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NICE U-turn on GSK's Revolade

Watchdog says yes to blood disorder drug three years after initial knockback

GSK - logo on buildingGlaxoSmithKline is one step away from gaining NICE approval for its blood pill Revolade after the cost effectiveness watchdog recommended its use this morning. 

The Institute's final draft guidance recommends Revolade (eltrombopag) as an option for treating some adults with the bleeding disorder, chronic immune (idiopathic) thrombocytopenic purpurai. 

This comes nearly three years after NICE rejected GSK's treatment, with the body saying in October 2010 that the drug's benefits were 'unclear' and its costs too high. 

Now it seems NICE has the information it needs to change that decision - a process that will have been swayed by GSK's offer of a patient access scheme to cut the cost of its drug. 

Chronic immune (idiopathic) thrombocytopenic purpurai is caused by abnormally low levels of platelets, which are needed for the blood to clot. 

Professor Carole Longson, health technology evaluation centre director at NICE, said: “People who have chronic immune (idiopathic) thrombocytopenic purpura are at daily risk of nosebleeds or other bleeding that is hard to stop. 

“Women with the condition may also experience heavier periods than normal. NICE is, therefore, pleased to recommend eltrombopag for this condition in final draft guidance. I am sure this will be welcome news to all those affected.”

Revolade is licensed for use in adults with the condition who have had splenectomy (surgery to remove the spleen), and whose condition does not respond to other treatments, including corticosteroids or immunoglobulins, which are antibodies that help the immune system. 

Revolade, known as Promacta in the US where it gained approval in 1998, also has a European licence as a second-line treatment in adults who have not had a splenectomy because surgery is not advisable.

NICE has recommended the drug as an option for both of these patient groups, but only if they have the severe form of the disease and a high risk of bleeding that needs frequent courses of rescue therapies.

The watchdog said it would also only allow the medicine to be funded by the NHS in England and Wales if GSK lowers Revolade's price in-line with the patient access scheme agreed with the Department of Health. The scale of the discount, as is usual with such schemes remains 'commercial in confidence'. 

GSK initially told NICE that the average daily cost of its medicine would be £56.43, although this will be lower given the patient access scheme. 

NICE's final draft guidance puts Revolade on course to be the second NICE-approved drug licensed for the condition. In April 2011 the Institute recommended Amgen's Nplate (romiplostim), but only after the US biotech firm offered the drug at a discounted price under a patient access scheme.

NICE's Revolade decision is set to be finalised next month and the NHS will then have a maximum of three months to ensure it makes Revolade available to patients. 

12th June 2013

From: Sales



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