NICE rejects GSK’s Revolade

NICE has rejected GlaxoSmithKline’s Revolade saying in draft guidance that the blood disorder drug’s benefits were unclear.

The watchdog assessed Revolade (eltromopag) for chronic immune thrombocytopenic purpura (ITP) in adults that have had their spleen surgically removed (splenectomised) and have not responded to other treatments.

NICE also rejected its use as a second-line treatment for non-splenectomised adults when surgery is not advised.

The committee concluded that although the drug can raise platelet levels, the evidence was very unclear about benefits Revolade would provide compared with existing treatments for the bleeding disorder, such corticosteroids and immunoglobulins.

The annual cost for Revoldade is between £22-33,000. NICE considered these costs in relation to the estimated health benefits, and decided it’s not an effective use of NHS resources.  

NICE’s deputy chief executive Gillian Leng said the appraisal committee understood the considerable effect the risk of bleeding has on patients with ITP.

“Unfortunately, the committee felt there was not sufficient evidence to recommend eltrombopag as a treatment for ITP. There are existing treatments available for ITP and, from the clinical evidence, it is very unclear how much health benefit eltrombopag provides, compared with these current alternative treatments.

“The cost of eltrombopag in relation to the estimated health benefits is too high to be a cost-effective use of NHS resources. The committee therefore concluded that it could not recommend eltrombopag for people with chronic ITP.”

Revolade, known as Promacta in the US where it gained approval in November 1998, was discovered as part of a research collaboration between GSK and biotech company Ligland Pharma. It gained European approval this March.

ITP occurs in about 6 in 100,000 people. It is more common in women and predominantly occurs in those of child bearing age. It may also be seen more often in the elderly.

It comes on gradually and there may be no symptoms such as mild bruising, bleeding, or severe bleeding. Because most adults with ITP do not have any symptoms, ITP is usually diagnosed on a routine blood test that has been done for other reasons.

Final guidance is likely to be published in October this year.

Brett Wells