CBD-Based Life-Changing Drug For Tuberous Sclerosis Patients, Epidiolex, Now Available Via England's NHS

The National Health Service England confirmed Tuesday that starting this week, doctors can prescribe Jazz Pharmaceuticals JAZZ Epidiolex, a CBD-based medicine, to patients suffering from tuberous sclerosis complex (TSC). This means that patients who use this cannabidiol product in the U.K. will be reimbursed starting on March 1.

"We’re thrilled that people with TSC in England will now have access to cannabidiol, a potentially life-changing medicine for the eight in 10 people in the UK who have TSC and also difficult-to-treat TSC-related epilepsy,” said Dr. Pooja Takhar of the Tuberous Sclerosis Association.

Tuberous sclerosis complex is known as a dominant cause of genetic epilepsy. It induces the growth of benign tumors in the brain, heart, lungs, kidneys, skin and eyes, with epilepsy being the most frequent neurological component. According to TSC Alliance, at least two children are born each day with TSC. Around one million people across the globe suffer from this disease, with around 50,000 in the U.S., and between 3,700 to 11,000 in the U.K.

What Is Epidiolex?

Epidiolex is the first FDA-authorized CBD medicine for treating children with severe forms of epilepsy. The medicine was first approved for treating seizures connected to Lennox-Gastaut syndrome and Dravet syndrome, and last July for treating seizures related to tuberous sclerosis complex. Epidiolex's net product sales were $463 million in 2021, whereas in just the first three quarters of 2022, sales surpassed $529 million.

GW Pharmaceuticals developed Epidiolex, but the company was acquired by Jazz Pharma in February 2021 for $7.2 billion.

This new development in England’s health care system is estimated to benefit around 1,000 patients, writes The Sun.

"Epilepsy can have a massive impact on overall quality of life for individuals and entire families, meaning that this approval could have a huge benefit to many people with TSC-related epilepsy,” Takhar added.

According to clinical trials, CBD oral solution can reduce the number of seizures by up to 30% in some people, potentially saving thousands of lives. 

“This demonstrates the importance of randomized clinical trials and regulatory approval in providing reimbursed access to cannabinoid-based medicines to patients who may benefit,” said Simon Newton, Jazz’s general manager, reported Fierce Pharma.

Medical Marijuana In The UK

The news comes about a month and a half after a teenager from Dunmow in Essex became one of the first patients to be given free medical cannabis. Harry Siddans, 15, who suffers from refractory epilepsy, also known as drug-resistant epilepsy, has been using medical marijuana (MMJ) for two-and-a-half years.

According to his parents, only cannabis helped stop Harry’s otherwise constant seizures. It has enabled him to walk and go back to school. Until recently, the Siddans family had been spending around £995 (around $1196.62) a month for this medicine.

The UK legalized medical marijuana use in 2018. The need for cannabis as medicine was highlighted by two cases involving children with severe epilepsy.  Billy Caldwell and Alfie Dingley were both using cannabis oil with low THC to treat their disease.

Billy, who had been suffering from life-threatening epileptic seizures since he was a baby, became the first person to be prescribed medical cannabis by the National Health Service (NHS). That was in 2020.

His case first hit the headlines after his mother flew to Canada to get a new supply of cannabis oil, which was seized at customs upon her return. Billy’s condition worsened and he was taken to the hospital for life-threatening seizures. That’s how Billy was first granted an exceptional license to use marijuana oil for medical purposes.

Billy’s case effectively legalized medical marijuana in the UK, but his fearless mother thought this was not enough. She wanted to help others who were going through a similar nightmare. Caldwell believed that more clinical trials were needed for NHS doctors to feel comfortable prescribing the medication so that MMJ could become more accessible and covered by UK’s taxpayer-funded NHS.

Caldwell launched her “I am Billy” campaign under which, earlier last year she helped set up a scheme wherein several global marijuana producers agreed to provide free MMJ to epileptic children if their medical data and outcomes could then be shared with doctors.

Photo: Courtesy of Michael Fischer on Pexels

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Posted In: CannabisNewsMarketsAlfie DingleyBilly CaldwellCBD-based medicineEpidiolexepilepsy cannabisFierce PharmaPooja TakharSimon NewtonThe Suntuberous sclerosis complex
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