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    Cannabidiol for treating seizures caused by tuberous sclerosis complex

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    1 Recommendations

    1.1 Cannabidiol is not recommended, within its marketing authorisation, as an add-on treatment option for seizures caused by tuberous sclerosis complex in people 2 years and over.

    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 were tried and are not tolerated.

    Clinical trials show that cannabidiol plus usual care reduces seizure frequency and increases the number of seizure-free days compared with placebo plus usual care. But its long-term effects are uncertain. It is also uncertain how well cannabidiol works compared with individual antiseizure medications.

    There are uncertainties in the economic model, including:

    • the dose of cannabidiol that would be used in clinical practice

    • how many people would be seizure-free over 7 days

    • the quality of life of people with the condition and their carers, especially for carers of people who are seizure-free

    • the number of hospital admissions.

    When considering these uncertainties, the cost-effectiveness estimates are higher than what NICE considers an acceptable use of NHS resources. So, cannabidiol is not recommended.