We welcome the NICE guidance on CBD Isolate Epidiolex for Paediatric Epilepsy but are NICE asking the right questions for CBMPs
The National Institute for Care Excellence (NICE) have released their guidelines on Cannabis-Based Medical Products (CBMPs). The guidelines advise the medical professional on how, and for which conditions, they should be prescribing for in the UK. The guidelines will inform NHS strategies and it is hoped they will provide some much-needed clarity.
Sapphire Medical Clinics Welcome NICE Guidance on CBD Isolate Epidiolex for Paediatric Epilepsy
One of the drugs approved and recommended for prescription is the CBD isolate drug Epidiolex for certain patients affected by two types of severe intractable epilepsy, Dravet Syndrome and Lennox Gastaut Syndrome. Epidiolex has been subject to a series of Randomised Control Trials (RCTs) and has already been made available over recent months to a number of UK paediatric patients under the compassionate access program.
Commenting on the positive recommendations, Paediatric Epilepsy lead at Sapphire, Dr Sushil Beri said, ‘These NICE recommendations are another sign that medical cannabis is rapidly maturing as a field of medicine. Dravet Syndrome and Lennox Gastaut Syndrome are some of the most challenging childhood epilepsies and this new drug at least offers some hope for these children and their families, and an option for clinicians to consider. It can potentially reduce seizure rates by up to 40 per cent. And as it has been through an RCT program, clinicians can prescribe it with confidence. However, these guidelines only recommend its prescription for these two specific syndromes which account for only about 20% of the total population of severe childhood epilepsies and, even in these cases, there are stringent conditions to the prescription. So there is a continuing and urgent need to develop more evidence as to how medical cannabis could help across a range of other severe drug-resistant childhood epileptic conditions’.
It is right that NICE put the highest emphasis on evidence gathered through RCT trials. But Cannabis-Based Medical Products are not a single medicine and there is an argument that particularly in these early stages other forms of evidence should be given more priority. RCT trials are lengthy, complex and take a considerable amount of time to undertake. Usually RCTs precede the availability of medicines but we are in the ‘real-world’ situation of CBMPs being available and in use elsewhere before the RCT evidence base has been developed.
Commenting on the NICE guidelines, Managing Director of Sapphire Dr Mikael Sodergren said:
Medical cannabis is not a single medicine. Rather, it is a family of medicines and the evidence from RCTs is modest at the current time. So we’re advocating that evidence from other forms of studies and trials relating to the CBMPs most widely prescribed internationally should be taken into account. And the current NICE calculations about cost effectiveness only take into account any savings from purely health related areas. The NICE analysis doesn’t take into account wider socio-economic benefits such as the person being able to go back to work sooner. There’s a strong argument for a much more holistic view of such cost modelling for CBMPs due to the favourable side-effect profile and tolerability. It’s important to note that the decision to recommend prescription of Sativex is not because of new evidence on efficacy but on the fact that the cost has come down. That’s why it’s so important that the cost benefit analysis of medical cannabis more generally is undertaken taking more factors into account. If it is, it will help NICE make more recommendations for its prescription
For this reason, Sapphire will be creating a Patient Registry which prospectively captures adverse events, clinical efficacy and patient reported outcomes within a national registry. The Sapphire method of monitoring, collecting and analysing the response to the use of medical cannabis is even more comprehensive and robust that than advocated by NICE. This approach will allow Sapphire to understand in detail not only the objective clinical benefits of treatment but also the wider improvements in quality of life
Co-authors Dr Simon Erridge, Business Development Director at Sapphire Medical Clinics and Academic Clinician at Imperial College London and Dr Mikael Sodergren, Research Director at EMMAC Life Sciences, Managing Director & Academic Lead at Sapphire Medical Clinics and Academic Clinician at Imperial College London review the guidelines in full and suggest that we should not propose for NICE to change the rules, but in the short-term ask a different question. Read the full report here