fingolimod (Gilenya)

following a resubmission:

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

Indication under review:  As single disease modifying therapy in highly active relapsing remitting multiple sclerosis (RRMS) for the following adult patient groups:

• Patients with high disease activity despite treatment with a beta-interferon.
  These patients may be defined as those who have failed to respond to a full and adequate course (normally at least one year of treatment) of beta-interferon.  Patients should have had at least one relapse in the previous year while on therapy and have at least nine T2-hyperintense lesions in cranial magnetic resonance imaging (MRI) or at least one gadolinium-enhancing lesion.
  A “non-responder” could also be defined as a patient with an unchanged or increased relapse rate or ongoing severe relapses as compared to the previous year.
  or
• Patients with rapidly evolving severe RRMS 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: restricted to use as single disease modifying therapy in highly active RRMS in adult patients with high disease activity despite treatment with a beta-interferon with an unchanged or increased relapse rate or ongoing severe relapses as compared to the previous year. 

Fingolimod reduced the annualised relapse rate significantly more than a beta-interferon in patients with clinically active RRMS. An indirect comparison also demonstrated similar efficacy to another disease modifying therapy in established use in RRMS.

This SMC advice takes account of the benefits of a Patient Access Scheme (PAS) that improves the cost-effectiveness of fingolimod. This SMC advice is contingent upon the continuing availability of the patient access scheme in NHS Scotland.