The body responsible for approving drugs to be used on the NHS has denied approving the only cannabidiol-based drug in the UK market designed to treat severe cases of epilepsy, after the mother of one epilepsy victim revealed she would be selling her house to pay for medical cannabis.
The National Institute for Health and Care Excellence (NICE) – which provides national guidance and advice on health and social care – said in late August it had decided not to approve the drug Epidiolex, produced by GW Pharmaceuticals.
Exactly a month later, last week, the JC reported that Elaine Levy, whose daughter suffers with severe epilepsy, was having to sell her house to buy medical cannabidiol, which costs £4,000 a month in the UK without an NHS prescription.
In a statement, NICE said that the clinical trials suggested that “cannabidiol with clobazam reduces the number of the main types of seizures associated with these conditions compared with usual care with anti-epileptic drugs”.
However, the appraisal committee “had concerns about the validity of the economic models provided by the company” and that “the longer-term effectiveness of cannabidiol with clobazam is uncertain”.
A spokesperson for GW Pharmaceuticals told the JC that they saw the decision as being an “interim” one and were “hopeful” of it being approved in the future.
“We are encouraged that NICE recognises the significant unmet need of patients with Lennox-Gastaut syndrome and Dravet syndrome [two forms of severe epilepsy], and the benefit the cannabidiol oral solution can bring to patients battling these diseases,” they said.
“We are committed to working with NICE to address the technical questions it has raised, with the aim of ensuring patients can access the medicine on the NHS as soon as possible following regulatory approval.”
Ms Levy – who is Jewish – has already spent £30,000 on cannabis oil, which lessened the severity of her daughter Fallon’s condition.
“We just can’t do it any more,” Ms Levy said. “It’s been a year and three months but we’ve got less than a month’s medicine left and we’re now at the end of the road.
“Why am I having to beg when it was made legal last November?”
The only case to have had a license granted for the drug on the NHS is that of Alfie Deacon. No others have been given the same dispensation since the law change.
