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Epidiolex

Drug - Epidiolex® (cannabidiol) [Greenwich Biosciences, Inc.]

April 2019

Therapeutic area - Anticonvulsants

Approval criteria

Lennox-Gastaut syndrome

  • Patient must be 2 years of age or older AND
  • Patient has a diagnosis of Lennox-Gastaut syndrome AND
  • Epidiolex will be prescribed in combination with at least one other antiepileptic drug AND
  • Baseline serum transaminases (ALT and AST) and total bilirubin levels must be provided at time of request AND
  • Patient has tried and failed THREE or more anti-epileptic drugs which include: clobazam, clonazepam, felbamate, lamotrigine, rufinamide or topiramate at maximum daily dosage or at highest tolerated daily dose as supported by pharmacy claims data or other relevant documentation OR
  • Prescriber is a neurologist and patient has tried and failed at least TWO anti-epileptic drugs which include: clobazam, clonazepam, felbamate, lamotrigine, rufinamide or topiramate at maximum daily dosage or at highest tolerated daily dose as supported by pharmacy claims data or other relevant documentation
Drug Maximum daily dosage
Clobazam 40mg
Clonazepam 20mg
Felbamate 3600mg
Lamotrigine 500mg
Rufinamide 3200mg
Topiramate 400mg

Dravet syndrome

  • Patient must be 2 years of age or older AND
  • Patient has a diagnosis of Dravet syndrome AND
  • Prescriber is a neurologist AND 
  • Epidiolex will be prescribed in combination with at least one other antiepileptic drug AND
  • Baseline serum transaminases (ALT and AST) and total bilirubin levels must be provided at time of request

Renewal criteria

Lennox-Gastaut syndrome

  • Patient continues to meet above criteria AND 
  • Annual serum transaminases (ALT and AST) and total bilirubin levels must be provided at time of request

Dravet syndrome

  • Patient continues to meet above criteria AND 
  • Annual serum transaminases (ALT and AST) and total bilirubin levels must be provided at time of request

Quantity limits

  • 20mg/kg/day
  • Patient’s current body weight (in kg) must be submitted at time of request

Questions?

MHCP Provider Call Center 651-431-2700 or 800-366-5411

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