I thank the Cabinet Secretary. We now move to the next item on our agenda, a statement by the Cabinet Secretary for Health, Well-being and Sport on the establishment of the new treatment fund and the independent review of the individual patient funding request process. To make the statement, I call on the Cabinet Secretary, Vaughan Gething.

At the Plenary session on 12 July, I set out my plans for establishing a new treatment fund and undertaking a sharply-focused, independent review of the individual patient funding request process, commonly known as IPFR. I am pleased to have this opportunity to provide Assembly Members and the people of Wales with an update on the progress that we have made over the summer.

I’ll begin with the new treatment fund. Work is progressing well to set up the fund, which will make £80 million available over the life of this Government. It will provide these extra funds for new medicines that represent a significant advance in treatment for life-limiting and life-threatening diseases. The fund will support the introduction of medicines that fit these criteria that are recommended by the National Institute for Health and Care Excellence, known as NICE, or the All Wales Medicines Strategy Group, the AWMSG. I expect this additional financial support will be for up to 12 months, giving health boards time to factor in future spending from within their budgets.

We rely on the expertise of NICE and the AWMSG to assess the effectiveness of a new medicine, taking account of clinical opinion and the patient perspective. Both of these highly-respected organisations base their recommendations on the most up-to-date evidence. Basing our access to new medicines policy on the authoritative guidance of NICE and AWMSG reduces the risk of inequalities and variation in access. It will ensure patients across Wales receive treatments proven to be clinically effective, with a price in balance with the benefits. The new treatment fund will support our evidence-based approach, providing health boards with additional funding to ensure innovative, new medicines are introduced as quickly as possible. Options for the operational set-up of the fund are being developed and we are on target to establish the fund by December this year. I will, of course, make a further, detailed announcement later in the year.

Turning to the review of the IPFR process, there is a good deal to report. The NHS Wales IPFR process is the mechanism used by all health boards across Wales to make a decision at an individual patient level on access to a treatment not routinely available. Following the 2014 IPFR review and the implementation of its recommendations, I agreed the time was right for a new, independent review of the IPFR process. This will concentrate on the number of panels, the clinical exceptionality criteria, and take account of the patient’s perspective.

I am pleased to announce today the membership of the group that will take forward the review. Mr Andrew Blakeman will chair the review group. Mr Blakeman is a chartered accountant and has worked for BP for over 20 years in a variety of senior financial roles. He will bring a solid customer-focused background to the work of the group. There are five more members comprising the rest of the group. Mr Irfon Williams is a retired senior nurse, who will provide the review with valuable insight based on his recent experience of the IPFR process. Professor Peter Littlejohns is an independent medical academic and professor of public health, being an honorary consultant at King’s College London. Professor Littlejohns has extensive experience and understanding of the medicines appraisal process and the equity issues arising out of treatment decisions. Professor Phil Routledge is a former chair of the AWMSG and director of the All Wales Therapeutics and Toxicology Centre; that is the executive arm of AWMSG. The review group will benefit from his extensive experience of the medicines agenda in Wales, and the ethical and safety considerations associated with access to new medicines. Dr Ben Thomas is a consultant nephrologist and will provide expert input into medical ethics and law. Professor Chris Newdick is a barrister and professor of health law at the University of Reading. His special interests are the rights and duties arising within the NHS, including medical ethics and prioritisation.

So, I hope Members will see that, from its membership, the group is independent of Welsh Government and comprises a range of relevant expertise and knowledge. I want to reassure Assembly Members that the review group will have sole responsibility for the content of their report, their findings and their recommendations. I’ve circulated a short note detailing their biographies and the terms of reference I agreed with opposition health party spokespeople. I would also like to take this opportunity of thanking the review group members for agreeing to give us their expertise and time to undertake this challenging work.

In broad terms, the review group will examine the evidence of current good practice in Wales, the UK and elsewhere for making individual funding decisions on treatments that are not routinely available. It will consider the advantages and disadvantages of retaining eight IPFR panels or moving to a smaller number, including the possibility of a national IPFR panel. The review group will examine the criteria that an IPFR panel will use to make their decisions, including clinical exceptionality. It will consider options for improving how the IPFR process and subsequent decisions are communicated to patients. The end result will be a report with practical recommendations for next steps.

Assembly Members will know from my earlier announcement in July that I want this review to be sharply focused. I have therefore asked the group to work towards producing their report by end of this calendar year, and I will, of course, keep Members updated. Last week I met with Andrew Blakeman, and he also took the opportunity to brief personally the health opposition spokespeople and other parties, reassuring them of the independence of the review and how he intends to ensure patient views are fully reflected during the process.

The Deputy Presiding Officer (Ann Jones) took the Chair.

The review group have begun their work and will meet for the first time together on 6 October. I will publish the report and announce actions arising from the review group’s recommendations early in the new year. Taken together, the new treatment fund and the review of the IPFR process will lead to a real change in how patients in Wales gain access to innovative medicines, and I expect a real improvement in the service that patients rightly expect from the NHS here in Wales.

May I welcome this statement? We are talking here about two elements of weaknesses in health provision, which at the moment do lead to frustration among patients and their families, and where there is a real feeling that there is some unfairness in the system. I will first of all cover the announcement of the independent review of the IPFR. We in Plaid Cymru certainly felt strongly that it was time to review this area, that it was an area where a solution was required, a sustainable solution was required. I was pleased that we had been able to include the pledge to go ahead with this review in our post-election agreements, and I’ve been pleased to be able to work with the Cabinet Secretary to ensure that we do make progress in this area.

It is not fair that consent can be given in one geographical area of Wales whilst it is not given for treatment in another part of Wales. The process of exceptionality isn’t fair. Too many seriously-ill people have had to fight bureaucratic battles when clinical issues and the individual’s well-being should have been the priority in taking any decision. Now, of course, I don’t need to continue to make this case, because we do now have this independent review.

I was very pleased to have an opportunity to meet with Andrew Blakeman. I was certainly convinced that he would be entirely independent in undertaking this work. I wish him well. He will have to do this work in a very brief period of time, and I know that will be a challenge. I do wish the other members of the panel well also. May I particularly welcome the involvement of Mr Irfon Williams, who is going to be a member of this panel? I was very eager to see that happen. He brings professional experience within the health service, of course, but he will also ensure that there is a patient voice in this process, as someone who has been through the process and has felt these frustrations himself.

Now, in terms of the new treatment fund, we and the party of Government here have had some sort of fund as an objective in our manifestos, and I’m pleased that we’ve been able to move towards a statement in this area. There are few references in this statement today from the Cabinet Secretary to that new fund, and I think that reflects the fact that there is some work still to be done in deciding on a few practical elements of how this is to be implemented. The Cabinet Secretary admits that in his statement, but he does set out a tight timetable.

So, the few questions that I have relate to the decision that will need to be taken in terms of this new treatment fund over the next few months. Will there be a brief consultation during that window, as we work on the details? Can we be given an assurance that data will be released in full in terms of how the new system would be used? What process will be in place to ensure that local health boards do actually adhere to what is expected of them, according to the Act, to fund treatments that have been approved by NICE, once they cease to be new treatments? That is an important point. Also, NICE, these days, not only can approve or reject treatments; they can say ‘maybe’. What will the Welsh Government’s attitude be towards NICE’s decisions that are in that ‘maybe’ category?

Thank you for the questions. I want to begin by welcoming the constructive conversation, both with Rhun and with other opposition health spokespeople, up to this point, on the terms of reference of the review. I hope that other opposition spokespeople found it useful to meet Mr Blakeman as the chair of the review group. I think we have an excellent appointment, not just of the chair, but of the whole group. I look forward to receiving their work.

Just a point on Irfon Williams and the patient voice. We wanted to make sure that membership reflected that for the review group, but equally—to be really clear—this isn’t just that Irfon Williams is on the group, and therefore the patient voice is sorted. There is a recognition that, in the way that they conduct the evidence, and the way that they listen to people, they need to talk to both the wider third sector and with a range of campaign groups who can help to give a patient’s perspective, but equally to look directly to some patients who have been through the process—both those who have had successful applications, but equally to those who have not as well. It’s important that they get some direct experience from a wider group of people. I’m pleased to see that that is going to be taken on board in the way that they conduct their work.

On the new treatment fund, as you’re aware, it’s a manifesto pledge that is being implemented. I will update Assembly Members on the detail of how we expect that to work, and the criterion that will be used. When it comes to the attitude of this Government, if health boards take the money but don’t want to ensure that access is provided, well, then they won’t get the money. It’s very simple. The money will be provided for particular drugs to be made available, and we expect them to be made available. The whole point about this is to make sure that there is an evidence base for the effectiveness of medication, to make sure that, once there is approval for them, within a limited period of time, it is available consistently across Wales. Because we recognise that there is, sometimes, an inequity in having medications available in different health boards and the way they are able to manage their position. It’s also important to make sure that that innovation and that evidence base is available on an equitable basis across the country. I think, when we get to announcing how the fund will work—the practical detail of it, and its implementation by the end of this year—I think a range of the questions you have will be satisfied.

On the point about ‘maybe’ drugs, there’s a challenge in England about looking at the cancer drugs fund, which has come to an end after fairly universal criticism, at the end of it, about its value for money and the equity that it provided. The Public Accounts Committee in the House of Commons said that there was no evidence of improved patient outcomes. Well, there’s a different approach that they’re looking to take, but there’s still a challenge of working that through practically, because with the idea of having a ‘maybe’ category, or a ‘promising’ category of drugs, NICE need to be able to work through and understand what that is. There has to be some clarity around that so that NICE understand what they’re working to, and equally, then, the public. To be fair, the industry that will want to come to NICE for appraisals of new medicines need to understand what their category might mean as well. As there is clarity around that, we need to then understand what we want to do here in Wales as well, rather than inventing a new category ourselves. I don’t think that that’s very helpful. What I will say is that, just as with the cancer drugs fund, we took, I think, the principled and correct view that it was unethical to say that cancer patients—that their lives were of greater value than other patients in the national health service and in this country. We will not proceed down the route of wanting to advantage a particular cohort of conditions. It must be a properly equitable access to new and innovative medication and we want to be able to make sure that there is a proper evidence base for that. That will continue to be the approach that this Government takes.

Minister, thank you for this statement. I’m very pleased to welcome both elements of it on behalf of the Welsh Conservatives. I do have a couple of questions to ask, though, and I’d like to turn in the first instance to the new treatment fund that you speak of here. You have said previously that the new treatment fund has been developed from Welsh Government experiences of managing high-cost treatments. Last year, for example, Welsh Government funded four new treatments for hepatitis C and a rare genetic disease, atypical hemolytic uremic syndrome. I’m so glad I got that out. Those were just going to be funded by Welsh Government. Can you confirm, in light of your treatment fund, that those particular four new treatments—all high-cost and innovative—have now all been absorbed by the health boards? The reason I ask this is that all my questions do revolve around the funding issue, because I have a bit of concern, given the £75.5 million deficit that we have throughout the joint health boards, as to whether they’re going to be able to absorb the cost of these without Welsh Government funding.

Now, you answered Rhun’s question by saying that you would be seeking for them to do that, but what I wasn’t clear on is: once you’ve withdrawn the funding for a drug, you will expect the health board to pick up that cost. You mention in other evidence that you’ve given on this subject that you would expect the health board to follow the Welsh Government priorities. What would happen if a health board said, ‘Yes, that is a good drug, yes, we’ve had it for a year, yes, it has been effective in some areas, but we can’t afford to prioritise that in the way that you would wish it to be prioritised’? You were funding it when you were funding it, and it was fine, but you’re now no longer funding it. Therefore, it’s become a financial cost to the health board. Will you either be giving them additional funding—and that’s what I couldn’t quite work out from your answer to Rhun—or will you be issuing a very strict set of guidelines that say, ‘Now that this new drug has been trialled by us, has been accepted by us, has been part of the new treatment fund, and is now going to go into mainstream’—although, obviously, rare use, because otherwise it wouldn’t be in this fund—‘you have simply got to find the money for it yourself and prioritise it’. Some clarity there would be really helpful. I’ve used the previous treatments that you funded last year for the hepatitis C and aHUS to understand where they’ve gone. Have they been absorbed by the health boards? Will they still be in the new treatment fund? Will some drugs always be in the new treatment fund for funding, because they are so rare and/or so expensive, even though they do have a good outcome? Will Welsh Government always be putting forward some money, or do you actually see that £80 million being redeployed every year, year after year, on completely different drugs?

Finally, my final question on the new treatment fund is that, when you are looking at using that £80 million, will you be looking at any weighting between the health boards? So again, I’m not quite clear whether the funding will go to the health boards for the new drugs, or whether you will only give the money to the health boards once they’ve used the drugs. Because I would suspect that some health boards, particularly those such as Cardiff and Vale, where they hold more of the rare and specialised clinics, will end up dishing out those drugs and authorising those drugs far more than, perhaps, Withybush hospital in my patch, because they don’t have the very rare and unusual clinics. I’m just trying to understand where the responsibility for that money will lie. Will there be any weighting amongst the health boards on the use of that?

Turning to the independent patient funding programme, I’m really delighted about this. Do you know, First Minister—Cabinet Secretary—

Member of the Senedd:

Not yet.

Not yet. Probably shortly, but not quite yet. I’m really pleased by the way you’ve set this up. We’ve had a number of conversations, with Rhun, with Caroline, between us. I’m really pleased with the collaborative manner in which you’ve approached this. I’m really pleased that we’ve been involved. But above all, I’m really pleased about two things. One is the absolute independence of the chair, and the fact that the chair has got commercial experience of running a people-centred organisation, and has not just come out from our small pool of talent within Wales, because we do need fresh ideas, fresh blood and a fresh perspective, and that individual certainly brings that to the party.

The second thing that I’m exceptionally pleased to hear is that you are making the patient voice an overarching theme for this review. Because, at the end of the day, this is all about the patient. They are first, second and last in this. And I’m very, very pleased to hear that they are going to be the overarching theme—it’s not just going to be the members of the panel, but all of the evidence that you take. So, absolutely, hats off to you. Congratulations. I’m really pleased about that.

I was delighted to meet Andrew Blakeman and we had a very useful conversation. There was only one question I asked him that he wasn’t clear on. I’ve asked him to go back and check the remit with you. It comes from some of the cases that I have dealt with in my constituency, and that is over whether or not he’ll be looking at the issue of co-funding. It’s a very difficult issue. It can be very contentious. But, some of the times, when I’ve dealt with patients who’ve been desperate to try to access a drug that they haven’t been able to access—and they want to go through the independent patient system that we have now—when they’ve had a no, they’ve sometimes asked, then, if they can go off and do other types of funding. All I wanted to know was whether or not he’s going to look at it. I suspect not, which is fine, but I just wanted that clarity, because I pointed out to him that that is going to be one of the outcomes that comes out of this whole process and will eventually have to be an area where you as Welsh Government and the NHS are going to have to make some kind of very clear line so that patients know exactly where they are.

Are you coming to the end?

I certainly am. My final comment to him was that I will, certainly—and it may be something other Assembly Members may wish to bear in mind—be furnishing him with a number of case studies, because I think that will be another way of getting the patient voice to be heard loud and clear.

Thank you for the comments and the questions. I’ll try and deal relatively briefly with them. On the new treatment fund, then, if you like, the predecessor to this will help to inform where we are on hepatitis C and a range of other conditions where we’ve provided significant resources to make sure they’re available on a consistent basis. It is for the initial year, as I said before and in this statement, and we expect health boards to be able to resolve and to manage their resources thereafter. It is often the first year of a new medication coming on board that is difficult for a health board to manage and to budget for. So, it is based on our practical experience. I don’t actually think that the challenges of keeping the NHS to budget can all be laid at the door of the cost of innovative medications that are approved by NICE or the AWMSG.

That’s the second point, about this being an evidence-led process. So, it won’t simply be that, at the end of the first year, I will decide, or a health board will decide, that we actually don’t want to provide this medication any more. It will be there, it will be available. Politicians won’t decide on its effectiveness—it will come from an authoritative review from NICE or the AWMSG. That’s the point about the medication then being available.

On the money, we’re targeting at need. So, you’re right that some health boards will prescribe or deliver or lead on the treatment of a range of conditions, and tertiary centres will have a different experience of that than others. It’s really about making sure that the patient—the citizen—gains the benefit. I hope that’s helpful.

I welcome your comments about both the review group and the patient voice. I’m pleased to hear that you found the meeting with Mr Blakeman useful in giving you some confidence about the expertise and independence of this particular group and making sure the patient voice is heard loud and clear through the process and, indeed, the contact that the review group will have with Members as part of that as well.

On your point about co-funding, it is not part of the terms of reference we agreed with the group. I think there’s a broader question there. There’s more than just the IPFR about co-funding. I think it is ethically incredibly difficult to go down that route. I’ve not asked the review group to look at that. It’s not been part of the conversation that we’ve had and I don’t think I should try and introduce it after the conversations that we have had. I think it’d be the wrong thing to do. I think it is definitely a debate for another time and another day.

Thank you for your statement, Cabinet Secretary, on the new treatment fund. We look forward to receiving more concrete details in the future. Your statement mentions that the fund will provide extra funds for new medicines, but can you confirm it will also fund new treatments, for example proton beam therapy? My question on co-funding has already been answered, so I’ll move on. Moving on to the independent review of the IPFR process, I would like to thank you for the inclusive way you have approached the IPFR review. It is refreshing that you have approached the IPFR review process in a non-partisan way, and panel appointments reassure me that this will be a truly independent review.

It was a pleasure to meet Andrew Blakeman last week, and I would like to thank you also for facilitating that meeting. Mr Blakeman is an excellent choice as chair of the review panel, and he has assured me that this review will achieve what many previous ones have not, namely putting in place a process whereby patients can receive the best available treatment based on clinical needs. We have had reviews in the past, but nothing much has changed. But this time, I believe the panel has the expertise, and, more importantly, with the inclusion of Irfon Williams, the experience truly to understand the failings of the current system, and the ability to deliver suggestions on how we can reform the system.

Thankfully, Cabinet Secretary, Andrew Blakeman answered most of my questions last week. I would just like to put on record my thanks, once again, for the way you’re handling this review. I look forward to working with you to implement the review’s recommendations. Far too many are, often, let down by the IPFR process, and we must ensure that we have a system in place that works for patients and clinicians. I look forward to being a part of this. Thank you.

Thank you for those comments. Again, I am pleased that each of the spokespeople have felt able to come into the Chamber and talk about the way in which we’ve approached this issue and welcome the membership of the group. I look forward to them all being equally positive when they provide their recommendations. Although we may have different issues to deal with at times, we actually have to make choices, because this isn’t an easy area. It’s what the previous review group found as well in 2014—a range of their recommendations at the time has been implemented. There has been real progress made, but there are still real challenges, which is why we are now looking at this again, and I’m pleased that we’re doing so.

On your points about wider access to non-medicine technologies, I’m pleased to confirm that there is a new hub that is being developed to be based at Velindre NHS Trust, which will deliver a strategic and national approach to identify, appraise and then adopt new technologies into health and care settings. So, this work is not proceeding on its own. On proton beam therapy, we’re actively looking at what we can do to increase capacity and make it more localised here in Wales, and, in fact, at investment the Welsh Government is making within the private sector to make that happen.

Thank you very much. Finally, David Rees.

Diolch, Ddirprwy Lywydd. Can I thank the Cabinet Secretary for his statement this afternoon? I very much appreciate the effort that’s gone into this. In the fourth Assembly, the Health and Social Care Committee looked at the cancer delivery plan, and one of the recommendations was that we needed a review of the IPFR process, with a view that, perhaps, we would have a single panel to look at the consistency better across Wales. So, I very much appreciate that that’s coming through.

A couple of quick points—I’m very pleased you answered the previous question on treatment, because I notice that the statement focuses very much on medicines and not on treatments, and we talk about treatments very much. I know you believe in treatments, Cabinet Secretary, but it is important that we get that message to the public.

One of the issues I have is the need to actually communicate with the consultants. I notice in your—. It’s in your remit, in a sense. I have constituents who are desperate for some medication, and they come and say that the consultant has said, ‘We need to apply for this, but it’s not likely we’re going to get it’. I think we need to build confidence in consultants and the clinical profession to ensure that the process is going to deliver for clinical need.

On that point, I am a little bit disappointed that we still have the words ‘clinical exceptionality’ in there. I would’ve rather seen it justified as to why it should be there than, actually, whether it is appropriate or not. Clinical need is the issue, and, sometimes, we can’t put a price on clinical need. I have a constituent—as you know, because I’ve written to you about the constituent—who needs a particular drug. That drug will prolong life, and will, perhaps, allow the one-year-old child to remember his or her mother as a consequence of that particular drug. So, it is a need more than an exceptionality question. I think it is important that we address the word ‘exceptionality’. I, personally, would like to see it gotten rid of and look at clinical need, but I appreciate that your remit actually says ‘appropriateness’. Perhaps we can go a bit further than that. The communication aspect is critical. We need to make sure our profession has confidence in the system we are delivering.

Thank you for the comments. I’ll start with the last points that you were mentioning on clinical exceptionality and/or need. The reality is that we already have a system providing evidence on what should be provided. Need is very much a part of it—whether it’s something that is clinically effective—but you can’t get away from the reality of resource as well. The NHS has a budget to work to in every part of the argument and every healthcare system. If we simply say that it doesn’t matter what the price is—. We regularly have negotiations with pharmaceutical companies about patient access schemes, and, in fact, within Wales, since it was introduced in 2012, by delivering a patient access scheme where the pharmaceutical company agree to change their price to get access, that’s meant that 36 new medicines have been available in Wales as a result of that. So, we’ve always got to be able to balance that properly, and if we’re going to have an honest debate about the future of high-cost medicines, we do need to set out—. But there are times you do have to talk to pharmaceutical companies about the price for which a medicine is provided. It was part of the reason why the cancer drugs fund failed because there was no control over pricing, as well as the lack of control over the clinical evidence that a treatment was actually going to be effective.

The reason why exceptionality is in is because we’re reviewing where we are and making recommendations for the future. We’ve been completely clear in the terms of reference that if the review group believe that exceptionality is not the appropriate criteria and there is a better formulation of that, then we want to hear from them, because I want the recommendations that I make to be really practical for us as well. And, indeed, if they say that, for all of the challenges about exceptionality, it is the right criteria, we need to understand how we deal with that more effectively.

That goes back to your first point, really, and that’s about the relationship between the consultant and the patient, because we’ve been really clear again in the terms of reference—we’ve got to understand that with that interface, when someone wants to understand what the treatment options are and what’s available, there’s got to be a way for both the treating consultant and the patient to understand what is available and why, and if you’re going to go through an individual funding request, what that really means too as well. So, we’ve got to equip our clinicians to have those difficult conversations in the most consistent manner possible, so that people don’t come out and think that it’s either the health board area they live in or the consultant they see that actually governs what their access to effective treatment is. So, that is a really important and a very difficult challenge for us to get over.

Just finally—I’ll finish on this point, Deputy Presiding Officer—I had a very constructive meeting yesterday with the Wales Cancer Alliance, and they were interested in my statement today. I indicated that I wouldn’t be giving them an advance copy of what I was going to say or the membership of the panel of the IPFR review, but they’re interested in what we’re doing and they, too, still want to see more consistency. They want it to be an evidence-led process, but there also wasn’t support for a process that advantaged their group of conditions over others. So, having that genuine equity across the piece and having a genuine evidence base to govern what we’re doing was really important to them too. So, there’s a whole range of actors in the field who are looking at what we’re going to do and why, and I look forward to hearing from the review panel in the relatively near future.

Thank you very much.