Browse Conditions Browse Medicines

NICE to recommend cannabidiol (Epidyolex▼) for treating Lennox-Gastaut syndrome

Epidyolex▼, for Epilepsy and Lennox-Gastaut syndrome 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 Lennox-Gastaut syndrome.

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

Recommendations - Lennox-Gastaut syndrome
Cannabidiol with clobazam is recommended as an option for treating seizures associated with Lennox-Gastaut syndrome in people aged 2 years and older, only if:
  • the frequency of drop 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 Lennox-Gastaut 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 the recommendations was made - Lennox-Gastaut syndrome
Current treatment for Lennox–Gastaut syndrome includes antiepileptic drugs. People with Lennox–Gastaut syndrome would have cannabidiol with clobazam if their drop seizures are not controlled well enough after trying 2 or more antiepileptic drugs.

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

About Epidyolex (source EMA)
Epidyolex is a medicine used in addition to clobazam, another epilepsy medicine, to treat patients from the age of two years who have Lennox-Gastaut syndrome or Dravet syndrome, rare types of epilepsy that begin in childhood and can continue into adulthood.

Symptoms include multiple types of seizure (fits), abnormal electrical activity in the brain, learning disability and behavioural problems.

Although the way it works is not clearly understood, the active substance in Epidyolex, cannabidiol, is thought to act on targets that play a role in the movement of calcium in the cells. As this is important for the transmission of electrical signals in some nerve cells, and seizures are caused by excessive electrical activity in the brain, altering the movement of calcium is expected to reduce or prevent the seizures in patients with Lennox-Gastaut syndrome or Dravet syndrome. Cannabidiol is also thought to act on adenosine, a chemical messenger in the brain that plays an important role in suppressing seizures.

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

Sources
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 Lennox-Gastaut syndrome [ID1308]. In development [GID-TA10410]. 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.


Cannabidiol for adjuvant treatment of seizures associated with Lennox-Gastaut syndrome

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 yellowcard.mhra.gov.uk or search for MHRA Yellow Card in the Google Play or Apple App Store.


Disclaimer: This site is designed to offer information for general educational purposes only. The health information furnished on this site and the interactive responses are not intended to be professional advice and are not intended to replace personal consultation with a qualified physician, pharmacist, or other healthcare professional. We cannot provide individual medical advice. You must always seek the advice of a professional for questions related to a disease, disease symptoms, and appropriate therapeutic treatments.


About Epilepsy About Lennox-Gastaut syndrome About medicine