Zytiga regulatory update
The U.K.’s NICE issued a final appraisal determination (FAD) recommending against the use of Zytiga abiraterone from Johnson & Johnson in chemotherapy-naive patients with metastatic castration-resistant prostate cancer (CRPC) -- 1 of its approved indications in the EU. The FAD is in line with May draft guidance (see BioCentury, May 19).
According to the committee, J&J still did not clarify how much Zytiga extended life and did not meet the end-of-life considerations in the population. NICE said it also still had concerns about J&J’s calculated estimated cost-effectiveness for Zytiga in the indication. NICE said J&J’s base case incremental cost-effectiveness ratio (ICER) per quality-adjusted life year (QALY) gained was L46,700 ($78,148) -- above the threshold usually considered cost-effective. ...