NICE has issued final guidance recommending abiraterone (marketed as Zytiga by Janssen) for some prostate cancer patients*. This is a change from the appraisal committee's previous draft guidance decision.

It is estimated that 5,900 people with prostate cancer could be eligible for treatment with abiraterone each year.1

Initial evidence submitted by the manufacturer to NICE failed to demonstrate the quality of life and long-term survival for patients receiving abiraterone, meaning NICE could not recommend the drug as indicated.

When requested, Janssen submitted new evidence focusing on a large group of patients treated with abiraterone in the USA. The data showed that 14% of the patients were still taking abiraterone after 4.4 years. The appraisal committee expressed some concerns about whether these results could be generalised to the UK, but they recognised that the new data supported the case for some patients taking abiraterone for long periods of time. As such the committee has now concluded that abiraterone is a cost-effective treatment option.

Commenting on the final decision, Professor Carole Longson, Director of the Centre for Health Technology Evaluation at NICE said: "I am very pleased that the new evidence submitted has meant we are able to recommend abiraterone. There are few treatments available for patients at this stage of prostate cancer so this is very good news."

Where NICE recommends a treatment, the NHS is legally obliged to begin funding the drug within 3 months of the final publication date.

Responses to the NICE approval of abiraterone

Janssen UK & Ireland:
Mark Hicken, Managing Director Janssen UK & Ireland, said: "This long overdue but welcome decision means that patients in England will finally be able to access this innovative cancer medicine routinely on the NHS, putting them on a par with patients in many other European countries who have had access to abiraterone as an option before chemotherapy for some years. We have worked tirelessly for several years to ensure abiraterone, a UK-discovered medicine, which demonstrates long term survival and quality of life benefits for patients, is made widely available for men who cannot have or do not want chemotherapy and are delighted that this is now possible for them."

"Janssen has been successful in making abiraterone before chemotherapy available to men with prostate cancer in 95 countries worldwide, but the length of time taken to gain approval in the UK demonstrates a clear need for reform of the way NICE appraises innovative cancer medicines. We are concerned that the CDF changes recently approved by NICE and NHS England will only exacerbate these problems, resulting in even greater restrictions for cancer patients in England. Janssen will continue to work collaboratively with NICE, NHS England and the Department of Health to create a more flexible system which will support and improve patient access to the best care."

The Institute of Cancer Research:
Professor Paul Workman, Chief Executive of The Institute of Cancer Research, London, which discovered abiraterone, said:

"We're extremely pleased. This is a big victory for men in England with prostate cancer, and means they will finally catch up with the US, Europe and indeed Scotland in being able to access abiraterone earlier in the course of treatment. Abiraterone was discovered at the ICR's laboratories in London, and it's great that men with advanced cancer who are treated on the NHS will now routinely receive a drug that allows them to live longer and delay chemotherapy.

"The answer today is the right one, but I would urge NICE to implement the planned overhaul of its drug appraisal processes as soon as possible to avoid repeated delays in getting the best, most innovative treatments to patients. It's been more than three years since NICE first started evaluating use of abiraterone pre chemotherapy, and it's very frustrating that it has taken that long for NICE and the drug's manufacturer to find a way of making it available cost-effectively."

Cancer Research UK:
Professor Malcolm Mason, Cancer Research UK's prostate cancer expert, said: "We're delighted to hear that NICE has approved abiraterone to be used before chemotherapy for men with prostate cancer that has spread and has come back after their first line hormone therapy. Cancer Research UK funded the research that led to the discovery and development of this drug, which was only possible thanks to the generosity of our public supporters, making this a true UK success story. This is a great development for prostate cancer patients."