The Institute of Cancer Research, London, has expressed disappointment at the decision by NICE not to recommend abiraterone as a first-line treatment on the NHS for newly diagnosed, advanced prostate cancer.
The decision puts the NHS in England and Wales out of step with Scotland, where the drug was approved as a first-line treatment at the start of this year.
Abiraterone was also made available first line on an interim basis for patients who aren’t suitable for enzalutamide as part of NHS England guidance in May in response to the COVID-19 pandemic, to spare some men with prostate cancer the need for chemotherapy in hospital.
The ICR is now calling for NHS England and the manufacturer of the drug, Janssen, to come to an agreement on pricing that would allow men to benefit from abiraterone at the start of treatment.
First-line abiraterone could extend many more lives
Two large clinical trials, STAMPEDE and LATITUDE, found that first-line abiraterone 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.
The drug has revolutionised prostate cancer treatment for men who have received the treatment before or after chemotherapy – and bringing it forward as a first-line treatment option could extend the lives of many more patients.
Currently, men who are first diagnosed with advanced prostate cancer are treated with hormone therapy with docetaxel chemotherapy, or hormone therapy on its own. However, because chemotherapy can come with serious side effects, around three quarters of men with advanced prostate cancer can’t tolerate it or choose not to have it.
The new decision will not affect the interim guidance by NHS England which allows the use of abiraterone as a first-line treatment in the context of the COVID-19 pandemic, but raises the prospect that in the near future men who are not able to have chemotherapy will lose access to abiraterone.
Clear improvement in quality of life
Professor Nick James, Professor of Prostate and Bladder Cancer Research at the ICR, led the STAMPEDE clinical trial assessing the benefits of both abiraterone and docetaxel, and was one of the clinical experts for the NICE appraisal of abiraterone as a first-line treatment. He said:
“I am deeply disappointed that abiraterone has not been approved by NICE as a first-line treatment option for men with advanced prostate cancer. 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. 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.
Future-proofing the NHS
“Interim guidance from NHS England has allowed men first-line access to abiraterone in the particular context of the COVID-19 pandemic – easing the pressure on the NHS as it comes with fewer risks to the immune system and is taken as tablets at home, sparing men multiple visits for chemotherapy.
“I believe that NICE approval of abiraterone in the longer term as a first-line treatment would not only offer a much kinder option for patients, but could also help future-proof the NHS, as it’s becoming increasingly clear that the effects of the pandemic will continue to reverberate for years to come.
“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.”