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    Has all of the relevant evidence been taken into account?

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    Are the summaries of clinical and cost effectiveness reasonable interpretations of the evidence?

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    Are the recommendations sound and a suitable basis for guidance to the NHS?

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Draft guidance consultation

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1 Recommendations

1.1

Fenfluramine is not recommended, within its marketing authorisation, for treating seizures associated with Lennox-Gastaut syndrome (LGS) as an add-on to other antiseizure medicines for people 2 years and over.

1.2

This recommendation is not intended to affect treatment with fenfluramine 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 for them before this guidance was published, until they and their NHS clinician consider it appropriate to stop. For children or young people, this decision should be made jointly by the clinician, the child or young person, and their parents or carers.

Why the committee made these recommendations

People with LGS are offered a range of antiseizure medicines that collectively make up standard care. If this does not control their seizures, other treatments can be introduced, including cannabidiol plus clobazam.

Evidence from a clinical trial shows that people who have fenfluramine have fewer drop seizures per month than people who have standard care. There is no evidence directly comparing fenfluramine with cannabidiol plus clobazam. But, an indirect comparison suggested that fenfluramine may be more effective than cannabidiol plus clobazam in reducing the number of drop seizures.

The economic evidence for fenfluramine has some uncertainties, including how well it works in the long term and around some of the assumptions used to estimate cost effectiveness. Even when considering the condition's severity and its effect on quality and length of life, the most likely cost-effectiveness estimates are above what NICE considers an acceptable use of NHS resources and highly uncertain. So, fenfluramine is not recommended.