23 Jul 2014

The National Institute for Health and Care Excellence (NICE) has decided that the new drug enzalutamide can be prescribed on the NHS for men in England and Wales with advanced prostate cancer who’ve already been treated with chemotherapy.

This is great news for some men but unfortunately it doesn't mean that all men who might benefit from it will be able to get hold of it. This is because NICE hasn't given any guidance on whether or not men can have this medicine if they've already had another drug called abiraterone - leaving it up to health boards to decide whether or not they will fund enzalutamide for these men.

NICE published a draft of this decision back in May and at first we were cautiously optimistic because, after intense campaigning by us and 12,500 of our supporters, NICE had actually removed their recommendation that said enzalutamide couldn't be used after abiraterone.

At the time we didn’t know what this would mean in practice - but now we have a much better idea and it isn't great news for everyone.

What does this decision mean for men?

NICE’s decision has the potential to affect men in England, Wales and Northern Ireland

In England, now that NICE has issued its final guidance on the use of enzalutamide, men with advanced prostate cancer can have it if they've already tried the chemotherapy drug docetaxel.

However, it's been left it up to health board NHS England to decide whether men who've already had a different drug called abiraterone can have enzalutamide as well. And NHS England has decided that they can't.

So, for those men in England who have already tried abiraterone and were desperately hoping that enzalutamide would give them precious extra time, NICE's decision is shutting a door in their faces.

In Northern Ireland and Wales it’s not clear yet which men will be able to have enzalutamide. We have written to The All Wales Medicines Strategy Group in Wales and The Department of Health, Social Services and Public Safety in Northern Ireland to find out what this decision will mean for men in their areas.

Why won’t NHS England fund enzalutamide for men who’ve already had abiraterone?

The sticking point over enzalutamide is based around the lack of evidence around it’s ‘sequential use’. This means evidence to show how well one drug works when taken after another.

Because NICE has said that there isn't enough clinical evidence to make a decision about how effective enzalutamide is after abiraterone, NHS England is refusing to fund it.

Not only that but, they are also now refusing to fund abiraterone for men who’ve already had enzalutamide, based on the same argument.

What this means is that NHS England is putting further restrictions on already limited options, rather than allowing doctors to prescribe whatever drugs may benefit to their patients, and without having to worry that they’re closing off future treatment options.

And through not making a clear decision about funding enzalutamide after abiraterone, NICE have left men, for whom abiraterone is no longer working, isolated and unprotected by any form of guidance.

So what evidence is lacking?

Because abiraterone and enzalutamide are both relatively new treatments, we just don’t know yet whether the order in which they are used makes a difference to how well they work.

Astellas and Janssen, the companies that make these drugs, are working together to design a large clinical trial to find this out. But this will take years and will be too late for those men who need enzalutamide now but won't be able to get it because they've already had abiraterone.

These men didn’t have the chance to try enzalutamide, which may have worked better for them. And thanks to NICE and NHS England, they are still being denied that chance.  

The last remaining hope for these men is the Cancer Drugs Fund, which is due to make its decision about whether or not they will fund enzalutamide after abiraterone and vice versa any day now, and we urge them to make the right decision for men.

What next?

Read the latest on the availability of enzalutamide and abiraterone.

And if you have any questions about prostate cancer, what to talk about what treatments may be suitable for you or you want to find out more about taking part in a clinical trial, please call our Specialist Nurses on 0800 0748383.

And for men based in Scotland...

The NICE decision doesn’t directly affect men in Scotland.

The Scottish Medicines Consortium (SMC) has already approved both enzalutamide and abiraterone after chemotherapy on NHS Scotland without restrictions, which means that men should have access to enzalutamide even after abiraterone.

Unfortunately, this doesn’t seem to be true for all men in Scotland, because of regional protocols that contradict the SMC guidance. We are raising this issue with Cancer Networks, the Scottish Government and the SMC.

If you are experiencing difficulty in accessing enzalutamide in Scotland please let us know by emailing campaigns@prostatecanceruk.org or by calling 0141 314 0050

comments powered by Disqus