Epilepsy and cannabis-based medicines

What’s happened?

On the 31 October 2018 the UK government rescheduled cannabis-based medicines. This means that legally, specialist doctors in the UK can prescribe these medicines for patients, including for some people with severe and treatment-resistant epilepsies. Epilepsy Action covered this legal change when it happened. You can read more about it here.

Since the change in the law, health organisations have published guidance on prescribing cannabis-based medicines:

• In November 2019 the National Institute for Health and Care Excellence (NICE) published final guidance on cannabis-based medicines. The NICE guidelines set out how and when cannabis-based medicines can be prescribed in the NHS.
• In October 2021 the British Paediatric Neurology Association (BPNA) updated it’s guidance on the use of cannabis-based products for medicinal use in children and young people with epilepsy.

NICE has also made a recommendation for Epidyolex, a purified CBD product, as a treatment option for Dravet syndrome and Lennox-Gastaut syndrome, two severe and treatment-resistant epilepsy syndromes. The final decision from NICE is to recommend Epidyolex as an add-on treatment with clobazam for seizures associated with these epilepsies.

Epidyolex is the first cannabis-based medicine for epilepsy to be licensed and recommended for use in the NHS. This is very welcome and offers a much needed additional treatment option for people affected by Dravet syndrome and Lennox-Gastaut syndrome.

In the guidelines, NICE has not made practice recommendations for severe and treatment-resistant epilepsies. This means that NICE has not recommended cannabis-based medicines for epilepsy in the NHS, but has not actively said they should not be used.

NICE does not believe there is enough high-quality evidence to know whether cannabis-based medicines are safe or effective as a treatment for epilepsy. The guidelines include a number of research recommendations for epilepsy including calling for research into:

• CBD for severe treatment-resistant epilepsy
• THC in combination with CBD for severe treatment-resistant epilepsy

It is clear that more research is needed, particularly into cannabis-based medicines that contain THC. These research recommendations are welcome and we hope this research will begin quickly.

It is important to note that the NICE guidelines do not prevent specialist doctors from prescribing cannabis-based medicines for epilepsy. Decisions will be made on a case-by-case basis. There are currently no licensed cannabis-based medicines for epilepsy that contain THC. If a specialist doctor decides it is clinically appropriate to prescribe a cannabis-based medicine containing THC for epilepsy, this could be done through the ‘Specials’ process. This would have to be paid for by the individual NHS Trust.

Epilepsy Action is also aware of a number of research projects that are in development stage. This could include observational trials and randomised-controlled trials (RCTs). It is possible that some people affected by severe and treatment-resistant epilepsies could access cannabis-based medicines through these clinical trials. We will be following these potential research projects and clinical trials closely and will provide updates when we have more information.

Where are we at now?

These decisions represent an important and welcome step forward. They go some way towards removing the barriers for people with epilepsy who could benefit from accessing cannabis-based medicines in the NHS.

However, despite the change in the law, we have heard from many people that they are unable to access cannabis-based medicines through the NHS.

The NICE guidelines mean that barriers to accessing cannabis-based medicines in the NHS are likely to remain for those who don’t have a diagnosis of Dravet syndrome or Lennox-Gastaut syndrome.

There is high-quality clinical evidence that this treatment can reduce seizure frequency in people with these specific epilepsies. It is possible that the treatment could also be used for other treatment-resistant epilepsies. This needs to be looked into.

It is clear that more research is needed. We need to see research into products that also contain THC and research into whether Epidyolex could also benefit people affected by other epilepsies.

What is Epilepsy Action doing?

It is vital that organisations, including NHS England and the National Institute of Health Research (NIHR), act on the research recommendations quickly. This includes setting up clinical trials and other research projects.

More research is needed, particularly into products that also contain THC. Epilepsy Action believes that this research should also ensure that people with severe and treatment-resistant epilepsies can access these treatments as a matter of urgency.

We are aware that trials are being developed for cannabis-based medicines as a potential treatment for epilepsy. It’s vital that these trials begin as soon as possible and that they involve as many patients as possible.

Epilepsy Action will continue to put pressure on the Department of Health and Social Care, NHS England and others to ensure this happens urgently.

We know that this is an important issue for many people with epilepsy. Epilepsy Action will continue working to ensure that everyone with epilepsy who could benefit from cannabis-based medicines can access them in a safe and timely manner.

If you would like to talk to someone about epilepsy, you can contact the Epilepsy Action Helpline for free on 0808 800 5050 or email helpline@epilepsy.org.uk.