It took nearly 18 months, but after authorizing Jazz Pharmaceuticals’ Epidyolex for seizures associated with tuberous sclerosis complex (TSC), the U.K. now will reimburse users of the cannabidiol product.
The decision was rendered on Tuesday by the National Institute for Heath and Care Excellence (NICE). In the U.K., the highly purified oral solution can be used by those age 2 and older. Patients will become eligible for reimbursement on March 1.
Epidyolex, known as Epidiolex in the U.S., was initially approved in the U.K. in July of 2019 to treat seizures associated with Lennox-Gastaut syndrome or Dravet syndrome in conjunction with decades-old clobazam. Four months later, NICE recommended it for reimbursement.
When the FDA signed off on the use of Epidiolex for Lennox-Gastaut and Dravet in 2018, it became the first drug with ingredients derived from marijuana to be approved in the U.S. The FDA followed in 2020 with the label expansion to treat TSC. The agency allows patients age 1 and older to use Epidiolex.
TSC causes tumors which are mostly benign to grow in vital organs such as the heart, brain, skin, eyes, kidneys and lungs. It has been detected in infants but it is usually not diagnosed until epileptic seizures begin later in childhood. Anywhere from 3,700 to 11,000 have it in the U.K., Jazz said.
When the U.K.’s Medicines and Healthcare Products Regulatory Agency (MHRA) sanctioned Epidyolex for TSC in August of 2021, Jazz said it would work with “relevant stakeholders in the U.K., including NICE, to secure reimbursement.
“This demonstrates the importance of randomized clinical trials and regulatory approval in providing reimbursed access to cannabinoid-based medicines to patients who may benefit,” Simon Newton, Jazz’s general manager, said in a statement.
Sales of Epidyolex are growing rapidly. In the first three quarters of 2022, it generated $529 million in revenue compared to $270 million in the first three quarters of 2021.
Epidyolex was developed by Cambridge, England-based GW Pharmaceuticals, which specializes in cannabinoid-based medicines. Dublin-based Jazz acquired the company in May 2021 for $7.2 billion.