NICE issues negative FAD on Zytiga

Unlike in Scotland, where abiraterone acetate was recommended earlier this year, men in England and Wales with newly-diagnosed high-risk, metastatic hormone-sensitive prostate cancer (mHSPC) denied access to a life-extending treatment option.

The health technology assessor the National Institute for Health and Care Excellence (NICE) has today announced that it will not be recommending Johnson & Johnson (NYSE: JNJ) subsidiary Janssen’s Zytiga (abiraterone acetate) with prednisone or prednisolone plus androgen deprivation therapy (ADT), within its marketing authorization, for treating-newly diagnosed high-risk mHSPC in adults. Zytiga generated 2019 revenues of $2.8 billion for J&J.

The NICE’s negative recommendation will affect around 4,000 men newly-diagnosed with high-risk met mHSPC who could have been eligible for abiraterone acetate in combination with prednisone/prednisolone and ADT. It also highlights the discrepancy in routine access between patients in England and Wales, and those in Scotland, where the Scottish Medicines Consortium (SMC) approved abiraterone acetate for use in the full licensed population earlier this year, based on the same evidence base, commented Janssen.