Zelboraf vemurafenib regulatory update
The U.K.'s NICE issued final guidance recommending the use of Zelboraf vemurafenib from Roche to treat unresectable or metastatic melanoma in patients with BRAF V600 mutations - its approved indication. The recommendation is contingent on Roche providing Zelboraf at an undisclosed discount under a patient access scheme. The guidance is line with a November final appraisal determination (FAD), in which the committee estimated Zelboraf's incremental cost-effectiveness ratio (ICER) at £44,000-£51,800 ($70,567-$83,077) per quality-adjusted life year (QALY) (see BioCentury, Nov. 5). NICE said the oral small molecule inhibitor of the oncogenic BRAF V600E met the criteria for being a life-extending, end-of-life treatment. £50,000 is usually the highest cost per QALY of a recommended drug under the criteria. ...