“Momentous occasion”: NHS England approves first cannabis-based medications

11 Nov 2019 --- The UK’s National Institute for Health and Care Excellence (NICE) has recommended that some cannabis-based medicinal products (CBMP) receive routine reimbursement from NHS England. These include GW Pharmaceuticals’ Epidyolex, containing cannabidiol (CBD), and Sativex, made of nabiximols, a mix of CBD and tetrahydrocannabinol (THC). CBD is recommended for seizures associated with Lennox Gastaut syndrome (LGS) or Dravet syndrome, while nabiximols were deemed a cost-effective treatment of spasticity due to multiple sclerosis. This is the first time that any plant-derived cannabis-based medicine has been recommended by NICE for use on the NHS, and could mark a turning tide in attitudes toward the plant.

“This is a momentous occasion for UK patients and families who have waited for so many years for rigorously tested, evidenced and regulatory approved cannabis-based medicines to be reimbursed by the NHS,” says Chris Tovey, GW’s Chief Operating Officer. “This is proof that cannabis-based medicines can successfully go through extensive randomized placebo-controlled trials and a rigorous NICE evaluation process to reach patients.

The NICE recommendations include considering nabilone as an add-on treatment for adults with chemotherapy-induced nausea and vomiting that persists with optimized conventional antiemetics. It also proposes a four-week trial of THC:CBD spray to treat moderate to severe spasticity in adults with multiple sclerosis under certain conditions.

A notable omission
Interestingly, the recommendations do not include the treatment of chronic pain. NICE notes that this is because while some evidence showed that CBD reduced chronic pain, the treatment effect was modest (an average improvement of about 0.4 on a scale ranging from zero to 10). The evidence did not show a reduction in opioid use in people prescribed medicinal cannabis. As the number of people who might benefit is large and the cost potentially high, an economic model was developed to compare benefits with the potential costs.

NICE's recommendations do not include the treatment of chronic pain.The model used data from the trials in the base-case analysis but also assumed a larger potential benefit from cannabis-based medicinal products in various sensitivity analyses. 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. The evidence included CBD in combination with THC, THC alone, dronabinol and nabilone so the committee named these products in the recommendation. The committee also agreed that the recommendation should follow the evidence and specify adults.

However, NICE did make the following key recommendations for further research:

• Fibromyalgia or persistent treatment-resistant neuropathic pain in adults: For adults with fibromyalgia or persistent treatment-resistant neuropathic pain, what is the clinical and cost-effectiveness of CBD, containing no, or traces of, THC, as an add-on to standard treatment?
• Chronic pain in children and young people: For children and young people with intractable cancer-related pain and pain associated with specific diseases (such as epidermolysis bullosa), what is the clinical and cost-effectiveness of cannabis-based medicinal products as an add-on to standard treatment to improve symptoms compared with treatment with standard care?
• CBD for severe treatment-resistant epilepsy: What is the clinical and cost-effectiveness of CBD in epileptic disorders in children, young people and adults?
• THC in combination with CBD for severe treatment-resistant epilepsy: Does the addition of THC to CBD have an effect on seizure frequency, brain structure and neuropsychological performance when compared with both CBD alone and placebo in epileptic disorders in children, young people and adults?
• Spasticity: What is the clinical and cost-effectiveness of cannabis-based medicinal products other than THC:CBD spray for children, young people and adults with spasticity? In particular, what is the impact of spasticity on improvements in quality of life?

NICE also highlighted chemotherapy-induced intractable nausea and vomiting in adults or in babies, children and young people as a potential area of research, as well as intractable nausea and vomiting not caused by chemotherapy. 

A long journey
GW’s CBD oral solution was approved by the European Medicines Agency and received marketing authorization in September 2019 under the trade name Epidyolex. This came as an adjunctive therapy for seizures associated with LGS or Dravet syndrome, in conjunction with clobazam, for patients aged two and older. Following this approval, GW has been working with the relevant regulatory bodies in the UK, Germany, Spain, France and Italy to secure reimbursement ahead of the anticipated launch of the medicine in these countries. 

The inclusion of nabiximols in NICE guidelines comes as part of the comprehensive evaluation of the clinical and cost-effectiveness of CBMPs. Nabiximols has been approved by medicines regulators in more than 25 countries around the world. Nabiximols was approved in the UK by the Medicines and Healthcare products Regulatory Agency (MHRA) in 2010 and is marketed in the UK by GW’s commercial partner, Bayer.

Commenting on the NICE recommendation for CBD oral solution, Dr. Rhys Thomas, Consultant Neurologist at the Royal Victoria Hospital, adds: “This is a significant moment for adults and children with the most difficult-to-treat epilepsies. NICE’s recommendation of CBD oral solution follows a period of great anticipation and enthusiasm for patients and their clinicians. The European Medicines Agency license and availability through the NHS are welcome as we badly need additional effective treatments for Dravet and Lennox Gastaut syndromes.”

Edited by Katherine Durrell