For the second time this week, Scotland’s cost watchdog has given the green light to a GlaxoSmithKline drug to be used on the National Health Service there, this time for the clotting disorder treatment Revolade.

The Scottish Medicines Consortium has recommended Revolade (eltrombopag) for the treatment of chronic immune thrombocytopenic purpura (ITP)1. The drug is indicated for ITP splenectomised adults who are refractory to other treatments, such as corticosteroids and immunoglobulins, and may be considered as second-line treatment for adult non_splenectomised patients where surgery is contraindicated.

However the SMC has ordered certain restrictions, saying that Revolade in both the splenectomised and non-splenectomised patient populations should only be used in those people with severe symptomatic ITP or a high risk of bleeding. It also states that eltrombopag treatment “should remain under the supervision of a physician who is experienced in the treatment of haematological diseases”.

Scotland is the first place in the UK to have recommended eltrombopag, as a cost effective treatment for the NHS, GSK noted, “which is positive news for patients with this rare disease who have few treatment options available”. Revolade is the first oral thrombopoietin receptor agonist licensed for this patient population and has an innovative mode of action which increases platelet production; traditional ITP treatments reduce platelet destruction.

The drugs major quoted Mark Drummond at Gartnavel General Hospital in Glasgow as saying that “this is fantastic news for patients in Scotland and we are delighted with the decision from the SMC”. He said Revolade “represents a big step forward in the management of ITP – it is relatively easy to take and offers a reduced risk of bleeding during treatment, something that we know worries patients and has an impact on their quality of life”.

GSK has had less success with the National Institute for Health and Clinical Excellence which ruled against Revolade for funding on the NHS in June. The agency said it was “very unclear about how many health benefits eltrombopag would provide compared with other existing treatments”, adding that the price was “also far greater than what is normally considered a cost effective use of NHS resources”. Revolade has an average cost of £55 for each 50mg tablet, resulting in an annual price from £22,020-£33,030. NICE’s recommendation is preliminary and final guidance is scheduled to be published in October 2010.

Revolade was given the go-ahead in Europe in March this year, having been granted accelerated approval by the US Food and Drug Administration, under the trade name Promacta, in November 2008. The SMC’s recommendation for Revolade comes days after the agency backed Combodart (dutasteride/tamsulosin), GSK’s new combination treatment for benign prostatic hyperplasia.