The UK’s National Institute for Health and Care Excellence (NICE) has announced that it would not recommend Epidyolex (cannabidiol) combined with clobazam (Frisium) for the treatment of Lennox-Gastaut syndrome and Dravet syndrome.
Epidyolex is a CBD-based drug which was recently recommended by the European Medicines Agency for marketing approval in the EU. It was approved by the US FDA in 2018 for use in Lennox-Gastaut syndrome and Dravet syndrome.
NICE’s draft recommendation has not recommended the drug due to unknowns around the long term efficacy and due to the cost-effectiveness of the treatment.
Director of the Centre for Health Technology Evaluation at NICE, Meindert Boysen, commented:
“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 modelled the effect on people living longer or having a better quality of life.
“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.”
This recommendation is now open for consultation before a final decision is reached later in the year. If the draft recommendation stands, it will mean that UK specialists will not be able to routinely prescribe Epidyolex on the NHS. UK charity Epilepsy Action has criticised the decision as leading to a two-tier system for accessing new drugs in the UK.
Last month, NICE published a separate guideline which highlighted the lack of evidence for cannabis-based products in severe treatment-resistant epilepsy and concluded that it was unable to make a recommendation on its use at the current time.
Further information regarding NICE’s decision can be found at the following link.
It is important to note that the decision made by NICE does not affect patients in Ireland. However, in order for the drug to be made available in Ireland, a similar process will need to be undertaken by the National Centre for Pharmacoeconomics (NCPE). No application has yet been made by the drug’s manufacturer GW Pharma.
Further information regarding the use of medicinal cannabis and CBD based products can be found on our website here.