Medicines watchdog the National Institute for Health and Care Excellence (Nice) has rubber-stamped the use of two drugs developed by British-based GW Pharmaceuticals in a move that offers new hope to parents whose children don’t respond to existing treatments.
Epidyolex, or cannabidiol, is an oral solution to help treat seizures in children with epilepsy, while Sativex will help treat spasms and sudden stiffening of muscles in multiple sclerosis patients. They do not have the “high” linked with recreational use of cannabis.
The decision to approve the drugs for the NHS is a significant step in the use of cannabis-derived medication, for which pressure has grown after the case of eight-year-old Alfie Dingley, who was granted a special licence to use cannabis oil as he was experiencing up to 150 seizures a day.
But despite new rules allowing the use of cannabis-related drugs, none has been fully licensed for routine use by the NHS until now.
Dr Rhys Thomas, consultant neurologist at the Royal Victoria Hospital in Newcastle, said: “This is a significant moment for adults and children with the most difficult to treat epilepsies.
“Nice’s recommendation of cannabidiol oral solution follows a period of great anticipation and enthusiasm for patients and their clinicians. The European Medicines Agency licence and availability through the NHS is welcome as we badly need additional effective treatments.”
Epidyolex is recommended for use for patients two years old and above with Lennox Gastaut syndrome (LGS), a rare and severe form of childhood-onset epilepsy, as well as Dravet syndrome, a form of infant epilepsy triggered by fevers.
When added to other anti-epileptic therapies, the oral solution significantly reduced the frequency of seizures in patients with LGS and Dravet syndrome.
Earlier this year, however, Nice had rejected funding for Epidyolex, with one epilepsy doctor saying medicinal cannabis remained ”a medical minefield” and and that the pharmaceutical industry should work to ensure drugs were cost-effective and that their long-term effects were clear.
The decision was welcomed by patient group Dravet Syndrome UK, whose chair, Galia Wilson, said: “Dravet syndrome is a devastating condition and having a new treatment option offers potential new hope to patients and their families searching for better seizure control.
“Many families come to us asking about the potential of cannabis-based medicines, particularly cannabidiol, and we are thrilled that one is now available on the NHS.”
Chris Tovey, of GW Pharmaceuticals, said: “This is a momentous occasion for UK patients and families who have waited for so many years for rigorously tested, evidenced and regulatory approved cannabis-based medicines to be reimbursed by the NHS.
“This is proof that cannabis-based medicines can successfully go through extensive randomised placebo-controlled trials and a rigorous Nice evaluation process to reach patients.”