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Archived: fingolimod (Gilenya)


following a full submission

fingolimod (Gilenya®) is not recommended for 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.


• 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.

Fingolimod reduced the annualised relapse rate significantly more than a beta-interferon in patients with clinically active RRMS.

The submitting company did not present a sufficiently robust economic analysis to gain acceptance by SMC. 

Drug Details

Drug Name: fingolimod (Gilenya)
SMC Drug ID: 763/12
Manufacturer: Novartis Pharmaceuticals UK Ltd
Indication: for the treatment of highly active relapsing remitting multiple sclerosis in adults.
BNF Category:
Sub Category: 8.2 Drugs affecting the immune response
Submission Type: Full submission
Status: Not Recommended
Date Advice Published: 12 March 2012

Current Advice

Resubmission 10 September 2012