Effective immediately, the U.S. Drug Enforcement Administration (DEA) has descheduled GW Pharmaceuticals’ Epidiolex, an anti-epileptic drug that contains cannabidiol (CBD).
Initially, following approval from the DEA in 2018, Epidiolex was listed under Schedule V.
At the time, many industry stakeholders stressed that this move did not reschedule CBD alone as a Schedule-V substance. CBD, as a single compound, remained under Schedule I with the rest of the cannabis plant. (Shortly after Epidiolex was approved, the U.S. Congress passed the 2018 Farm Bill and legalized hemp. CBD derived from hemp, then, was removed from the list of controlled substances. Still, CBD derived from cannabis plants that contain more than 0.3% THC remained Schedule-I.)
By then, though, the fact that CBD was listed as an active ingredient in an approved pharmaceutical drug prevented it from being added freely to food and beverages. It would be comparable to adding acetaminophen to a latte: not permitted under federal law.
Thus, the U.S. Food and Drug Administration began its ongoing quest to understand and regulate CBD. This process continues to this day, leaving CBD product manufacturers in a sort of limbo as hemp producers and state-legal cannabis growers operate further up the supply chain.
In the meantime, the Schedule-V classification for Epidiolex began to change the way that regulators might conceive of a drug that contains CBD. Those drugs are seen as having a proven medical use and a low potential for abuse (like Robitussin-AC, for another example, which contains codeine and is listed under Schedule V).
While Epidiolex can be purchased with a physician’s prescription, the pricing stands at around $32,500 per year. The company declined to get into specifics on insurance reimbursement during an earnings call last fall, but U.S. Chief Commercial Officer Darren Cline did say that, “Yes, again, we're pleased with the payer coverage. There's kind of this escalation, if you will, from more restrictive to a little bit more open. We're not breaking out what that looks like at this point. But I think if you look at the execution around Dravet, LGS, we find the payer community to be very, very favorable to that utilization there. So we're very pleased with it.”
“This notification from DEA fully establishes that Epidiolex, the only CBD medicine approved by FDA, is no longer a controlled substance under the federal Controlled Substances Act,” GW CEO Justin Gover said in a public statement. “We would like to thank DEA for confirming the non-controlled status of this medicine. Importantly, the descheduling of EPIDIOLEX has the potential to further ease patient access to this important therapy for patients living with Lennox-Gastaut Syndrome and Dravet syndrome, two of the most debilitating forms of epilepsy.”