ARTICLE | Company News

NICE rebuffs Xofigo

March 25, 2014 12:17 AM UTC

U.K.'s NICE issued a Xofigo radium-223 dichloride from Bayer AG (Xetra:BAYN) to treat adults with castration-resistant prostate cancer (CRPC), symptomatic bone metastases and no known visceral metastases -- its approved indication in the EU. NICE said Bayer did not provide data comparing Xofigo to the appropriate treatments -- docetaxel as a first-line treatment of CRPC and Zytiga abiraterone from Johnson & Johnson (NYSE:JNJ) as second-line treatment. Bayer submitted data from the Phase III ALSYMPCA trial, which compared Xofigo plus best supportive care (BSC) vs. BSC alone; and the Phase II BC1-02 trial, which compared Xofigo with placebo.

Additionally, NICE said that even with an undisclosed discount under a patient access scheme, the incremental cost-effectiveness ratio (ICER) for Xofigo compared with BSC was L57,400 ($94,676) per quality-adjusted life year (QALY) gained. Comments are due April 11. ...