1 Recommendations
1.1 Cannabidiol is recommended as an add-on treatment option for seizures caused by tuberous sclerosis complex in people aged 2 years and over, only if:
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their seizures are not controlled well enough by 2 or more antiseizure medications (either used alone or in combination) or these treatments were not tolerated
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seizure frequency 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
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the company provides cannabidiol according to the commercial arrangement.
1.2 These recommendations are not intended to affect treatment with cannabidiol that was started in the NHS before this guidance was published. People having treatment outside these recommendations may continue without change to the funding arrangements in place for them before this guidance was published, until they and their NHS clinician consider it appropriate to stop. For children, this decision should be made jointly by the clinician and the child and/or the child's parents or carers.
Why the committee made these recommendations
Usual care for seizures caused by tuberous sclerosis complex includes antiseizure medications. Cannabidiol is licensed as an add-on treatment option for people aged 2 years and over. The company has positioned it for use when seizures are not controlled well enough by 2 or more antiseizure medications or when these were not tolerated.
Clinical trial evidence shows that cannabidiol plus usual care reduces seizure frequency and increases the number of seizure-free days compared with placebo plus usual care.
The cost-effectiveness estimates for cannabidiol are uncertain because some of the assumptions in the company's economic model are uncertain. However, cannabidiol has benefits that are not included in the modelling, such as reducing the severity of seizures and lowering the risk of sudden unexpected death in epilepsy. When taking the uncertainties, uncaptured benefits and severity of the disease into account, cannabidiol is considered an appropriate use of NHS resources. So, it is recommended.