fenfluramine (Fintepla)

following a full submission:

fenfluramine (Fintepla®) is accepted for restricted use within NHSScotland.

Indication under review: treatment of seizures associated with Lennox-Gastaut syndrome as an add-on therapy to other anti-epileptic medicines for patients 2 years of age and older.

SMC restriction: patients whose seizures have not been controlled after trying two or more anti-epileptic medicines.

In a randomised, double-blind, phase III study, fenfluramine significantly reduced drop seizure frequency in patients (aged 2 to 35 years) with Lennox-Gastaut syndrome that was inadequately controlled by current anti-epileptic medicines, compared with placebo.

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.