Jakavi ruxolitinib regulatory update

The U.K.'s NICE issued draft guidance recommending against the use of Jakavi ruxolitinib from Novartis to treat disease-related splenomegaly or symptoms in adults with chronic idiopathic myelofibrosis, post-polycythemia vera or essential thrombocythemia myelofibrosis - its approved indications. The committee said the drug was effective in reducing spleen size and in treating symptoms, including itch and fatigue, and that it was "plausible" that Jakavi offers a survival benefit. NICE also said that Jakavi is "innovative" and that it would consider an incremental cost-effectiveness ratio (ICER) at the top end of the £20,000-£30,000 range the agency typically considers a cost-effective use of NHS resources. However, the committee said that the ICER for Jakavi was likely to be closer to £149,000 ($234,779) per quality-adjusted life year (QALY) gained compared with best available therapy, rather than Novartis' estimate of £74,000 ($116,601). Best available therapy included hydroxycarbamide, prednisone and epoetin alfa, as well as Revlimid lenalidomide from Celgene Corp. (NASDAQ:CELG, Summit, N.J.), but did not include a splenectomy.

NICE said it may be plausible to apply end-of-life criteria to a subgroup of myelofibrosis patients classified as high risk, but the committee noted that Novartis did not provide any data or an analysis of this subgroup. Jakavi is available in the U.K. at an annual cost of about £43,200 ($68,070) per patient, which would put the annual cost to NHS for the drug at about £10.8 million ($17 million) based on about 250 eligible patients in the U.K. Comments are due March 5. ...