Tysabri wins NICE approval
pharmafile | August 23, 2007 | News story | Sales and Marketing |Â Â Â
NICE has approved Biogen Idec's Tysabri for rapidly evolving severe relapsing/remitting multiple sclerosis (RRMS), using its fast-track, single technology appraisal system.
Tysabri is also licensed for MS patients with high disease activity when beta-interferon treatment fails, but NICE ruled it was not cost effective in this indication and needed more research into its clinical effectiveness.
Patient group the MS Society welcomed NICE's decision on the RRMS indication, saying it would benefit nearly 3,000 people in England and Wales, but warned PCTs against withholding funds for the treatment.
Chief executive Simon Gillespie said: "We will be keeping a close eye on prescribing to make sure that people who stand to benefit from Tysabri are able to get the drug locally and we hope no one finds their access limited by local funding concerns."
PCTs are now legally required to make the drug available to suitable patients within three months after NICE ruled it to be a cost-effective use of NHS resources.
NICE's Scottish equivalent, the SMC, is currently revising its initial judgement in December last year to reject Tysabri and a decision is due in September.
Tysabri (natalizumab) is the first treatment to be licensed for highly active RRMS, which is diagnosed when patients have two or more disabling relapses in one year and an active MRI scan.
Patients suffering from highly active RRMS experience more relapses and become disabled more quickly than those with the typical form of MS.
Tysabri was launched in Europe last year after overcoming significant safety concerns when several patients developed a rare, but potentially fatal, brain infection.
Its prescribing information carries safety warnings about the increased risk of progressive multifocal leukoencephalopathy (PML) and the need to regularly monitor patients for any signs of the infection.
