After many months of intense lobbying, the NHS will shortly prescribe Epidiolex with clobazam for UK patients with two rare forms of epilepsy. The move comes shortly after the election result, with Blair Gibbs of the Tory-backing Centre for Medical Marijuana ensconced in No 10 as a policy adviser.
Research has suggested the drug can cut seizures by up to 40 per cent. The NHS has negotiated a price well below the listed £850-a-bottle. Up to 2,000 patients with Dravet syndrome or Lennox Gastaut syndrome could benefit at an annual cost of £10m
Health bosses have officially confirmed the drug combination Epidyolex with clobazam will be available on prescription from January 6 in England.
The drug has been hailed as a game-changer for children with severe epilepsy and studies suggest it can cut seizure numbers by up to 40 per cent.
It was tipped for health bosses’ approval in November and this has now been finalised and the funding fast-tracked so patients can get it almost right away.
The announcement makes Epidiolex the third cannabis-based medicine to be approved for NHS prescription, and the first one for epilepsy.
This approval was made possible after a lengthy campaign by the parents of epileptic children, such as Charlotte Caldwell and her son Billy, persuaded the Government to legalise cannabis medicines.
Chief executive of the charity Epilepsy Action, Philip Lee, said he was ‘delighted’ by the news.
‘New treatment options for severe epilepsies do not come very often and many families feel they have already been waiting too long to access medicines like Epidiolex,’ he said.
‘This announcement brings much-needed hope and could be life-changing for some.’
Epidiolex and other cannabis-containing drugs were legalised by the Government in November 2018 but were not deemed cost-effective for the NHS.
A lack of official approval has meant doctors wanting to prescribe them had to do it on their own initiative and patients had to pay to get them privately.
The National Institute for Health and Care Excellence (NICE) published official guidance recommending Epidiolex for NHS patients on Wednesday this week.
NICE said people with the rare forms of epilepsy, Dravet syndrome and Lennox Gastaut syndrome, are now eligible to have the drug.
An estimated 3,000 people in England have Dravet syndrome and 5,000 Lennox Gastaut syndrome, the BBC reports – around 2,000 are expected to qualify for Epidiolex.
Epidiolex is an oral solution containing cannabidiol (CBD), which is legal, and has trace amounts of THC in it – the chemical which makes people high.
It is combined with the existing anti-epileptic drug clobazam, which is already used by many to keep seizures under control.
HOW MANY CANNABIS MEDICINES ARE AVAILABLE ON THE NHS?
The Government legalised cannabis-based medicines in the UK in November 2018.
The law change was made after a high pressure public campaign by families of children with severe forms of epilepsy, who said their youngsters could benefit from the drugs.
However, patients have found it hard to access drugs since then because medications must also be licensed and funded before an NHS patient can get them.
Any licensed drug can be prescribed by a private doctor, but patients have to pay for them themselves.
Only three cannabis-based medicines currently have NHS funding.
Nabilone – Nabilone is a drug taken orally to reduce sickness in patients having chemotherapy for cancer. It was approved by the National Institute for Health and Care Excellence (NICE) in August.
Sativex – Sativex is a nasal spray cannabis-based drug which is used to reduce spasticity (muscle stiffness) in some patients with multiple sclerosis. NICE approved Sativex in November.
Epidiolex with clobazam – Epidiolex is an oral solution used to reduce the frequency of seizures in children with Dravet syndrome and Lennox Gastaut syndrome, severe forms of epilepsy. Clobazam is an already approved anti-epileptic drug which does not contain cannabis.
And the NHS today announced it has negotiated with the manufacturer, GW Pharma, to set up the supply chain in just 19 days.
This process usually takes three months.
NHS chief executive Simon Stevens said: ‘The NHS is committed, through the Long Term Plan, to improving the lives of all those affected by rare diseases.
‘Thousands of people including children will now have access to this treatment, which has the potential to make a real difference.’
Dravet syndrome is a rare genetic illness affecting around one in every 15,000 children – it causes uncontrolled electric activity in the brain and seizures.
And Lennox Gastaut syndrome makes up between one and five per cent of childhood epilepsy cases and may be caused by brain damage at birth.
Both conditions can also cause development problems and learning difficulties.
GW Pharmaceuticals, which will supply the Epidiolex to the NHS, uses cannabis grown in the UK.
The product contains trace amounts of the chemical THC (tetrahydrocannabinol), which is the psychoactive component that makes people ‘high’ and makes weed illegal.
Medicines containing cannabis were legalised 13 months ago by then-Home Secretary Sajid Javid.
He pushed through the law change after a campaign of pressure from the parents of children with severe epilepsies such as Dravet syndrome.
Some families had discovered Epidiolex and similar drugs were slashing the number of life-threatening seizures their children were having and were buying it illegally or smuggling it into the country.
One mother at the forefront of the campaign, Charlotte Caldwell, was accosted at Heathrow and had her son’s medication confiscated after she tried to smuggle it from the Netherlands.
Epidiolex will become the third cannabis-based drug to be approved for prescription by NHS doctors, and the first one for epilepsy.
Sativex, a nasal spray used to treat muscle stiffness in multiple sclerosis patients, and nabilone, which reduces vomiting in chemotherapy patients, are also approved.
GW Pharma said the move was a ‘milestone’ and would pave the way for more cannabis medications.
Its chief operating officer, Chris Tovey, said: ‘Its chief operating officer, Chris Tovey, said: ‘This demonstrates that if routed through rigorous clinical trials, approved by a medicines regulator and proven to be cost-effective, cannabis-based medicines can reach patients who need them.’
But Millie Hinton, director of campaign group End Our Pain, said the announcement would bring joy to some families but would prolong the suffering of people who need access to products containing CBD and THC.
Epidiolex only contains tiny amounts of THC, and is mostly CBD (cannabidiol), which is completely legal.
Some families are paying around £2,000 a month privately for products which contain both, she added.
Ms Hinton said: ‘They have been pushed to financial breaking point funding the only medicine that gives their children significant seizure control and the quality of life they deserve. Some have actually felt forced to sell their family homes.
‘So, whilst fast-tracking access to a CBD-only product is a step in the right direction for some desperate families, for those that need the products containing both CBD and THC it’s another false dawn and missed opportunity.
‘These families need immediate action to secure NHS prescriptions for the CBD and THC whole plant medical cannabis products.
‘It is unbelievably cruel to leave these vulnerable families in such a desperate state. All these families want for Christmas is for the Government to honour the promises they made to them.’