NICE Recommends Epidyolex for Tuberous Sclerosis Complex Seizures
The UK’s National Institute for Health and Care Excellence (NICE) has recommended Jazz Pharmaceuticals’ Epidyolex (cannabidiol,100 mg/ml oral solution) for National Health Service (NHS) use as add-on treatment for people two years and older who have seizures caused by tuberous sclerosis complex — a rare genetic disorder involving benign tumor growth — if two or more antiseizure medications aren’t effective or well tolerated.
NICE advised that seizure frequency be checked every six months and that Epidyolex be stopped if the seizure frequency isn’t reduced by at least 30 percent when compared with the six months prior to starting treatment.
Clinical trial evidence showed that Epidyolex plus the usual care reduces seizure frequency and increases the number of seizure-free days compared with placebo plus the usual care. However, the cost-effectiveness estimates are uncertain, NICE said.
The list price for the drug is more than $1,040 per 100 mg/ml bottle. The negotiated price for NHS use was not disclosed.