natalizumab 300mg concentrate for solution for infusion (Tysabri)

Following a full submission.

Natalizumab (Tysabri) is not recommended for use within NHS Scotland as single disease modifying therapy in highly active relapsing remitting multiple sclerosis (RRMS) for the following patient groups; patients with high disease activity despite treatment with beta-interferon and in patients with rapidly evolving severe RRMS.

In a sub-group analysis of the pivotal trial, which included patients with rapidly evolving severe RRMS, there was a significant reduction in the annualised relapse rate in those treated with natalizumab compared with placebo. In addition, sustained progression of disability over two years was significantly less likely in patients receiving natalizumab than those receiving placebo.

The economic case has not been demonstrated.

The licence holder has indicated their decision to resubmit.