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 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.|
|Sub Category:||8.2 Drugs affecting the immune response|
|Submission Type:||Full submission|
|Date Advice Published:||12 March 2012|
|fingolimod (Gilenya)||Resubmission||10 September 2012|