Written by Jen Keehn
Updated September 13, 2021
Medically Reviewed by Dr. Sandra El-Hajj
In June 2018, the FDA announced the approval of Epidiolex, a CBD-based drug, as a Schedule Class V substance under the Controlled Substance Act. Its adaptation came three months after it has been approved as a treatment of seizures associated with Dravet syndrome and Lennox-Gastaut syndrome, two rare and extremely serious forms of epilepsy1.
GW Pharmaceuticals CEO, Justin Gover said, “We are pleased that the DEA has placed Epidiolex in the lowest restriction Schedule, because it will help ensure that patients with LGS and Dravet syndrome, two of the most debilitating forms of epilepsy, can access this important new treatment option through their physicians. With this final step in the regulatory process completed, we are working hard to make Epidiolex available within the next six weeks as we know there is excitement for a standardized version of cannabidiol that has undergone the rigor of controlled clinical trials and been approved by the FDA2“.
While this is undoubtedly a step forward, the DEA hasn’t changed its stance on other forms of CBD, which highlights the federal government’s viewpoint that several CBD products available on the market are still considered a Schedule I substance.
According to the DEA, Schedule I substances are drugs with no current accepted medical value that pose a high risk of abuse. These are the most dangerous that exist and include substances such as heroin, MDMA (ecstasy), cannabis, and LSD and other psychedelics. Meth and cocaine are both Schedule II substances.
Epidiolex is pure CBD and the first cannabis-derived medication approved by the FDA.
How much does Epidiolex cost, though?
Prescription medication in the US isn’t known to be cheap, and Epidiolex doesn’t seem to be an exception.
After the FDA publicized its approval of the drug, GW Pharmaceuticals (the UK-based company responsible for its manufacturing) announced that the estimated price would be right around $32,500 a year.
Say what? Is Epidiolex really that expensive?
Will it be covered by insurance so those who need it can actually afford it? How does Epidiolex compare to other CBD products available without a prescription?
Let’s take a look at these questions and more.
What is Epidiolex?
Epidiolex is the first FDA-approved prescription medication derived from the Cannabis sativa plant3.
Epidiolex contains cannabidiol (CBD) derived from high-CBD strains of marijuana.
Does this mean that Epidiolex is actually medical marijuana? No, not at all.
CBD is found in both varieties of the Cannabis sativa plant: hemp and marijuana.
When it comes down to it, CBD is CBD, regardless of whether it was derived from hemp plants or marijuana plants.
Hemp-derived CBD is so popular because there are far fewer legal obstacles when it comes to CBD from hemp then there are with CBD from marijuana.
Why is this important?
Epidiolex is derived from marijuana, where most other CBD products widely available are derived from hemp.
Does this make a difference?
Not so much.
While comparing Epidiolex to other high-quality, hemp-derived CBD products on the market is difficult since the FDA-approved medication is so new, the two are actually quite similar based on their effectiveness in significantly reducing the number of seizures individuals suffering from intractable epilepsy.
How Much Does Epidiolex Cost?
In an August 2018 call with investors, GW Pharmaceuticals revealed the price of Epidiolex would cost roughly $32,500 a year.
While on the lesser end of the 2016 estimated annual cost of $30,000-$60,000, it’s still a hefty price tag to pay.
According to GW Pharmaceuticals CEO, Justin Grover, the price keeps Epidiolex in line with the cost of other prescription epilepsy drugs available on the market4.
“We wanted to make sure that we were pricing Epidiolex in such a way where the means to access this medication would be consistent with branded epilepsy drugs these patients already use,” said Grover in August after the price of the drug was revealed.
The decision of the final cost was also heavily based on insurance company feedback.
Will Epidiolex Be Covered by Insurance?
Considering the price of Epidiolex (over $2,700 monthly), it would be beneficial if the drug was covered by insurance.
Will insurance companies cover Epidiolex, though?
It is derived from marijuana after all, and insurance companies don’t cover medical marijuana.
They do, however, cover FDA-approved drugs.
Seeing as Epidiolex is FDA-approved, there’s a good chance that it will be covered by insurance.
For those who do have health insurance, Epidiolex could be less expensive than purchasing marijuana-derived CBD from a dispensary.
“The cost of a co-pay [for Epidiolex] is significantly-or could be significantly-less onerous and burdensome than the cost of either over the internet or from a dispensary,” said Julian Gangolli, president of GW Pharmaceuticals US operations5.
It’s estimated that patients who participate in state Medicaid programs could pay as little as $5-$10 a month for Epidiolex.
Private insurance patients might have to pay up to $200 a month, which is still far less expensive than paying out of pocket.
What about those without health insurance who could benefit from Epidiolex?
How Does Epidiolex Compare with Buying Your Own CBD?
The high price of Epidiolex is all but impossible for many patients to afford without health insurance.
Remember, that before Epidiolex was approved by the FDA, people were using CBD oil for epilepsy and several other health ailments.
We mentioned at the beginning of this article that Epidiolex is derived from marijuana rather than hemp.
While this is true, there are other slight differences between Epidiolex and full-spectrum (or broad spectrum) hemp CBD oil.
For one, Epidiolex is CBD that has been isolated from marijuana, which is typically referred to as CBD isolate.
After CBD is extracted from the cannabis plant, in order to produce CBD isolate, it must go through a further extraction process that removes all other cannabinoids, terpenes, and flavonoids that work in synergy to offer the myriad of benefits CBD is known for.
This being said, CBD isolate is a popular option among CBD users.
Why? Everything has been removed but the CBD.
Because full-spectrum CBD has trace amounts of THC (0.3% or less), it could potentially show up in a drug test or affect individuals with extreme sensitivity to THC.
CBD isolate is 99.9% pure CBD with nothing additional.
So how does Epidiolex compare with buying your own CBD?
It’s very similar to high-quality CBD isolate products.
So far, Epidiolex has only been approved (and researched) for two forms of rare epilepsy: Dravet syndrome and Lennox-Gasaut syndrome.
Could full-spectrum CBD or CBD isolate purchased online compare to the FDA-approved version?
It’s safe to say they do compare, however, seeing that Epidiolex hasn’t yet hit a larger mainstream market, it might be too early to tell.
There are several accounts, both clinical and anecdotal, that show CBD to be effective in reducing or eliminating seizures.
Can Anyone Get a Prescription for Epidiolex?
Some people feel better knowing that a given medicine is approved by the FDA. It is understandable.
When it comes to Epidiolex, it’s not available to any individual who wants to help any possible condition he or she may have.
So far there have only been two conditions approved for the use of Epidiolex.
Again, these are two forms of extremely rare and very serious epilepsy: Dravet syndrome and Lennox-Gasaut syndrome.
Not everyone can get a prescription for Epidiolex, but anyone can purchase high-quality CBD products online or at specialized retailers across the US.
Is Epidiolex Medical Marijuana?
Because Epidiolex is derived from marijuana strains rich in CBD, some might assume that it’s actually medical marijuana.
Yes, Epidiolex is derived from the Cannabis sativa plant. But, it only contains isolated CBD.
It cannot get you high and is not considered “medical marijuana” which is still illegal at the federal level despite the fact that several states have passed medical marijuana laws.
The FDA approval of Epidiolex marked an important moment in history.
It is the first federally-approved drug that is derived from cannabis.
It is expensive; but, worth it!
And with the price that it costs, there’s a big possibility that people who need it the most will simply buy their own CBD or even make their own CBD products from isolate.
Over-the-counter options aren’t always cheap, but they are certainly more affordable than $32,500 a year. Some CBD companies even offer CBD financial assistance programs.
As the future of Epidiolex continues to unfold, we’ll be sure to keep you updated.
1Commissioner, O. (2018, June 25). FDA Approves First Drug Comprised of an Active Ingredient Derived from Marijuana to Treat Rare, Severe Forms of Epilepsy. Retrieved January 13, 2021, from https://www.fda.gov/news-events/press-announcements/fda-approves-first-drug-comprised-active-ingredient-derived-marijuana-treat-rare-severe-forms
2Gill, L. L. (2018, September 27). DEA Clears the Cannabis Drug Epidiolex for Sale in the U.S. Retrieved January 13, 2021, from https://news.yahoo.com/dea-clears-cannabis-drug-epidiolex-224820525.html
3Epidiolex: Side Effects, Dosage & Uses. (2020, December 1). Retrieved January 13, 2021, from https://www.drugs.com/epidiolex.html
4Lovelace Jr., B. (2019, August 08). GW Pharma CEO: More education needed on real health benefits of drugs derived from cannabis. Retrieved January 13, 2021, from https://www.cnbc.com/2019/08/07/gw-pharma-ceo-more-education-needed-on-real-health-benefits-of-drugs-derived-from-cannabis.html
5Herrington, A. (2018, August 09). Pharmaceutical Company Reveals Cost of FDA-Approved Cannabis Based Medicine. Retrieved January 13, 2021, from https://hightimes.com/news/pharmaceutical-company-reveals-cost-fda-approved-cannabis-based-medicine/
Article first appeared on cbdschool.com