The next item on the agenda is a statement by the Cabinet Secretary for Health, Well-being and Sport on the individual patient funding request review. I call on the Cabinet Secretary to make his statement. Vaughan Gething.

Thank you, Presiding Officer. Last July, I announced the establishment of an independent review of the IPFR process—the individual patient funding request process. The purpose of the review was to look afresh at the clinical criteria—usually referred to as ‘clinical exceptionality’—used to make IPFR decisions and the potential to reduce the number of IPFR panels in Wales. My approach to this review has been to try to be open, inclusive and transparent from the outset. That involved all political parties, the public and the NHS in Wales. For example, health opposition spokespeople have been fully involved in the whole process, including briefing sessions with the chair of the review group at the outset and conclusion of the review. The patient perspective featured strongly. Two patients were members of the review group and discussion sessions were held across Wales for patients, their families and carers and patient organisations. The pharmaceutical industry, health boards and clinicians participated fully, giving their views on how the process could be improved.

I published the report of the review in January this year, as soon as it was available, to provide everyone with the earliest opportunity to consider the findings and the recommendations. In parallel, my officials have been discussing the report with health boards, the Association of the British Pharmaceutical Industry Cymru Wales and our medicines experts at the All-Wales Therapeutics and Toxicology Centre, which I hope you’ll forgive me for referring to, from now on, as the AWTTC. The consensus is that this is a helpful report that makes thoughtful and pragmatic recommendations that will help health boards to deal with what are sensitive and very often complex decisions. I am particularly pleased that the patient voice has centre stage in the report.

I will now deal with the review group’s recommendations on the issues that they were asked to consider. Clinical exceptionality has been the underpinning principle upon which IPFR decisions have been made across the UK. It is not a well understood concept, and is open to varying interpretation. This is discussed fully in the report with practical recommendations to reform the IPFR decision criteria, which have been broadly welcomed. The proposed changes cover situations where there is a recommendation from the National Institute for Health and Care Excellence or the All-Wales Medicines Strategy Group, which I’ll now refer to as NICE and the AWMSG respectively. They also refer to cases where a recommendation from NICE or the AWMSG has not been made. The review group recommends a new two-part test covering, as a first point, a significant clinical benefit to the patient and, secondly, value for money. This means assessing the degree of clinical benefit expected by the treatment, and whether the cost of the treatment is in balance with the expected benefits.

In relation to whether the number of IPFR panels should be reduced, the review group concluded that the risks inherent in moving to a single national panel or reducing the number of panels negated any compelling argument for change. The review group has, however, made other helpful recommendations to support health boards in making further improvements to the process. This includes clarifying commissioning policies and embedding IPFR policy within those frameworks, and strengthening the central expert support, quality assurance and governance function of the AWTTC.

Health boards, supported by the AWTTC, have already begun the initial work to reform the clinical decision criteria with the aim of making this change to the guidance by May. Today, I’ve written to health board chairs to confirm the arrangements for implementing all of the recommendations by September of this year. Health boards will always have to make difficult choices about the relative clinical benefits versus the cost and the value for money at an individual patient level, balanced against the health needs for their local population. IPFR decisions will therefore always be sensitive. However, taken together, all of the recommendations, when implemented, will have a positive impact on the IPFR process, making it more easily understandable and less prone to being misused.

The IPFR process has a place within the policy framework for access to treatment for a relatively small number of individuals. For the majority of the population, we will continue to place the appraisal process at the centre of our evidence-based approach, ensuring people have access to clinically and cost-effective treatment. The new £80 million treatment fund I announced in January supports this approach by providing earlier access to new medicines recommended by NICE or the AWMSG. The review group endorses our policy position of placing appraisal at the heart of decisions on the routine availability of treatment. They also highlight the importance of appraisal as the best way to evaluate clinical effectiveness and value for money. In particular, I welcome their recommendation that the pharmaceutical industry should submit their medicines for appraisal as soon as possible after licensing to ensure a timely and transparent appraisal of the clinical benefits.

We have a good relationship with the industry and the Association of the British Pharmaceutical Industry Cymru Wales. The ABPI and individual companies engage with us and the AWMSG on the appraisal agenda and the wider new medicines work. The ABPI contributed to the review group’s work and are supportive of implementing the report’s recommendations. I will, of course, continue to support and encourage industry to work with us and NHS Wales to ensure the earliest possible access to innovative treatments.

I would like to finish by thanking the review group in their entirety for their effort and commitment in tackling what is a highly complex area, and in doing so compassionately and intelligently, and delivering their recommendations within a challenging timeframe.

I would also like to add to those words of the Cabinet Secretary. I certainly congratulate the panel on a very thorough review, yes, completed within a tight schedule, and a review I think that makes a number of very important recommendations that will, I have no doubt, improve the lives of many patients. The review, of course, was secured by Plaid Cymru in that post-election agreement, showing the real value of co-operation where that is appropriate, and the outcome I think clearly demonstrates to me that we were right to pursue it. The solutions actually put forward by the review panel aren’t all as we envisaged as a party, or put forward as proposals by us as a party, but the outcome is, and that is what is important. I am certainly very pleased that the Cabinet Secretary has agreed now to implement the recommendations of the review. I think it would’ve been difficult for him not to implement those recommendations. We look forward, now, of course, to seeing them being implemented in practice.

A couple of quick questions, because it now is down to what happens on the ground. First, perhaps you could explain just a little bit more about the implementation process, for example, how clinicians themselves are going to be made aware of the changes and how they can help their patients through the process. Also, I think the value of the patient voice in the process has been demonstrated clearly, and the engagement of the review panel has shown that. Will the Government now consider what ways that patient perspective can be maintained permanently within the system, for example in the quality assurance processes designed to ensure consistency, which, after all is one of the main elements that we were looking for from this review?

I thank the Member for the questions. Of course, there was agreement between Plaid Cymru and Welsh Labour in coming to an agreement on the compact to take forward a review in this area. And we’ve then expanded it to make sure that other parties have been engaged in the conversation in advance of that, and it has been, I think, a sensible and constructive process.

In terms of the two particular areas of questioning about the clinicians’ awareness of change and how they can help patients through it, that was one of the challenges that we recognise exists already—that some clinicians are better at explaining what the process is and how to help their patients through that. Equally, there were some comments about making sure that the process isn’t used simply instead of explaining to an individual patient in front of you, as a clinician, that there isn’t a reasonable treatment option that exists. And so there’s something here about that honesty in the conversation, which is not easy, but as we recognise, any individual patient funding request in itself isn’t easy. So, there are real human sensitivities around this.

Part of the point about the awareness is that there’s the national debate that we’re having, and lots of clinicians are very definitely interested in the discussion and in the review itself and in today’s statement. But I’ve made clear that the criteria to support decision making should be in place in guidance by May. That should certainly be part of ensuring that, in the run up to that and then subsequently, clinicians are properly aware of the change in the guidance about the decision-making criteria, and then all of the associated recommendations should be in place by September. But you can’t get away from the fact that clinicians will still have to go through what is a difficult process. It isn’t about the technical expertise in deciding what is an appropriate treatment option, but it’s the human interaction with their patient and how they guide that person and explain what they can do and make clear that the process will still require the clinician to support the case to be made for an IPFR. So, I’m sure that you, myself and other Members will still have contact from individuals in our constituencies about these particular choices and decisions.

Angela—sorry.

Sorry, just quickly on patient voice. On the continuing work we’re talking about from the quality function, the AWTTC actually do have engagement with patient groups and individuals as well, so we do need to see that continue as part of the review of the effectiveness of what’s happening as well. So, I recognise the point that’s made.

Angela Burns.

Diolch, Lywydd. Good afternoon, Cabinet Secretary. Thank you very much for bringing forward this statement today. I would also like to put on record my thanks to the review panel for conducting this and my thanks to you for involving all the opposition parties so comprehensively in this entire process. I’d also like to thank the great many members of the public. Particularly, I know that a lot of my constituents put forward their cases and they were very brave to do so. I’m grateful to all of them, because I think this is a very well-balanced report and I’m delighted that you’ve accepted all the recommendations and intend to move forward on it.

I do want to ask you just a couple of questions that come from it, though. A lot of this is predicated on the word ‘significant’. I’m sure all of us around this Chamber will be delighted that we no longer have to use the exceptionality clauses, but it says here quite clearly,

‘By “significant”, we mean that the nature of the benefit to be expected, and the consideration of cost-effectiveness of the intervention, should be comparable to the criteria normally applied to patients whose conditions have the benefit of HTA guidelines’.

So, ‘significance’ is obviously an accepted word for the main cohort when you are passing a medicine and saying that it is all right to be used on a general level, and now, of course, you’re looking to use that word, or the review recommends using the word ‘significant’ for rare and ultra-orphan diseases, for those who do not have an HTA, and for new interventions. So, I’d be very grateful if you could just give a little bit of clarity on how we define ‘significance’—how that’s defined and how we can remove any lack of clarity around that so people are very clear that it’s a very, sort of, logical assessment, because, of course, we’re trying to take the heat out of what is a very emotional subject.

I’d be very grateful as well if you could just give us a quick update on where you see the new national IPFR quality function sitting. Would it be part of one of the existing areas such as—I don’t know—Healthcare Inspectorate Wales, or will you be looking to set up something within your own portfolio, or an independent arm’s-length body?

Just two more questions: there was one area I didn’t think the review dealt with, particularly, and that was the question of putting timings onto decision-making processes. I haven’t been able to spot it when going through the review, and I just wondered if you might comment on that. By timings, that’s timings for a decision to be made, because, of course, most of the people who are applying for these through the IPFR treatment are people who are grievously sick—time is not their friend—and I know that there have been examples put forward to the review panel about how long it’s taken for a decision to be made, and how, in the end, that person has passed a point where what they were applying for would help them. So, if you could make some comment on that.

And finally—again, it’s timing, but this time the timing of the reports. I understand now that the health boards have between now and September to implement the recommendations, with a first report back to us in June 2018, and then ongoing reports every June after that. One of the criticisms of a previous method for the IPFR was that it wasn’t transparent enough, and that public and clinicians have lost confidence in it. I’m concerned that if we don’t get a full report back until June 2019, with a full 12 months of data, this may be too long to tweak it, pick up any issues, and correct any problems. So, I wonder if you might consider bringing forward, perhaps, for the short term, maybe three-monthly reports. I think it would help to increase public confidence, and it would allow problems to be identified and course corrections to be made much earlier, although I do accept that in the long term you’d want to lengthen that reporting process back out again. Thank you.

Thank you for the series of questions. Again, I recognise the significant public involvement and interest from a discrete group of the public, but an important group of the public, and a number of Assembly Members across different parties also gave their own perspective on behalf of their constituents, but also about how that affects individual Members in trying to represent and support constituents through what I recognised before as a difficult and sensitive process.

If I just deal with the time and the number of panels first, because that’s part of the consideration that the review took into account—you know, the fact that if you move to a national panel, you’d either have to have a standing panel, or you’d have to tolerate and accept the fact that there’d be a greater period of time, and that in itself wouldn’t be acceptable. We’ll always want to see how we have panels available to meet at a prompt and appropriate time, and that’s part of the reason we’re having a network of panels. Typically, the time of the decision isn’t a problem. I do appreciate there are some people where time is such a short window that this can be a factor. That’s part of learning and understanding what we can do to improve. There’s no pretence that actually the review provides all the answers for improvement in this area.

Again, we’ve put evaluation and reporting. We have an annual report on IPFRs and decisions that are undertaken, and, actually, we’re impressed by the fact that that exists. And those people involved in the English system I think were very positive about the information that we’re starting to now make available, and we want to see that continue, and it will. As we get through the evaluation reporting on the changes that we are making, as they become fully implemented, I expect, as I said today and in my letter to health boards, from September this year, I’ll need to give some thought as to what is a useful time period to start reporting on that. So, I won’t say ‘definitely no’ to having a different timescale, but I will go away and think about it, because I’m not completely persuaded that a quarterly report will be potentially helpful. But I’m happy to look at the issue.

On the quality function, I see that is developing the work the AWTCC should be doing, rather than creating something wholly new, to develop what we have to try and make sure it undertakes the areas of activity that the report recommends that we undertake with some more purpose, and visibility as well.

On your first question, really, about significant clinical benefit, we’re trying to make sure that we have a formulation that is more easily and better understood to make sure that where there isn’t a technology appraisal, we still have some evidence that there is a real benefit to be gained that would reach the same sort of criteria, and you’d expect there to have been a health technology appraisal. Now, the difficulty here always is that, without that full and formal appraisal, your evidence base is more difficult. There are a range of areas, for example, on off-patent medication—we had a meeting yesterday with the Torfaen Member, who isn’t here, but, as you know, has been a champion in the cause for the review—Lynne Neagle—about looking at how we look at that area, where, again, there isn’t a technology appraisal for the use of those drugs in a different field, but, often, there is enough evidence to make a reasonable assessment of their clinical benefit. I don’t want to go into too much detail, though, because, of course, I could spend a long time in this one area, but in the report and in the associated appendices, they go through, in much greater detail, how they look at both the question of significant clinical benefit and also the question of value for money as well. Because we haven’t really been as upfront in the past about the fact that it’s both limbs—you look at the benefit to the individual and you look to see whether the NHS can afford the treatment itself, because, as we all know, there is a finite resource to every part of the health service, and we have to take account of that in an upfront way. We’re upfront also about the value we want to determine for the individual and the whole service.

Thank you for your statement, Cabinet Secretary, and I would also like to take this opportunity to thank Andrew Blakeman and his team for the open and transparent way in which they approached the review and for their excellent recommendations. We all accept that the NHS doesn’t have access to unlimited funds; however, we also all accept that there are times when a novel treatment that isn’t generally cost-effective is the best available treatment for an individual patient. These decisions should be taken on clinical evidence, rather than on an accountant’s spreadsheet. This is what the IPFR process was designed to do, but, unfortunately, the design was flawed.

As the review panel found during the course of their review, the exceptionality principle was confusing and unfair. I therefore wholeheartedly endorse the panel’s recommendation that exceptionality be replaced with a decision-making process based upon whether the patient will gain significant clinical benefit at reasonable value for money. I am pleased that the Cabinet Secretary has accepted this recommendation.

The other big design flaw of the existing IPFR process was the lack of a consistent approach. Individual IPFR panels would apply the decision-making criteria differently, which led to a postcode lottery. I accept the review panel’s conclusion that is not practical to have a single national IPFR panel and, therefore, welcome their recommendation that there will be a new body to monitor the individual IPFR panels for consistency. We have to end the perverse situation whereby you can get treatment, or not, based on where you live. Can you confirm, Cabinet Secretary, whether the new national IPFR quality function will be in place by September and whether it will be looking at historical applications or will only be considering new applications going forward?

Regarding the implementation, I am grateful that the Cabinet Secretary has indicated that he hopes to have all the recommendations implemented by September. This is great news, but can the Cabinet Secretary confirm that patients currently pursuing IPFRs will be judged against the new criteria, rather than the old exceptionality criteria?

Finally, Cabinet Secretary, I welcome your assurances that you have a good relationship with the pharmaceutical industry and ABPI Cymru. Wales has traditionally been less effective at working with the industry on horizon scanning. In order to support new medicines in the future, we have to plan for them. Cabinet Secretary, will you outline how you are working with the ABPI and the pharmaceutical sector so that the NHS can prepare for future treatments and drugs? And thank you, once again, for your statement, Cabinet Secretary, and for the truly inclusive and transparent way you have approached this review. I look forward to seeing the panel’s recommendations being implemented to benefit patients in Wales. Diolch yn fawr.

I recognise that there are number of questions and I’ll try to be brief and to the point with each of them, but I do want to recognise the contribution of Andrew Blakeman, which was recognised by Members in different parties here but also by other members of the review panel, and stakeholders as well. We are fortunate to have secured his services, with his background in the private sector but also an understanding of how the health service works as well.

On the point about funding: everyone objectively signs up to and recognises that the NHS has a limited resource and there has to be a system of understanding how we allocate and prioritise treatment, and how we understand clinical value and wider financial value in the service. The challenge always gets to where individuals recognise they’re on the wrong side of the line in that, either because, unfortunately, some people have conditions where we can’t actually help them, and other times where, actually, there is a treatment that is potentially effective but is hugely expensive. We see examples of that on a regular basis. Every few months there will always be something in the wider press about a potentially effective treatment that is actually really expensive, and the National Institute for Health and Care Excellence turn it down. These recommendations aren’t going to stop that being the case. Hopefully, though, there will be a more rational conversation about how those choices are made, where there is a technology appraisal, as well as how we deal with the individual patient funding request. But exceptionality remains a criterion for the rest of the UK, so we are very much different to the rest of the UK as a result of accepting these recommendations.

I don’t think it’s fair to characterise the continuing process we’ll have for the next few months at least as being clinical evidence versus an accountant and their spreadsheet. The people who make decisions on IPFR panels are experts. They are people who treat people; they’re not faceless, nameless bureaucrats. These are people who run, lead and manage our service and provide front-line patient care. And we should take care in the way that they make those choices and the way we then describe the choices they make, in what I’ve said are really difficult, complex and sensitive choices to have to make. And the point about the postcode lottery—the suggestion that there was a postcode lottery was part of the reason that we went through the review, and, actually, the panel found that there wasn’t significant evidence of a postcode lottery. There were instances where people could point to an example and you couldn’t properly explain it. That goes into us needing to properly deal with an all-Wales cohort set of decisions, and, actually, we’re doing more of that. And what we should see spurred on as a result of this report is actually how we see that all-Wales cohort of decisions made and taken. Because, on examination, it would appear that what on the face of it looked like an inconsistent decision is actually about a variation in the individual characteristics of the patient, and the likely benefit that they would receive, and that goes back into the difficulty intercommunicating this area honestly and concisely. I’m happy to confirm the quality function should be in place by September, but that the criterion for the clinical guidance should be in place by May. So, actually, we should see exceptionality removed at the time that that guidance is in place.

And finally, on the point about horizon scanning, I had a recent helpful and constructive meeting with the ABPI about how we want to make improvements in this part of the process. So, there is work that is ongoing between industry representatives and the Government. And just to be really clear, this isn’t about somehow either selling out the health service, to give in to the ability for companies, who of course, after all, have to make a profit to continue their business, but it is about understanding that it’s in their interests to have a more upfront process, where you have information at an earlier point in time, so we don’t have an expensive contest between them and the service on whether their new products are available to provide the clinical benefit that we all expect that they will achieve. So, I think we’re in a good place and I’ll have more to say in the future on this particular aspect.

Like earlier speakers, I agree that they make very clear recommendations in this review. A lot of it is around the quality of the communication between patients and doctors. So, for example, recommendation 25 indicates that some doctors seem to have been have hiding behind IPFR rather than telling patients that they’re unable to accept a request for a particular treatment where there is no evidence that it will be effective, but, equally, we don’t want doctors to simply be saying, ‘The computer says no.’ We need doctors who are going to be looking at the whole needs of the patients, and making it clear to them that patients are able to make informed decisions about the options and alternatives, risks and benefits, as outlined in recommendation 24. So, I think it’s absolutely essential that we have transparency and clarity in decision making, and also that we ensure that there is consistency across Wales.

The guidebook that’s been recommended in recommendation 4—to make it clear and easy to understand how the IPFR operates—seems to me absolutely essential, so that we’re not raising people’s hopes unnecessarily and being clear about the decision-making process. So, I would like to know a little bit more about how quickly we’re going to see an update in the quality of IPFR decision making because, clearly, nobody should be making decisions unless they have to hand the specialist recommendation that may be required for a particular treatment, if it’s something that’s out of the ordinary. Can you assure us that the IPFR won’t be used as a way of delaying referral for a specialist service that is deemed effective and approved, but by nature of its specialism may only be available in England?

I thank you for the questions. It’s actually really helpful on the final points that we haven’t talked about today. Your first point about communication between the clinician and the patient, and having a more informed patient, are really important points in this and in every area of treatment and decision making. We want our citizens to be more informed and more engaged in the healthcare choices made for them. This particular area of decision making, affecting a very small number of people, often has this profile because of the impact of any decision that is made, either to offer treatment or not. Lots of these people have life-limiting, life-changing and potentially terminal conditions. So, actually, the decisions that are made in this area—that’s why they have such a huge profile. That’s also why they’re incredibly difficult in terms of developing a judgment, particularly if the answer is going to be ‘no’ to a particular treatment. So, I have some sympathy with clinicians who have to go through and have that difficult conversation, but it is part of the skill and the expectation on the clinician to be able to have that conversation, and not to tell someone that they may get a different answer if they moved down the road to talk to a different clinician or a different group of them, or indeed an elected representative. So, that’s part of the—[Inaudible.]—how we support clinicians to do that, how we enable and empower them, but also that we are clear about our expectations that it’s part of what we expect from them within our healthcare system. The points you raised were made by other Members in their individual submissions and, obviously, the conversations that the review group themselves had.

On your final point about where there is effective and approved treatment, whether it’s medicines or otherwise, this was part of the issue that was raised in the review of people inappropriately using an IPFR when, actually, it’s a commissioning decision. It’s a choice that should be made by the health service as to whether it will or won’t commission a certain service. The IPFR is sometimes used as an excuse or a reason not to have that happen. Sometimes it’s actually about the people running and leading the service needing to be more clear. That’s why there are recommendations on this in the report, but it’s also about making sure that clinicians are directed in the right way to do that. The guidance is about clinicians and their understanding of how to access the process appropriately, and the distinction between this part and the commissioning, but equally from the patient’s point of view as well. So, I think it’s really helpful to highlight that that is definitely part of the work that will follow on, and that’s why on the broader recommendation we expect to see implementation by September this year as well.

Thank you, Cabinet Secretary.