It’s official—the first FDA approved CBD product is on the market. GW Pharmaceuticals announced this morning that its cannabinoid Epidiolex, approved in the treatment of two rare forms of epilepsy, is now available by prescription. However, it may already be facing its first stumbling block with its price tag.
Epidiolex has racked up angry social media comments since August when it announced its list price as $32,500 per year—with a new surge following today’s news. GW Pharma has been quick to point out that the drug is a rare disease therapy specifically approved to treat seizures associated with Lennox-Gastaut and Dravet syndromes, and its pricing is in line with similar FDA-approved anti-epileptics.
GW has also set up a patient support program which includes help lowering out-of-pocket costs and even no cost for some patients. It's working with payers and in its last financial call in August said it had presented plans that would “cover over 80% of commercial covered lives in the United States,” according to a Seeking Alpha transcript. It estimated out-of-pocket costs to average less than $10 per month for Medicaid patients and less than $35 per month on average for commercial patients.
The pricing blowback is part of what has been GW Pharma’s marketing challenge from the beginning—show doctors and potential patients that the FDA-approved Epidiolex is vastly different from the cannabis-shop oil people have come to know through some state’s legalization of marijuana in the U.S.
Speaking to FiercePharma earlier this month about launch plans, Stephen Schultz, VP of investor relations, said GW has hired 66 neurology sales representatives who will target some 5,000 epilepsy specialists with a message to trust the science and rigor behind the only FDA-approved CBD.
Epidiolex was initially approved in June, but had to wait until September for the Drug Enforcement Agency to figure out how to handle the plant-derived cannabidiol CBD. The good news for GW was a rescheduling from a Schedule I drug—others in that class include heroin and marijuana—to a Schedule V, the class considered with the least potential for abuse; it includes medicines such as Robitussin AC and Lyrica.
Epidiolex’ approval and now launch has been seen as a positive sign for other companies working toward FDA approval for their own CBD medicines, including AXIM Biotechnologies and Cure Pharmaceutical.