GW Pharmaceuticals‘ breakthrough cannabis-based drug Epidiolex finally became available to patients in the United States in recent weeks, four months after the U.S. Food & Drug Administration approved it in June.
This was a breakthrough moment in the march to make cannabis a normal product with accepted health uses.
I’m not surprised that the company is already testing Epidiolex’s efficacy for other medical problems, including forms of epilepsy that afflict a wider audience and for a rare tumor disorder that causes seizures. These additional applications have captured the attention of the pharmaceutical industry and GW Pharmaceuticals shareholders. Success in the general epilepsy market or crossovers into treatment of other diseases would make Epidiolex an enormous success financially.
For now, Epidiolex is available for prescription only to patients suffering from the somewhat uncommon Dravet Syndrome and Lennox-Gastaut Syndrome. But GW chose those diseases strategically – to speed the path to approval for Epidiolex. Again, no other cannabis-based drug had earned an FDA approval previously, so it made targeting more of a niche window the smartest play.
Also, because these two forms of epilepsy are rare and do not respond to other treatments, GW got an “orphan drug” designation for Epidiolex, which lowered the company’s costs significantly and gave it a window in which other pharmaceutical competition would not be allow to compete.
But that doesn’t mean Epidiolex is without competition from another sphere…
Over-The-Counter Product Could Push Epidiolex for Market Share
Epidiolex’s reach will ultimately depends on what percentage of epilepsy patients will be allowed to use it.
Dr. Jokubas Ziburkus, a neuroscientist and renowned expert on the human endocannabinoid system that I met briefly with during the Maryland Medical Cannabis Forum, actually called Epidiolex a “disappointment.” He acknowledge that it was groundbreaking because it earned an FDA approval and has showed the path for other pharmaceutical companies to do the same – but he believes GW Pharmaceuticals could have gone much farther when developing the drug.
And, if you think about it, the chief competitor to Epidiolex is already available on health food shelves around the country. That’s a rare situation for a new pharma product.
Epidiolex is basically just a very high dose of CBD (cannabidiol), the most common non-psychoactive, natural component in cannabis plants. So, while Epidiolex will cost $32,500 per year, many parents can treat their children’s epilepsy with over-the-counter CBD oil. In theory, it would achieve most of the same effect and, depending on the brand, at less than half or even a third of the cost.
Now, those economics will not stymie GW Pharmaceuticals’ success here.
For one thing, Epidiolex will almost certainly be covered by insurance at some point, whereas over-the-counter CBD is not covered. A family with insurance and without a sky-high deductible will probably find Epidiolex more affordable than the non-pharmaceutical form of CBD.
Next, non-pharmaceutical CBD companies do not have permission to market their products as treating any disease, whether they do so effectively or not.
Finally, with the high dosages of CBD called for by Epidiolex, higher than any person has typically received before, many patients will want a doctor’s direct oversight of the administration of the drug. That means going with the prescribed choice (Epidiolex) in most cases.
The National Institute for Cannabis Investors estimates that GW Pharmaceuticals will be successful with Epidiolex, but strong competition from over-the-counter CBD will limit the market size of the drug.
GW Pharmaceuticals is a fine company, and its achievement was an historic one. Nobody can take away from GW that it opened the door to more health applications of non-psychoactive cannabinoids.
The product will be a hit. But it’s just as possible that the windfall gains from GW Pharmaceuticals have already been made.
Thanks for being an important part of the National Institute for Cannabis Investors,
Executive Director, National Institute for Cannabis Investors