Advice

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 Lennox-Gastaut syndrome, in conjunction with clobazam, for patients 2 years of age and older.

In two phase III, placebo-controlled studies cannabidiol reduced drop seizure frequency in the clobazam-treated subgroup of children and adults (aged 2 to 55 years) with Lennox-Gastaut 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 details

Medicine name:
cannabidiol (Epidyolex)
SMC ID:
SMC2263
Indication:

As adjunctive therapy of seizures associated with Lennox‑Gastaut syndrome (LGS) in conjunction with clobazam, for patients 2 years of age and older.

Pharmaceutical company
GW Pharmaceuticals Ltd
Submission type
Full
Status
Accepted
Date advice published
07 September 2020