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fingolimod (Gilenya®)

Reference No. 2777

Publication date:

Appraisal information

fingolimod (Gilenya®) 0.25 mg hard capsule
fingolimod (Gilenya®) 0.5 mg hard capsule

Company: Novartis Pharmaceuticals UK Ltd
BNF category: Malignant disease and immunosupression
NMG meeting date: 03/04/2019
AWMSG meeting date: 15/05/2019
Submission Type: Limited Submission
Status: Recommended
Advice No: 0719
Ratification by Welsh Government: 11/06/2019

Current Progress

Ratification by
Welsh Government

AWMSG advice

Fingolimod (Gilenya®) is recommended as an option for use within NHS Wales as a single disease modifying therapy in highly active relapsing remitting multiple sclerosis for the following groups of paediatric patients aged 10–17 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 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. This recommendation applies only in circumstances where the approved Patient Access Scheme (PAS) is utilised or where the list/contract price is equivalent or lower than the PAS price.
Final Appraisal Recommendation (FAR)
AWMSG Secretariat Appraisal Report (ASAR)