fenfluramine (Fintepla)

following a full submission assessed under the orphan medicines process:

fenfluramine (Fintepla®) is accepted for restricted 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.

SMC restriction: as add-on therapy for treating seizures associated with Dravet syndrome where seizures have not been controlled in people aged 2 years and older after trying two or more anti-seizure medicines.

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.