following a full submission assessed under the orphan medicines process:
fenfluramine (Fintepla®) is accepted for use within NHSScotland.
Indication under review: for the treatment of seizures associated with Dravet syndrome as an add-on to other anti-epileptic medicines for patients 2 years of age and older.
In three phase III studies compared with placebo, the addition of fenfluramine significantly reduced convulsive seizure frequency in children aged 2 to 18 years with Dravet syndrome that was inadequately controlled by current anti-epileptic medicines.
This advice applies only in the context of an approved NHSScotland Patient Access Scheme (PAS) arrangement delivering the cost-effectiveness results upon which the decision was based, or a PAS/ list price that is equivalent or lower.
This advice takes account of the views from a Patient and Clinician Engagement (PACE) meeting.
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- Medicine name:
- fenfluramine (Fintepla)
- SMC ID:
Treatment of seizures associated with Dravet syndrome as an add-on therapy to other anti-epileptic medicines for patients 2 years of age and older.
- Pharmaceutical company
- UCB Pharma Ltd
- BNF chapter
- Central nervous system
- Submission type
- Date advice published
- 09 October 2023