Draft NICE guidance rejects GSK's Revolade

Draft guidance from the UK's National Institute for Health and Clinical Excellence (NICE) has not recommended GlaxoSmithKline's (GSK) Revolade (eltrombopag) as a second-line treatment for chronic immune (idiopathic) thrombocytopenic purpura (ITP) in adult patients following spleen removal.

The guidance also states the drug is not recommended for adults as a second-line treatment for the condition when surgery to remove the spleen is not advised.

Chronic ITP is a condition which causes a decrease in a patient's blood platelet production. This can lead to bruising and excessive bleeding.

Revolade is developed to increase platelet production by activating the thrombopoietin receptor, helping to reduce symptoms of chronic ITP.

Despite evidence that Revolade was effective in increasing platelet levels, the NICE Appraisal Committee who made the recommendation said that the long term effectiveness of the drug in the treatment of the condition was unclear.

The Committee also had concerns over the price of the drug, with the annual cost of treating a patient being between £22,020 and £33,030.

Speaking on the guidance, Dr Carole Longson, Health Technology Evaluation Centre director at NICE said: "From the clinical evidence presented, it is not clear how much long term health benefit eltrombopag provides, compared with current alternative treatments available. Given this and the high cost of eltrombopag in relation to the estimated health benefits the committee concluded that it could not recommend eltrombopag for people with chronic ITP."

Final NICE guidance is due to be published in October 2010.