South Carolina physicians are prescribing a medication containing a marijuana byproduct for the first time, following approval this summer from the Food and Drug Administration.
Epidiolex, manufactured by GW Pharmaceuticals, was approved by the FDA in late June, specifically to treat two rare forms of epilepsy. The medicine became available for prescription in early November.
The medication contains CBD. It is THC, not CBD, that is the component of marijuana that can get the user high. Epidiolex is approved for anyone 2 years old or older with two specific epilepsy syndromes.
In late September, the Drug Enforcement Administration announced they would move Epidiolex into Schedule 5 of the Controlled Substances Act, which is the least restrictive option. Marijuana is still in Schedule 1.
Leadership at the pharmaceutical company told investors in August the drug costs about $32,500 per year, Business Insider reported.
GW Pharmaceuticals has said that cost is on par with other epilepsy drugs, and it has a patient support program to help make the product more affordable.
The CBD-based medication is approved to treat Lennox-Gastaut syndrome and Dravet syndrome, both serious forms of epilepsy. Lennox-Gastaut, in particular, is resistant to many other medications, according to the National Organization for Rare Disorders. Both appear in early childhood.
“Because these patients have historically not responded well to available seizure medications, there has been a dire need for new therapies that aim to reduce the frequency and impact of seizures,” Justin Gover, GW Pharmaceuticals’ CEO, said in a statement.
Dr. Emma Grace Carter, a pediatric neurologist at the Medical University of South Carolina, said she has begun prescribing Epidiolex to her patients. She explained the approval of the drug is good news for patients with the two syndromes, who often try many medications in attempts to address their epilepsy.
“Some of them are interested in it because they feel it’s a more natural medication,” Carter said. “It’s another option to look into.”
She said Epidiolex is not going to be the first option specialists turn to. Rather, they will prescribe it when other medications have failed.
Carter said her team has only been prescribing the medication for a short time, so it is hard to say yet how effective it will be among her patients.
“We are hopeful about it, but we don’t have a lot of the clinical data ourselves,” she said.
BlueCross BlueShield of South Carolina, the largest health insurance company in the state does not yet cover it.
Dr. Matthew Bartels, chief medical officer for BlueCross BlueShield of South Carolina, said in a statement last week that Epidiolex is still going through the insurer’s review process for newly approved medicines.
“This approach allows us to evaluate the drug’s effectiveness and safety in a population beyond the clinical trial participants,” he said. “In the meantime, there are other anti-epileptic drugs available and covered, and we have processes to ensure that our members receive appropriately prescribed medications.”
Colleen Mullis, spokeswoman for the S.C. Department of Health and Human Services, said the drug will be covered by the state’s Medicaid program, so long as it meets the FDA requirements.
Medicaid covers mostly children in South Carolina.
In South Carolina, 53,400 people and 7,100 minors have some form of epilepsy, according to the Centers for Disease Control and Prevention .
No comments:
Post a Comment
Note: Only a member of this blog may post a comment.