NICE knocks back Janssen’s Zytiga combo for newly diagnosed, hormone-sensitive metastatic prostate cancer.

pharmafile | June 29, 2020 | News story | Sales and Marketing  

Drug watchdog NICE has chosen to stick with its earlier decision not to recommend Janssen’s Zytiga (abiraterone aetate), combined with prednisone/prednisolone plus androgen deprivation therapy (ADT), for use on the NHS in England and Wales for the treatment of newly diagnosed, high-risk hormone-sensitive metastatic prostate cancer.

This is despite trial data supplied in support of the NICE application showing that patients receiving the Zytiga combo survived for a median of 53.3 months overall, compared to 36.5 months with placebo plus ADT. The review committee agreed with these benefits, but could not be certain on its long-term survival benefit due to possible confusion over patients receiving life-extending treatment after seeing their disease progression following ADT.

Janssen expressed its disappointment at the decision, with the company announcing that it “believes this decision does not accurately reflect the evidence submitted to the Committee. This outcome 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.”

Sarah Scanlon, Business Unit Director, Oncology, at Janssen, remarked: “We are extremely disappointed with this decision, and particularly for those patients and clinicians who were anticipating access to this innovative therapy. It is particularly surprising in light of the recent decision by NHS England which, due to the current COVID-19 pandemic, has recognised abiraterone acetate as an alternative option by agreeing to provide it for an interim period to those who are intolerant to other treatments. We are currently reviewing the FAD in detail and we will assess our options for a potential challenge to this decision, particularly given the evidence supporting the value of abiraterone in patients who are ineligible for chemotherapy.”

Prostate cancer is the most commonly diagnosed cancer in the UK, with over 57,000 cases identified each year. It’s estimated that around 4,000 men in England and Wales would have been eligible to receive the therapy.

Matt Fellows

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