Regulatory Focus™ > News Articles > In Reversal, NICE Gives GSK’s Revolade Thumbs-up for Bleeding Disorder

In Reversal, NICE Gives GSK’s Revolade Thumbs-up for Bleeding Disorder

Posted 25 July 2013 | By Louise Zornoza 

The UK's cost containment agency, the National Institute for Health and Care Excellence (NICE), issued final guidance on 24 July 2013 recommending reimbursement for GSK's Revolade (eltrombopag).

NICE's recommendation covers its indication as an option for treating patients with the bleeding disorder chronic immune (idiopathic) thrombocytopenic purpura who have severe disease and a high risk of bleeding that needs frequent courses of rescue therapies. 

The positive recommendation reverses an earlier negative recommendation issued in October 2010, and is based solely on GSK lowering the price of the drug in the interim. 

Chronic immune thrombocytopenic purpura is caused by abnormally low levels of platelets, and patients who have it are at daily risk of nosebleeds or other bleeding that is hard to stop, which can have a significant impact on quality of life. Women with the condition may also experience heavier periods than normal. Some people may experience serious hemorrhaging, which can be fatal. Anxiety related to bleeding may affect work or leisure activities, and, in extreme situations, causes people to become housebound.


NICE Guidance on Revolade

Read all Breaking News from RegLink


Tags: GSK, UK, EU

Regulatory Focus newsletters

All the biggest regulatory news and happenings.

Subscribe