U.K. Physicians Now Can Prescribe Epidyolex Cannabidiol Solution to Treat Dravet, LGS Patients
Since Jan. 6, physicians in England are able to prescribe the oral cannabidiol solution Epidyolex, in combination with clobazam, to treat persistent seizures in eligible people with Dravet syndrome and Lennox Gastaut syndrome (LGS).
The announcement by the United Kingdom’s public National Health System (NHS) follows the recommendation by the National Institute of Health and Care Excellence (NICE), the arm of the NHS that provides evidence-based guidance and advice for health and social care practitioners. NICE recommended that the plant-derived, cannabis-based medicine be routinely covered by the NHS to give patients access to the treatment at low cost or free of charge.
Epidyolex — developed by GW Pharmaceuticals and approved under the name Epidiolex in the U.S. in 2018 — is a purified, oral form of the non-psychoactive component of cannabis. It is thought to indirectly regulate the brain’s endocannabinoid system to suppress seizures in children and adults with Dravet syndrome and LGS.
NICE’s recommendation comes after Epidyolex was approved by the European Commission in September 2019, allowing it to be used in combination with anti-epileptic generic medication clobazam — sold under the brand names Onfi and Sympazan — in the same patient population, ages 2 and older.
The approvals were based on a number of clinical trials and extension studies (NCT02091375, NCT02224703, NCT02224560, NCT02224573), the results of which suggested that Epidyolex treatment could reduce seizure frequency by as much as half, and improve overall health in around 80% of participants. Common side effects in these trials included sleepiness, fever, decreased appetite, vomiting, and diarrhea.
Earlier last year, the NHS branch that oversees the U.K., NHS England, published a review to address the barriers that patients face when accessing clinically appropriate, cannabis-based products for medicinal use (CBPM).
In December 2019, the U.K. government’s Department of Health and Social Care issued a letter to the NHS to provide medical professionals with resources and guidance in prescribing unlicensed CBPMs where there is an unmet need and its use is deemed clinically appropriate.
“The NHS is committed, through the Long Term Plan, to improving the lives of all those affected by rare diseases,” Simon Stevens, chief executive of the NHS, said in a press release.
The UK’s Long Term Plan is a 10-year, government-funded initiative drawn up by front-line staff, patient groups, and national experts to move the NHS to a new service model that gives patients better support, more options, and coordinated care in a proper setting. It also focuses on disease prevention, health inequalities, and staff support.
“Living with or caring for someone with severe epilepsy is exceptionally challenging, especially as there are so few treatments available for the rare forms of the condition,” Stevens said. “Thousands of people including children will now have access to this treatment, which has the potential to make a real difference.”