NICE Officially Recommends Tysabri for Severe Multiple Sclerosis

The UK’s National Institute for Health and Clinical Excellence (NICE) officially recommended the use of Biogen Idec/Elan’s Tysabri for the treatment of rapidly evolving severe relapsing-remitting multiple sclerosis (RES), NICE said Aug. 22.

The firms originally announced the NICE recommendation in July when they said reimbursement for Tysabri (natalizumab) by the UK’s National Health Service should commence in a few months.

However, the product was not recommended for use in a subgroup of multiple sclerosis patients that have failed to respond to treatment with beta interferons, such as Bayer Healthcare’s Betaseron, Merck KGaA’s Rebif and Biogen’s Avonex.

Although Tysabri has been approved by the European Medicines Agency for the treatment of multiple sclerosis in patients that exhibit high disease activity despite treatment with beta interferon, NICE said the clinical effectiveness of the product has not been fully established to support use of the product in that setting.