Epidiolex
Drug - Epidiolex® (cannabidiol) [Greenwich Biosciences, Inc.]
June 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 Adult Daily Dosage |
Maximum Pediatric Daily Dosage |
| Clobazam |
≤30kg: 20 mg
>30kg: 40 mg
|
≤30kg: 20 mg
>30kg: 40 mg |
| Clonazepam |
20mg |
≤30 kg or ≤10 years: 0.2 mg/kg |
| Felbamate |
3600mg |
2-14 years: 45 mg/kg |
| Lamotrigine |
500mg |
2-12 years: 15 mg/kg (max 400 mg) |
| Rufinamide |
3200mg |
1-17 years: 45 mg/kg (max 3200 mg) |
| Topiramate |
400mg |
Monotherapy:
2-9 years:
≤11kg: 250 mg
12-22kg: 300 mg
23-38kg: 350 mg
≥10 years or ≥38 kg: 400 mg
Adjunct therapy: 400 mg |
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
