The NHS has announced that from Tuesday 1st February 2023 it will begin prescribing cannabis-based medicine to patients in England with a rare genetic condition named tuberous sclerosis complex, (TSC).
Changes to the guidelines have been allowed by the National Institute for Health and Care Excellence, (NICE), a public body connected to the Department for Health and Social Care, which publishes guidelines on what medicines are allowed to be used by doctors and practitioners working in the NHS.
The NHS estimates that around 1 in 6000 people live with TSC, which translates to about 1000 patients in England who are trying to manage their symptoms with drugs that often come with ‘debilitating’ side effects.
By updating their recommendations, NICE has provided access to a medicine which could be a huge benefit to the treatment of severe epileptic seizures patients with TSC often experience, as well as helping with many other symptoms caused by this rare disorder.
Studies, used by NICE to make their decision, have demonstrated a 30% reduction in seizures by using a combination of a cannabis-based-medicine and typical anti-seizure medication. This has resulted in patients reporting a huge increase in their quality of life.
What is TSC?
TSC, also known as tuberous sclerosis complex, is a rare condition that causes tumours, mostly non-cancerous, to grow in different areas of the body. These tumours mostly affect the brain, kidneys, eyes, lungs, skin and heart. TSC is present in patients from birth, but may not cause noticeable problems in the early stages.
Many patients with TSC have to contend with other symptoms as well as epilepsy, these can include; a form of autism, learning difficulties, hyperactivity, skin abnormalities, breathing difficulties, kidney problems and others. Patients may experience any number of these symptoms, and the degree of distress caused can range from mild to severe.
Some people with TSC can live a normal healthy life, however, some can develop life-threatening illnesses as a result of it that require life-long care.
There is currently no cure for TSC, and as mentioned previously the side effects of medications typically used to treat symptoms of it can be unbearable, which is one of the reasons why scientists have been exploring other ways to treat patients living with this rare disorder.
Which cannabis-based medicine has been licensed by NICE?
Epidyolex is the brand name of a drug developed in the UK by GW Pharmaceuticals, which in 1998 became the first company to be granted permission by the government to grow cannabis, for use in cannabis-based medicines.
Epidyolex is also licensed for two other rare epileptic conditions on the NHS; Lennox-Gastaut syndrome and Dravet syndrome. It contains cannabidiol, otherwise known as CBD, but doesn’t contain any THC which is the component in cannabis that causes the high experienced by cannabis users. Epidyolex is administered via strawberry-flavoured oral drops, twice daily.
“It is great news for patients that the NHS is able to offer this latest licensed cannabis treatment, which in this instance can help reduce the seizure frequency for those living with a serious genetic condition and significantly improve their quality of life,” said NHS Director of Specialised Commissioning and interim Director of Commercial Medicines, John Stewart.
The licensing of Epidyolex to treat TSC makes it the fifth condition that doctors and practitioners can prescribe it for, and it marks a positive step forward for campaigners who believe the NHS should prescribe more cannabis.
Dr Simon Erridge, Head of Research and Access at private cannabis clinic Sapphire Medical said, “The news that the NHS will start prescribing cannabidiol to patients with tuberous sclerosis complex (TSC), a rare, seizure-causing form of childhood epilepsy, is a huge step forward in the use of medical cannabis. This adds to two other rare forms of epilepsy previously covered by the NHS, Lennox-Gastaut syndrome and Dravet syndrome, indicating greater understanding and confidence in the treatment effect of this preparation of medicinal cannabis for these conditions.”
While recognising the decision to licence cannabis for TSC as important, Dr Erridge believes the NICE and NHS should do more for patients.
“This decision only covers Epidyolex, a CBD isolate, and does not cover other unlicensed medical cannabis preparations which can be prescribed by consultants on the GMC specialist register, provided patients have had a sufficient trial of licensed products and are otherwise appropriate candidates. There are many other forms of childhood epilepsy that also demonstrate changes in the number of seizures following treatment with medicinal cannabis, but there is still a lack of clinical trial evidence which is necessary before these can all become available on the NHS.”
Marcus’ story
Marcus is a 16-year-old boy diagnosed with TSC and Lennox-Gastaut syndrome at just 10 weeks old. Two years ago he was prescribed cannabidiol for his Lennox-Gastaut syndrome. Although unavailable at that time for TSC treatment his mother and carer, Sarah, noticed a huge change in his condition, especially compared to the ‘limited success’ of traditional anti-epileptic medication after the ‘honeymoon’ period ended.
“With cannabidiol being such a new medication, I read up as much as I could about it and agreed to give it a go. My theory has always been ‘If you do not try, you will never know’, after all, this could be ‘the one’… which I have hoped for with every new medication he has tried, and you cannot give up,” Sarah told the NHS.
“Marcus started cannabidiol in October 2020, as always on a low dose and we gradually increased to his current dose. Marcus’ neurologist suggested giving clobozam on a daily basis, as reports had shown that cannabidiol and clobozam work very well together.
“It worked! Marcus has gone from around 6-10 seizures a day to 1-2 in a week! I am absolutely thrilled!
“As a parent of a child with TSC the seizures are very difficult to control. I have always been aware the ‘best we can get them’ is the reality. The combination of clobozam and cannabidiol has been phenomenal for us, but if we had not been given the opportunity to try it I dread to think where we would be now.
“I have been doing this for 16 years so after that amount of time, trying all kinds of different medications and having my son being the best he has ever been is just amazing and I thank my lucky stars every day.”
The use of cannabis to treat epilepsy has been one of the major areas studied by scientists over the past decades, especially more recently. Two weeks ago leafie reported on three major UK studies involving cannabis, one of which was the largest-ever study into childhood epilepsy in Europe.
However, while there does seem to be positive traction, and good possibilities going forward in the medicinal cannabis world, for governments and governing bodies to be convinced about cannabis more evidence, and importantly, more high-quality evidence needs to be produced by the scientific community.
