Zytiga abiraterone acetate regulatory update
The Scottish Medicines Consortium recommended the restricted use of Johnson & Johnson's Zytiga abiraterone acetate on the National Health Service (NHS) in Scotland in combination with prednisone or prednisolone in patients with metastatic, castration-resistant prostate cancer (CRPC) that has progressed on or after docetaxel-based chemotherapy - the drug's approved indication. Following a resubmission from the company, the consortium recommended the use of Zytiga in patients who have received only 1 prior chemotherapy. The recommendation is contingent upon J&J providing Zytiga at an undisclosed discount under a patient access scheme. In March, the consortium recommended against Zytiga and said J&J did not sufficiently justify the treatment's costs in relation to its health benefits (see BioCentury, March 19).
In June, the U.K.'s NICE issued final guidance recommending Zytiga for the indication, which was also contingent upon a patient access scheme (see BioCentury, July 2). ...