Epidyolex (cannabidiol) oral solution and Sativex (nabiximols) have been recommended for use by the UK’s National Institute for Health and Care Excellence
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Epidyolex (cannabidiol) oral solution and Sativex (nabiximols), two medicines by GW Pharmaceuticals, have been recommended by the UK’s National Institute for Health and Care Excellence (NICE) to receive routine reimbursement from NHS England.
This represents the first time any plant-derived cannabis-based medicine has been recommended by NICE for use on the NHS.
Cannabidiol oral solution is recommended as adjunctive therapy for seizures associated with Lennox Gastaut syndrome (LGS) or Dravet syndrome, in conjunction with clobazam, for patients two years of age and older.
Nabiximols, reviewed as part of NICE’s evaluation of cannabis-based medicinal products (CBMPs), has been considered cost-effective for the treatment of spasticity due to multiple sclerosis.
“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,” said Chris Tovey, GW’s Chief Operating Officer.
For Tovey, 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. "I am hugely proud of the entire GW team for achieving this milestone in the country where the company was founded and where both of these medicines were developed and are manufactured," he said.
GW’s cannabidiol oral solution was approved by the EMA and received marketing authorisation in September 2019 under the trade name Epidyolex as adjunctive therapy for seizures associated with LGS or Dravet syndrome, in conjunction with clobazam, for patients two years of age and older.
Following this approval, GW has been working with the relevant bodies in the UK, Germany, Spain, France and Italy to secure reimbursement ahead of the anticipated launch of the medicine in these countries.
The inclusion of nabiximols in NICE guidelines comes as part of the comprehensive evaluation of the clinical and cost-effectiveness of CBMPs. Nabiximols has been approved by medicines regulators in more than 25 countries around the world. Nabiximols was approved in the UK by the Medicines and Healthcare products Regulatory Agency (MHRA) in 2010 and is marketed in the UK by GW’s commercial partner, Bayer.
Commenting on the NICE recommendation for cannabidiol oral solution, 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 (EMA) licence and availability through the NHS is welcome as we badly need additional effective treatments for Dravet and Lennox Gastaut syndromes.”
“We welcome the addition of cannabidiol oral solution as a new medicine to add to the Dravet syndrome treatment armamentarium. 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,” said Galia Wilson, Chair, Dravet Syndrome UK. “Many families come to us asking about the potential of cannabis-based medicines, particularly cannabidiol (CBD), and we are thrilled that one is now available on the NHS.”
When added to other anti-epileptic therapies, GW’s cannabidiol oral solution significantly reduced the frequency of seizures in patients with LGS and Dravet syndrome.
The most common adverse reactions that occurred in patients treated with the medicine were somnolence, decreased appetite, diarrhoea, pyrexia, fatigue and vomiting. GW’s development programme represents the only well-controlled clinical evaluation of a cannabinoid medication for patients with refractory epilepsy.