The next item on our agenda is the statement by the Cabinet Secretary for Health, Well-being and Sport on the new treatment fund. I call on Vaughan Gething.

Thank you, once again, Presiding Officer. I am pleased to announce that the new treatment fund is now established and I will be releasing, immediately, £12 million for the first tranche of funding for this year. The new treatment fund was a key commitment that we put before the people of Wales in May 2016 and we are delivering on that commitment. Our commitment was to invest £80 million over the life of this Government in a new treatment fund. We are delivering, with the new fund providing an additional £16 million each year, for five years, to speed up access to new medicines in Wales.

The fund will support health boards to make all new medicines recommended by the National Institute for Health and Care Excellence and the All Wales Medicines Strategy Group available faster and more consistently across Wales. I wrote to Assembly Members this morning, providing the detail of how the new treatment fund will operate. The new fund will benefit patients in Wales in three key areas. All new recommended medicines will be made available within two months of the recommendation being published, rather than the current three months. Medicines recommended by NICE will be made available within two months of the first publication of the final appraisal determination, rather than waiting for the final technology appraisal guidance, which is published after the appeal period, which can be up to eight weeks later. And, new cancer medicines given an interim recommendation by NICE will also be available to patients in Wales within these same timescales.

The new treatment fund has been designed to treat all conditions equally. We recognise that each person affected by a condition that impacts upon their life will want to be assured that the Welsh Government is just as interested in their situation by making sure all new recommended medicines are introduced as quickly as possible and consistently no matter where an individual lives within Wales, and that is not an approach that has been taken in other parts of the UK. The Welsh Government has already provided an extra £200 million for NHS Wales in the 2016-17 budget to fund the ongoing impact of demand for health services and pay and other cost increases, as was set out in the recent Health Foundation report, ‘The path to sustainability’. This additional funding of £80 million over the life of this Government for the new treatment fund represents a significant further investment that will deliver that faster and more consistent early introduction of new medicines.

We recognize that new medicines and treatments are being discovered, developed and tested all of the time, offering the hope of a cure or a better quality of life for people with a range of life-threatening illnesses. This significant investment will help remove uncertainties around funding for new treatments in the future and help NHS Wales prepare sustainable plans for the introduction of new medicines. The £12 million I am making available now will be used to help support the all-Wales delivery of new and effective medicines recommended since April last year. This includes new medicines to treat prostate and ovarian cancer, muscular dystrophy and heart failure. Each one of these carries an annual cost of around £1 million.

It will also be used to support the introduction of new medicines recommended in the last few months, plus those coming through the National Institute for Health and Care Excellence pipeline this month. That includes new medicines to treat cancer, severe psoriasis, hepatitis C, the treatment of cystic fibrosis in children under six, severe asthma, and a new drug that represents a much-needed treatment option for rare and life-threatening lung diseases. All of these diseases are life threatening and/or debilitating, and these new medicines address an unmet clinical need or represent a step change in treatment. The £12 million that I am releasing now to health boards will support the fast and consistent delivery of all of these important new medicines that have been recommended.

The final tranche of £4 million for this financial year will be released to health boards later this month to support the fast introduction of these medicines and to enable health boards to plan more effectively to introduce new medicines coming through the appraisal pipeline between now and the end of March 2017.

During 2017, we will be improving the medicines appraisal forward look to facilitate the funding being released in advance at regular intervals throughout each year of the fund and to support early planning to introduce the new medicines. I will be issuing new directions to health boards before the end of the month to ring-fence the fund for the purpose of supporting the introduction of newly recommended medicines. We’ll also be monitoring the take-up of new medicines and the reduction in timescales, because I want to be clear that the fund is being used for its purpose and that it is making a real difference.

To further support access to medicines in Wales, I will continue to encourage the pharmaceutical industry to work with NHS Wales on supporting our agenda to make new recommended medicines available quickly. The industry has a key role to play in supporting and improving our forward planning linked with longer-term financial forecasting and assisting health boards to identify at the earliest possible stage where infrastructure and/or service reconfiguration are needed to support the introduction of a new medicine. If our healthcare system is to deliver a sustainable, responsive approach to the introduction of new medicines that is fast and responsible, we need a concerted joint effort between industry, NHS Wales and the Welsh Government, and this message was well received when I spoke at the annual conference of the Association of the British Pharmaceutical Industry in November last year.

This Government pledged to deliver a new treatment fund to give the people of Wales fast access to new, innovative and effective treatments. I am proud to confirm that we’re delivering on our commitment in the first year of this Government and ‘Taking Wales Forward’. I’ll report on progress with the operation of the new fund before the summer recess.

Cabinet Secretary, I welcome your statement today, and of course the Welsh Conservatives are delighted to see £12 million going into the NHS—all additional moneys into the NHS are more than welcome. However, I am somewhat confused by the promise that you made to people in your manifesto, which was, and I will read it to you, if I may:

‘We will introduce a ground breaking New Treatment Fund, enabling the most advanced drugs and high cost treatments for cancer and other life threatening illnesses to be available in Wales first.’

Now, many people will have taken that to read that, in those instances where drugs have been approved in terms of their technical ability—they do the job—but they have not been approved by NICE because of the cost-benefit analysis, then people have been trying to get those drugs through. And, when we talked about a cancer treatments fund from the Welsh Conservatives, we were talking about putting the money out for those kinds of drugs, whereas it seems to me that this money you are talking about today, the £12 million leading to the £80 million over five years, is actually about getting health boards to provide the drugs that have already been agreed by NICE, and already been agreed by the All Wales Medicines Strategy Group, a bit faster. To be frank, they should be doing that anyway, because all of the people of Wales, all of the citizens of Wales, have a right to access treatments that have been agreed and approved by those bodies, and no health board should be dilly-dallying over that.

So, please can you clarify for me what will happen for those drugs that have been approved in terms of their technical efficiency, but have not been approved because of the cost-benefit analysis—drugs that don’t fit into the independent patient funding requests system? Does this mean that there will be an end to the postcode lottery, where people in Wales were trying to travel into England or other home nations to access drugs and treatments that they couldn’t access here? If it means an end to that postcode lottery, I, for one, will be utterly, utterly delighted. So, I’d be grateful if you can clarify that for us.

I took on board the point the Welsh Government made that, actually, the problem with just having, for example, a cancer treatments fund was that it was too narrow, and I do welcome the fact that this is for all cruel and unusual illnesses, that this is for all new treatments, and, actually, could you please confirm to me that it doesn’t just relate to drugs but it might also relate to technical treatments—very specialised kinds of surgery, for example? Because I’d like to make sure that they were also included—surgery that’s not run of the mill. Could you clarify for me what would happen if NICE approve a drug? Is there ever a situation where the All Wales Medicines Strategy Group might not have the same opinion? Is there ever a conflict? If there is a conflict, is there a proposal in place for the resolution of that conflict?

Will you also confirm to me whether or not the money that is for new treatments will also include extra support around the drugs? Now, I did, obviously, read your paragraph that says to

‘support access to medicines in Wales, I will continue to encourage the pharmaceutical industry to work with’ health boards, et cetera, but, of course, quite a lot of these drugs will require dedicated support to implement them. So, will the money be used for just the drug, or the drug and the support, or would you expect the health board to do their reconfiguration of their support staff and their infrastructure from within their own funds? I think that would be a useful piece of clarification, because although £12 million, maybe £16 million, a year—£80 million over five years—is incredibly welcome, it’s a very finite number, and there are a lot of very new drugs coming on to the market that can do an awful lot to help prolong people’s lives and give them the treatments that they need, but of course are eye-wateringly expensive at the moment. So, I want to ensure that that money really does go just for the drug and not to enable a health board to do internal reconfiguration. Thank you for that.

Thank you for the comments and suggestions and questions. I’ll try and pick up your final point about the drugs that you described as being effective but eye-wateringly expensive. Well, those drugs that are eye-wateringly expensive are drugs that are unlikely to be approved by NICE or the AWMSG. That’s why we have a recommended process: the benefit has to be in accordance with the cost as well, because part of the challenge why the cancer drugs fund was a failure and has been reformed—in fact, junked and remade completely and gone through a NICE process—is they recognise they are providing access to drugs at a price where they had no control over them at all, so that’s why it massively overspent, but also access to drugs where, on a number of occasions, you could not prove that they were effective. You don’t need to take my word for it: look at the Public Accounts Committee of the House of Commons; ask Dr Sarah Wollaston what she thinks of the previous cancer drugs fund. So, actually, that’s why the UK Government has ditched the previous cancer drugs fund, which was politically effective but a poor use of public money, and they’ve gone down a process where they’re actually now having a proper appraisal through NICE. What we’re saying through this fund is that we’ll make sure that people in Wales are not treated any less favourably. So, where those drugs go through and they get the interim appraisal from NICE, those are now available in Wales.

I’ve already determined on the previous indication that had come through, the previous medications. They are available in Wales too. Part of the reason why we’re talking about effective medication is that it goes through that authoritative process to understand that it is really effective. Those medications, they will be available on a more consistent basis, on a more rapid basis, because we recognise that there was a challenge previously in health boards’ ability to plan for introducing new medications, not having that grown-up relationship and conversation with the aim of what was coming on board, and different health boards had different abilities to manage significant costs into the drugs budget. That’s why we saw inconsistency across the piece in different parts of Wales for approved medications. This new fund will ensure that does not happen in the future and we’ll have more rapid access. In terms of NICE, because we’re making this at an earlier point in time and not waiting for the appeal period, that’s why it’ll be certain that we will have recommended medications available at an earlier point in time in Wales than in England. It is a real benefit and is genuinely groundbreaking, in accordance with our manifesto pledge.

I want to turn back to the point that you’re making about the industry and the support and service reconfiguration that may be necessary. I made comments and reference to this in my statement and in my letter as well. There is something here about our developing a more grown-up and mature relationship with the pharmaceutical industry here in Wales, because, if they want their medications to be available rapidly within the system, they have to go through a proper appraisal process, they need to be upfront about what is coming on board and to have some trust in those conversations with the service and in the whole appraisal process. That includes how that medication is delivered, and we’ve seen this on a number of fronts, where, actually, the industry is more open to talking about what you would need to do to be able to deliver a new medication effectively and what that means for the health board—not just the money, but the support around it as well. That is what the fund is intended to help deliver. So, I’m genuinely positive about what we’re doing in delivering on a manifesto pledge, delivering on a key commitment in the programme for government, and I think it will be proven to make a real difference to the NHS, but, much more importantly, a real difference to the people of Wales we are here to serve.

I certainly welcome this development. I’m pleased that through both deliberations following the election leading to the compact and in more recent discussions on the budget we have been able, working with the Government, to make sure that we have this package that will, hopefully, make a difference to patients in Wales. I’ll make a note that it is important to await the result of the IPFR review, because that is going to be key also for people with rare diseases and rare forms of disease. I’m pleased that the Conservatives now see that they were not pursuing patients’ interests in Wales in pursuing the cancer drugs fund. [Interruption.] No, if you were here a minute or so ago, you would have heard—[Interruption.] You would have heard your spokesman saying that this is rightly opening the door to funding for patients suffering from all diseases, because it’s not just cancer sufferers that Government needs to be helping, and I am pleased that this is a new treatment fund and not just a cancer drugs fund, as important as it is to get drugs to cancer patients.

I have a number of questions. The change to two months following approval is to be welcomed, but we know that three months was a struggle for LHBs at times, despite it being a requirement—we must remember that—and often patients had to have interventions from Members here to get access to medicines approved for general use. So, mechanisms to ensure delivery are key here. Would the Minister outline those mechanisms and explain what happens if he hears of an LHB that doesn’t add a new medicine to the formulary?

Secondly, both NICE and AWMSG are respected organisations, they do valuable work, but the process of evaluating new medicines can sometimes be time consuming and can also neglect new uses of older medicines. I’m thinking, for example, of bisphosphonates and breast cancer. Does the Minister think that there is a case for AWMSG to meet more frequently now to look at these issues, particularly given that finance shouldn’t be as much of an issue in these cases?

The statement doesn’t mention how long funding of each medicine will last, but you have previously said it’s 12 months funding before LHBs have to fund the drugs themselves. Could you confirm that that continues and what processes you’re putting in place to ensure that that does happen?

And finally, sometimes the best treatment may not be pharmaceutical and may not be a medicine; it may be a new piece of equipment or technique for surgery. It may be a new non-clinical intervention. Perhaps increasingly, in future, we’ll see wearable technology playing a role in monitoring patients. But we know that, often, Wales has been, in the past, slow to adapt to these new technologies as well. So, how are you ensuring that the Welsh NHS is able to monitor these new technologies to ensure we are able, here, to use the latest machinery and equipment where doing so is in the best interest of the patient?

Thank you for your series of questions and comments. To be fair, I didn’t expressly deal with the question that Angela Burns asked about other new technologies, which you finished on as well. Indeed, this announcement is about a new treatment fund for medicines. There are other processes and means to assess the effectiveness or otherwise of other interventions, whether they’re talking therapies or whether they’re other technological interventions in different parts of the service. For example, I previously talked about new microsurgery for lymphedema as a new innovation that is actually groundbreaking and leading here in Wales, as well. So, I’m disappointed to hear the Plaid Cymru spokesperson saying about Wales being slow on the uptake on a range of things. Actually, on a range of things, we’re at the forefront of them as well.

There’s a balance in what we should do and in talking about what the NHS in Wales is doing, but of course, we always want to understand what progress means, where progress can be made and how to actually have a whole-system approach to doing that. For example, in technology, there’s a range of different measures that we are taking to try and deliver a genuinely once-for-Wales approach on a range of these different areas. But that is a different matter outside the subject of today’s statement and announcement.

On the individual patient funding request, as you will be aware and as other health spokespeople and Members will be aware, I’m expecting to receive the report to be published at some point early in this year and I look forward to receiving it from the group that’s been set up, following conversations with people across parties. That will deal with those things that are not recommended through NICE or the AWMSG. That is that more difficult area where there are difficult choices to be made about the balance and individual benefits. So, I look forward to having the report with recommendations for us to consider and debate, and then, ultimately, the Government will have to decide on a way forward for the service. But that is a separate matter that will come in the coming weeks.

I recognise the point of the discussion you were having across the Chamber with the Conservatives about the fact that this a genuine all-condition approach. We agreed with what the King’s Fund said when they talked about the cancer drugs fund having difficult ethical questions and the inequity that arises in valuing some NHS patients’ lives more than other people, depending on the nature of their condition. We were never going to take that approach and we’re being consistent with a genuinely equitable all-condition approach in delivering the new treatment fund.

On the accountability for making sure that the money is used for a purpose, that’s why I’ve been clear that there’ll be new directions and that there’ll be monitoring for the use of that money. So, I’m clear that the money is there for a purpose, I expect it to be used for that purpose and health board leaders will be held to account if that’s proven not to be the case.

Again, on your point about the evidence for the frequency of the meeting of the AWMSG, if there is more evidence that it should meet more frequently, that is something we will consider. That’s not something that’s been brought to me at present, either by other individuals or by the group itself, but I’m always open-minded if there’s something that the evidence tells us we could or should do to improve the position here in Wales. I’m happy to confirm again that this is to help the first year of the introduction of these new medications. After that, our evidence tells us that health boards are much better at managing and delivering new medicines thereafter. So, it’s to make sure that, in the first year, there isn’t that inequity, either in the consistency or in the speed of access to genuinely life-changing new medications.

Thank you for your statement, Cabinet Secretary, and your letter earlier today. The news that patients can now benefit from the new treatment fund is most welcome and will be of great relief to many Welsh patients, some of whom have gone to England previously for treatment.

When access to medicines is discussed, it usually relates solely to cancer drugs, so it is refreshing to see that new medicines have become available to treat conditions such as cystic fibrosis, severe asthma and hepatitis C, as well as treatments for lung, breast and renal cancer. Other than to welcome the fund’s introduction, Cabinet Secretary, I only have a few questions for you, as we have discussed this scheme at length last year. Cabinet Secretary, in your letter, you mention that 60 new medicines have been approved since April. Are you working with the pharmaceutical sector to ensure that we are conducting sufficient horizon scanning, so we are adequately equipped to deal with new medicine appraisals in future?

Your statement and letter talk about the introduction of new medicines, but there is little mention of new treatments. Can you confirm that the fund will also allow for patients to access innovative new treatments, such as new types of radiotherapy and any new treatment that demonstrates clear clinical benefit for patients?

I am pleased to see you will be encouraging closer working relationships between the NHS and the pharmaceutical industry. We must work much more collaboratively with the pharmaceutical industry in future if we are to deliver improvements to patient care.

Cabinet Secretary, the new treatments fund is clearly earmarked to deliver better treatments for patients, so will you be allocating further resources in order to improve this collaborative working in future? We need improvements to the NHS infrastructure if we are to continue delivering the best available treatments to Welsh patients.

Thank you once again for your statement, Cabinet Secretary. I look forward to receiving details of how the scheme is working in practice when you report on progress later in the year. Diolch yn fawr.

Thank you for your comments and questions, and your welcome for the delivery of this part of the programme for government. I’m happy to reconfirm the point about the appraisal process for other new forms of technology. The new treatment fund we’re talking about is for the delivery of new and approved medicines. In terms of your point about horizon scanning for new medicines; that is part of what we’ve got better at in Wales because we’ve had a change in the nature of our relationship with the industry. That maturity really matters to us, to make sure that our public service values are secure, and that the value we get for the new medicines for the health service and for patients is maintained as our first priority—but equally, understand how we maximise the opportunities for that to be the case, and to make sure that, if there are other benefits that can be taken in terms of the ability to develop the industrial potential for this industry in Wales, we take those up too.

But, actually, we recognise, with the industry having a different relationship, that it’s actually in their interest to have this grown-up conversation with us. If they want their new medicines to be made available, to be properly appraised so they can understand what they will do in a patient access scheme if that is required, to understand all of the advice and information that is required to allow the appraisal to be undertaken rapidly and effectively and then delivered, it is in their interest to have that conversation about what is coming on stream in the future. I’m genuinely optimistic about that—not from the simple point of being a naturally optimistic person, but actually the conversations that we’ve had with industry. I particularly welcome and recognise the supportive comments made today by the Association of the British Pharmaceutical Industry on the introduction of the fund.

The point about new medicines—and again, on the point that this isn’t just about choosing cancer as our only basket of conditions where we’re prepared to spend additional money in this way—in the launch for the new treatment fund I actually went to the blood-borne viruses clinic in the Heath. It’s an all-Wales service and it does a quite amazing job for people right across the country. What’s really changed there is not just the access to new medication that we’ve delivered with new money—that’s made a huge difference for the staff and the way they network and work across Wales—it’s actually delivered a real sense of clinical purpose in the way they talk about the way they want to deliver this on a genuine all-Wales basis. So, the new money and the new medicines have actually been part of helping to change real progress in clinical behaviour, treatment and outcomes for patients. Because that, for me, was the most inspiring part of the visit—to meet patients who have actually now had a genuine cure as a result of the new medication that’s been introduced on the back of the specific investment that’s been made. That’s what I want to see more of now and in the future. So, good news for the health service, but even better news for the patients that the health service serves.

Can I thank the Cabinet Secretary for his statement? I very much welcome this announcement today and the additional funding that comes with it. I’m also very pleased that the money that’s going to be going out to health boards is going to be ring-fenced and monitored. With that in mind, I would just like to ask: my experience in Aneurin Bevan health board is that they are actually very, very quick at making drugs available to patients once they’ve been through the appraisal process, so I do have a little bit of a niggling concern that, by setting timescales for all health boards, there is a danger that things may fall behind in other health boards where the performance has been, to date, very, very good. So, can I just ask you about that, and also ask you about the mechanism for actually allocating the resources to each health board? Will it go out on a formula? Will it be done on the basis of need? Because I also wouldn’t want to see us paying health boards that haven’t been performing when organisations like Aneurin Bevan health board have been delivering, as far as I can see, very well in this area.

The other point that I wanted to raise was in relation to the AWMSG and the way that it works. I welcome the tone of your statement where you talk about the concerted joint effort between industry, NHS Wales and the Welsh Government. I was grateful to you for meeting with me recently to talk about Avastin, and also to Roche for coming to see me about it, but I understand that one of the problems that Roche have had is lack of information from AWMSG, unlike the Scottish medicines authority and NICE, who give detailed information on the reasons for declining an appraisal. They haven’t been able to get that information from AWMSG. So, can I ask that that’s something that you look at so that we can make sure that this process, which is key now to accessing this extra funding, is as transparent and as open as possible?

Thank you for the comments and for the question. Of course, I monitor the use and the impact of the fund. It’s important not just to have a statement where we can say we’ve made a promise and we’ve delivered on it. We then need to make sure it’s doing what we thought it would do and providing that real benefit for individuals across the country. And, in doing that, there’ll be money for each health board. I want to ensure that every health board gets a proper share of the resource, but then has a proper expectation that they’ll deliver against that. This isn’t just money to go into the pot to do what they want with. That’s why it is going to be ring-fenced. That’s why there will be directions. That’s why we will be monitoring the use and the impact of the money.

The AWMSG process has been successful for us in Wales. At least 29 new medicines have been available much quicker than NICE have been able to do for the whole of the UK as well. So, that’s a real benefit in our ability to have medication available on an earlier basis in Wales. This will add to that as well. Part of the challenge has been on delivering patient access schemes—the point about the benefit and the cost between the public purse, the company and the individual who could benefit from the treatment. That does mean that I have difficult conversations sometimes with the pharmaceutical industry. I want to see that improve as we go through.

The information that I’ve had about the issue you raised about Roche and Avastin has been about the challenge over the provision of information, the time that should be provided, the ability and the willingness to sign up to a patient access scheme, but then also about the conversations about how that information is transferred between the two. I’d be very happy to have a conversation with you to respond to information about what’s happened in a particular case, but also for the future as well, because I do want to see that maturity in relation to what I’ve described being developed and continuing for the future. Because, as I say, it’s in the interests of the industry; but equally, it’s in the interests of the NHS and the patients that we’re here to serve as well.

It is the case that, if a Cabinet Secretary or Minister in any part of the UK comes forward with additional money to assist in the accessibility of drugs that have proved problematic over the years, and indeed have also, through the administrative process, proved cumbersome in getting those approvals through for patients who have got life-limiting conditions, that decision is definitely going to be warmly welcomed, Cabinet Secretary. I very much hope that, obviously, you do see this through and you make sure that we’re not, in 12 months, 18 months or two years, still talking about administrative blockages within our LHBs that prevent people from accessing the drugs that NICE and the All Wales Medicines Strategies Group have approved. The problem that is always at the crux of this is the drugs that are not approved. You have touched on the fact that you’ll be bringing forward another statement in the coming weeks and months around the IPFR process, and AMs from across the Chamber here have worked on an all-party basis, highlighting issues around this particular issue. It is this issue that, time and time again, really comes to the root cause of many families, many patients, and indeed many clinicians’ issues about accessing life-enhancing and life-improving drugs that haven’t got over the initial trials but show promising progress in the development work that has been undertaken by the pharmaceutical companies. Am I correct to assume that this money that you’ve announced today will do nothing to assist the IPFR process, and that the money that you have announced today is not available to the IPFR process to assist patients or clinicians in making decisions about attracting funding for those medicines? In particular, on cystic fibrosis, for example, Orkambi—I hope I’ve pronounced that right; I think you’re familiar with the drug because of, I think, a constituent of yours and mine, but I’m not asking you to comment on the constituent because I appreciate that you can’t do that—would not be available under the scheme that you’ve announced today, because, while it has had promising trials, it has not been approved by NICE. Is that the case? And can you appreciate the frustration and the importance, now, of a very quick turnaround in any deliberations you may be having to solve the blockage that has been in the IPFR process here in Wales?

Thank you for the question. As I said through the statement—previous statements and today—this is about quick, consistent access to approved, effective medication. For those that are not approved through NICE or the AWMSG process, there is the individual patient funding request process—the IPFR process. Members are all aware that we have undertaken a particular piece of work with a rapid review to look at what we have done in terms of improvements we think we might have been able to make in the last couple of years, and further improvements that we wish to make—and to have a genuine and challenging piece of work to try and help us do that. Now, I’ve indicated in response to the questions that Angela Burns and Rhun ap Iorwerth have asked today that I’m expecting that report to be with me within the coming week. It is a matter of weeks, not months, when I will receive that. I’m sure that everyone will have a view on it, and the Government will ultimately have to respond. That is a separate issue. That is not the issue that I am announcing today. That is not what our manifesto pledge was designed to deliver. I look forward to coming back to this Chamber in the coming weeks to provide you with another statement, Llywydd, on the IPFR process, on the review, and what the Government’s response to it will be. So, at that point in time, I will have an answer for you on the issue that you raise today.

I thank the Cabinet Secretary.