A marijuana-derived drug that recently became the first of its kind to win federal approval is not going to be cheap.
Called Epidiolex, the drug is designed to treat two rare forms of childhood epilepsy using a cannabis compound called cannabidiol (or CBD) .
On a call with investors this week, British-based GW Pharmaceuticals, who makes the drug, said it would cost roughly $32,500 per year. The medication does not contain THC, the well-known psychoactive component of marijuana responsible for the drug’s characteristic high.
Julian Gangolli, who leads GW’s commercialization efforts in the US, said the price point would keep Epidiolex in line with other epilepsy drugs and was largely based on feedback from insurance companies.
Gangolli also said that he expected the wait time to receive the medication — after patients get a prescription from a clinician — to be three weeks, on average. But before any prescriptions for Epidiolex can be written, the Drug Enforcement Administration must reschedule its active ingredient, the marijuana compound CBD.
Currently, CBD is scheduled alongside marijuana as a schedule 1 drug with “no currently accepted medical use.” Beginning on June 25 when Epidiolex was approved, the agency had 90 days to reschedule or reclassify it as a schedule 2, 3, 4, or 5 substance.
“We don’t have a choice on that,” DEA public affairs officer Barbara Carreno told Business Insider in June. “It absolutely has to become Schedule 2, 3, 4, or 5.”
Epidiolex’s approval in June came on the heels of several months of promising research results and a positive preliminary vote from the Food and Drug Administration this spring. Experts are hopeful that the approval will unleash a wave of new interest in the potential medical applications of CBD and other marijuana compounds.
“This approval serves as a reminder,” Scott Gottlieb, the FDA commissioner, said in a statement shortly after the approval, “that advancing sound development programs that properly evaluate active ingredients contained in marijuana can lead to important medical therapies.”
In three large clinical trials which the FDA considered before giving Epidiolex the official green light, researchers presented strong evidence that the pharmaceutical-grade CBD in the medicine had the power to significantly curb some of the worst symptoms of two of the hardest-to-treat forms of epilepsy, known as Lennox-Gastaut syndrome and Dravet syndrome .
“This is clearly a breakthrough drug for an awful disease,” John Mendelson , a panel member and senior scientist at the Friends Research Institute , said at a public FDA meeting this spring that was called to discuss the scientific merits of the drug.
But although the green light means that patients will soon be able to access Epidiolex with a doctor’s prescription, many will also likely turn to less expensive sources of CBD , such as those sold in marijuana dispensaries. Researchers and advocates caution against this, however, with the caveat that it’s impossible to verify that what’s in those products is actually pharmaceutical-grade CBD.
Gangolli added that with insurance, Epidiolex could be substantially cheaper than dispensary CBD.
“The cost of a co-pay [for Epidiolex] is significantly — or could be significantly — less onerous and burdensome than the cost of the product either over the internet or from dispensary,” Gangolli said.