Regulatory Focus™ > News Articles > GSK's Less Effective, Less Costly Bleeding Disorder Treatment Wins NICE Backing

GSK's Less Effective, Less Costly Bleeding Disorder Treatment Wins NICE Backing

Posted 13 June 2013 | By Louise Zornoza

The National Institute for Health and Care Excellence (NICE) yesterday issued final draft guidance recommending reimbursement for GlaxoSmithKline's Revolade (eltrombopag) for chronic immune (idiopathic) thrombocytopenic purpura (ITP), a bleeding disorder, even though the drug is less effective than Amgen's Nplate (romiplostim), which NICE recommended in 2011.

In guidance released on 12 June 2013, NICE agreed that eltrombopag was less effective but also less costly than romiplostim, and therefore concluded that eltrombopag is "a cost-effective use of the National Health Service (NHS) resources in this population."

The review of the original negative recommendation for eltrombopag, published by NICE in October 2010, was prompted by GSK's submission of a patient access scheme, which provides the NHS with a discounted price for its drug. 

ITP affects around 3,500 people in England and Wales, and is more common in women and in older people of both sexes. It is caused by abnormally low levels of platelets which are needed for the blood to clot. Removing the spleen - part of the lymphatic system - is recommended in some cases because this can increase the platelet count. Revolade is approved for use in adults with ITP who have had a splenectomy, and whose condition does not respond to other treatments, and as a second-line treatment in those for whom surgery is not advisable.

NICE Final Guidance on Revolade

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