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NICE to recommend cannabidiol (Epidyolex▼) for treating Dravet syndrome

Epidyolex▼, for Severe myoclonic epilepsy of infancy and Epilepsy from GW Pharma Ltd

The National Institute for Health and Care Excellence (NICE) have stated that they are to recommend the use of GW Pharma's cannabidiol, brand name Epidyolex▼, a cannabis-based medicinal product, for severe treatment-resistant epilepsy.

The NICE decision came after considering feedback from consultation. NICE has prepared a Final Appraisal Document on cannabidiol for adjuvant treatment of seizures associated with Dravet Syndrome.

This means that Epidyolex will be available for use by NHS England and Wales.

Recommendations - Dravet syndrome
Cannabidiol with clobazam is recommended as an option for treating seizures associated with Dravet syndrome in people aged 2 years and older, only if:
  • the frequency of convulsive seizures is checked every 6 months and cannabidiol is stopped if the frequency has not fallen by at least 30% compared with the 6 months before starting treatment
  • the company provides cannabidiol according to the commercial arrangement
This recommendation is not intended to affect treatment with cannabidiol, with clobazam, that was started in the NHS before this guidance was published. People having treatment outside this recommendation may continue without change to the funding arrangements in place before this guidance was published, until they and their NHS clinicians consider it appropriate to stop. For children and young people, this decision should be made jointly by the clinician and the child or young person, or the child or young person’s parents or carers.

For more information about Dravet syndrome see the epilepsy entry under conditions in Keep Me Informed.

You can follow developments on Epidyolex by using our Medicines Tracker service which provides users with updates about the medicines they are interested in.

Why these recommendations were made - Dravet syndrome

Current treatment for Dravet syndrome includes antiepileptic drugs. People with Dravet syndrome would have cannabidiol with clobazam if their convulsive seizures are not controlled well enough after trying 2 or more antiepileptic drugs.

Clinical trials show that cannabidiol reduces the number of convulsive and non-convulsive seizures when compared with usual care.

Epidyolex was first made available in the EU in 2019. It is manufactured by GW Pharma.

European Medicines Agency website page for Epidyolex
National Organisation for Rare Diseases
Accessed 13/11/19
Links available in External Resources

© NICE [2019]

Cannabidiol for adjuvant treatment of seizures associated with Dravet syndrome [ID1211]. In development [GID-TA10274]. Expected publication date: 18 December 2019
Available from: See Link below. All rights reserved. Subject to Notice of rights
NICE guidance is prepared for the National Health Service in England. All NICE guidance is subject to regular review and may be updated or withdrawn. NICE accepts no responsibility for the use of its content in this product/publication.

The information provided by NICE was accurate at the time this article was issued.

NICE information on Epidyolex

New medicines and vaccines that are under additional monitoring have an inverted black triangle symbol (▼) displayed in their package leaflet and summary of product characteristics, together with a short sentence explaining what the triangle means – it does not mean the medicine is unsafe. You should report all suspected adverse drug reactions (ADRs) for these products. ADRs can be reported by your doctor, pharmacist or online via the Yellow Card system.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions (side effects) after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals or patients are asked to report any suspected adverse reactions via the Yellow Card Scheme at or search for MHRA Yellow Card in the Google Play or Apple App Store.

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