First ever NICE guidance on cannabis-based medicinal products

NICE has published its first ever guidance on cannabis-based medicinal products. NG144 has just been published this November and outlines guidance across 4 key areas (fig 1): chemotherapy-induced nausea and vomiting, chronic pain, spasticity, and treatment-resistant epilepsy.

The National Council of Health and Care Excellence (NICE) have examined the evidence for the use of both cannabidoil (CBD) and delta-9-tetrahydrocannabidoil (THC) elements of cannabis to help manage these four areas of health, and have announced their verdict on whether the medicines should be made available via the NHS.

This opens up some new avenues for treatment within neurology, with those living with epilepsy and multiple sclerosis (MS) predominantly affected positively.

Sativex for spasticity

Most welcome is the news that NICE support the use of Sativex, the cannabis-derived nasal spray to manage spasticity in people with MS (1.3). Sativex, which contains both CBD and THC elements of cannabis, is recommended to be offered as a four-week trial to treat those with ‘moderate to severe spasticity in MS’, if other pharmacological treatments have not been effective, and the drug is being locally commissioned.

The MS Society have campaigned for access to Sativex for a number of years, and told the Daily Telegraph that whilst

‘it’s brilliant NICE have finally listened’, the guidelines ‘don’t got far enough’.

Highlighting that the guidance does not recommend cannabis-based treatments for pain relief, the Society also note the challenge of leaving Sativex to local provision as this is reliant on local bodies having the resources required and could contribute to the challenge of unwanted variance in MS service provision in the UK.

Chronic pain

Chronic pain is a ‘frequent component’ of a number of neurological conditions, ‘affecting 20-40% of patients for many primary neurological diseases’ (Borsook: 2011).

Whilst anecdotally, we know that many people are using CBD oil to help manage their pain and reporting an improvement, the new guidance does not recommend the use of cannabis-related medicines to help manage chronic pain (1.2), listing the various medicines not to be offered, and noting that CBD alone may only be offered ‘as part of a clinical trial’.

NICE has declared that the rationale for this is ‘no evidence for the use of CBD alone’ and that

‘In all cases, the potential benefits offered were small compared with the high and ongoing costs, and the products were not an effective use of NHS resources’.

Whilst there is a growing body of evidence suggesting its efficacy, it is clear given NICE’s response that more research is needed to provide conclusive evidence.

Severe treatment-resistant epilepsy

NICE has made research recommendations on the use of cannabis-based medicinal products for severe treatment-resistant epilepsy and has recommended Epidyolex, a purified cannabidiol (CBD) oral solution, for use in the NHS for two rare and severe epilepsies, Lennox-Gastaut syndrome and Dravet syndrome.
Epilepsy Action’s CEO Simon Wigglesworth said via the charity’s website that this ‘could be life-changing for some’ but shared with the Telegraph that

‘there were many thousands of people with other complex and treatment-resistant epilepsies who could potentially benefit from cannabis-based medicines.’