The next item is the statement by the Cabinet Secretary for Health, Well-being and Sport on the new treatment fund and the progress report. I call on the Cabinet Secretary to make his statement. Vaughan Gething.

Thank you, Presiding Officer. The new treatment fund became active immediately after it was established in January of this year. The purpose of our new treatment fund is to speed up access to those medicines that have been proven to demonstrate clinical and cost effectiveness and therefore represent good value for money for the NHS resources and the public purse. This statement is to update Members on progress.

This Government is providing £80 million over the next five years to speed up access to medicines that have been recommended by the National Institute for Health and Care Excellence—NICE—and the All Wales Medicines Strategy Group, the AWMSG. In practical terms, that means we are allocating an additional £16 million a year to health boards. In return, health boards must make these recommended medicines available for prescribing, where clinically appropriate, within two months. This represents a reduction in the required implementation timescale of a third. Health boards are also required to plan for the implementation of NICE recommendations from the earlier date of the publication of the final appraisal document, rather than waiting for the publication of the final technology appraisal guidance. That makes a difference because it can reduce the time to availability by up to eight weeks. All new cancer medicines with an interim recommendation from NICE must also be made available within the same time frames.

I have issued directions to health boards mandating the new timescales for implementation. A surveillance system has been established to monitor health board compliance on a regular basis, and the All-Wales Therapeutics and Toxicology Centre will publish a report of the data later this year after summer recess.

We’ve designed our new fund to treat all conditions equally, assuring Welsh citizens that we want to see an evidence-based new medicines approach being made available quickly and consistently regardless of condition. The annual allocation of £16 million for 2016-17 was released in two tranches between January and March. That’s helped to support the delivery of effective, new treatments for a wide range of life-limiting and/or life-threatening diseases, including heart failure, cancer, arthritis and diabetes—to name a few. A list of medicines recommended, to date, will be published alongside this statement.

This £80 million fund is for the express purpose of enabling recommended medicines to be made available faster and to reduce variation in access across Wales. That was a commitment we put to the people of Wales in May last year, and we’re delivering on that commitment to make the funding available and to set the new parameters for faster and more consistent access. I will, of course, hold health boards to account for putting this into effect and making this a reality for patients across Wales.

In the first two months of the fund, health board compliance showed some variation in the availability of recommended medicines on health board formularies, and that was reflected by the First Minister during questions on 20 June. He commented that whilst some good progress had been made, there was still more to do to ensure full compliance with the new timescales across the whole of Wales. Following that, discussions have taken place at a chair and chief executive level since the fund was established. Health boards and trusts are absolutely clear as to the specific purpose of this fund and our commitment to secure faster, more consistent access to recommended medicines.

So, I’m pleased to report that the latest data show a further improvement. As of 9 June, there were 17 applicable medicines. One health board, Cardiff and Vale University Local Health Board, made 15 of the 17 recommended medicines available by this date. All 17 medicines are now available within Cardiff and Vale, and the board has confirmed that systems have been reviewed to ensure full compliance going forward. The other six health boards, however, had made all 17 medicines available within the time frame. And Velindre NHS Trust has made all but one of the relevant medicines available within the two-month time frame, but all are now available as well.

The money for the fund is being provided to ensure that new medicines are available within that two-month time frame. I previously indicated that, in exceptional circumstances, the chief medical officer can be contacted to agree a further month to comply. If organisations do not meet the required timescales, moving forward, then I will have no hesitation in clawing back the allocated moneys, either partially or completely.

The approach that we are taking to supporting faster access to medicines with proven value for money across all diseases is supported by the Association of the British Pharmaceutical Industry, and they continue to work with us on improving planning, through our forward planning, to introduce new medicines—in particular, strengthening the data for financial forecasting and the earlier identification of new medicines, which may require substantial infrastructure development.

In January, when I launched the new treatment fund, I said a concerted, joint effort was needed between the pharmaceutical industry, NHS Wales and the Welsh Government to deliver a sustainable and responsive approach to the introduction of new medicines. That was illustrated effectively just last month when the new breast cancer treatment, Kadcyla, was made available quickly because the manufacturer engaged with NHS Wales to secure an early agreement. The new treatment fund has had a positive impact on the time taken by health boards to make new, recommended medicines available sooner, and good progress has been made. That now needs to be consistent across Wales, with every health board achieving full compliance within the two-month timescale for every medicine. I expect that full compliance to be sustained over the five-year period of the fund, and to make a real difference with and for patients. I will, of course, continue to report progress to the National Assembly.

Good afternoon, Cabinet Secretary, and thank you very much for your statement today. We’re delighted to read of the progress that has been made, because we do welcome the £80 million commitment by Welsh Government over the next five years, and we welcome the plan—or your intention for the proper plan to be put in place—for the implementation of NICE recommendations, and we think it will make an enormous difference.

There are just a couple of questions I would like to ask on this. You mentioned earlier about the First Minister’s comments, saying that there was some variation in the availability of recommended medicines on health board formularies and that you are taking steps to try to address this issue. You may recall that, a couple of weeks ago, I mentioned the use of radium-223 as a prostate cancer treatment available here in Wales. There is real confusion. I can’t get any answers from anyone, and I’d be very grateful if you would look at this. The health board in north Wales is using the new treatment fund to make it available. The health board in south Wales says, ‘No, you have to claim treatment for this through the individual patient funding request route.’ And when I ask Members’ research services and Welsh Government, I’m having real difficulty in getting the answers back. I think my real concern isn’t so much this one particular drug, although I think it highlights it, but are there many other areas where there is this disparity in how a treatment is being made available to people in Wales? I know that you will agree with me that the one thing we must stamp out is the postcode lottery, so I’d be very grateful for your commentary on that particular element of your statement.

You also talked about the fact that, in exceptional circumstances, the chief medical officer could be contacted to allow health boards further time to comply. I wonder what you might consider to be an exceptional circumstance. Health boards are mighty organisations. They have a significant amount of resources at their disposal. I just wonder what could possibly be an excellent excuse that would mean that they weren’t able to implement what they should be implementing on time.

I was really pleased to see your commentary about the Association of the British Pharmaceutical Industry. I think they do sterling work in trying to work together. I am pleased to see that they are going to be doing the data sharing and the planning. Will we be able to bring any transparency to this? Of course, I’m sure that we’ve all had many pressure groups approach us about particular drugs, and I’m sure that your door is always being beaten down either by groups or reps from drugs companies. It would be really great, though, if we could bring any transparency available, obviously without breaching commercial confidentiality, so that patients and campaigners in Wales really understand what’s being looked at, so that they can have a feeling for how close or far away the decision-making process is on a particular drug that they feel should be included.

Finally, I was wondering, on the financial side, will the allocated moneys that you do end up claiming back from non-performance by particular health boards be retained within the new treatment fund? If not, where would you intend to put that money? If it is being retained within the new treatment fund, how would you then disperse that money? Would you be giving it to them at a later date, or would you be sharing it out among some of the more proactive health boards? I think that’s quite a tricky one because we do want to get rid of that postcode lottery, but we can’t hang around and only do it at the pace of the slowest and most tardy of our health boards. Thank you.

Thank you for the comments and questions. I think we have had a brief discussion about radium-223, which you mentioned last week, and I’m happy to repeat my undertaking to look at the issue and to report back—not just to you but, as it has been mentioned in the Chamber, I will make sure that a copy goes to other Members as well. I am sure that a number of them will take—[Interruption.] Yes, I understand about the particular issue, but with the principle of making sure that the new treatment fund does what it’s supposed to: that it resolves the differential access in terms of time and also geographic access to recommended treatments. And that’s the point of it. What we are able to set out today is that there’s been real progress. So, you can see that there are only indications across the relevant seven health boards and Velindre where that access hasn’t been made within the timescales set. So, that is significantly better than before the introduction of the new treatment fund. But I want to see that people genuinely meet the objectives that we set. That brings me to your point about the accountability for—[Inaudible.]—because there may be exceptional circumstances where it is possible that there are good reasons why people can’t meet the two-month timescale. It may be that there are wider infrastructure challenges about delivering the treatment safely and effectively that are there. But those should be matters that are properly understood in advance. If they don’t understand those, and it’s something that arises during the implementation, they need to notify the chief medical officer, to make sure that that’s properly understood, rather than that simply being a pressure valve or a get-out if it just seems to be difficult. To be fair, the new chief executive at Cardiff and Vale and the chair understand that there’s a requirement to use the moneys for a purpose.

And that takes me on to your point about clawing back money. I haven't made a definitive decision on what would happen if we did claw money back. My aim is not to have to, frankly. But if we did, we would then consider how best to use it within health spend. I have found some of the frustration that any Minister in any Government would find about trying to achieve Government objectives and how you achieve change successfully and sustainably, and our accountability mechanisms are often difficult, in the sense that you can do something with the whole organisation—that's what an escalation framework is for, if the organisation overall is not succeeding, not delivering as it should do on a range of really important fronts. On more specific measures, like this, I don't think we'd be suggesting that we should remove individuals at the head of an organisation, but there's got to be some form of accountability, and I have found that, actually, the potential use for money in a way that is visible has a really encouraging effect on encouraging organisational compliance. So, as I say, I am optimistic that I will not have to claw back moneys, but if I do, well, obviously, I'll report back about the fact of that and how those moneys will be used.

On your last, and broader, point in the middle about the ABPI and welcoming the engagement with the decision-making process, again, to reiterate: this is about recommended medicines. So, the NICE appraisal process—again, independent expertise. The same for the AWMSG, because they aren't politicians deciding what is good for them in the short term. It's not about having there a large enough or emotively-run-enough campaign to persuade people to change the view of politicians; otherwise, all of us are vulnerable and susceptible, not just to campaigns persuading to change our minds, but actually the evidence, and this has to be a genuinely evidence-led process. Otherwise, we can all anticipate that money will be used for purposes that we cannot objectively justify—we're talking about precious but significant public resource that's going into this area to genuinely benefit treatment of patients across the country.

May I, too, welcome this update from the Cabinet Secretary on this important fund? Just a few questions from me. In terms of reference, in a way, how much do we think the introduction of the 17 new drugs has cost health boards in Wales in real terms? I assume that it’s not all being paid for from that £16 million annually, because the purpose of the fund is to enhance access to these drugs, not to pay for them all. Or is central funding the default now for all new drugs and treatments?

One thing that strikes me is that, although I welcome the fact that there is compliance within the two month period, what happens with older drugs—drugs that aren’t, perhaps, new, but drugs that are older and haven’t been available when they should have been? Those are also very important for patients. And what is the process that should be followed in terms of patient advocacy and so on to ensure that a solution is found?

And, finally, we are talking here about drugs, but this is a new treatment fund. So, what happens when a drug isn’t the appropriate treatment, and it may be a new form of physiotherapy or an expensive new piece of machinery? How can this new fund feed into that when alternative treatments are required?

Thank you for the three areas of questions. If I deal first with the financial point, then—you're right that the new treatment fund is not there to pay for all of the costs of medicines. It simply would not. If I can sort of point out, in the last three years, expenditure on new recommended medicines increased by a third, from £186 million to £247 million annually. So, the new treatment fund could not possibly fill that gap. This is about making sure there is, as I say, more consistent access, geographically and in timescales. We've actually managed to squeeze down the timescale in which the new recommended medicines will be available by introducing the fund. That's the express purpose and point of it. We recognise that there were some potential variations that, on an equitable basis, you couldn't and you should not try to live with. So, the fund is delivering against that point and purpose at this point in time, but, again, as you and others in the room do, I look for further improvement to ensure we have full compliance.

On your point about older drugs, there are two points—older drugs that are still appropriate as treatment options, and older drugs where new purposes are found. On the one, there’s a point about the licensing and availability and the evidence base for the use of those in a different way, but, where it’s still an appropriate clinical treatment, then, again, that goes into clinicians still being charged to use their judgment to actually provide the most clinically appropriate treatment.

A good example has been with a debate we previously had on hepatitis C. Actually, clinicians together, by forming an effective network, supported and challenged by peers, haven’t just agreed different ways to make use of new medications, but also the particular brandings within those about the drugs they use altogether. Actually, they’ve driven down the drugs bill and, at the same time, raised the effectiveness of the treatment they are providing. So, it doesn’t mean that every single indication we have means that older drugs are simply passed over. Those drugs that are appropriate remain on the formulary and it is for clinicians to actually then properly and appropriately prescribe.

On your broader point on the new treatment fund for those issues that are not medicine related, well, we’ve thought about the new treatment fund, and I made clear this is actually about the provision of medicines. So, other forms of treatment are about the rest of the funding within the national health service, whether that is, for example, new forms of radiotherapy or chemotherapy, whether that is, for example, other new surgical techniques, or whether it is forms of physiotherapy and others, as you’ve indicated. But, in many of these fields, it’s actually about how we consistently apply what we already know, and that is much of our challenge about quality improvement in experience terms but also in outcome terms as well.

If you look at the significant progress we’ve made in the area of cardiac rehabilitation, for example, it wasn’t learning something new that saw that significant improvement that was welcomed by the British Heart Foundation so that they then branded us as world leaders in this field, it was actually about the more consistent application, using a multi-disciplinary team, to better meet the needs of patients that had already been understood.

So, this new treatment fund is about medicines—faster, rapid access, on a more consistent basis, to effective medication. Those other issues are different quality improvement challenges for our service, which I’m sure you and I and others will return to on many occasions in the future.

Thank you for your statement, Cabinet Secretary. The new treatment fund has brought hope to many cancer sufferers, making drugs such as Kadcyla routinely available to Welsh NHS patients. Of course, it is not just cancer patients who will benefit from the new treatment fund, and it will fund more than drugs.

Cabinet Secretary, while I welcome the introduction of the fund, I do have some questions about the day-to-day operation of the scheme. Clinicians who oversaw the introduction of disease-modifying drugs for MS patients state that it took over two years following the approval of Sativex for patients to receive it, because the infrastructure needed to administer and monitor the drug was not in place. Many of the new types of medication becoming available require close monitoring and have to be administered in a day bed. Cabinet Secretary, will the new treatment fund ensure that it’s not only the cost of the medication that is taken into account but also ensure that the infrastructure is in place to deliver the medication?

Of course, the scheme will only fund the first 12 months of treatment costs, with local health boards having to meet the ongoing cost of treatment. Cabinet Secretary, how are the local health boards being made aware of new treatments in the development pipeline so they can plan for future funding needs? It is proving difficult to get information about what treatments are available under the scheme. Cabinet Secretary, do you have any plans to publish a continuously updated list of available treatments so patients can be clear on what is available and whether their local health board is complying with the fund?

Do you have any plans to regularly publish data on the operation of the scheme, such as the number of patients who benefit, what funding is allocated to each treatment, and the length of time taken from approval of the treatment to when it is received by patients? The fund will provide health boards with £16 million per year. Cabinet Secretary, how do you ensure that the budget is maximised, and what systems do you have in place to ensure that any overspends do not impact on other areas of patient care?

Finally, Cabinet Secretary, England’s chief medical officer has said that cancer patients should be given whole genome screening in order to help select the best treatment for the patient. So, Cabinet Secretary, is this something you will consider and could the new treatment fund be used to fund the initial introduction of this type of screening? Thank you. Diolch yn fawr.

Thank you for the comments and questions. The last point I think we tried to cover in the statement I made last week about our approach on precision medicine. That’s a different question to the new treatment fund, and I think that’s one that I’d be happy to discuss in more detail with Members on a future occasion. We’ll be launching our precision medicine strategy over the summer, and I’m sure it’ll be a matter that members of the health committee and others will take a continuing interest in. It’s a really significant and exciting area of development, but, as I say, that’s not really the point and the purpose of the new treatment fund.

Now, on the point you raised about this being not just about cancer, that’s exactly where we are and that’s why we say that we’re not taking a condition-specific approach, because we don’t think that we should value the lives of some NHS patients more preciously than others depending on the condition that they have, and, again, to remind people again that the English cancer drugs fund spent over £1.27 billion and yet they think that only in about one in five cases they can justify the use of it. So, that’s broadly £1 billion wasted or poorly used. We want to avoid that sort of poor use of public funds that I think we could and should be rightly criticised for if that were the approach that we chose to take in Wales.

The point you make about Sativex is instructive in that we made a choice, with our own appraisal process, to approve Sativex for a particular group of patients. The English system has still not got to that point. So, in that sense, there’s a real benefit for patients in Wales. The challenge then has been making sure that all of the infrastructure around the prescribing and support for people who it’s potentially clinically appropriate to prescribe Sativex for is there and in place. I know that there are continuing challenges about this: challenges within, if you like, the service wholly within Wales, but also those patients who are going to see consultants as a regular part of their treatment where those consultants are based in England, and the challenge of those consultants making prescription choices for people where Sativex is an available choice, and there are challenges about those consultants in their desire or their willingness to make a clinically appropriate prescription. But it isn’t simply the case that it’s a blockbuster drug for everyone with MS. It does still have to be clinically appropriate and a proper trial of the course of treatment to be provided, because it won’t work for everyone. It is an issue that is absolutely on my radar, but, again, it’s instructive about what we want to try and avoid wherever possible with the new treatment fund to make sure those infrastructure challenges are understood properly and early in advance.

It also goes to your point about service planning. Part of the way we’ve introduced this new treatment fund is to understand that, in the first 12 months of introducing new treatments, new drugs, the first 12 months are the ones most difficult to plan for, and to understand that’s because of the additional cost that comes and how that’s then budgeted for properly through the lifetime of health boards and relevant trusts. But it’s also about developing the more grown-up relationship that I described with the Association of the British Pharmaceutical Industry. I had a useful meeting with them some months ago where we agreed about understanding and sharing more information with the service on treatments in the pipeline, and understanding how the service can plan more effectively for those. So, patients should benefit, we should make better use of public resources, but also it should still be good for those businesses as well, for the products they which to sell to the service.

On the final point that I haven’t covered yet, that’s about publishing information: I indicated in my statement that I’ll publish information at the end of summer recess. There’ll be a quarterly release of funds, and I expect to publish information at least twice a year, but I’ll give consideration to whether we could or should publish information more regularly than that, and that’s really about understanding the data that we have and making sure they are properly robust. But I’m keen to make sure that information continues to be put into the public domain about the use of the new treatment fund and the likely benefit that patients across Wales could and should be receiving.

Thank you. First of all, I’d like to welcome wholeheartedly this statement today, and the fund, which obviously was a manifesto pledge, which we have delivered on. Thank goodness we were not diverted to the cancer drugs fund, as was set up in England. So, I think it’s really important, as the Cabinet Secretary has said, that the fund applies to medicines of all conditions, so that everybody has an equal chance; I think that’s very important. The issue about MS drugs has already been mentioned, and at an MS Society Cymru round-table meeting last week. The issue of the difficulty of delivering the drugs because of the lack, perhaps, of the infrastructure to deliver them is something that I would like to emphasise as well, because that did come up very strongly from patients who were attending the meeting, about the difficulty of actually getting the drugs and monitoring the drugs. And, for some drugs, you need regular MRI scans and all those sorts of issues. I’d like to reinforce those points.

I welcome the fact that the Cabinet Secretary has said that he will be publishing a report in August that will show where we’re going. I was also interested in his response to Rhun ap Iorwerth about drugs, because I was looking at the list of drugs and noticed that sofosbuvir is on it—a treatment for hepatitis C, as the Cabinet Secretary mentioned. And, obviously, this was made available in 2015 and is now on the list of these drugs. So, I just wondered if you could explain again how the older drugs are treated as the new drugs in this scheme.

[Inaudible.]—for sofosbuvir first and the treatment for hepatitis C, there was a previous individual choice made about this particular generation of funds, and moneys released specifically for it. We’re now talking about these drugs being generally available across the scheme. There’s a challenge about whether we deal with drugs on an individualised basis, which we have done in the past, or whether we actually deal with the evidence of their process and then see them delivered across the service. I’d still say that sofosbuvir is still a relatively new drug, and we’ve got people who are now having a significant improvement in the quality of their lives as a direct result of it being provided. Again, it goes back to the example I gave about how hepatitis C clinicians have come together to agree how to use that, and we’re actually now in a better position in terms of how we treat Welsh citizens as a direct result.

On your broader point about MS, again, I recognise there’s a real issue here as to how we gear up and provide it consistently across Wales in a way that is still clinically appropriate, so that the medicines have the effect that is desired and that clinicians are properly monitoring their patients through that as well. But I do know there is a continuing issue that the MS Society have raised with me as well in a recent Neurological Alliance clinicians meeting.

I’m happy to reiterate again that we made a choice that we were criticised for at the time in not going down the cancer drugs fund route, not only for the ethical challenges but, actually, because we could not be at all sure at that time that it would be a good use of money. We now know that it was a very poor use of money, and I think it would have been not just ethically outrageous, but, you know, thinking about the finances that we face in this term, the reality that we’ll see money for the Welsh Government and wider public services in Wales reducing year on year—if we had chosen to waste precious funds on doing something that was politically convenient at the time, we could and should have faced a high price for doing that, and I think we did absolutely the right thing in refusing to take the condition-specific approach. It certainly had no evidence base to support the use of the great majority of medication and, again, I’m really pleased that we are, at an early point in the term, delivering on the manifesto we put before the people of Wales in May last year.

I thank the Cabinet Secretary.