This week, the Government’s Accelerated Access Review – which aims to speed up access to innovative drugs, devices and diagnostics for NHS patients – closed its first round of consultation. Dr Iain Frame, our Director of Research, explains how the STAMPEDE trial shows why accelerated access matters and how he thinks it can be achieved.
As a scientist, I understand the frustration researchers experience when they’ve invested years in a clinical trial that results in a significant clinical benefit, but then it takes a very long-time to reach the patients it was supposed to help – if it ever gets to them at all. But I’m sure that the frustration I and the research community feel must pale into insignificance compared to that of patients and their families.
How many times have you read that the National Institute for Health and Care Excellence (NICE) or the Scottish Medicines Consortium (SMC) has rejected a new treatment because it’s too expensive or the evidence isn’t robust enough to justify the cost? Of course, if the treatment doesn’t work, you would expect regulatory agencies to turn it down. And if the price tag is too high, you’d want them to work with pharmaceutical companies to negotiate on the price. But let’s not forget that not all new treatments and technologies will stretch the NHS’s limited resources.
Pioneering research often shows us new ways to use existing drugs and technologies. This kind of research can benefit thousands of patients at far less cost than it would take to develop and pay for a brand new treatment. So it would make sense for these sorts of developments – innovations that bring real benefits to patients at a price the NHS can afford – to be adopted quickly, wouldn’t it? But they aren’t.
This year, the results of a large UK-led trial called STAMPEDE were revealed to great cheers at the American Society of Clinical Oncology (ASCO) annual meeting – the largest international cancer conference. The results were staggering.
In an age where we’ve learned to talk about new cancer treatments in terms of 'incremental benefit', the researchers showed that men who were newly diagnosed with cancer that had spread outside the prostate and surrounding tissue lived on average for an extra 22 months – just by giving them docetaxel chemotherapy at the same time as, instead of after, hormone therapy. Staggering indeed.
Yet, despite the fact that docetaxel is an off-patent, inexpensive drug, men are still being denied earlier access to this treatment. What’s more, we have no idea just how long it will take for this to change. Results like this don’t come around very often, and we need to make sure that when they do we’re ready to implement them without undue delay. So what’s the hold up?
First, docetaxel is off-patent. This means that no one company owns the right to this drug anymore, which also means that there isn’t any incentive for the original manufacturer to champion its use earlier in the treatment pathway.
Alongside this, and more importantly, the STAMPEDE results haven’t been published in a peer-reviewed journal yet. Although it has been widely talked about and widely praised by leaders in prostate cancer clinical research at conferences, peer-reviewed publication is still the 'gold standard' for assessing and validating scientific evidence. This is what UK health services are waiting for before they implement the findings of this trial.
Unfortunately it takes time for research to get published and we’re certainly not suggesting that we should do away with peer-reviewed publication. We’re working in a number of ways to see if the publication process could be sped up. But there’s also another way forward that could help us get cost-effective treatments with proven clinical benefit to the people who need them.
If we truly want the UK to be at the forefront of medical innovation, shouldn’t we also champion our health services – who are actually leading this type of research – to become early adopters of innovation? In practice this would simply mean health services being aware of the research taking place in their hospitals and engaging with the research teams as soon as early trial evidence indicates promise and cost-effectiveness. This would allow for assessment of any necessary infrastructure and resource changes in advance of results being published.
Forward planning could turn our health services into proactive leaders in innovation, rather than leaving them scrambling to react to old news.
I strongly believe that the docetaxel arm of STAMPEDE can be a trailblazer for a new coordinated forward-planning approach across the UK’s health services. If we get it right, we could see Health Bodies across the UK being able to provide accelerated access to cost-effective and clinically beneficial treatments and technologies.
And what better time than now? The Government’s Accelerated Access Review was set up earlier this year to look at how to speed up access to innovative drugs, devices and diagnostics for NHS patients. The first round of consultation has just closed and we’re excited by the opportunity it provides to get the NHS forward planning in the way we’ve suggested.
This is a golden opportunity to make a real difference, not just for men with prostate cancer, but for everyone in the UK. And there can be no excuse for any of us not to try to make this work.