2 Information about cannabidiol

Marketing authorisation indication

2.1 Cannabidiol (Epidyolex, GW Pharma) is licensed as 'adjunctive therapy for seizures associated with Lennox-Gastaut syndrome (LGS) or Dravet syndrome (DS) in conjunction with clobazam, for patients 2 years of age or older'.

Dosage in the marketing authorisation

2.2 It is administered orally as 100 mg/ml cannabidiol solution. The recommended starting dosage is 2.5 mg/kg taken twice daily for 1 week. After 1 week, the dosage should be increased to a maintenance dosage of 5 mg/kg twice daily (10 mg/kg/day). Based on individual clinical response and tolerability, each dosage can be further increased in weekly increments of 2.5 mg/kg taken twice daily up to a maximum recommended dosage of 10 mg/kg twice daily (20 mg/kg/day). Any dosage increases above 10 mg/kg/day should take into account individual benefit and risk.

Price

2.3 The list price of cannabidiol has been agreed with the Department of Health and Social Care, but is considered confidential by the company until January 2020. The company has a commercial arrangement. This makes cannabidiol available to the NHS with a discount. The size of the discount is commercial in confidence. It is the company's responsibility to let relevant NHS organisations know details of the discount.

  • National Institute for Health and Care Excellence (NICE)