NICE publishes draft guideline on use of medical cannabis
Following a review of clinical and cost-effectiveness, NICE has published draft guidance for consultation on the use of cannabis-based medicinal products for treatment of nausea and vomiting, chronic pain, spasticity and epilepsy.
The guidance was fast-tracked following the UK government’s re-classification of cannabis-based medicinal products from Schedule 1 to Schedule 2 of the Misuse of Drugs Regulations, meaning that they can now be legally prescribed by specialist doctors where there is an unmet clinical need.
The draft guidance advises that the synthetic cannabinoid nabilone can be considered as an add-on treatment for adults with chemotherapy-induced nausea and vomiting that persists with optimised conventional antiemetics. However, it does not recommend nabilone, dronabinol, delta-9-tetrahydrocannabinol (THC), or combined cannabidiol (CBD) and THC for the management of chronic pain; CBD alone should be considered for chronic pain only as part of a clinical trial. NICE advises that the licensed THC/CBD oromucosal spray Sativex should not be offered to treat spasticity in people with multiple sclerosis because it is not cost effective; furthermore, other cannabis-based medicines should only be offered for this indication as part of a clinical trial.
NICE adds there is a lack of good-quality evidence for the use of cannabis-based medicines in patients with severe treatment-resistant epilepsy, and therefore the committee were unable to make recommendations on their use in this population. Further research is required to inform future practice. Separate technology appraisal guidance is being developed on the use of cannabidiol for the adjuvant treatment of seizures associated with Lennox-Gastaut and Dravet syndrome. In July, the EMA recommended the cannabidiol preparation Epidyolex for EU approval for the adjunctive treatment of seizures associated with Lennox-Gastaut and Dravet syndrome, in conjunction with clobazam, in patients aged two years and older. The initial draft NICE guidance did not recommend Epidyolex because of a lack of evidence for its long-term effectiveness and concerns about economic modelling, but NICE is currently working with the company GW Pharma to try to resolve these issues.
More general NICE recommendations include that the initial prescription of all cannabis-based medicines must be made by a specialist clinician; in the case of children, the initiating prescriber should be a tertiary paediatric specialist. However, after the initial prescription, subsequent prescriptions may be issued by other prescribers as part of a shared-care agreement.
The consultation documents can be viewed on the NICE website, and final guidance is expected in November.