Will the Cabinet Secretary make a statement on the All-Wales Medicines Strategy Group’s decision not to make Avastin, a potentially life-prolonging cancer drug, routinely available on the Welsh NHS? (TAQ0041)

The All Wales Medicines Strategy Group, the AWMSG, has appraised Avastin to treat recurrent or advanced cervical cancer. The AWMSG recommended against its routine use as the evidence for clinical cost-effectiveness was insufficient.

Thank you for that very disappointing answer, I have to say. The All Wales Medicines Strategy Group does estimate that each year around 50 cervical cancer patients in Wales will receive a terminal diagnosis who could require Avastin treatment. But given your endorsement of their recommendation, I find it very hard to understand the process going forward for these patients. Cervical cancer patients will now have to attempt to access this via the independent patient funding request route, which is often an untimely and uncertain process, and I do accept, Cabinet Secretary, that you’ve made great strides to try to solve some of the problems there. But, nonetheless, in 2016 the IPFR annual report stated that an average of just 50 per cent of all cancer drug requests were accepted, so by this estimation potentially half of all of those with advanced stage cervical cancer will not get access to a potentially life-prolonging drug.

What assurances can you give that all cervical cancer patients who need Avastin will be able to access it in a timely manner via IPFR, especially when you remember that time is a luxury that these patients can ill afford? And could you please explain to me why it is the case that the Scottish Medicines Consortium and England’s cancer drugs fund both approved Avastin as a drug routinely accessible within their respective health services, whilst the All Wales Medicines Strategy Group did not? Why is your Government putting female cancer patients in Wales at a distinct disadvantage to English and Scottish patients in the same situation? And finally, Cabinet Secretary, what efforts has your Government made to ensure greater consistency in how clinicians across Wales’s seven health boards will interpret the clinical exceptionality clause when submitting applications via the IPFR? These women are in desperate need, it’s a dreadful disease, it buys them a little time, and they have as much right as their sisters across any of the borders north or to the east of us.

This is a good example of where there are emotionally charged, and understandably so, questions for our national health service to address, and to be properly sensitive and yet robust about our evidence base for actually making choices. And it’s a good example of whether we make choices on an evidence base, about how we use our precious and finite resources, or whether we make choices on a campaign-led basis. The honest truth is that we have an expert group that has reviewed the evidence on a clinical and cost-effectiveness basis, and they have given us their recommendation. If I simply say that I will overturn that in the absence of evidence that it is the right thing to do for the whole service, then I don’t think I’m meeting the responsibilities that I have and I take seriously as Cabinet Secretary for health for the people of Wales.

And, when we look at Scotland, they made a different choice on the evidence presented to them. It’s not for me to try and explain their system. When you speak about England, though, the cancer drugs fund has got a notice of removal around Avastin. So, this is not going to be routinely available at the end of this month in the English system, because NICE do not appraise Avastin as something that’s clinically cost effective for routine use. So, if the evidence changes, and if the price changes along with that, then of course we can look at that again.

We’ve just been through a significant review on the independent patient funding request process, to look again at these questions of how any form of health intervention is looked at to be clinically effective and cost-effective as well. And nobody disagrees that we need that twin approach to how we make decisions for our service. And that is where we need to be. Otherwise, we have a system that will not be affordable and not make good value for precious and significant public funds put in to our health service. The IPFR group review, we said it would be completed by the end of September, all clinicians up to speed and up to date. I have previously committed to providing information to Members on the new way in which that reform process will be working, and I stand by the commitments that I made, to be transparent about information, and to make sure Members are regularly updated on the current and future practice.

This is one of those situations that’s likely to get more and more common, I guess, as treatments that prolong life, rather than cure cancer, get developed, but with a potential for major cost implications. Now, we’ve had concerns, which you know well about, about IPFR and exceptionality, and I certainly look forward to seeing how changes recently announced will improve access. But we’re also concerned about whether the current appraisal processes reflect the changing way that medicines are developed and used in clinical practice. Do you think that the current system is sustainable, or will public concerns—whether those concerns are justified or not—lead to you making changes, do you think?

I’ve not had any serious or significant thought to undo either the NICE appraisal process for us to withdraw from that, or, indeed, to change the way the AWMSG undertake their appraisal process. We have particular different ways to look at orphan and ultra-orphan medications, recognising the rarity of those conditions. And these are incredibly difficult choices. I recognise these are incredibly charged for individuals who have conditions, and are looking for the health service to help prolong their life. I do understand that, and it’s why I recognise these are sensitive and emotionally charged choices to make.

I’m open to other people having a view on how we could look at a different way to have a generally evidence-led process. I certainly wouldn’t say, ‘It’s this far, and no further, and no change ever, ever, ever.’ But, actually, we have a process that is robust, that is respected and accepted by clinicians across the country, and I would need to be persuaded that there is a better way to do that. If there’s evidence available to do that, I’ll happily ensure that it’s looked at, but, again, as politicians, we need to recognise our role and responsibilities within the system, and I won’t put myself in the place of these independent experts who are making choices, based on their expertise, for the good of our whole system. There’s something here about the things that we could and should do as politicians, and equally to recognise that, sometimes, we have to be responsible and not get involved in a campaign that looks like it might be the right thing to do from an emotional point of view, but, actually, we’ll fundamentally undermine parts of the rest of our service for those who need it if we make choices that we know are not sustainable and not based on clinical effectiveness.

Cabinet Secretary, I know that you are aware of my concerns about access to medicines generally, and I’m grateful to you for meeting with me previously to discuss Avastin. And I do understand the difficulties, but I think we also have to recognise that it’s very difficult for people to understand that something can be made available in Scotland, and in England, and not in Wales. I have raised with you previously my concerns about the All Wales Medicines Strategy Group, and the transparency involved, and also the levels of engagement with the drugs manufacturers, which does appear to vary between the different countries in the UK.

So, I would like to ask whether this is something you will take another look at, to check that the AWMSG has done absolutely everything possible to engage with the manufacturer—in this instance, Roche. But you also mentioned price. I would be grateful if you could advise whether there have been any discussions between AWMSG and Roche about obtaining a suitable patient access scheme that would bring down the cost, and enable this to be made available to patients in Wales.

I’m happy to respond to those points now, actually, because in terms of the AWMSG and their transparency, they actually undertake their review meetings in public. People can and do attend. For example, the recent decision where they did not recommend that we take forward PrEP on an all-Wales consistent basis, and we announced a trial, that meeting took place in public and the decisions are published. They are made publicly available. So, this isn’t a committee that meets in secret and keeps its decisions secret either. In terms of this particular issue, on price, yes, there was engagement. Roche offered a patient access scheme, a reduction on the headline price, and it was on that basis that Avastin was then appraised. So, there was engagement through the appraisal process, and equally, after the AWMSG indicated their initial decision, their likely decision, they were given the opportunity to come back and to use the appeal mechanisms that we have, and to date, they’ve chosen not to do so. That’s a choice for them, but they were told at an early stage what the likely choice was going to be. They were given the opportunity to appeal before the choice came to me, after that, but they’ve chosen not to, and that’s a matter for them.

The position in England where the cancer drugs fund has recommended removal, there is a notice of removal, so from October this will not be available in the English system. That’s partly because NICE recommended to the system in England that the evidence wasn’t there that it was clinically effective and cost-effective at the same time. So, in that sense, there’s a consistent approach now being taken. The cancer drugs fund distorted the picture by actually providing medication, providing hope to people, yes, but every independent and objective review said that it was poor value for money, and I think ethically challenged, frankly, and I think ethically outrageous to provide medications that were not effective that gave people the hope and the impression that they would be. We need to stick to a genuine evidence-led system, where we give people realistic points about the efficacy of the treatments available, and we make them available on a much more consistent basis, and that will be the focus of this Government. It’s why, for example, we’ve introduced the new treatment fund.

Thank you, Cabinet Secretary. And the final topical question from Adam Price.