Advice

following an abbreviated submission:

fingolimod (Gilenya®) is accepted for use within NHSScotland.

Indication under review: as a single disease modifying therapy in highly active relapsing remitting multiple sclerosis for the following groups of patients aged 10 to <18 years:

-  Patients with highly active disease despite a full and adequate course of treatment with at least one disease modifying therapy.
or

-  Patients with rapidly evolving severe relapsing remitting multiple sclerosis defined by two or more disabling relapses in one year, and with one or more gadolinium enhancing lesions on brain MRI or a significant increase in T2 lesion load as compared to a previous MRI.

SMC has previously accepted fingolimod for use in adults in both of these patient groups.

This SMC advice takes account of the benefits of a Patient Access Scheme (PAS) that improves the cost-effectiveness of fingolimod. This advice is contingent upon the continuing availability of the PAS in NHS Scotland or a list price that is equivalent or lower.

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Medicine details

Medicine name:
fingolimod (Gilenya)
SMC ID:
SMC2154
Indication:
As single disease modifying therapy in highly active relapsing remitting multiple sclerosis for the following groups of adult patients and paediatric patients aged 10 years and older: Patients with highly active disease despite a full and adequate course of treatment with at least one disease modifying therapy (for exceptions and information about washout periods see sections 4.4 and 5.1 of the SmPC), Or: Patients with rapidly evolving severe relapsing remitting multiple sclerosis defined by 2 or more disabling relapses in one year, and with 1 or more Gadolinium enhancing lesions on brain MRI or a significant increase in T2 lesion load as compared to a previous recent MRI.
Pharmaceutical company
Novartis Pharmaceuticals UK Ltd
BNF chapter
Central nervous system
Submission type
Abbreviated
Status
Accepted
Date advice published:
10 June 2019