cannabidiol (Epidyolex)

following a full submission assessed under the orphan equivalent medicine process:

cannabidiol (Epidyolex®) is accepted for use within NHSScotland.

Indication under review: for use as adjunctive therapy of seizures associated with tuberous sclerosis complex (TSC) for patients 2 years of age and older.

Cannabidiol reduced TSC-associated seizure frequency compared with placebo in one randomised, double-blind, phase III study in patients with TSC-associated epilepsy 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 the views from a Patient and Clinician Engagement (PACE) meeting.