The fast-tracked guidance follows the re-classification of these products last year to allow specialist doctors to prescribe them where the clinical needs of patients cannot be met by licensed medicines.
In particular, the draft guidance considers their use for patients with intractable nausea and vomiting as a result of chemotherapy, chronic pain, spasticity, and severe treatment-resistant epilepsy. Products include Sativex used for treating spasticity in people with multiple sclerosis, and nabilone for treating symptoms of nausea and vomiting in people having chemotherapy.
NICE cannot recommend Sativex because it was not found to be cost-effective at its current list price in relation to the benefits provided. Other similar cannabis-based medicinal products should not be offered to treat spasticity unless as part of a clinical trial.
Use of cannabis-based medicines for severe treatment-resistant epilepsy was also not recommended, again because of a lack of clear evidence that these treatments provide any benefits. The guidance also says that no cannabis-based medicinal products (other than cannabidiol used on its own in the context of a clinical trial) should be used for treating chronic pain. This is because the “benefits they offer are very small compared with their high costs and so they can’t be considered a cost-effective use of NHS resources”.
Nabilone is recommended as an add-on treatment for adults with chemotherapy-induced nausea and vomiting which hasn’t responded to conventional licensed medicines.
NICE also makes eight separate recommendations for further research across all the indications and cannabis-based medicinal products covered in the guidance, reflecting the overall lack of clinical and cost-effectiveness evidence for these products.
Paul Chrisp, director of the Centre for Guidelines at NICE, said: “We recognise that some people will be disappointed that we have not been able to recommend the wider use of cannabis-based medicinal products. However, we were concerned when we began developing this guidance that a robust evidence base for these mostly unlicensed products was probably lacking. Having now considered all the available evidence it’s therefore not surprising that the committee has not been able to make many positive recommendations about their use.
“In most cases, the draft guidance recommends that more research is carried out, echoing the recent call by the National Institute of Health Research for research proposals for these products. To that end NICE welcomes the recent suggestion from the House of Commons Health and Social Care Committee that companies should be encouraged to undertake or enable research into their medicinal cannabis products.”