The National Institute for Health and Care Excellence (NICE) has recommended GW Pharma's Epidyolex (cannabidiol) for two rare, severe forms of childhood-onset epilepsy.
Initially the organisation rejected the cannabinoid prescription medicine but promised to “work with the company to resolve the economic modelling issues identified by the committee, and to help them understand what they may need to do to mitigate the cost of cannabidiol to the NHS.”
Now, NICE has recommended the drug in combination with clobazam for Lennox Gastaut syndrome (LGS) or Dravet syndrome in patients two years of age and older.
The news is being hailed as 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.
Additionally, the organisation recommended Sativex (nabiximols) – another plant-derived cannabis-based medicine. Reviewed as part of NICE’s evaluation of cannabis-based medicinal products (CBMPs), the drug has been considered cost effective for the treatment of spasticity due to multiple sclerosis.
The approvals mark the first time that a medicine of its kind has been elected to receive routine reimbursement from NHS England.
“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," said Tovey. "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.”
“It’s excellent news for patients that two cannabis-based medicines, Sativex and Epidyolex, for epilepsy and multiple sclerosis, have been approved for use by the NHS in England," commented RPS chief scientist Gino Martini.
“Pharmacists will be on the frontline of supplying cannabis-based medicinal products and can give advice to patients on them as part of their treatment plan. It’s essential there is robust governance around prescribing and dispensing, and pharmacists have a key role to play in ensuring this is in place across health systems.”
The news was welcomed by many, but Sarah Ellson, a healthcare lawyer at Fieldfisher, also stressed that there is still “disappointment surrounding the restrictions on prescribing cannabis-based drugs in the UK.
"Although frustration with the UK's (and EU's) current regulatory position on cannabis continues to mount, more information is becoming available and regulators are slowly manoeuvring into a position to make informed decisions.
"As things stand, industry consensus appears to be that restrictions on medical and medicinal cannabis use will ease as more companies progress through the relevant approvals processes," she said.