Following US Food and Drug Administration (FDA) approval in June, and the Drug Enforcement Agency (DEA)’s Schedule 1 ruling in September, GW Pharmaceuticals’ Epidiolex (cannabidiol) oral solution is now available by prescription in the US.
The cannabis-derived therapy is indicated for the treatment of epileptic seizures associated with Lennox-Gastaut syndrome (LGS) or Dravet syndrome in patients two years of age or older.
According to GW Pharma, the treatment has already attracted attention within certain patient and physician groups in the US.
“We believe that awareness is very high for Epidiolex in the US with patients actively reaching out to their physicians to know more about availability,” a GW Pharma spokesperson told us.
“For physicians, Epidiolex pivotal trials have been published twice in The New England Journal of Medicine and once in The Lancet – both serving to raise awareness and support clinician use of the new medicine,” the spokesperson added.
The company is assured it can support potential demand: “GW has invested significantly in growing its manufacturing capability and is confident that the company can produce sufficient product to meet expected demand.”
GW Pharma is also hoping to expand supply in Europe. Epidiolex is currently under review by the European Medicines Agency, and expects a decision in Q1 2019.
The spokesperson continued: “Following hopeful approval and discussions with the relevant national regulatory bodies, our aim is to make the medicine available on prescription to suitable patients as soon as we possible can.”
$32,500 price tag
The average US list price for Epidiolex is $32,500 (€28,327) annually – an average blended rate of children and adults – which the spokesperson confirmed is on par with certain epilepsy treatments available.
“The price is in line with other branded, FDA-approved anti-epileptic drugs (AEDs), such as [Eisai Inc’s] Banzel, and access for eligible patients is expected to be similar to such AEDs for similar indications for LGS (eg. [Lundbeck’s] Onfi and Banzel),” said the spokesperson.
“We anticipate that Epidiolex will be covered by most insurance plans for the appropriate patients,” the spokesperson added.
The company has also announced a patient support programme designed to improve patient access. ‘Epidiolex Engage’ offers patient/caregiver-focused education and resources, and for eligible patients, will provide the product at no cost.
UK medicinal cannabis reform
GW Pharma’s announcement comes days after the legalisation of medicinal cannabis in the UK. Earlier this month, the UK Government announced that as of November 1 2018, specialist doctors can describe the product to patients.
While the UK reforms have little to no impact on GW Pharma, the spokesperson told us it is a positive move for patients and physicians alike. “The Government’s reforms rightly encourage further scientific research and clinical trials into cannabinoid science and medicines, which is excellent news for clinicians and patients.
“GW hopes this will see other companies follow us into this exciting area of medicine and develop regulatory approved cannabis-based medicines.”