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UK’s Health Service Can Now Prescribe Epidiolex For Tuberous Sclerosis Complex

By Leo Bear-McGuinness

Published: Feb 01, 2023   
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People in England with tuberous sclerosis complex (TSC) can now receive the cannabis-based medicine Epidyolex from the country’s National Health Service (NHS).

The change comes after the National Institute for Health and Care Excellence (NICE) issued final guidance recommending its use.

One prescription at a time

TSC is a rare genetic condition that causes benign tumors to develop in different parts of the body. These tumors can lead to the child developing epilepsy, among other conditions.

Epidyolex (known as Epidiolex in the US) has proven to be a viable treatment for epileptic seizures. Indeed, back in 2019, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) approved the CBD spray, in conjunction with the anti-epileptic medication clobazam, as a treatment for seizures associated with the rare epilepsies Lennox Gastaut syndrome and Dravet syndrome in patients aged two years and older. Then, in 2021, the same agency added TSC as a third viable indication for the use of the drug.

Now NICE has added its endorsement and recommended Epidyolex be given to TSC patients aged two years and older.

Thanks to this approval, the CBD spray can now be prescribed within the NHS.

“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,” John Stewart, NHS Director of Specialised Commissioning and interim Director of Commercial Medicines, said in a statement.

“The NHS is committed to making innovative treatments available to patients as quickly as possible, at a fair price to taxpayers, following regulatory approval that provides patients with the knowledge that new treatments are safe and manufactured in a quality controlled environment.”

One patient reportedly benefitting from Epidyolex is a 16-year-old named Marcus, who was diagnosed with TSC and Lennox-Gastaut Syndrome from an early age.

“Marcus started cannabidiol in October 2020, as always on a low dose and we gradually increased to his current dose,” Marcus’ mother said in a statement. “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!”

Since the UK legalized medical cannabis in 2018, few prescriptions have come via the NHS. This paucity is partly because regulators like NICE and the MHRA have taken time to validate and approve the use of cannabis medicines for certain conditions.

In the meantime, the private sector has met the demands of many patients with conditions like chronic pain, insomnia, and anxiety.

“The news that the NHS will start prescribing cannabidiol to patients with […] TSC, a rare, seizure-causing form of childhood epilepsy, is a huge step forward in the use of medical cannabis,” Dr. Simon Erridge, the head of research and access at the private medical cannabis clinic Sapphire Medical Clinics, said in a statement.

“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. However, 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 [General Medical Council] specialist register provided patients have had a sufficient trial of licensed products and are otherwise appropriate candidates.”


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