following a full submission assessed under the ultra-orphan medicine process:
everolimus (Votubia®) dispersible tablets are accepted for use within NHSScotland.
Indication under review: Adjunctive treatment of patients aged two years and older whose refractory partial-onset seizures, with or without secondary generalisation, are associated with tuberous sclerosis complex (TSC).
A phase III study identified that everolimus significantly reduced seizure frequency when compared with placebo as adjunctive treatment in patients whose refractory partial-onset seizures, with or without secondary generalisation, are associated with TSC.
This SMC advice takes account of the benefits of a Patient Access Scheme (PAS) that improves the cost-effectiveness of everolimus. This advice is contingent upon the continuing availability of the PAS in NHSScotland or a list price that is equivalent or lower.
This advice takes account of views from a Patient and Clinician Engagement (PACE) meeting.
Everolimus (Votubia®) dispersible tablets are also licensed for use in treatment of subependymal giant cell astrocytoma (SEGA) associated with TSC. The manufacturer’s submission related only to the use of this product in refractory partial-onset seizures associated with TSC.
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