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U-turn on NICE approval of prostate cancer drug

Abiraterone now approved for use in NHS in England and Wales

Adrian O'Dowd

Tuesday, 22 March 2016

The National Institute for Health and Care Excellence (NICE) has reversed an earlier decision and now approved the advanced prostate cancer drug, abiraterone, to be prescribed on the NHS in England and Wales for men who have not yet had chemotherapy.

The drug had previously been approved in 2012 for men who have already had chemotherapy, but was rejected for use before chemotherapy in August 2014.

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as Zytiga by Janssen) for some prostate cancer patients, which is a change from the appraisal committee’s previous draft guidance decision.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

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

However, 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 recognised that the new data supported the case for some patients taking abiraterone for long periods of time.

Consequently, the committee had now concluded that abiraterone was a cost-effective treatment option.

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.”

The charity Prostate Cancer UK said some men in England were still able to access abiraterone before chemotherapy through the Cancer Drugs Fund, but it welcomed the agreement to allow routine access.

Heather Blake, Prostate Cancer UK’s director of support and influencing, said: “This long-awaited decision is fantastic news and brings an end to years of uncertainty for men and their loved ones. After 18 months, our calls have finally been heard as NICE and the manufacturer have managed to negotiate a way forward. However, it cannot continue to take so ludicrously long to get men what they need.

“If the newly reformed drug appraisal process really is to work better for men, manufacturers must present best value for money first time around while greater flexibility from NICE must come as standard. We need to see much more focus on what patients need and deserve, otherwise men will men will lose out as they continue to be caught in the middle.”

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