natalizumab (Tysabri®)

in the absence of a submission from the holder of the marketing authorisation:

natalizumab (Tysabri®) is not recommended for use within NHS Scotland.

Indication under review: single disease modifying therapy in highly active relapsing remitting multiple sclerosis (RRMS) for adult patients aged 18 years and over with high disease activity despite treatment with glatiramer acetate.

SMC has previously not recommended natalizumab for use in patients with high disease activity despite treatment with beta-interferon.  The marketing authorisation has now been extended to include use in patients with high disease activity despite treatment with glatiramer.  The holder of the marketing authorisation has not made a submission to SMC regarding this product in this setting.  As a result we cannot recommend its use within NHSScotland.

SMC has previously accepted natalizumab (Tysabri®) for restricted use as a single disease modifying therapy in highly active RRMS in patients with rapidly evolving severe RRMS and this advice remains in place.