So we hope you share our delight over this morning’s news, that NICE and pharma company Janssen have finally reached an agreement, and the drug will now be available to suitable men on the NHS in England, Wales and Northern Ireland.
NICE say they were able to reach their decision after Janssen gave them additional data about the number of men the drug will be suitable for, which men it will benefit most, and – crucially – offered the NHS a better deal on the drug’s price.
This is fantastic news.
All suitable men in these three countries will be now able to easily access the drug, which can dramatically improve quality of life, and offers men with advanced prostate cancer extra time with their families and friends.
But let’s be clear. Abiraterone was licensed in the EU in September 2011. It is now May 2012. In the eight months it took for the regulatory horse-trading to run its course, depending on where they live, some men with advanced prostate cancer in the UK have been able to get it easily, whereas others have had to get their doctors to apply for access on an individual basis.
On top of this, since the Scottish NHS has a separate system, until we hear the results of an appeal, Scottish doctors continue to have to jump through similar bureaucratic hoops to get the drug for their patients.
So our joy is tempered with yet more frustration that, despite recent political focus, the UK’s drug approval systems still aren’t working nearly as efficiently as they should.
And while the high cost of new drugs is a fundamental issue here, we also need reform, so that the UK’s cancer patients aren’t left stranded and without options available to their counterparts in other countries.
Abiraterone – a homegrown success story
In the past, we’ve devoted a considerable amount of space to our involvement in abiraterone’s development, so we won’t labour the point – but here’s a very quick recap for new readers.
Abiraterone was developed as a result of fundamental lab research that took place at The Institute of Cancer Research in the 1980s, which we helped fund.
This led to the development of a chemical that could, with exquisite precision, stop a man’s body from producing testosterone – a hormone that can fuel prostate cancer’s growth.
The chemical was developed into a drug by Cancer Research UK scientists, and we helped support the first-in-man trials that showed such initial promise. From there, the rights to develop the drug were licensed to the pharma industry (which has the financial firepower to run the large trials necessary to prove a drug’s effectiveness and safety).
And Janssen pharmaceuticals then took the drug all the way to market, driven by the researchers and doctors at The Institute of Cancer Research.
This part of the story is as clear-cut an example as you could wish for of how basic molecular studies, followed by collaborations between researchers, doctors and industry, can lead to drugs that can transform lives. It’s a story we hope will inspire people to continue to support medical research charities like Cancer Research UK.
Hitting the buffers
But – as is the case with drug approval in general in UK – the story began to get more complex.
Shortly after Janssen were given a license to sell the drug in Europe, eligible patients in England began to receive the drug if their local NHS trust had decided to pay for it under England’s Cancer Drugs Fund – a scheme set up by the coalition government to fast-track drugs to patients.
But patients in Wales, Northern Ireland and Scotland faced a more difficult situation.
Wales and Northern Ireland aren’t covered by the Fund, so while NICE assessed the drug’s cost-effectiveness, patients in these countries had to apply individually through so-called ‘exceptional case committees’ in order to get it.
And men in Scotland had to do similar, while they waited for their own country’s body – the Scottish Medicines Consortium – to reach a decision too.
Being told by your doctor that he or she has to ‘apply’ to get a treatment that could help you, must be the last thing a man with advanced prostate cancer wants to hear.
In February, NICE announced that they were minded to reject the drug on cost grounds unless more data were forthcoming, or a better price was offered.
But they failed to use their own, more lenient ‘end-of-life’ criteria to assess the drug (which allow a higher price to be accepted) – something we said at the time made ‘no sense’. And so we had to wait for their final decision, in the hope that they’d be able to strike a deal with Janssen.
Just a few days later, in a decision that surprised many, Wales’s drug approval body, the All Wales Medicines Strategy Group decided to give abiraterone the green light, having used the ‘end-of-life’ criteria – a decision that could only be overturned by a final ‘no’ from NICE.
But a month later, Scotland said the opposite – they didn’t think the drug was cost-effective – a decision that is currently open to consultation (a final decision is expected in September, according to the Daily Express).
This left a ridiculous situation. By March this year, eligible English prostate cancer patients had had access to the drug since December, but through a temporary and finite pot of money (the Cancer Drugs Fund).
All eligible men in Wales were now getting the drug on the NHS, but this situation was temporary, and could change if NICE said ‘no’.
But no-one in Scotland or Northern Ireland was able to receive abiraterone routinely on the NHS – they had to apply for it individually.
And so to today’s news. Janssen ultimately decided they were able to lower their price further, NICE decided to use their end-of-life criteria, and as of today the drug is now available on the English, Welsh and Northern Irish NHS.
If you’ve managed to make sense of all of that on first reading – well done. It truly is a complex and frustrating situation. But what next? This debacle highlights two key issues – process and price.
Firstly, process. We need to re-think how the drug approval systems work together across the UK.
The Cancer Drugs Fund in England is a welcome sticking-plaster – it gets new drugs to patients that need them, but it can throw up regional disparities. We need the Department of Health to ‘show its working’ on the new proposed system – Value-Based Pricing – so that the medical community can begin to help build something we hope will be better, fairer, and more transparent.
We also need to see urgent progress on an ‘early access’ scheme, promised in the Government’s life sciences strategy late last year. The idea is that where treatments show exceptional promise in early clinical trials, patients (under very close supervision) get early access to them.
This could benefit both patients and drug developers. Many cancer patients would be willing to try experimental treatments showing early promise where there are no alternatives. For the pharmaceutical companies, this scheme means speeding up the time it takes to get drugs to market, while collecting valuable ‘real world data’ about their effects.
We also need to make sure that the reorganisations taking place in the NHS are used to improve the drug approval process, rather than make it even more complex.
Secondly, price. We fully appreciate that the pharmaceutical industry is facing considerable pressures, and not just from the current global financial crisis. As this must-read piece in the Financial Times outlines, as its patents expire, the pharma industry – a vital and necessary part of the drug development pathway – is facing a huge squeeze on its future profits.
But the financial crisis affects all of us, including governments and healthcare services. We need industry to be much more flexible and forthcoming in setting prices that governments can afford, particularly as populations age and diseases like cancer become more common.
We simply can’t afford to go on like this.
The story of abiraterone is, at its heart, a motivating, inspirational success story – and one day, it will likely be regarded as a turning point in the fight against prostate cancer. We are genuinely proud to see a drug that we helped develop being released, so to speak, into the wild.
But today, the story of the drug’s emergence leaves us here at Cancer Research UK with our pride tinged with frustration.
The British public supports medical research to a phenomenal degree, donating over £1bn to UK medical research charities every year. And around the UK, our researchers continue to make serious inroads in understanding cancer’s inner workings, and in translating that knowledge into treatments that can bring real benefits to patients.
So we worry when stories like abiraterone, which should be about scientific success and medical breakthrough, lead to headlines about financial constraints, red tape, and missed opportunities.
All of us – governments, funders, regulators and pharma companies – owe it to cancer patients, charity supporters and the wider public, to do better next time.