A new marijuana-derived drug to treat rare forms of severe epilepsy in children will cost about $32,500 per patient, per year.
Epidiolex, the first cannabis pharmaceutical to be approved by the U.S. Food and Drug Administration, contains the active ingredient cannabidiol (CBD). It does not contain psychoactive molecule THC, which generates the high for which marijuana is best known.
In an earnings call Tuesday, GW Pharmaceuticals said about 1,200 people — primarily patients with Lennox-Gastaut Syndrome and Dravet Syndrome who participated in the drug trials — currently are receiving Epidiolex.
CBD remains a Schedule 1 drug according to the federal government, which means it has no recognized medical use. Before Epidiolex can be prescribed, the FDA must reschedule CBD.
"We expect to make Epidiolex available to U.S. patients this fall, following rescheduling, which is expected to occur within 90 days of FDA approval," said GW Pharmarceuticals' CEO Justin Gover. "We have been building commercial inventory in recent months and are in a position to ship product into the U.S. supply chain, once rescheduling is complete."
Many CBD preparations are commercially available on the gray market in grocery stores, vape shops, and online. The company said physicians, assured by pharmaceutical quality controls, would have "little reason to consider non-FDA approved CBD products."
The retail price of the drug is high, but GW said costs were in line with other brand-name antiepileptic drugs used to treat the same intractable conditions. With insurance, out-of-pocket costs per month could range from $5 to $200 a month, GW executives said.
During the same call, executives also touted the company's Sativex for treatment of spasticity due to multiple sclerosis. Sativex contains both THC and CBD in a one-to-one ratio. Together, the two molecules are thought to work in concert to treat a number of conditions. GW said it will meet with the FDA later this year to seek approval for the drug.