Dozens of children and young people with epilepsy are faced with losing access to a “life-saving” medical cannabis product as imports are to be stopped.
Patients who are prescribed a cannabis oil through private clinics in the UK have learned they will no longer be able to access this medication in what has been described as a “major setback” for families.
The MHRA has removed a compassionate licence for the importation of Celixir20, also known as NOIDECS, a whole-plant cannabis product which is currently being prescribed to over 30 children and young people with treatment-resistant epilepsy.
A number of adult patients who are also prescribed the product for symptoms such as chronic pain and anxiety, are also faced with having to find an alternative.
In an email to the co-founder of Medcan Support, Matt Hughes, whose son is one of those affected, the MHRA said the product, which is imported from Israeli company Bol Pharma, did not meet Good Manufacturing Practices (GMP) standards.
“In the absence of assurances that Celixir 20 is manufactured at a facility operating to the same rigorous standards as other medicinal products, the MHRA is not able to process import notifications of this medicine on the grounds of patient safety,” the letter stated.
Officials went on to advise Hughes to contact Charlie’s prescriber to find a “suitable alternative”.
However, there is currently no other product on the market which is similar in strength and chemovar profile as Celixir20, which contains 20:1 CBD to THC.
Charlie, now five, has a condition known as West syndrome, which at its worst caused him to experience over 100 seizures a day.
He has been prescribed Celixir20 since June 2020 and according to Hughes has now been seizure-free for 150 days.
His parents fear that Charlie’s seizures will return if he is no longer able to access the product which has been so beneficial for his health.
“Charlie has been seizure free now for 150 days, which is the longest period in his life,” said Hughes.
“In that time, his development has been amazing, the school has been singing his praises, he’s winning certificates and is really progressing in life in his own little way. This news is a major setback and is extremely concerning for his future – especially considering the short notice we have been given.”
Eaststone Ltd, the importer of Lyphe Group products, is said to have been informed of this in June 2021, and was advised to contact prescribers and patients so that “therapeutic alternatives could be found in a timely manner”.
Hughes and the clinics involved are awaiting confirmation from the MHRA of a six-month extension to allow the product to be supplied until January 2023, although he is not confident that an appropriate replacement can be found within that time frame.
“There is currently no other product on the market in the UK that is the same in strength or chemovar profile to Celixir, and we potentially only have six months of access, if MHRA approves the extension,” he continued.
“This is children’s lives that they’re playing with. I just can’t believe we’re here, four years after the law change and we’re still struggling with products and consistency and reliability.
“This is exactly why we continue to fight for NHS access, so we have reliable access to cannabis-based medicinal products and to remove the burden of funding them each month.”
Switching medication in epilepsy
Switching medication for patients with severe epilepsy carries the risk of inducing breakthrough seizures and can be life-threatening.
In a letter to UK leaders in January 2021, Dr Evan Lewis, a world-leading expert in paediatric epilepsy at the Neurology Centre Toronto, said there is ‘significant variation’ from one product to the next and ‘many unknowns’ as to how the cannabinoids will interact with each other to treat seizures.
He added that it is ‘imperative that children who are benefiting from a particular medical cannabis product are not changed to another product.’
The letter was in relation to Brexit regulations which threatened to stop the import of Bedrocan oils from the Netherlands.
Campaigner Hannah Deacon, whose son Alfie Dingley is one of those prescribed the oils through the NHS, successfully lobbied for an extension period.
She told Cannabis Health that she had “huge sympathy” for those families affected by this latest setback and said the current system is “failing” patients.
Deacon commented: “This is unacceptable and I have huge sympathy and understanding for all those affected and what all these families are going through, faced with a position where they will not be able to access their prescription.
“The fact that this issue was known about over a year ago deeply concerns me, as patients once again have not been put at the centre of the decision making by the MHRA and the company involved. The system is just not good enough and it is failing patients all the time.
“I really hope that with the support of the company, the MHRA and the patient’s involvement – which should have been sought right from the beginning – that a solution can be found, at least for the first six months whilst parents and clinicians decide how to best move forward.”
Deacon added: “This is why we continue to campaign for NHS access, because if this was a problem within the NHS, as it was for me and my son, the government would have to get involved to sort it out. It’s very sad that the private sector has not done enough in this instance to protect these patients.”
The wider impact on patients
Adult patients are also fearful of the impact this could have on their quality of life.
Melissa* told us that no other product she has tried has been as effective for managing her chronic pain condition.
“I’ve tried other oils and none were as effective as Celixir for managing my condition without an increase in adverse side effects. It would take many months and potentially a significant decrease in my quality of life to find a replacement,” she said.
“Adult patients have faced product availability issues for the past two years, with many going out of stock or discontinued – it might not be life threatening to lose access but the process of finding new products that are effective is not always straightforward.
“The industry should focus on improving the supply chain so that we aren’t faced with frequent changes like this.”
Cannabis Health has contacted the MHRA for comment but has not received a statement at the time of publication.
A spokesperson for Lyphe Group said: “We have done everything in our power to ensure that patients are able to access this life-changing medicine. We are pleased to have reached an agreement with the MHRA for enough supply of Celixir20 to be allowed in until the end of the year.
“We will continue to work closely with the MHRA in order to find a permanent solution suitable for all parties and most importantly, to provide clarity and certainty for patients.
“Our children’s lives are at risk”
Teagan Appleby was one of the first children to be prescribed medical cannabis in the UK when it was legalised in 2018. At the time, she was in intensive care suffering from up to 300 seizures every day.
Within a few weeks of starting a prescription of Epidiolex, her seizures had reduced so dramatically that she was allowed home. She later changed to a full-extract product produced in Holland and went six months with hardly any seizures.
For the past two years, Teagan has also been taking Celixir20 which is the medication she responds to best according to her Mum, Emma Appleby.
“Every day, her quality of life is so much better and the seizures are less intrusive and frequent,” she said.
“We’ve accepted that she has good days and bad days, but now we have more good days than bad.”
With MHRA’s decision to halt Celixir20 imports, Teagan’s life is now at risk.
“They’re playing with my daughter’s life, because if she doesn’t have this, we all know what happens,” Emma said.
“We’ve been here before. It happened in the first lockdown, we ran out of oil and money and Teagan was in intensive care in a coma within weeks.
“Thinking about not having this oil, I don’t think I can even contemplate what could happen. They may as well have signed her death warrant.”
Five-year-old Oliver tried multiple pharmaceutical drugs to help combat his seizures but none of them worked.
After his Mum, Michelle Rice, discovered CBD his number of seizures reduced by more than half, from around 100 per day to around 40. With more respite between seizures, he was able to find joy again in his life, Michelle said.
Oliver no longer takes any pharmaceutical drugs and relies solely on Celixir20 to manage his condition.
“His quality of life is the best we could have hoped for a year ago,” Michelle said.
Oliver now has just a matter of weeks left before his medication runs out, with no time to wean off the product and no time for his parents to research a possible alternative.
There is now a significant chance that he will slip back into having life-threatening seizures that have the potential to cause devastating brain damage.
“We’ve got no options; we don’t know where to turn,” Michelle added.
“We need the decision to be reversed. We have evidence that it is safe, it has given our children the best quality of life. We have to have access to it.”
Abbie, 17, has been prescribed medical cannabis for almost two years. After first trying a broad spectrum oil that made little difference to her condition, she moved onto Celixir20 which halved her number of daily seizures.
She was “brighter, happier and more settled,” her Mum, Amy Errico, said.
But when she found out just a few days ago that her daughter’s medication supply would be stopped, it was as if the rug had been pulled from underneath them.
Abbie has just three weeks of her prescription left and neither she nor her Mum know if, or when, she will have access to her medication again.
“I’ve no clue how long we’re going to be able to get the oil for,” Amy said.
“I’m angry because we found a treatment for her which has made her life so much better.
“It’s given her a chance to lead a bit more of a normal life and then suddenly, we’ve got the threat of it disappearing.
“I feel fearful about her future. It’s not right to put parents and children through this, it’s cruel. There should be no reason for it to be withdrawn.”
Bailey Williams, 20, who suffers from a form of epilepsy that can cause hundreds of daily seizures also relies on Celixir20 to keep the fits at bay.
His mum, Rachel Rankmore said the medication has given him his life back. The news that it could be cut off hit her “like a tonne of bricks” with there being no other alternatives for her son.
“It’s the only thing that works for Bailey,” she said.
“He’s doing better than ever. He’s got goals and ambitions in his life now that he’s never had before and that’s going to be stripped away from him.”
Bailey has four weeks of medication left. After which his supply of Celixir20 will stop, but like other families, Rachel and Bailey have had no support.
“We are patients in a life-threatening situation,” Rachel continued.
“We’re getting no support at all and it’s shocking because this is children’s lives. All our children want to do is live their best quality of life, we just want our children to be safe.
“We watch Bailey doing things that he hasn’t normally done. And I look at him and I’m thinking, ‘it’s all going to get taken away from you’. I can’t even look at my own son because I feel so helpless.”
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