UK-wide therapy for patients who have seizures linked to tuberous sclerosis complex
Jazz Pharmaceuticals has revealed that Epidyolex – a cannabidiol oral solution, developed with GW Pharmaceuticals – has received a vital recommendation for reimbursement by National Institute for Health and Care Excellence (NICE).
The therapy concerns patients of two years of age and above, and relates to the adjunctive therapy of seizures associated with tuberous sclerosis complex (TSC).
The news has emerged after consultations by the Scottish Medicines Consortium, Northern Ireland’s Strategic Planning and Performance Group, and the All Wales Medicines Strategy Group, ensuring the recommendation will positively affect all eligible UK patients. Consequently, Epidyolex will be available from 1 March this year.
Simon Newton, general manager at Jazz Pharmaceuticals, commented: “We welcome NICE’s recommendation which provides appropriate patients across the UK, who are living with TSC, a difficult to treat condition, access to a new treatment option.”
“This is an important milestone not only for those living with TSC but also for their families, carers and clinicians. This demonstrates the importance of randomised clinical trials and regulatory approval in providing reimbursed access to cannabinoid-based medicines to patients who may benefit,” he added.
Dr Pooja Takhar, joint chief executive at Tuberous Sclerosis Association (TSA), reflected: “TSC is a very difficult to manage condition, with common issues including epilepsy in eight out of ten people. Up to half of the people with TSC-related epilepsy are unable to manage their seizures with standard anti-seizure medication, leading to a massive unmet need for new treatment options.”
He concluded: “This underlines why we are so pleased that this medicine will now be available on the NHS in England, improving lives in the TSC community.”
TSC causes benign tumours to grow in vital organs of the body, including the heart, skin, brain, eyes, kidneys and lungs. Epilepsy is one of the most common neurological results and can severely impact on the lives of these patients.
The condition can be diagnosed in infancy but many children do not receive a diagnosis until later in childhood when symptoms appear. Across the UK, it is estimated that between 3,700 and 11,000 people in the UK live with TSC.