LONDON—The National Institute for Health and Care Excellence (NICE) announced recently its intention to work with Cambridge, U.K.-based GW Pharma to address issues highlighted by its independent appraisal committee in its evaluation of cannabidiol for treating two types of severe, treatment-resistant epilepsy.
NICE’s published draft guidance does not recommend cannabidiol (also called Epidyolex and made by GW Pharma) with clobazam for treating Dravet and Lennox-Gastaut syndromes, types of epilepsy which begin in early childhood and which are lifelong and difficult to control.
The committee noted that the clinical trial evidence shows that cannabidiol with clobazam reduces the number of the main types of seizures associated with these conditions compared with usual care with antiepileptic drugs, and heard from patients and their caregivers how important these benefits are for them. However, because the duration of the clinical trials was only 14 weeks, the longer-term effectiveness of cannabidiol with clobazam is uncertain.
The committee concluded that the models may not capture all aspects of severe treatment-resistant epilepsy. For example, only the effects on health-related quality of life from reducing the number of main types of seizure are modeled, and not the effects of reducing other types of seizures.
“The often distressing and life-limiting nature of these very difficult to control epilepsies means that we should all welcome new treatment options. Cannabidiol is a promising treatment for people with these types of epilepsies,” said Meindert Boysen, director of the Centre for Health Technology Evaluation at NICE. “Even though the committee accepted that the evidence shows that cannabidiol with clobazam reduces seizure frequency, its long-term efficacy is unknown, and the committee was not convinced about the way the company had modeled the effect on people living longer or having a better quality of life. However, we are committed to working with the company to resolve the economic modeling issues identified by the committee.”