Will the Cabinet Secretary make a statement on the commercial access deal struck between NHS Wales and Roche, which will mean that breast cancer patients in Wales can access the Kadcyla drug? TAQ(5)0192(HWS)

Thank you for the question. I’m delighted to announce that the commercial access agreement for Kadcyla commenced in Wales today, exactly the same time as in England, and is identical to that negotiated with NHS England. It’s the type of medicine that the £80 million new treatment fund was set up to support.

Thank you, Cabinet Secretary. Your decision to enable access to Kadcyla is a welcome development, and I would like to pay tribute to all the campaigners throughout the UK who have fought for so long to have access to this life-extending drug. This targeted therapy is vital for those who have certain HER2-positive breast cancers, but it originally came with a very high financial cost, and we all recognise that it is incumbent upon the National Institute for Health and Care Excellence to ensure that taxpayers’ investment in modern drug treatments has a measure of cost-effectiveness. Of course, it’s not just about the money, as those who use this drug and want more time with their loved ones will attest.

My understanding is that one of the reasons that Kadcyla was able to gain NICE approval was because of the revised methodology used to compare its efficacy against different combinations of treatment. Are you able to give an insight into the methodology process used by NICE? Is the principle behind the revised methodology process for green-lighting Kadcyla able to be used in connection with other drugs that are currently not available? Orkambi, for example, comes to mind. I appreciate that you will not be able to disclose the detail of the commercial agreement between the Welsh Government and Roche, however I would be interested to know if it is the same deal as the one NHS England secured. Finally, what lessons are we able to take from this in order to exploit new drug therapies to help our sickest people whilst preserving an appropriate margin window for developers and manufacturers and, at the same time, ensuring that taxpayers’ money is spent wisely?

Thank you for the three distinct points of questioning. On the first of understanding whether there’s been a different approach to the technology assessment undertaken by NICE on both the clinical effectiveness but also the cost-effectiveness in terms of improved life outcomes, I couldn’t honestly tell you about the detail of that, although I’ll happily have a conversation with officials and people in the All Wales Medicines Strategy Group to understand whether there was any difference, but I’m certainly not qualified to give you an answer on whether there was a different approach. I’ll happily have a look at the process and the manner in which that’s been undertaken and come back to you.

On the second point, about whether we have the same deal in Wales, yes, we do. We have the same terms applying in Wales at the same time. That’s been a part of that negotiation. I was actually in the audience at the NHS Confederation conference in England when Simon Stevens announced the deal from the stage, which set a few hares running about whether it was an England-only deal or not. So, I’m really happy to have been able to confirm it’s an England and Wales deal, with no differential in terms of the availability of the treatment here in Wales.

Then, for the future, I think this really does tell us something about not just campaigning, but actually about the grown-up relationship we need to have, both with the public and decision makers, but also with the people in the pharmaceutical industry. Because it’s easy to run a campaign based on the emotions of people potentially having a life-extending or a life-saving drug, but as you rightly recognise, there has to be a balance for the public purse and for all of us together about how much we are collectively prepared to pay for individual treatments and to understand the genuine efficacy of those treatments. We’ve seen in the cancer drugs fund, the independent review, that it recognised that of the £1.27 billion, about £1 billion couldn’t really have been said to have been spent on improving outcomes. That’s a poor way to go about this, and I don’t think it’s a great use of public money. So, we do have to understand that a process that is genuine, that is expert and evidence led provides proper reassurance about the value and the efficacy of treatments, and equally that more grown-up conversation throughout the pharmaceutical industries about what they can expect and what the public purse can and will deliver, and that evidence we require on that efficacy and the cost and value of it.

May I welcome this step that’s been taken? The principle is established in terms of this drug. It’s the practicalities that are important to the sufferers of this cancer for which this drug has been designed. So, two simple questions: when, practically speaking, will this drug be available in Wales, and how long will patients have to wait to receive a prescription to access this drug?

And one further question on another drug that Breast Cancer Now has raised concerns about. Whilst welcoming the agreement on Kadcyla, I will quote from Delyth Morgan, the chief executive of Breast Cancer Now:

daw’r newyddion hwn ar adeg pan fo posibilrwydd gwirioneddol y gallai’r defnydd o Perjeta— esgusodwch fi os nad wyf wedi’i ynganu’n gywir— y driniaeth gyntaf ar gyfer y grŵp hwn o gleifion, ddod i ben cyn bo hir yn y GIG, gyda phenderfyniad ar fin digwydd. Mae manteision Perjeta yn eithriadol, yn cynnig bron i 16 mis ychwanegol o fywyd i fenywod â chanser y fron na ellir ei wella, ac mae’n hanfodol ein bod yn dod o hyd i ffordd o achub y cyffur hwn, ar gost sy’n fforddiadwy i’r GIG a’r trethdalwr.

So, whilst we welcome the decision on Kadcyla, can you give us an update on this other drug?

Yes, and the point about Kadcyla is that, initially, the manufacturer had a cost price that was simply too high for the health service to pay, and that was the advice that health Ministers were given. That’s why the drug wasn’t available. There’s now been a reconsideration, and that’s very welcome. But the challenge is for any medication, whether it’s for Perjeta or any other drug, that there’s a balance between effectiveness in clinical terms and the cost-effectiveness of it as well.

In the individual patient funding request process that we collectively agreed to run through, that came out very clearly as a unanimous point from the panel: about not losing sight of the fact that there is a cost to this. Every penny we spend on one particular treatment is a penny and a pound that we don’t spend on other treatments as well. So, that balance has to be maintained, and I would again encourage manufacturers to get involved at an early point to discuss the effectiveness and the cost-effectiveness of their treatments. What that means is them having genuine access to the service to actually understand more about the development of the treatment as well as more people taking it, because otherwise we’ll continue to have these emotionally driven campaigns about people who think that a drug may offer them a chance to extend life or to save life. But all of our understanding is that, actually, you can’t simply pay any price for any treatment. That’s really difficult, when you look someone in the eye and say, ‘I think that this potential treatment that you want to have is too expensive’, but if we don’t do that, then our service becomes unaffordable. If we’re not prepared to do that, potentially we risk the whole service that does so much good and so much positively as well. So, if we can’t hold the line about having an evidence-led approach to this, then I think we actually risk and undermine the whole service. That’s a difficult point, but I think it’s absolutely the right one and it’s certainly the unanimous view of the IPFR panel in the recent reports to all of us in the last few months.

Thank you to my colleague Angela Burns for bringing forward this important topic. Cabinet Secretary, the deal between NHS Wales and Roche is terrific news for breast cancer sufferers in Wales and a perfect example of what we can achieve when we work in conjunction with the pharmaceutical industry. This deal and the new treatments fund means that women with HER2 positive tumours can gain a few valuable extra months of life and avoid the issue we had Herceptin. These new innovative treatments are targeted at relatively small cohorts, and are much more expensive. What is the Welsh Government doing to ensure we are aware of drugs in the pipeline? And will you work with your colleagues in England, Scotland and Northern Ireland to achieve commercial access deals on other initiative treatments in future?

Yes, I’m happy to respond. Of course, this particular drug has an average six months of extra life, and it’s about the value and the cost of that. Again, these are really difficult assessments to make, which is why, frankly, politicians are often the worst people to try and make that assessment. However, on the broader point about the understanding of what is in the pipeline, I’ve actually had, in recent months, a very sensible conversation with the Association of the British Pharmaceutical Industry and their Wales rep board member, who happens to work for Roche, which is a matter of coincidence, about the manner in which we have conversations as drugs are being developed, and at what point in time the pharmaceutical industry can have that conversation with governments and with appraisal bodies. Because the sooner you know something’s potentially available, the earlier you are able to plan.

Actually, that sort of grown-up approach is really important for us, because the NHS has to be able to try and budget for new treatments coming on board. It has to be able to try and plan the infrastructure around those as well, which is often more important than the cost of paying the medication costs. It’s then also about the industry understanding that it has an interest in being open at a slightly earlier stage with us about what is coming down the line. Otherwise we’ll end up having these sorts of fights on a basis that isn’t good for them as an industry partner, isn’t good for the health service, but ultimately isn’t good for the individual citizens who are then caught up in a campaign between different parts of the public sector and the industry, who are trying to offer a treatment that they are saying will provide a real benefit for them.

So, I’m optimistic that we are continuing to have that grown-up and necessary conversation about the way in which we work together and to understand our competing interests. I don’t try to say to the pharmaceutical industry that they should not be entitled to make a profit in the way they run their business and what they put into developing new treatments, but it has to come at a price that is affordable for the taxpayer and with real value in terms of improving outcomes for the individual citizen as well.

Thank you, Cabinet Secretary.