UK’s medical advisory body refuses to approve cannabis-based epilepsy drug

The UK’s medical advisory body has refused to recommend a cannabis-based drug on the NHS to treat two severe forms of childhood epilepsy.

The National Institute for Health and Care Excellence (Nice) announced on Friday that it would not recommend cannabidiol combined with anti-seizure drug clobazam for the treatment of two types of severe epilepsy, Lennox-Gastaut syndrome and Dravet syndrome.

Nice was asked by the Department of Health and Social Care to examine whether the cannabis oil drug, used in the United States, should be used in the NHS in England to treat the rare conditions which begin in childhood.

A clinical trial found the cannabis oil drug did reduce the amount of seizures for sufferers of both conditions, which are difficult to manage.

But Nice said that as the trial had only lasted 14 weeks, the long-term effectiveness of the medication was still unknown and therefore could not be recommended.

It was also rejected on cost grounds, as Nice said it was not clear how cost-effective the drug was as the manufacturer GW Pharma’s figures were said to be invalid.

Nice also said it was unclear whether the drug really improved the quality of life of sufferers and reduced the care required from their families.

Meindert Boysen, director of the Centre for Health Technology Evaluation at Nice, said: “The often distressing and life-limiting nature of these very difficult-to-control epilepsies mean that we should all welcome new treatment options.

“Cannabidiol is a promising treatment for people with these types of epilepsies.

“Even though the committee accepted that the evidence shows that cannabidiol with clobazam reduces seizure frequency, its long-term efficacy is unknown, and the committee was not convinced about the way the company had modelled the effect on people living longer or having a better quality of life.”

Nice said that people who currently had access to cannabis-derived drugs to treat epilepsy would not be affected by the lack of recommendation.

A limited number of parents have licences to use medical cannabis oils to treat epilepsy, with some resorting to bringing in the medication from abroad in addition to having a valid UK licence.

Cannabidiol itself is not licensed for use in the UK but a Nice spokesperson said it expected this to change in the near future.

The decision to not recommend the cannabidiol and clobazam combination drug is open for consultation and comments on the Nice website until September 16.

Final guidance on the medication is expected in November.

Friday’s announcement comes after NHS England announced a review into the use of medical cannabis earlier this year, which recommended further clinical trials and was praised as “forward-looking” by campaigners.

But Professor David Nutt, head of the Centre for Neuropsychopharmacology, Imperial College London, warned that having effective cannabis-derived medication on the NHS may now be “a lost cause” after the lack of recommendation.

He said research into the drugs was expensive and difficult, as there were a number of active ingredients in cannabis-derived medications that determined how effective they were.

He added: “What we need to do now is learn from the parents who have gone overseas to find experts to treat their children and have seen remarkable outcomes.

“Their UK doctors are allowed to prescribe medical cannabis as this was made legal in November 2018, yet less than 10 NHS scripts have been issued in the past 10 months.”

Andy McDonald MP, Labour’s shadow transport secretary, whose son died after an epileptic seizure, and who has campaigned on this issue, said: “We know from their use in other countries that cannabis-based epilepsy drugs are efficacious, so it is hugely disappointing that NICE have refused to recommend potentially lifesaving drugs for use in the UK.

“Parents in the UK have travelled oversees to treat their children with medical cannabis because it can be the most effective treatment for reducing the frequency and severity of seizures. Patients in the UK shouldn’t be denied treatment that is available elsewhere and which could help them live longer and healthier lives.”

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