The National Institute for Health and Care Excellence (NICE) has announced its intention to work with GW Pharma to address the issues highlighted by its independent appraisal committee, after it rejected the company’s Epidiolex (cannabidiol).
The organisation did not recommend the drug in combination 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 rejection occurred as the committee noted that despite the clinical trial evidence showing that the combination reduces the number of the main types of seizures associated with epilepsy, because the duration of the clinical trials was only 14 weeks, the longer-term effectiveness of the treatment is still uncertain.
The committee also cited concerns about the economic models provided by the company. Importantly, they concluded that the models may not capture all aspects of severe treatment-resistant epilepsy that are important to people with these conditions, and to their carers and families.
Meindert Boysen, director of the Centre for Health Technology Evaluation at NICE, said that the committee was “not convinced about the way the company had modelled the effect on people living longer or having a better quality of life.”
He continued, “Based on the evidence presented to it, the committee could not recommend cannabidiol with clobazam as an effective use of NHS resources. However, we are committed to working with the company to resolve the economic modelling issues identified by the committee, and to help them understand what they may need to do to mitigate the cost of cannabidiol to the NHS. Patients, carers and their families deserve no less.”
In England it is estimated there are around 600 people with Dravet syndrome and around 4,000 people with Lennox-Gastaut syndrome.