The families of children with severe epilepsy and epilepsy charities are pleading with the UK government to act on promises made two years ago around access to cannabis-based medicines.
On 1 November 2018, the UK law changed to allow specialist clinicians to prescribe cannabis-based medicines to patients with “exceptional clinical need”. This included children with severe epilepsy syndromes like Dravet and Lennox-Gastaut syndromes.
Two years on, campaign group End Our Pain and charity Epilepsy Action say that they believe only three NHS prescriptions for cannabis-based medicines containing cannabidiol (CBD) and tetrahydrocannabinol (THC) have been written. CBD and THC are both parts of the cannabis plant, but THC is associated with the part of the plant that causes the feeling of a ‘high’.
Two of these three prescriptions have been made out to two boys at the centre of campaigns to make these products legal in the first place – Billy Caldwell and Alfie Dingley.
The organisations say that the lack of NHS prescriptions has left many families having to fund their own prescriptions at a cost of thousands of pounds a month. Many others are not able to afford these, so don’t have access at all to this medicine for their children.
Following pressure from families, Health Secretary Matt Hancock instructed the NHS to carry out a review of apparent barriers to these medicines in the health service. The review report showed many clinicians were concerned about a lack of knowledge and long-term safety data from trials on some types of cannabis-based medicines.
The review report recommended an “alternative study”, such as an observational trial, should be carried out on children already taking cannabis-based medicines. It suggested that in cases where benefits are seen, the families should be able to obtain the medicines from the NHS with appropriate monitoring and supervision.
The organisations are urging the Department of Health and Social Care and NHS England to honour their commitment to an “alternative study”, which they said seems to have been forgotten about in recent months.
There has been mention of randomised controlled trials (RCTs) instead. While the organisations have welcomed these, they added that these are not suitable for all the children who are already taking the medicines. This is because they would have to “wash out” the medicine from their system before starting the trial, meaning coming off a medicine that is working for them. As part of this type of trial, they may also be placed on a dummy medicine (placebo), which is a risk many families don’t want to take.
Deputy chief executive of Epilepsy Action, Simon Wigglesworth, said: “The current situation continues to leave many families with desperately ill children in an unbearable position. Many are unable to access these treatments on the NHS, despite evidence that they can be effective and in some cases life-changing.
“We’ve been calling for high quality clinical trials since the start of this debate and warmly welcome the progress in this area. In the longer term, this is the only way that could bring cannabis-based medicines for epilepsy into mainstream practice.
“However, these trials are likely to take time to generate the evidence needed to allow more routine prescribing. The reality is that these children simply don’t have time to wait. Every seizure poses a potentially serious risk and can ultimately be fatal. Some children are having hundreds of seizures every day.
“The government needs to urgently deliver on its promise to provide a way for these children to access funding for medicines which are helping them. They have already waited for two years. They cannot afford to wait any longer.”
Peter Carroll of End Our Pain said: “The law change on 1 November was visionary and much welcomed. It offered hope to thousands of patients with a range of conditions and in particular to families caring for a young person suffering with intractable epilepsy. But these hopes have been cruelly dashed. Families have had to resort to paying privately up to £2,000 a month. And now COVID restrictions have curtailed their ability to fundraise.
“These families are emotionally and financially broken. They have been passed from pillar to post in their quest for an NHS prescription. Everyone in the system seems to be blaming someone else for the failure to help these desperately ill children. We have presented potential solutions, including calling on the government to set up a special fund to help with the cost of the private prescriptions until the NHS gets its act together and NHS prescribing becomes more routine.”
Epilepsy Action and End Our Pain have put together an open letter to parliament urging them to find a workable solution for the families who need this medicine but are not able to access it.
There is more information about cannabis-based medicines on the Epilepsy Action website.