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news.The UK healthcare cost regulator has recommended Biogen Idec and Elan's Tysabri for the treatment of severe relapsing remitting multiple sclerosis.
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The National Institute for Health and Clinical Excellence (NICE) has approved the drug, despite concerns over its high cost and clinical effectiveness. The recommendation reverses an earlier decision by the agency to withhold the drug because of high costs, following campaigning by patient groups. Over a year, Tysabri costs approximately GBP14,730 per patient.
Tysabri is the first treatment to be specifically licensed for highly active relapsing remitting multiple sclerosis (RRMS). Over two years, treatment with Tysabri leads to a 68% relative reduction in clinical relapses and a 54% relative reduction in the risk of sustained disability progression compared with placebo, according to its manufacturers.
The drug was withdrawn in February 2005 after it was associated with an increased risk of progressive multifocal leukoencephalopathy (PML), a rare and potentially fatal brain disease. However, Tysabri was allowed back onto the market due to its efficacy, although it now has strict prescription guidelines.