an expanded HTT CAG repeat sequence greater than or equal to 36); AND
  • The member is ambulatory, AND
  • The member does not have any of the following:
    • Suicidal, or untreated/inadequately treated depression (a score of greater than or equal to 11 on the depression subscale of the Hospital Anxiety and Depression scale (HADS));
    • Hepatic impairment
    • Those taking MAOIs, reserpine, or tetrabenazine; AND
  • Tried and failed both tetrabenazine and amantadine

Reauthorization criteria:

  • Chorea symptoms have improved or stabilized; AND
  • The member does not have any of the following:
    • Suicidal, or untreated/inadequately treated depression (a score of greater than or equal to 11 on the depression subscale of the Hospital Anxiety and Depression scale (HADS));
    • Hepatic impairment
    • Those taking MAOIs, reserpine, or tetrabenazine; AND
  • Precautions include:
    • Neuroleptic malignant syndrome (NMS): discontinue if this occurs
    • Akathisia, agitiation, restlessness, and parkonism: reduce dose or discontinue if this occurs
    • Sedation/somnolence: may impair the patient's ability to drive or operate heavy machinery

Dosing:

  • Initial: 6mg once daily.  Titrate up at weekly intervals by 6mg per day to a tolerated dose that reduces chorea, up to a maximum recommended daily dosing of 48mg (24mg twice daily)
  • Administer total daily dosages of 12mg or above in two divided doses
  • Administer with food
  • Swallow tablets whole; do not chew, crush or break
  • If switching from tetrabenazine, discontinue tetrabenazine and initiate Austedo the following day
  • Mazimum recommended dosage in poor CYP2D6 metabolizers is 36mg per day (18mg twice daily)

Approval:

  • Initial: 3 months
  • Renewal: 1 year

Last review date: June 12, 2017