1 Recommendations

1 Recommendations

1.1 Cannabidiol with clobazam is recommended as an option for treating seizures associated with Dravet syndrome in people aged 2 years and older, only if:

  • the frequency of convulsive seizures is checked every 6 months, and cannabidiol is stopped if the frequency has not fallen by at least 30% compared with the 6 months before starting treatment

  • the company provides cannabidiol according to the commercial arrangement.

1.2 This recommendation is not intended to affect treatment with cannabidiol, with clobazam, that was started in the NHS before this guidance was published. People having treatment outside this recommendation may continue without change to the funding arrangements in place before this guidance was published, until they and their NHS clinicians consider it appropriate to stop. For children and young people, this decision should be made jointly by the clinician and the child or young person, or the child or young person's parents or carers.

Why the committee made these recommendations

Current treatment for Dravet syndrome includes antiepileptic drugs. People with Dravet syndrome would have cannabidiol with clobazam if their convulsive seizures are not controlled well enough after trying 2 or more antiepileptic drugs.

Clinical trials show that cannabidiol reduces the number of convulsive and non-convulsive seizures when compared with usual care.

The cost-effectiveness estimates are uncertain for cannabidiol because of some of the assumptions in the company's model. The cost-effectiveness estimates do not include the benefits of:

  • reducing the number of non-convulsive seizures

  • reducing the duration of convulsive seizures

  • improving the quality of life of the siblings of people with Dravet syndrome.

When taking both the uncertainties and the uncaptured benefits into account, cannabidiol is considered an appropriate use of NHS resources, and is recommended as an option for treating Dravet syndrome in the NHS.

  • National Institute for Health and Care Excellence (NICE)