NICE does not recommend Epidyolex as a treatment with clobazam forDravet and Lennox-Gastaut syndromes

The National Institute of Health and Care Excellence ( NICE) issued draft guidance although Epidyolex (cannabidiol) has been CHMP recommended but is not yet approved in Europe. The drug has been approved in the US since June 2018 (where it is known as Epidiolex) and where it became the first ever cannabis-derived product to gain FDA approval.

NICE has questioned the GW Pharma cost modelling for treatment and its draft guidance does not recommend Epidyolex with clobazam for treating Dravet and Lennox-Gastaut syndromes, types of epilepsy which begin in early childhood and which are lifelong and difficult to control. NICE’s appraisal committee concluded that the clinical trial evidence shows that cannabidiol with clobazam reduces the number of the main types of seizures associated with the conditions compared with usual care with anti-epileptic drugs. However, NICE considered that as the duration of the clinical trials was only 14 weeks its long-term efficacy is unknown. NICE stated that it is committed to working with GW Pharma to resolve the economic modelling issues and “to help them understand what they may need to do to mitigate the cost of cannabidiol to the NHS”.