Individual research recommendation details

Recommendation ID

NG144/5

Question

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?

Any explanatory notes
(if applicable)

Why the committee made the recommendations
The committee agreed that the evidence showed benefits of THC:CBD spray (licensed product in UK: Sativex) for treating spasticity in people with multiple sclerosis. There were reductions in some measures of patient-reported spasticity and no difference in adverse events in the treatment or placebo groups, although much of the evidence was assessed as low quality. The committee agreed that the longer-term benefits of THC:CBD spray are likely to outweigh any potential harms, although it was not clear how benefits related to improvements in quality of life.
The committee considered the evidence from 2 published economic evaluations but noted that they had contradictory conclusions about the cost effectiveness of THC:CBD spray and were subject to potentially serious limitations. So they considered results from a new economic model developed specifically for the cannabis guideline. The model included data from all relevant trials, longer-term registry data and data on adverse events. In reflection of the trial evidence, the model predicted that the average person would receive a quality of life (QALY) gain equivalent to around 30 days perfect health with THC:CBD spray added to standard care. The acquisition costs of the treatment are offset by predicted savings in management costs. The model estimates that THC:CBD spray would offer sufficient QALY gains if reduction in spasticity led to a halving of management costs and the acquisition cost of THC:CBD spray was also reduced (in addition to the existing pay-for-responders scheme). The committee agreed that under these conditions THC:CBD spray could be recommended to treat moderate to severe spasticity in adults with multiple sclerosis if other pharmacological treatments had not been effective.
The committee agreed that the evidence for the effectiveness and safety of other cannabis-based medicinal products was much more limited. There is also currently no evidence on the cost effectiveness of products other than THC:CBD spray and in other clinical indications (for example, motor neurone disease and spinal cord injury).
The committee acknowledged that women are more likely to receive a diagnosis of multiple sclerosis than men. However, they considered this would not cause an inequality in relation to treatment.
Because there is limited evidence from trials on how reductions in spasticity affect quality of life and no evidence was found for conditions such as cerebral palsy, the committee agreed to make a research recommendation to inform future guidance.

How the recommendations might affect practice
These recommendations are a change to NICE's previous guidance on treating spasticity in adults with multiple sclerosis, which did not support the use of THC:CBD spray. They are therefore expected to lead to THC:CBD spray being used as an add-on treatment for adults with treatment-resistant spasticity due to multiple sclerosis, with concomitant reductions in the need for supportive care.
Full details of the evidence and the committee's discussion are in evidence review C: spasticity.

Source guidance details

Comes from guidance

Cannabis-based medicinal products

Number

NG144

Date issued

November 2019

Other details