How much will it cost to start a regimen of Epidiolex?
U.K. company GW Pharmaceuticals has revealed how much their new epilepsy drug Epidiolex will cost. Epidiolex was approved for use in the U.S. by the Food and Drug Administration in June. The drug is the first medication derived from cannabis to receive approval from the agency.
Cost Revealed in Investor Call
In a conference call with investors on Tuesday, the company announced that Epidiolex will cost each patient about $32,500 per year. The estimate is based on assumptions of average patient weight and dosage. The company said the cost was comparable to that of other drugs used to treat severe forms of epilepsy.
During the conference call, GW Pharmaceutical CEO Justin Gover said Epidiolex will provide a reliable and safe cannabinoid treatment for patients.
“This first U.S. approval not only represents a transformative milestone for our company but a historic medical breakthrough, offering patients and their families the first and only FDA approved CBD medicine to treat two severe, childhood-onset epilepsies,” Gover said. “These deserving patients will soon have access to a cannabinoid medicine that has been thoroughly studied in clinical trials, manufactured to assure quality and consistency, and available by prescription under a physician’s care.”
GW Pharmaceuticals North American president Julian Gangolli said that the cost for patients with health insurance will likely be much less.
“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 [a] dispensary,” Gangolli said.
First FDA Approved Drug Derived From Cannabis
Epidiolex is the first medication derived directly from cannabis plants to be approved for use by the FDA. It was approved by the agency on June 25 for the treatment of Dravet syndrome and Lennox-Gastaut syndrome, two rare forms of epilepsy that can cause dozens or even hundreds of seizures per day.
The main ingredient of Epidiolex is cannabidiol or CBD, one of the more than 100 cannabinoids found in cannabis. Other cannabinoid medicines approved by the FDA such as Marinol have utilized synthetic THC.
CBD Must Be Rescheduled
Before Epidiolex can be prescribed for patients in the U.S., the DEA must reschedule the designation of CBD under the Controlled Substances Act. CBD is currently listed under Schedule 1, a classification reserved for substances that have no recognized medical value and a high potential for abuse.
Barbara Carreno, a DEA public affairs officer, told Business Insider in June that the agency is currently in the process of reviewing the classification for CBD.
“We don’t have a choice on that,” Carreno said. “It absolutely has to become Schedule 2, 3, 4, or 5.”
CEO Gover said that the DEA decision is expected soon. He also noted that the company has been building up stock of the drug and is ready to ship it into the U.S. market.
“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. The FDA has communicated its recommendation to DEA, and we understand that the rescheduling process is proceeding in a normal fashion and that it will be completed within the expected 90-day timeframe.”