Deutetrabenazine (Austedo®)

ORAL ADMINISTRATION

Indications for Prior Authorization:
  • Treatment of chorea associated with Huntington's disease

  • Treatment of tardive dyskinesia in adults

Patients must meet the following criteria for the treatment of chorea associated with Huntington's disease:
  • Prescribed by or in collaboration with a specialist (neurologist), AND
  • 18 years or older, AND
  • Diagnosis of chorea associated with Huntington'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
Patients must meet the following criteria for the treatment of tardive dyskinesia in adults:
  • Diagnosis of tardive dyskinesia secondary to a centrally acting dopamine receptor blocking agent (DRBA), AND
  • Prescribed by or in collaboration with a psychiatrist or a neurologist, AND
  • Age 18 years or older, AND
  • Failure, intolerance, contraindication to ONE of the following: a benzodiazepine, such as clonazepam (Klonopin®) OR second generation antipsychotic (i.e., Seroquel®, clozapine) OR Ingrezza® (valbenazine) OR tetrabenazine, AND
  • Baseline evaluation of TD using one of the following:
    • Abnormal Involuntary Movement Scale (AIMS) greater than or equal to 10, OR
    • Clinical Global Impression of Severity (CGI-S) score greater than or equal to 4, AND
  • At the time of the request, tetrabenazine or valbenazine is not prescribed concurrently; AND
  • Must not be taken with a monoamine oxidase inhibitor (MAOI) or reserpine (must be greater than 20 days post discontinuing therapy)
  • The dose does not exceed 48 mg/day
Reauthorization criteria:

Chorea associated with Huntington's disease:

  • 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

Tardive Dyskinesia:

  • Patient has disease stablization or improvement in disease as defined by one of the following scores:
    • AIMS- decrease from baseline by at least 2 points
    • CGI-S score less than or equal to 2; 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:

Huntington's disease:

  • Initial: 6 mg 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 48 mg (24 mg 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
  • Maximum recommended dosage in poor CYP2D6 metabolizers is 36 mg per day (18 mg twice daily)

Tardive Dyskinesia:

  • Initial: 12 mg daily (6 mg twice daily).  May be titrated up at weekly intervals by 6 mg per day to a maximum of 48 mg per day (24 mg twice daily)
  • Maximum dosing is 48 mg per day (18 mg per dose and 36 mg per day in poor CYP2D6 metabolizers)
  • Administer with food
  • Swallow tablets whole; do not chew, crush or break
  • If switching from tetrabenazine, discontinue tetrabenazine and initiate Austedo® the following day
Approval:
  • Initial: 3 months
  • Renewal: 1 year

Last review date: July 16, 2019

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