EPIDIOLEX (cannabidiol)

EPIDIOLEX (cannabidiol)

SELF ADMINISTRATION

Indications for Prior Authorization:

• Indicated for the treatment of seizures associated with Lennox-Gastaut syndrome (LGS) or Dravet syndrome (DS) in patients 2 years of age and older

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

Dravet Syndrome:

• Initial review:
  • The patient is 2 years of age or older, AND
  • The patient has tried at least two other antiepileptic drugs (e.g., valproic acid, topiramate, clonazepam, levetiracetam, zonisamide, others) OR one of Diacomit or clobazam; AND
  • Epidiolex is prescribed by, or in consultation with, a neurologist
• Subsequent reviews:
  • Patient is responding to therapy (e.g., reduced seizure severity, frequency, and/or duration) as determined by the prescribing physician

Lennox-Gastaut Syndrome:

• Initial therapy:
  • The patient is 2 years of age or older, AND
  • The patient has tried at least two other antiepileptic drugs (e.g., valproic acid, levetiracetam, zonisamide, Fycompa, Sabril, others) OR one of lamotrigine, topiramate, Banzel, felbamate, clobazam; AND
  • Epidiolex is prescribed by, or in consultation with, a neurologist
• Subsequent reviews:
  • patient is responding to therapy (e.g., reduced seizure severity, frequency, and/or duration) as determine by the prescribing physician

Treatment-Refractory Seizures/Epilepsy

• Initial therapy:
  • The patient is 2 years of age or older, AND
  • The patient has tried at least two other antiepileptic drugs (e.g., valproic acid, lamotrigine, topiramate, clonazepam, levetiracetam, zonisamide, Banzel, felbamate, clobazam, Fycompa, Sabril, others); AND
  • Epidiolex is prescribed by, or in consultation with, a neurologist
• Subsequent reviews:
  • patient is responding to therapy (e.g., reduced seizure severity, frequency, and/or duration) as determine by the prescribing physician

Dosing:

• The recommended starting dosage is 2.5 mg/kg taken twice daily (5 mg/kg/day).  After one week, the dosage can be increased to a maintenance dosage of 5 mg/kg twice daily (10 mg/kg/day).
• Based on individual clinical response and tolerability, Epidiolex can be increased up to a maximum recommended maintenance dosage of 10 mg/kg twice daily (20 mg/kg/day).
• Dosage adjustment is recommended for patients with moderate or severe hepatic impairment.

Approval:

• One year