GILENYA (fingolimod) - Multiple sclerosis

Opinions on drugs - Posted on Jun 12 2025

Reason for request

Reassessment at the request of the TC.

Summary of opinion

Favourable opinion for maintenance of reimbursement as single disease modifying therapy in highly active relapsing-remitting multiple sclerosis for the following groups of adult patients and paediatric patients aged 10 years and older:

Patients with highly active disease despite a full and adequate course of treatment with at least one disease modifying therapy,
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.

Clinical Benefit

Substantial

That the clinical benefit of GILENYA (fingolimod) remains substantial in the MA indication.

Clinical Added Value

Comments without ASMR value

The Committee deems that the data provided in the context of this reassessment are not likely to modify the assessment of the clinical added value expressed in the previous opinions of 3 October 2018 and 20 February 2019.