Wellness and Research

Epidiolex Gets Booted Off of Restrictive Drug Lists

Loren DeVito, PhD
Written by Loren DeVito, PhD

GW Pharmaceuticals made history in 2018 when their cannabidiol (CBD)-based medication Epidiolex® was approved by the US Food and Drug Administration (FDA) to treat Lennox-Gastaut and Dravet syndromes, two forms of severe pediatric epilepsy, in a landmark decision. While this ruling was a huge relief for families that have children with these disorders, it raised a number of questions regarding the hazy status of CBD.

The 2018 Farm Bill fully legalized the use of hemp-based CBD throughout the US. This ruling applied only to hemp, as CBD derived from cannabis is still prohibited outside of state medical programs and of course in states where cannabis use has been fully legalized.

Despite the medicinal properties of CBD and other cannabinoids, cannabis remains a Schedule 1 drug under the Controlled Substances Act of 1970. Other drugs in this category include heroin. While many advocacy groups have fought long and hard to reschedule cannabis, it remains stubbornly on this list, significantly limiting access to those who need it for medicinal purposes.

But since CBD does not cause the intoxication that cannabis is well known for, why is it too stuck on this list, especially since the FDA has already given the green light to a specific pharmaceutical formulation that can be prescribed by a doctor?

Using the traditional pathway for drug approval, Epidiolex was evaluated in a structured clinical trial program to demonstrate its safety and efficacy, just as any other medication you can find at the pharmacy. As such, the FDA was able to review the clinical data and determine whether the medication met their standards for approval.

That’s the most straightforward answer. However, there is a nuanced explanation that is not so simple.

Just a few months ago, the US DEA rescheduled Epidiolex to remove it from the Controlled Substances Act. And just recently, a similar designation was granted to  Epidyolex in the UK. These policy changes make it easier to prescribe the medication by reducing the amount of paperwork and hassle involved.

The rationale for this change was to expand access of this medication to those who need it. But wouldn’t it have been better to entirely reschedule any form of CBD?

Healthcare in the US is largely controlled by the insurance industry; carriers decide if they’ll cover the cost of a medication or not (this does not apply to patients enrolled in medical cannabis state programs, as insurance does not cover any of those costs). If your insurance decides a medication is too expensive, you are out of luck and may need to pay fully out of pocket. While this process works a bit differently in the UK (where the government does price negotiations), it still comes down to a barrier to access. Not to mention that patients use CBD for a number of medical conditions, not just epilepsy. But, for now, the proven clinically effective and safe Epidiolex can only be prescribed to the indicated population.

Cost as a barrier extends to hemp CBD as well. If you do get lucky enough to have an insurance plan that will pay for a prescription version of CBD, it may costs only dollars. But hemp CBD at the same concentration would be astronomically higher at current price points. And of course there’s no accessing cannabis-based CBD unless you live in a state with a medical program or one with full access.

Frustrated? Confused? Me too.

These policy changes are small but, together with other steps being made in the US and across the world, we progress closer toward the hopeful day when cannabis access is wide open and equal to all.

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About the author

Loren DeVito, PhD

Loren DeVito, PhD

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