Jevtana cabazitaxel regulatory update
The U.K.'s NICE issued a final appraisal determination (FAD) recommending against Jevtana cabazitaxel from Sanofi as a second-line treatment for prostate cancer in combination with prednisone or prednisolone. The recommendation is in line with a preliminary appraisal issued in September, despite an updated economic model provided by Sanofi to justify the health state utility values used in the original model (see BioCentury, Oct. 3, 2011). NICE said Jevtana met the criteria to be a life-extending, end-of-life treatment. However, the committee said Jevtana's most plausible incremental cost effectiveness ratio (ICER) is greater than £87,500 ($135,091) per quality-adjusted life year (QALY) gained, which is above the range considered cost effective. NICE added that there remains "considerable uncertainty in the robustness" of the ICER. NICE said there is no set threshold cost per QALY for drugs that meet the end-of-life criteria, but it added that the highest cost per QALY of a recommended drug has been £50,000. ...