UK's NICE says no to Novartis' Jakavi for enlarged spleen

UK drugs watchdog the National Institute for Health and Care Excellence (NICE) has published final draft guidance not recommending Swiss drug major Novartis’ (NOVN: VX) Jakavi (ruxolitinib) for the treatment of disease-related splenomegaly (enlarged spleen) or its symptoms in adults with primary myelofibrosis, or post polycythemia vera myelofibrosis or post essential thrombocythemia myelofibrosis.

The NICE’s independent Appraisal Committee concluded that ruxolitinib was clinically effective in reducing spleen size and symptoms such as itch and fatigue, but could not be considered a cost-effective use of National Health Service resources compared with best available therapy for treating disease-related splenomegaly or symptoms in adults with myelofibrosis. It concluded that although it was plausible that ruxolitinib could offer an overall survival benefit, the reason for this remained unclear because of uncertainties in the evidence.

Commenting on the final draft guidance, Sir Andrew Dillon, chief executive at the NICE, said: “Myelofibrosis and splenomegaly can be extremely debilitating, with symptoms such as severe itching and fatigue. It is disappointing not to be able to recommend this new treatment in our final draft guidance, but in order to do this we have to be sure that the treatment is both clinically and cost effective, because money has to be diverted from elsewhere in the health service to pay for it.”