NICE sticks to Zytiga rejection

NICE will not be recommending Janssen's Zytiga (abiraterone acetate) with prednisone or prednisolone plus androgen deprivation therapy (ADT), within its marketing authorisation, for treating newly diagnosed high-risk metastatic hormone-sensitive prostate cancer (mHSPC) in adults.

Around 4,000 men newly diagnosed with high-risk metastatic hormone-sensitive prostate cancer (mHSPC) would have been eligible for treatment abiraterone acetate in combination with prednisone/prednisolone and ADT.

Currently, men first diagnosed with advanced prostate cancer are treated with hormone therapy with docetaxel chemotherapy, or hormone therapy on its own, but because chemotherapy can come with serious side effects, around three quarters are unable to tolerate it or choose not to have it.

NICE's rejection of NHS funds for the drug in England and Wales highlights the postcode lottery of care that exists across the UK, as the Scottish Medicines Consortium (SMC) has approved use of the drug in this setting, based on the same evidence base.

The Final Appraisal Document (FAD) also seems to be in direct contrast to interim guidance issued by NHS England last month, which recognised Zytiga as an alternative option by agreeing to provide it for an interim period to those who are unable to have chemotherapy due to the current COVID-19 pandemic.

The Institute of Cancer Research (ICR) has expressed disappointment with the decision, and is now calling for NHS England and drug's manufacturer, Janssen, to come to an agreement on pricing that would allow its use on the NHS.

The ICR notes that large clinical trials, STAMPEDE and LATITUDE, found that first-line Zytiga “extended the time patients lived without their disease coming back, halved subsequent problems like bone fracture and the need for radiotherapy and offered them a better quality of life compared with a combination of hormone therapy and docetaxel chemotherapy”.

“Abiraterone offers men a clear improvement in quality of life compared with chemotherapy or hormone therapy alone, with long-term benefits that can last several years,” said Professor Nick James, Professor of Prostate and Bladder Cancer Research at The ICR, who led the STAMPEDE trial and was one of the clinical experts for the NICE appraisal of abiraterone as a first-line treatment.

“The quality of life benefits of abiraterone are particularly important for older men who might not be well enough to receive chemotherapy. It is especially frustrating that there will be such stark differences across the UK, with men in Scotland able to access abiraterone first line, but those in England and Wales facing the prospect of missing out.”

“I would urge the manufacturer of abiraterone and NHS England to urgently negotiate a suitable patient access scheme – the STAMPEDE and LATITUDE trial results were published in 2017 so this is long overdue. This would allow many men with advanced prostate cancer in England and Wales to be offered abiraterone from the outset and live well with their cancer for as long as possible.”

Sarah Scanlon, business unit director Oncology, Janssen-Cilag Limited, said: “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.”