Abiraterone should continue to be available on the NHS and opened up to all men with newly diagnosed advanced prostated cancer, argues our policy manager Tim Windle, as the UK’s drug guidelines body announces its initial ruling on the future of the costly treatment.
Today, the National Institute for Health and Care Excellence (NICE) has announced its initial verdict that it does not have enough evidence to recommend that abiraterone should be available on the NHS for all men with a 'high-volume' of metastasised prostate cancer.
Abiraterone is available for men with advanced prostate cancer once they have become resistant to hormones. But NICE has been considering whether it should also be offered to men who are newly-diagnosed with advanced prostate cancer and still responsive to hormone therapy.
For these men, treatment with abiraterone alongside hormone therapy has been shown to have impressive results. So it’s really disappointing that this draft decision from NICE does not to approve its use for any men in this group.
At the moment, men with advanced prostate cancer are given the chemotherapy treatment docetaxel. But some men – through no fault of their own – are unable to tolerate chemotherapy. It's vital that these men in particular are able to access abiraterone as an alternative treatment.
It is clear from today’s announcement that there are a number of questions and gaps in evidence that need to be resolved before that can happen and we want to see urgent action from Janssen, the manufacturer, working with NICE, to address these as soon as possible.
As our Specialist Nurse, Emma Craske, explained in a statement to NICE as part of our recent submission to the decision-making panel: "For men who can’t have docetaxel chemotherapy, abiraterone apparently offers an equal alternative in survival benefit.
"Many are now aware of abiraterone but can’t yet access it within the NHS. This means the apparent potential survival equity available [the potential benefit] from being able to receive either docetaxel or abiraterone is out of reach to this group of men."
Ultimately, we want to see abiraterone offered to all men with newly diagnosed prostate cancer that has metastasised
Last year, both the LATITUDE and STAMPEDE trials showed that the benefits of abiraterone (with hormone therapy and a steroid called prednisone) are similar to the benefits of docetaxel for men with advanced prostate cancer. But because abiraterone has only been licensed for men with a 'high-volume' of metastasised tumours, there will be some men with advanced prostate cancer who cannot have abiraterone or docetaxel.
Ultimately, we want to see abiraterone's manufacturer and the administrators of the STAMPEDE trial work together to ensure that the license can be extended to all men with newly diagnosed prostate cancer that has metastasised. And we are working with the different parties involved to try and make this happen.
Currently, the manufacturer believes it has a competitive price and is making the case that men should be able to choose between abiraterone and docetaxel chemotherapy. Given the similar outcomes, NICE’s assessment should mainly focus on the comparative side-effects of each treatment and the price. However, NICE have come up with further questions and, in their view, this uncertainty means they are currently unable to determine whether abiraterone is cost-effective, hence their initial recommendation.
This is not the final decision, it does not mean that this treatment will never be available for these men on the NHS and it is not unusual for cancer drugs to initially receive a negative recommendation from NICE. In the not too distant future, research will give us a better understanding of exactly which men will benefit more from either docetaxel or abiraterone. We will also know if abiraterone and docetaxel taken together can provide even more benefit for men.
Until then, and because we currently don't know which of these treatments is better, we will continue to lobby NICE, the manufacturer and NHS England to ensure that – at the very least – all men with newly diagnosed metastatic prostate cancer who cannot have chemotherapy can have abiraterone made available to them.