The drug maker behind the first FDA-approved marijuana medication reveals its cost

Shutterstock

• On a call with investors this week, GW Pharmaceuticals
  revealed the price of
  Epidiolex, its newly-approved, marijuana-based drug for
  rare forms of epilepsy.
• Designed to treat two rare forms of childhood epilepsy
  using a
  marijuana compound called CBD, the drug is the
  first medication of its kind to get FDA approval.
• 
  The person leading the company’s
  commercialization efforts in the US said the goal is to keep
  the price of the drug on par with other epilepsy
  medications.
  

A marijuana-derived drug that recently became the
first of its kind to win federal approval is not going to be
cheap.

Called Epidiolex, the drug is designed to treat two rare forms of
childhood epilepsy using a cannabis compound called cannabidiol
(or CBD). 

On a call with investors this week, British-based GW
Pharmaceuticals, who makes the drug, said it would cost roughly
$32,500 per year. The medication does not contain THC, the
well-known psychoactive component of marijuana responsible for
the drug’s characteristic high.

Julian Gangolli, who leads GW’s commercialization efforts in the
US, said the price point would keep Epidiolex in line with other
epilepsy drugs and was largely based on feedback from
insurance companies.

Gangolli also said that he expected the wait time to receive the
medication — after patients get a prescription from a clinician —
to be three weeks, on average. But before any prescriptions for
Epidiolex can be written, the Drug Enforcement Administration
must reschedule its active ingredient, the marijuana compound
CBD.

Currently, CBD is scheduled alongside marijuana as a schedule 1
drug with “no currently accepted medical use.” Beginning on June
25 when Epidiolex was approved, the agency had 90 days to
reschedule or reclassify it as a schedule 2, 3, 4, or 5
substance.

“We don’t have a choice on that,” DEA public affairs officer
Barbara Carreno told Business Insider in June. “It absolutely has
to become Schedule 2, 3, 4, or 5.”

‘A breakthrough drug for an awful disease’

Epidiolex’s approval in June came on the heels of several months
of promising research results and a positive preliminary vote
from the Food and Drug Administration this spring. Experts are
hopeful that the approval will unleash a wave of new interest in
the
potential medical applications of CBD and other marijuana
compounds.

“This approval serves as a reminder,” Scott Gottlieb, the FDA
commissioner, said in a statement shortly after the approval,
“that advancing sound development programs that properly evaluate
active ingredients contained in marijuana can lead to important
medical therapies.”

In three large clinical trials which the FDA considered before
giving Epidiolex the official green light, researchers presented
strong evidence that the pharmaceutical-grade CBD in the medicine
had the power to significantly curb some of the worst symptoms of
two of the hardest-to-treat forms of epilepsy, known as
Lennox-Gastaut syndrome and Dravet
syndrome.

“This is clearly a breakthrough drug for an awful disease,”
John Mendelson,
a panel member and senior scientist at the Friends Research Institute,
said at a public FDA meeting this spring that was called to
discuss the scientific merits of the drug.

But although the green light means that patients will soon be
able to access Epidiolex with a doctor’s prescription, many will
also likely turn to less expensive sources
of CBD, such as those sold in marijuana dispensaries.
Researchers and advocates caution against this, however, with the
caveat that it’s impossible to verify that what’s in those
products is actually pharmaceutical-grade CBD.

Gangolli added that with insurance, Epidiolex could be
substantially cheaper than dispensary 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 said.