First FDA-Approved Marijuana-Based Drug Is Going To Cost You $32,500 Per Year

The First FDA-Approved Marijuana-Based Drug Is Going To Cost You $32,500 Per Year

First FDA-Approved Cannabis Based Drug Is Going To Cost You $32,500 Per Year from CannabisNet on Vimeo.

In June this year, the Food and Drug Administration (FDA) just approved GW Pharmaceuticals’ new cannabis-based drug called Epidiolex.

This is the first time in history that the FDA has ever done so, in what is a considered a historical move considering that cannabis is still federally illegal and a Schedule 1 substance. Epidiolex was developed for treating Lennox-Gastaut Syndrome and Dravet Syndrome, two rare forms of pediatric epilepsy. Epidiolex could save lives especially because there are no medications out there that have proven effective in treating Dravet Syndrome, except for cannabis. GW Pharma had to carry out three big clinical trials for the FDA to even consider Epidiolex, which they passed with flying colors. During these trials, researchers used strong evidence that even pharmaceutical-grade CBD was effective in treating drug-resistant epilepsy. Even then, Epidiolex still has some side effects including fatigue, sleep problems, vomiting, and diarrhea.

“This is clearly a breakthrough drug for an awful disease,” says John Mendelson, senior scientist for Friends Research Institute and a panel member during the FDA meeting early this spring.

Epidiolex contains cannabidiol (CBD), the non-psychoactive compound in cannabis that has been widely used for treating many forms of epilepsy.

However, we are still unsure if GW Pharmaceuticals is a friend or foe. After all, they are Big Pharma, and they will be laughing all the way to the bank thanks to Epidiolex.

A Business Insider report stated that the British company will be charging $32,500 a year for Epidiolex. Julian Gangolli, who oversees the distribution and marketing of GW Pharmaceuticals in the United States, told them that these rates would be at par with other epilepsy medicines in the market and is also based on input from insurance companies. Gangolli added that he expects the wait time for receiving the medicine to be around 3 weeks, and before any Epidiolex prescriptions can be written by clinicians, the Drug Enforcement Administration (DEA) still needs to reschedule CBD.

On June 25 when the FDA approved Epidiolex, the DEA was given 90 days to reschedule CBD because as a Schedule 1 substance, it is still considered as a drug with “no currently accepted medical use.”

But despite the approval, the shockingly high costs for the drug will mean that many patients will still prefer to purchase CBD products from more affordable sources like medical dispensaries. Some worry that these products can’t be trusted for their CBD content, although Gangolli says that if one has insurance, then Epidiolex can be more affordable than store-bought CBD.

“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 dispensary,” Gangolli says.

However, it’s still a huge price difference from the $1,800 per year spent by the average family for CBD medicines for treating epilepsy, according to a CBS report. And CBD doesn’t have any side effects, even for kids.

In April 2018, the FDA Advisory Committee meeting came out recommending CBD for pediatric seizures with a unanimous vote of 13 members. The committee said that the benefit to risk profile of CBD was favorable for treating both Lennox-Gastaut Syndrome and Dravet Syndrome in kids aged 2 and up.

“At this point, this is a spectacular advance,” Mendelson said. “It is clearly an honor to be making a decision based on science and public interest, rather than political discussion, says Dr. Green of the Icahn School of Medicine in Mt. Sinai, New York. The findings revealed that a 20mg/kg/day dose of CBD was effective in reducing drop seizures by 42-44% during a 14 week treatment period for kids with Lennox-Gastaut Syndrome while Dravet Syndrome patients saw a 39% reduction in convulsive seizures with a dose of 20mg/kg/day of CBD.

So the question lies for parents: will you choose to spend your money on an FDA-approved CBD medicine that could rack up a bill of $32,500 and up a year but still has side effects, or would you go for a completely natural version of CBD at around $1,800 per year with no side effects?

If you go for Epidiolex, GW Pharma will be laughing all the way to the bank.

First FDA-Approved Cannabis Based Drug Is Going To Cost You $32,500 Per Year from CannabisNet on Vimeo.