Insured patients in the USA would pay up to $200 per month for CBD-based drug Epidiolex under a recent pricing announcement from the maker, UK-based GW Pharmaceuticals.
Epidiolex is the first cannabis-derived pharmaceutical to gain federal approval in the U.S. It was primarily developed for the treatment of two severe forms of epilepsy — Dravet Syndrome and Lennox-Gastaut Syndrome
For the uninsured, Epidiolex will cost about $32,500 per year, or just over $2,700 per month. That’s in line with other prescription drugs used to treat the same afflictions.
“We wanted to make sure we were pricing Epidiolex in such a way where the means to access . . . would be consistent with branded epilepsy drugs these patients already use,” said Justin Grover, GW’s CEO.
Input of insurance companies
The price was determined mainly based on talks with insurance companies, according to Julian Gangolli, GW’s North American President.
However, Epidiolex’s status as an “Orphan Drug” allows for higher pricing while also letting the company develop variants to treat other maladies, indicating further earning power for the drug.
Awaiting rescheduling
Epidiolex, which was approved this summer by the U.S. Food & Drug Administration (FDA), is still is under scrutiny by the Drug Enforcement Administration (DEA), which also must approve it for the market. DEA is looking into the new drug’s potential for abuse.
As part of the further approval process, the agency must reschedule Epidiolex from its current status as a Schedule I narcotic to Schedule 2 or 3 before it can be made available to patients. The deadline for that rescheduling is Aug. 29. The drug could then be prescribed. GW has said it may take up to three weeks after a prescription has been issued for patients to receive their first treatment.
Vis a vis non-pharma CBD
What is to keep patients from cheaper forms of non-prescription CBD-based supplements remains to be seen, although Gangolli added that when covered by insurance, the co-pay will make Epidiolex more affordable than other non-pharma CBD products available through dispensaries and other outlets.
“The cost of a co-pay is significantly — or could be significantly — less onerous and burdensome than the cost of a (non-pharma) product either over the internet or from dispensary,” Gangolli said.
North America a fast-growing market for OTC CBD products, but some experts caution it’s difficult to verify the CBD content and purity of such non-pharma CBD.
A study last year from the Journal of the American Medical Association revealed about 70% of products on the OTC market had CBD levels different than that advertised on their labels. And in Europe (where Epidiolex is currently under review by EU health authorities), the Prague-based International Cannabis and Cannabinoids Institute study found carcinogens in 20 of 29 non-pharma CBD products it analyzed.
Fast growth predicted
Some analysts and investors have predicted rapid growth for Epidiolex. Analysts have pegged the U.S. OTC CBD market as approaching $200 million.
GW is also continuing clinical trials and seeking federal approval for other CBD-based pharmaceuticals such as Sativex, a mouth spray that alleviates some symptoms of multiple sclerosis, and heretofore the company’s flagship medicine.
The company also is looking at other single cannabinoid formulations, including a Cannabivarin-based pharmaceutical investigated for Autism Spectrum Disorder, and formulations for a particularly malignant form of brain tumors called glioblastoma, and even schizophrenia.