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.

Two national NHS clinical trials have now started. These will investigate the safety and effectiveness of cannabidiol (CBD) and tetrahydrocannabinol (THC) in adults and children with treatment-resistant epilepsy. The trials will determine whether these medicines are safe and effective in reducing number and severity of seizures, and how they affect learning, sleep, behaviour, quality of life, stress and anxiety.

Where are we at now?

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.

What is Epilepsy Action doing?

Epilepsy Action has long called for these trials to take place, and we are pleased that they are finally happening. If successful, the results of the trials may support applications to the Medicines and Healthcare Products Regulatory Agency (MHRA) and other regulatory bodies for approval for use in refractory epilepsy.

However, it is likely that we will have to wait for a long time before we have the results of the trials. Many families have already waited too long for access to these medicines or have been forced to spend up to £2,000 per month for a private prescription. While we wait for the outcome of the trials, more action should be taken to improve access to cannabis-based medicines through the NHS. In addition, the government should implement an interim funding mechanism to support those families currently paying for private prescriptions.

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.