Setback for myelofibrosis patients as UK's NICE rejects Novartis' Jakavi

Swiss drug major Novartis today (June 26) expressed disappointment at the decision of UK drugs watch dog the National Institute for Health and Clinical Excellence’s (NICE) to publish final guidance not recommending the firm’s Jakavi (ruxolitinib; INC424) for the treatment of disease-related splenomegaly (enlarged spleen) or symptoms in adult patients with primary myelofibrosis (also known as chronic idiopathic myelofibrosis), post-polycythemia vera myelofibrosis or post-essential thrombocythemia myelofibrosis. This follows the Final Appraisal Determination (FAD) issued earlier this year (The Pharma Letter April 26, 2013.

Novartis intends to request an early review of NICE’s decision taking into account additional data that has recently been announced at the European Hematology Association congress in Stockholm, which provides further clinical evidence of the benefits associated with ruxolitinib (TPL June 13).

“Novartis does not agree with the final guidance which does not consider ruxolitinib to be a cost-effective use of NHS resources, considering the clinical effectiveness of ruxolitinib in reducing spleen size and reducing debilitating symptoms such as extreme fatigue, bone pain, insomnia and uncontrollable itching, which are associated with myelofibrosis. Our priority is to continue dialogue with NICE and the NHS to ensure patients have the most clinically effective and innovative treatment options available to them,” said Panos Alexakos, oncology general manager, Novartis UK & Ireland.