Today NICE announced its decision not to recommend use of the prostate cancer drug abiraterone in patients who are yet to receive chemotherapy, saying it would not be cost-effective for the NHS.
I’ve been following the NICE assessment of abiraterone closely as it is a really important drug for us here at The Institute of Cancer Research. It was discovered by the ICR and the early clinical development of the drug was carried out by the ICR and it’s clinical partner The Royal Marsden NHS Foundation Trust. We’re really disappointed, as you might expect, to see that NICE is not extending use of abiraterone to more patients.
What is abiraterone?
Abiraterone has been available for prostate cancer patients in the UK since the European Medicines Authority licensed the drug in 2011, quickly becoming one of the most requested drugs on the Cancer Drugs Fund. The drug works by blocking the production of testosterone, which prostate tumours rely on to grow. You can read more about the discovery and development of abiraterone in this feature article on our website.
Based on the results of a pivotal trial led by the ICR and The Royal Marsden, NICE ran an appraisal in 2012 looking at the use of abiraterone in patients who had already been treated with chemotherapy. Initially NICE said no then too, but it changed its mind and approved use of abiraterone after pricing negotiations with the manufacturer, and reappraisal using criteria that make special allowance for drugs used at the end of life.
Abiraterone is now used as standard treatment for prostate cancer after chemotherapy and has extended the lives of thousands of men in the UK with advanced prostate cancer, with fewer side-effects than chemotherapy. Since then, researchers have been looking at using abiraterone earlier in the course of treatment, without men needing to be treated with toxic chemotherapy first.
Professor Johann de Bono, Professor of Experimental Cancer Medicine at the ICR and an honorary consultant at The Royal Marsden, led the UK arm of a large study looking at abiraterone treatment before chemotherapy. It was this study that was the basis for NICE’s evaluation of the clinical effectiveness of abiraterone in its appraisal. The trial showed that when the drug was given to men with no or mild symptoms before chemotherapy, it could double the time before tumour progression could be detected by a scan. Men in the abiraterone group also reported less pain than those on placebo. The benefits seen in some men were so impressive that the trial was stopped early so that all men in the study could receive abiraterone.
Why did NICE turn abiraterone down?
NICE did not recommend abiraterone in this case because the estimated costs of the drug were substantially above the range for which a drug is normally considered cost-effective. NICE did not apply its end-of-life criteria, which are used when assessing treatments for patients with a short life expectancy, simply because men at this earlier stage in their course of treatment tend to live too long. End-of-life criteria are normally applied where patients are expected to live for less than 24 months, whereas in this case the men in question could expect to live at least 30 months.
It is of course good news that men with prostate cancer are living longer thanks to the advances we are seeing in cancer treatments. We’ve blogged here in the past on the big changes that have been happening in prostate cancer treatment in recent years and the effect they are having on life expectancy. On average, patients with advanced prostate cancer treated with the latest therapies are living with the disease for more than twice as long as they did a decade ago. Here, Professor de Bono who has led a lot of this work tells us more in a video interview.
But it’s disappointing that abiraterone has been a victim in a sense of these successes in prostate cancer medicine. The evidence is clear that abiraterone is effective when given before chemotherapy and can give men many months of extra life free of disease, with much milder side-effects than conventional chemotherapy. We are very disappointed that NICE has not been able to recommend use of abiraterone in these patients, at least in part because its end-of-life criteria were not met. NICE’s decision is a particular blow for men who are unable to have chemotherapy because they are too old or too frail, since these men – having not been treated with chemotherapy – will now presumably be deemed ineligble for abiraterone too.
What happens next?
At the moment, this is only a preliminary decision and there is a chance for us to feed our comments into NICE before it finalises its recommendations. We’ll be giving our views as part of the consultation, which is open until 5 June.
We’ll of course be expressing our disappointment that abiraterone was considered too expensive to be recommended before chemotherapy. But equally, NICE does have a duty to make sure the treatments it approves are cost-effective for the NHS. We will be urging NICE, the NHS and the manufacturer to reach an accommodation as soon as possible on the price of abiraterone, so that the drug can be made more widely available for patients without breaking the bank.
The committee will meet again to discuss the decision later next month. I’ll be following the twists and turns of the process closely, and will report back here.