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fingolimod (Gilenya®)

 

Following a limited submission

AWMSG advice

Status: Recommended

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 Recommendation: fingolimod (Gilenya) 2777 (PDF, 340Kb)
 Appraisal Report: fingolimod (Gilenya) 2777 (PDF, 276Kb)

Medicine details

Medicine name fingolimod (Gilenya®)
Formulation 0.25 mg and 0.5 mg hard capsules
Reference number 2777
Indication

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
Company Novartis Pharmaceuticals UK Ltd
BNF chapter Malignant disease & immunosuppression
Submission type Limited
Status Recommended
Advice number 0719
NMG meeting date 03/04/2019
AWMSG meeting date 15/05/2019
Date of issue 11/06/2019
Date of last review December 2022
Commercial arrangement PAS
Further information

Technologies recommended by NICE that include a commercial arrangement (Excel)

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