TYSABRI (natalizumab) - Relapsing-remitting multiple sclerosis (RRMS)

Summary of opinion

Favourable opinion for maintenance of reimbursement as single disease modifying therapy in adults with highly active relapsing-remitting multiple sclerosis (RRMS) for the following patient groups:

• 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.