Zytiga abiraterone acetate regulatory update
The U.K.'s NICE issued draft guidance recommending Zytiga abiraterone from Johnson & Johnson in combination with prednisone or prednisolone in patients with metastatic, castration-resistant prostate cancer (CRPC) that has progressed on or after docetaxel-containing therapy - the drug's approved indication. NICE reversed a prior negative decision after J&J submitted a revised patient access scheme, as well as information on the patients who are expected to benefit most from Zytiga and clarification on how many patients could receive the drug. NICE said Zytiga now meets the criteria for a life-extending, end-of-life treatment, with an incremental cost-effectiveness ratio (ICER) less than £50,000 ($80,370) per quality-adjusted life year (QALY). In February, NICE said Zytiga did not meet the life-extending, end-of-life treatment criteria and would have an ICER of £63,200 ($99,053) per QALY (see BioCentury, Feb. 6). ...