When a pricey, unique medication for two rare forms of childhood-onset epilepsy comes onto the market — which could happen later this year — payers are likely to cover it but will probably subject the drug to prior authorization, experts tell AIS Health.
The drug in question is Epidiolex (cannabidiol), which in June became the first FDA-approved treatment that contains a purified drug substance derived from marijuana. The oral solution, produced by GW Pharmaceuticals plc, is indicated for the treatment of seizures associated with Lennox-Gastaut syndrome (LGS) or Dravet syndrome for patients ages two and older.
The average gross price for Epidiolex will be $32,500 per year, Julian Gangolli, North America president of GW Pharmaceuticals, said during the company’s Aug. 7 earnings call, according to a transcript from Seeking Alpha.
Currently, Epidiolex is classified as a Schedule I drug by the federal government. Schedule I drugs are defined as those with no currently accepted medical use and a high potential for abuse — a list that includes heroin, ecstasy and LSD, according to the U.S. Drug Enforcement Administration (DEA).
On Sept. 19, Benzinga reported — citing a research note from Morgan Stanley — that the DEA was preparing to reschedule Epidiolex as a Schedule IV drug, a classification that would put it on the same level as drugs like Xanax, Valium and Ambien.
As for how payers will handle Epidiolex, Mesfin Tegenu, president of PerformRx, LLC, says “plans are naturally cautious regarding any new medication to market.”
“Epidiolex has a very specific FDA approved indication for specific forms of seizures, Lennox-Gastaut syndrome (LGS) or Dravet syndrome,” he says. “Off label use may be a concern, so most plans are likely to place a prior authorization on the medication to ensure appropriate use.”
John Watkins, Pharm.D., pharmacy manager, formulary development for Premera Blue Cross, says the Washington-based insurer is taking a similar approach. “It will be covered with PA [prior authorization] to label,” he tells AIS Health.