by Sophie Lutter

Sophie asks what this changes for men and examines the Catch-22 situation at the heart of our drug appraisal system, which means new and effective drugs don’t always reach the men who need them.

9 Dec 2014

Yesterday (December 8) the European Medicines Agency (EMA) licensed enzalutamide, a life-extending cancer drug, for men with advanced prostate cancer that is no longer responding to hormone therapy, and who haven’t yet had chemotherapy.

Before enzalutamide can become generally available on the NHS it will still have to be appraised by the National Institute for Health and Care Excellence (NICE) and the Scottish Medicines Consortium (SMC) for use before chemotherapy. But this is an important first step.

But can’t some men already get enzalutamide before chemotherapy?

Yes, they can. And that’s what really sticks out about this story. Normally men can’t access new drugs before the EMA has granted a license for that particular use. However, enzalutamide is already available via the Cancer Drugs Fund in England and the Peer Approved Clinical System in Scotland. (This was only possible because doctors are allowed to prescribe drugs that have been licensed by the EMA for a different purpose – in the case of enzalutamide, it already had a license for use for advanced prostate cancer after chemotherapy.) And since it was first included on the Cancer Drugs Fund list only five short months ago (after overwhelmingly positive clinical trial results), 82 men have already received this treatment.

This is proof positive that effective drugs can be made available to men earlier in the approval and licensing process. This has had the double benefit of getting men in England and Scotland access to much needed treatments as soon as possible, and of giving additional real-world evidence of how well the drug is working.

Which came first, chicken or egg?

As we know from NICE’s recent decision not to make abiraterone routinely available on the NHS before chemotherapy, drug appraisal bodies demand a lot of evidence before they decide that a drug works well enough to be worth its price tag. But not all of that evidence can come until the drug’s already in use.

This classic Catch-22 may sound like the start of a bad ‘chicken or egg’ joke, but it’s no laughing matter. It means that new and effective drugs don’t always reach the men who need them. But in this case, because men are already being treated with enzalutamide before chemotherapy, we now have real-world evidence of how well it works. So it’s good news that this is next up on NICE’s agenda, and we hope that the SMC won’t be far behind. It’s high time that enzalutamide became generally available on the NHS before chemotherapy so that men across the UK can have access to this important treatment option.

What we had to say about this

Owen Sharp, Chief Executive of Prostate Cancer UK said: “Enzalutamide is a highly effective drug which we know can give men with advanced prostate cancer the extra quality time they need. Making it available for use before chemotherapy is a no brainer. We hope today’s announcement that enzalutamide is now licensed for use in this way means we can finally see it appraised to become routinely available on the NHS.

“Enzalutamide was already being made available to some patients pre-chemotherapy before receiving its license. This has been via the Cancer Drugs Fund in England and the Peer Approved Clinical System in Scotland. This early access means that there is now real-world evidence of the drug’s effectiveness, leaving NICE and the Scottish Medicines Consortium with no excuse but to get on with the process of making it more widely available. We also hope that the fact that men have been accessing pre-chemotherapy enzalutamide before it received its license heralds a much needed step change in how a drug’s effectiveness is established, so that we have a faster, more effective appraisal process in the future.”

Next steps

The good news is that we’re not the only ones who feel strongly about this. Last week, MPs debated the issue of access to drugs on the NHS in Parliament, and the question of how to promote earlier access to effective drugs was a big part of their discussion. It was Andrew Lansley, former secretary of state for health, who called the debate and - in a testament to the hard work we’ve been putting in to influence real change for men - he asked us how we thought the current appraisal system affects access to prostate cancer drugs.

It was great to hear that he raised many of our points during the debate and that lots of MPs from different parties agreed with us that it’s time the system changed. One of the changes we want to see is an end to unequal access to drugs across the UK, which happens at least in part because the Cancer Drugs Fund is only available in England. So thank you to Roger Williams MP, whose constituency is in Wales, for raising this question for us.

That’s by no means the end of this story. We’re now working with leading cancer charities to make system changes a reality. It’s time that men had access to the effective drugs they need in a timely and affordable manner.

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