following a full submission considered under the orphan process:
cannabidiol (Epidyolex®) is accepted for use within NHSScotland.
Indication under review: for use as adjunctive therapy of seizures associated with Dravet syndrome, in conjunction with clobazam, for patients 2 years of age and older.
In two phase III, placebo-controlled studies cannabidiol reduced convulsive seizure frequency in the clobazam-treated subgroup of children (aged 2 to 18 years) with Dravet syndrome that was inadequately controlled by other anti-epileptic drugs.
This advice applies only in the context of an approved NHSScotland Patient Access Scheme (PAS) arrangement delivering the cost-effectiveness results upon which the decision was based, or a PAS/ list price that is equivalent or lower.
This advice takes account of views from a Patient and Clinician Engagement (PACE) meeting.
- Medicine name:
- cannabidiol (Epidyolex)
- SMC ID:
As adjunctive therapy of seizures associated with Dravet syndrome (DS) in conjunction with clobazam, for patients 2 years of age and older.
- Pharmaceutical company
- GW Pharmaceuticals Ltd
- Submission type
- Date advice published
- 07 September 2020