Cannabis treatment approved for Tuberous Sclerosis Complex

The NHS in England will be able to prescribe cannabidiol to patients with tuberous sclerosis complex (TSC) after the National Institute for Health and Care Excellence (NICE) issued final guidance recommending its use.

Around one in every 6,000 people suffer from TSC - a rare, seizure-causing genetic disorder. It becomes the fifth indication for which a cannabis treatment is approved by regulators alongside treatments for people with multiple sclerosis, severe epilepsies known as Dravet and Lennox-Gastaut Syndrome, and for adults experiencing nausea caused by chemotherapy.

Clinical trials showed that when used alongside standard patient care such as typical antiseizure medications, cannabidiol reduces the frequency of seizures by almost a third (30 per cent), increasing the number of days patients can go without a seizure compared with placebo.

NHS Director of Specialised Commissioning and interim Director of Commercial Medicines, John Stewart, said:

“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.

“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.”

Dr Pooja Takhar, Joint Chief Executive of Tuberous Sclerosis Association, said:

“We’re thrilled that people with TSC in England will now have access to cannabidiol, a potentially life-changing medicine for the eight in 10 people in the UK who have TSC and also difficult to treat TSC-related epilepsy.

“Epilepsy can have a massive impact on overall quality of life for individuals and entire families, meaning that this approval could have a huge benefit to many people with TSC-related epilepsy. We worked tirelessly to make sure that NICE came to the right decision. Although this is a big victory, our work doesn’t stop and we continue to advocate and campaign for the TSC community in all areas.”

Patients will have needed to have had limited or no success with two other anti-seizure medications to be eligible for cannabidiol, before specialist consultants will decide if it is clinically appropriate to be prescribed to a patient.