fingolimod (Gilenya)

following a full submission

fingolimod (Gilenya®) is accepted for restricted use within NHS Scotland.

Indication under review: as a single disease modifying therapy in highly active relapsing remitting multiple sclerosis for the following adult patient groups:

- Patients with high disease activity despite 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 recent MRI.

SMC restriction: For use in patients with rapidly evolving severe relapsing remitting multiple sclerosis.  SMC has previously published advice concerning patients with high disease activity despite treatment with beta-interferon.

Fingolimod reduced the annualised relapse rate significantly more than a beta-interferon in patients with clinically active relapsing remitting multiple sclerosis.

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 patient access scheme in NHS Scotland or a list price that is equivalent or lower.