GW Pharmaceuticals has announced its pricing stategy for Epidiolex, the CBD extract recently approved by FDA. In a Wall St. Journal interview, GW’s Justin Gover emphasized that the cost will be similar to other anti-epileptic drugs such as Onfi —$32,500/year. An officer of the Epilepsy Society expresses gratitude that GW didn’t set a much higher price.

Here’s Dale Gieringer’s back-of-the-envelope comparison of Epidiolex and a homegrown equivalent:

At $32,500 per year, Epidiolex, the new FDA-approved CBD drug, is a costly medication.  The standard dosage of Epidiolex is from 5 to 25 mg of CBD per kg bodyweight per day, which works out to 250 – 1,250 mg of CBD per day for a 100-pound patient (on the heavy side for pediatric cases).   Using high-potency flowers of 15% CBD, this works out to 1.67 to 8.33 grams of cannabis per day, or 1.2 – 6 pounds of cannabis per year.    At a price of $150/ounce, an equivalent amount of 15% CBD cannabis flowers would cost $2880 – $14,400 per year.   Another example of the high cost of FDA-regulated medication.   – D.G.

Here’s Peter Loftus in the August 8 Wall St. Journal:

GW Pharmaceuticals PLC said it plans to charge about $32,500 per patient annually in the U.S. for its new treatment for rare forms of epilepsy, the first prescription drug derived from the marijuana plant.

Chief Executive Justin Gover said in an interview Wednesday that the company set the price to be in line with other brand-name epilepsy drugs, such as H. Lundbeck A/S’s Onfi. He noted that the FDA designated the product an “orphan drug,” meaning it treats rare conditions, and that some other orphan drugs carry higher prices.

Out-of-pocket costs for patients taking Epidiolex could range from $5 to $10 a month for those in state Medicaid programs to as high as $200 a month for some private insurance plans, Julian Gangolli, president of the company’s North America unit, said on a conference call with analysts Tuesday. Uninsured patients may qualify for receiving the drug free.

Dr. Jacqueline French, chief scientific officer of the Epilepsy Foundation, said there are low-cost generic epilepsy drugs on the market, but many patients with the rare forms of the disease have already tried them and the drugs didn’t help much.

Dr. French said Epidiolex improved symptoms for many children in clinical trials, and she is happy the price isn’t significantly higher.

The company expects to make the drug available after the U.S. Drug Enforcement Administration assigns it a controlled-substance classification, a decision expected by late September. GW Pharmaceuticals will distribute the drug through specialty pharmacies that ship directly to patients and caregivers.

FDA approval of a CBD extract means that cannabidiol now has an acknowledged medical use and therefore doesn’t fit a key criterion of Schedule I status. DEA rescheduling is supposed to follow as day follows night. Logically, the DEA resked should apply to cannabidiol, the molecule. But fixisin.com says CBD will remain on Sked I, with an exception created for CBD in an FDA-approved pharmaceutical.