Good morning everybody and welcome to today's webinar my name is Mark Chapman, I'm the interim director for medical devices at NICE and it's my pleasure to welcome you to what I hope will be a very entertaining hour we've got a fantastic panel session lined up later on where we'll be speaking to some of the leading lights in in NICE and industry to get their views on the early value assessment program but I hope you're all surviving BT and Virgin apparently is struggling with the internet which is basically just an excuse to enjoy the sun in your back garden for for most people there in that regard but for those of you that have joined us I'd encourage you to participate as best you can with questions if you are able to make yourself known as the questioner that's going to be really helpful because unfortunately we're not going to be able to get through all of them but we would like to, where appropriate, follow-up with the individuals we've got good ideas, concerns or indeed are willing to help us on this journey as we as we embark upon some very exciting times for NICE in the in the field of medical technology and just a small rider at that point when I or the panel refer to medical technologies we're talking to the widest components of the sector so that will be diagnostics, digital and traditional medical technologies and practicals and capital etc that you will be familiar with. Before we get into the meat of the session I just want to give you an overview of NICE's priorities, how we've got here and where where we're going to. So many of you will have read this document which outlined NICE's strategy over the over the next five years, so our direction has been set and by popular consensus and feedback this is mirrored those uh those individuals and organisations that have participated and helped shape this strategy. And as it states there this is clearly a golden age and the innovation that we'll be seeing will be extremely beneficial to patients and the system alike and as well as industry and participating colleagues in and around the field. Next slide please. When we've been engaging with our stakeholders some but not all are in our illustrated down the middle column, what we heard was we need a topic selection that has to be aligned to system needs, we need to cover all of the relevant technology which is a big undertaking in of itself, the content needs to be more up-to-date and the information needs to be in a more accessible format to the front line and that's particularly important when you think about the development of evidence, whether that's use cases in the NHS that confirms the benefit of technologies or addresses some of those areas of uncertainty and as was NICE's guiding principle from the from its conception you know more needs to be done to address the unwarranted variation in care. Next slide please.
So we are undertaking quite a transformational change both with some of the outward looking guidance and products that NICE produce and and internally with the way that we go about some of those programs. So we're going to look at these three key elements you know actively draw in the most cutting-edge improvements in care you know rapidly and robustly translate this into useful and usable advice and I think that that's really important because it has been mentioned before that some some of the languages is a little bit ambiguous and that may contribute or not as the case may be to some of the uptake and adoption and then ultimately we want to purposefully influence that adoption to deliver the best possible care for the patients within the NHS and other systems that may actually draw upon the guidance that NICE produced. Next slide please. So acknowledging that we do a broad range of activities within NICE and we have reflected and also acknowledged that we can't do everything, every day so our priorities have been focused in these four areas for the coming financial year, and this hopefully sets the tone that what we say we're going to do we deliver and again the consequences improvement in patient care and and access and the four areas and the priorities that we want to just explain here are we're going to improve the usefulness and usability of our guidelines by developing what are referred to as digital living guidelines and the first topic area will be in the in the very important area of breast cancer and so what you'll see is a different front end to that we're going to move away from the traditional five-year updates or whatever the time frequency was you know the PDF printable copies that may ultimately end up just propping up a wobbly desk to things that are meaningful and alive and we'll be addressing the care recommendations with the up-to-date advice and guidance that is available any given moment in time. Also we're going to be looking to expand the technology appraisal capacity by approximately 20% and that'll be through developing a more proportional approach and that means you know consistency in models and collations of topics and again I think that's a very important piece of work because it just means that again our guidance is is relevant and timely and and that's something that when we've heard the feedback may not have necessarily always been the case. And then we're going to start to transform the way we work internally and I think again I just want to give a caveat to some of the answers you may hear later on today, NICE is very process and methods focus for important reasons and you know we need to continue to have that robustness but I think ever more the environment that we work in probably needs a more pragmatic approach to things, so get used to us saying we haven't got all the answers and get comfortable with that because if we can work through some of these things both from an internal change program but also from an external set of programs that we'll be working with you all alongside then we can resolve some of the challenges that we encounter, it'll be more dynamic and then ultimately the outputs will be more meaningful and more more rich for that and that leads us I hope nicely onto where we have today's topic of discussion and that is the early value assessment and that's about providing quicker assessments of technology that shows the most promise and that will be in the area of medical devices, digital and diagnostics and I think what is also worth emphasising here is NICE's commitment to the medical technology sector, both for stakeholders industries patients and clinicians alike.
What this will help us do as we learn our way through these these early assessments that Sarah will come on to explain shortly, will hopefully set the foundation for a very flourishing and rewarding output for the system in the field of medical technologies and with that I'd like to introduce Sarah Byron who's the program director for devices, digital and diagnostics and Sarah we look forward to you giving us our baseline in insights and knowledge from which the audience should be able to ask some I hope thought-provoking probing and and probing questions over to you Sarah, thank you. Thanks Mark, good morning everyone and as Mark said I'm programme director for devices, diagnostics and digital and I was just going to present a few slides just providing a bit more detail on what we mean by early value assessment in within our guidance programs and as Mark mentioned this is what we're looking at is actually drawing in having a pull into NICE approach to technologies that we think address national and unmet need and looking how we can do quicker assessments of those as well and next slide please. So what what we're really wanting to do is bring benefits to both patients and people and the NHS in terms of one of the big benefits of medical technologies is that sometimes they just increase efficiency in the NHS it's not necessarily as direct as patient outcomes as you may see with medicine so we want to make sure that we capture all the factors of those medical technologies and really understand that what we know from all you know decades you know a decade of working in this is that we really really need to understand what the system needs and what the system is looking for and really understand how the system is using those products so we want to do a lot more of that intelligence and really the front end at the very start of looking at selecting topics um and once we have those topics into the into the system into NICE and we then want to look at how we can do assessments of those and give a quicker signal of early value and looking at our methods can we do a lighter touch, where do we need to put most of our attention when looking at those different topics and also we want to make sure that not only we're looking at the unmet need but also drawing in new innovations from industry as well and in those particular areas that we know the system wants and so sort of building what we know from COVID where we sent out better signals the system about and the technologies we want them to develop and looking at how we can work with partners and doing that as well and just bring it all together a little bit more and have the system more connected in this in this space. Next slide please. So what we're looking to do is order to really understand early value assessment we're running ten pilots this year within NICE and with this business year um and we know there's a big policy at the moment focus on digital but also in terms of the benefits it can offer to the system, improving those efficiencies so we're going to look to make at least six of those six digital health technologies but also expand it across the whole medical technology area as well so we have some non-digital ones in there as well and just making sure that we've got a good spread of medical technologies across all our pilots um this year, next slide please. So some of you may be familiar with our current approach to guidance so operationally what does this really mean when we say about quicker value what are we looking to do so you'll see in the top there's our current approach of where we select a topic, we really understand how it fits the system understand the population that's used in the outcomes etc before going into evaluation and then develop guidance on it and it's at that point at the end that we might say actually we need some more evidence here to know whether it's effective or not as we make our recommendations at the end of guidance development, but this is quite a long process and also we think we know it's scoping for quite a few where we might not be able to identify those evidence gaps a lot earlier so rather than taking some of these technologies that we know the NHS are interested in we want to be able to make the decisions a bit earlier so we want to at the start of it have really good intelligence as I said in the selection those topics but after scoping look at which technologies we think actually we could make a reasonable decision here that that needs more evidence and so put it off into the system to get that evidence a bit earlier on halfway through our process, collect that evidence and then bring it back in at the end after that evidence has been generated to do the full evaluation for guidance development making a sort of a longer decision then on the longer term implementation of the technology and through that early value assessment at that point in the middle we would make recommendations there about using it while collecting evidence real world evidence and then generating that the necessary studies etc that we need to see um I think that's also the one thing that looking at an early value assessment is where do we have sufficient evidence to say actually this can be used, it's looking promising but we want to generate evidence at the same time and that's also what we're looking to do if we can make that decision a bit earlier on during early value assessment. And as part of those recommendations
you'll hear from some of the questions we're also going to develop an evidence generation plan so to articulate um the evidence that we're looking for in terms of the framework of the population of indication, some of the things that we learn so going through this process and engaging with the clinical experts as well as our committee and all our health technology assessment experts as well. Providing more comprehensive information packs with the system and and for companies as well and about what we're looking for and how what this happened needs to happen in order to see if we can use this technology and if it is indeed clinically and cost effective, next slide please. So on this in terms of benefits what benefits is offer we've covered some already but we really think the speed of which we can do this the quicker signal will be much really useful to the NHS so particularly as everyone knows the NHS is under enormous pressure at the moment and it's looking for ways of being more efficient can we get people home and in a safe way quicker, can we what other things that people might be more comfortable doing at home taking measurements themselves or monitoring or reporting results back into the NHS as well so looking at all what's happening at the NHS and how we can help patients get access to the care they need and so we think we have to quicker signal on the technologies that we think are promising and that where we can manage the uncertainty in the evidence and will be really helpful to the NHS and be much better way of working with the NHS to sort of deliver what it needs as well from NICE, we also know from my experience that a lot of the we want to be able to provide better evidence as well so we know that quite a few things that are using the NHS and data is collected but when it comes into NICE there might be an outcome missing or we want current practices and how we would determine it with our clinical experts so we want to be able to prevent that and work better with the system to be able to give that signal earlier to say this is what we think we would need and work better and to develop that evidence in a better way to actually get the evidence back that it actually informs the decisions that we're looking to make both in the clinical and the long term payments and decisions as well and so we think that'll be of value to be able to provide that framework for NICE about what should be collected we're also looking at earlier access for patients if we can look at the technologies and systems earlier as I mentioned the enormous pressure at the NHS is impacting patients so other things that we can recommend for use while collecting that evidence generation providing the access and helping the patients and get the care they need as well through this we are working also with partners NHS England in particular to create a clearer pathway to market access for industry as well so part of these pilots is not only delivering the NICE but it's understanding how what our product translates into the system as well and where we need to partner and have stronger networks as well to to make sure that the information we provide is actually used and is useful to the to the system.
I think all of this combined together with our partnerships as well is really about looking at how we can improve the productivity and efficiency of the system, we know it's got a huge amount to do, other ways that we can make life easier, both in the information we provide but also in working as partners and making sure that we're more joined up as well in in terms of what the different different organisations involved are saying and it's a really kind of a whole more holistic approach into how we do assessment and how we join up and just make it more clearer I think more visibility as well in terms of what we're doing and who we're engaging with as well, and the next slide please. As I mentioned we've got ten pilot topics this year, we're looking in the key areas the mental health, early cancer detection, cardiovascular elective recovery they're all the ones that have been identified in many policies but also from our partners and also from what we hear on the ground, so there are key areas that we're looking at. We're looking at making sure we've got as I said different types of technology spread as well so we can really test stress test our methods and processes, look at different use cases as well so we want to look at technologies that are predicting risk, things that cause you know making diagnostic efficiencies, treatments, actually diagnosing patients so trying to make sure we've got a pretty good spread of different technology types so that we can connect with our audiences that are interested but also we can show and learn the lessons that might be needed from the different types of technology we see through through our programs and also looking at what is the current data infrastructure in the NHS so what how do these pilots run if that data infrastructure is already there, what does it look like if it's not so really kind of creating spread of information that we can gather from the pilots and that's sort of one of the main drivers for how we're looking at the selected pilots. And the other part we're really keen to size in the pilots as Mark said is we're really taking a a test and learn approach so we don't have all the answers yet on these pilots, we really are stress testing things. We're looking at identifying where could we make efficiencies in the guidance production pathway where can we do things quicker and that also might be useful information to use in some of our other products that we produce as well so really looking to gain that information.
We're looking at different approaches to methods and processes again what what can we do lighter touch actually what is needed, can we tailor the evaluation and to the actual scenario that we're looking at and also as I mentioned strengthening our system engagement as well so if we strengthen our partnerships and we work together more what can we do there as well so really looking at what's feasible what isn't and and then from where we identify things that aren't feasible how can we drive that conversation forward and look at what what else needs to be done to try and make this quicker access into the NHS and quicker adoption as well for these technologies that we know really meeting a national need, thank you very much so I'll hand back over to Mark now for questions. Thanks Sarah and again if anybody has been taking notes we will provide all the slides for you to download, I'm just looking over here to our production team I'm not yeah it's on the screen so you should be able to download all those slides for for future reference so we're moving into the panel session and hopefully that was a whistle-stop tour that means we get more time for the probably the more enjoyable part of these type of webinars where you can interact with us and we can get the views unedited from from our from our panel and our panel today is Sarah who you who you've met and we've got Pall Jonsson who's our program director for data and real world evidence if I'm right in the screen, he's the one with the lovely picture in the background. We've got Mark Salmon, program director for information and resources at NICE a font of all knowledges and everything about NICE, and we're it's a pleasure to welcome our external contributor Andrew Davis who's the director at ABHI and he is responsible for the for the digital programs and industry engagement and again another another wealth of knowledge on the subject so we've got a few questions coming in and so I'll start with the first one and possibly best directed to Mark Salmon if that's okay the question is how will we identify and select the first products to be subjected to EVA as it's shortened that's early value assessment? Is there an associated criteria we will be using? That's a hot topic across all of NICE so so we look forward to the answer.
Yeah happy to answer that one Mark thanks very much, I think we were helped initially by selecting topics for the EVA pilots by what became known at NICE as a the Tim Ferris challenge he's as you know national director for transformation and he asked NICE to focus on these areas Sarah was talking about you know what can NICE do for the system think about digital technologies um but obviously the program's going to be much broader than that in the areas of cardiovascular, mental health and and support for system recovery so I mean these are very much reflected in the Long Term Plan where we can see the priorities focusing on blood pressure hypertension, AF, lipid management I mean mental health, depression, anxiety these are big burdens of disease and what we do is we we start by engaging with national clinical directors and national policy teams to really understand what those national priorities are and which technologies our national leadership and clinicians think might have the biggest impact on the system. We've been liaising with teams like the early cancer diagnosis team can we do about those waiting lists getting patients through more rapidly what are the technologies at the hub of those that that might make a difference and this business about identifying what's important is it's it's really important to the to the whole program, getting on the right topic in the first place is absolutely critical and that's what we're working to try and do because NICE has very scarce resources and we want to really deploy those in the right way it's going to have the biggest impact out there. So we don't engage just nationally we engage with all our partners it's a big reach out um across the AHSNs across, innovation networks, across the royal colleges using all of NICE's clinical networks and reach, to try and understand what makes an important topic and then we try and triangulate internally what we think those priority topics might be and we're already broadening out to looking at diabetes imaging some of the national funded programs like the AI award and virtual awards broadening out this program of intelligence so what are we looking at what are the factors that we think are important for early value assessments, well topics need to have appropriate regulatory approval by the MHRA so that's CE marking CA marking process that's really important to us. Increasingly important are things like the DTAC not mandated for the system but we can very much see NHS England pointing towards DTAC to give assurance around technical standards, data protection, technical security, interoperability and these are these are really important things to get right as NICE as thinking about what it does around effectiveness and value to have those standards met and assured is becoming increasingly important, so that's another factor we look at. It also has to be plausible that the technology addresses a national and meet unmet need or inequity, it's plausible that the technology is offering substantial benefit, it's relevant to a clinical purpose, that the evidence can be generated in a reasonable time frame, so there's a feasibility around evidence generation and collection, we like to see that there's clinical interest that there's some sort of frontline service validation of a topic that's already being rolled out in one or more Trusts and there's clinical support for it and we think about whether or not that technology has got the potential to scale.
So these are these are really important factors around how we consider this but we asked we are as Mark said about beginning still learning how to build these intelligence networks, how to get behind the right topics, how to validate them you know from um from from from a national perspective but also from a local perspective, are they going to make a difference, are they going to matter so that's the that's the scope of the work that we're doing and I think the place to land these technologies in the future if you want to bring them to the attention of NICE if you're an innovator or a manufacturer we're also watching that development of the NHS Innovation Service this is likely to be the place um where companies can put the details about their technology to make them visible to organisations like NICE but also all our partners across the UK involved in either evaluation or support in some way for technologies through to deployment that's a service it hasn't gone live yet but it's it is imminent I think that that will launch that NHS Innovation Service and that's on and innovation.nhs.uk probably over the next three to four weeks that's a website to keep an eye on to signal topics to the system so I thought I'd mention that so quick overview there Mark in response to that question. No excellent very comprehensive overview so again for for the audience there some some great insights we've had another question that's come through and as I'm quite new to NICE I could imagine me asking this question in my former role, what would be the first technologies NICE look at? Well I think we've probably got to be a little coy on this one in that we are looking at use cases in class and we've gone into the various you know cardiovascular, mental health space so we'll be looking at and hopefully multiple technologies within that area because I think and I hope people can understand that this the scale and volume of technologies that could be applicable to this it would be impractical and also probably not so useful to the system if we were to look at everyone individually so there'll be no names, no companies and no products mentions at this stage but uh to to Mark's earlier points please get yourself in the mix via the channels that that you are able to access and and during scoping sessions we'll be making sure we've we've captured the majority of those that would be eligible to be considered in the various categories and use cases that we're looking at. Another question that's come through and Andrew if you don't mind I'll bring you in on this one, how could this early value assessment approach help to transform health care and the lives of patients in the future and how has it been received by your industry members at this early stage? Yeah thanks Mark um Sarah really touched on this in her presentation where she mentioned about a clearer pathway to market access, I think that's really important for industry not just about the clarity about the speed of the access as well and if we have faster access for innovations in market access to possibly life-changing technologies that will enhance their lives improve outcomes faster the system will recognise any efficiency benefits faster and of course industry build their market presence faster. So that really you know is is quite critical to the whole process and at a macro level as well if we have these processes working slickly in the UK, it really helps make the UK a better destination for innovators to bring their products as one of their launch markets and we from that we we get a cyclical improvement you know people bring their innovations see it go through a clear, transparent, robust process get an outcome it encourages further innovation so I think there's a potential benefit here for patients, a system and and industry. Our industry have they got any concerns at this early stage? Because it's always the case on webinars like this that we want to come across as very positive about all these things but I think it's also in NICE's DNA and going forward we want to make sure that we don't fall into some of the traps that we may have done in the past or that others have foreseen that we haven't yet so is there any notes of cautions at this early stage that you may think he'll help guide us to success? I think there's a few areas that need to be looked at I think some of them are internal to NICEs o as question we've talked about you'll be chosen and why but there's the question of how many, what's the capacity in NICE because if if this we hope this program proves to be successful, everyone will want a piece of it so what's the capacity, how we're going to do the scale of the program itself. Imagines things outside of NICE, how does this fit in the wider ecosystem
of innovation adoption, so how does it fit into uh the signals to to the to the commissioners and how does it fit into reimbursements and funding pathways I think it needs to be part of a much wider process I think for me and industry those are the two of the bigger questions. Excellent I think some watch outs some of which we hadn't um and on the subject of capacity I think colleagues in NICE think let's if everybody wants to benefit from EVA, the capacity will be forthcoming so let's I think that I think this I think the in between the line statement there it's about making this a success so people will want to benefit from this and and and the rest will follow adoption and I hope through the reimbursement programs, through our colleagues at NHS England that are thinking about this on our behalf, our behalf is the system. One thing that struck me since I've joined NICE is the amount of good work that goes on behind the scenes that possibly isn't acknowledged sometimes by the industry members and again I'll probably draw on some of my earlier career on this but one of the questions that's come through, evidence generation it's a it's busy in the healthcare environment what what sort of support is available to help the innovators? What sort of data platforms are available? And what's NICE'S committees appetite for accepting different types of data? Because this is going to be treading new ground and clearly Pall you're the expert in this area and for those of you that don't know if there's anything evidence in data that so you ever need to know Pall's the man he's is a brain box so Pall not setting you up for a fall with that introduction can you just give us a flavour of how you feel those those evidence needs, demands and interpretations will will be will be achieved? Or indeed just give us some temperance and we can just manage expectations. Yeah thanks Mark, yeah I mean it's evidence nowadays it's a fast moving feel really but NICE has been in the business of developing evidence-based guidance for a really long time as as everyone knows so we have the expertise in house to a large extent although there are some challenges related to this sort of real world evidence and how we incorporate better and broader data in our guidance, but essentially I think we have a number of products available to us that will be interest to those who are at the moment developing evidence base for new technologies that could come come under the early value assessment program so I just want to flag a couple of those. The first one is the evidence standard framework and this is specifically developed for digital health technologies and and the framework was developed with NHS England and the aim essentially of of the evidence standards framework is to make it easier for innovators and commissioners to understand as you said Mark what good levels of evidence look like and specifically for digital health technologies and the evidence standards framework provides advice to innovators about how NICE and the NHS more broadly make their decisions about technologies and specifically the sort of level of evidence that they would be expected to produce for different types of digital health technologies, so we acknowledge that it's not one size fits all certain technologies will need deeper and more robust evidence than others depending on the risk of deploying those technologies, so essentially the standard effectively relates to both clinical effectiveness and also the sort of economic impact of the technology, so that's a really good starting point for for people in this in this field to look at and then I want to plug one of the latest products that we've launched so this is the NICE's real world evidence framework, so the scope of the real depths framework in contrast with the evidence standards framework is is that the real world evidence framework covers all types of technologies, so essentially we want to aim to improve how we use as I said broader types of evidence in our guidance and we want to do that in the framework by identifying when we can use real world data to reduce the uncertainties that we see when we assess our products and by doing that improving our guidance and the framework does this by describing best practice for planning, for conducting and also reporting remote evidence studies and that will be relevant in the context of the early value assessment programme essentially one of the key aims all is also about improving the transparency of how evidence is generated and improve the quality of real-world evidence to inform our guidance. So essentially we want to improve trust in in evidence real world evidence particularly and therefore speed up access uh to patients of new technologies and interventions so both these frameworks are available online so I encourage those who are not seeing them to Google and or or find them online and but specifically to relevant relevant to the early value assessment program Sarah mentioned that we will provide and produce evidence generation plans for the products that will be going through the program, so essentially this is a multi-stakeholder approach we're not working in a in a vacuum so once a topic has been identified, the early value assessment program team will look to identify the relevant stakeholders and draw them in into a conversation, so these could be stakeholders such as evidence generation partners national registries or more regional data repositories there could be funders for evidence generation that we need to draw into the conversation, commissioners, clinicians and patient representatives so as that will bring stakeholders together to develop this evidence generation plan for each product and this is to maximise the opportunity that we'll have good quality evidence developed in time for a full assessment when the products come back for full assessment I just want to emphasise that with sort of the flavour of this is to do it in an active way we're not going to stand by passive and our role is really to to sort of clarify roles and responsibilities and broker relationships all with aim to encourage a successful emergency generation I hope that sort of answers some aspects of that question but we're happy to elaborate.
No thank you, thanks Pall that's very um and drawing the audience's attention to the real world evidence framework and the evidence standard framework is very important because I think sometimes it's levelled that the evidence isn't the correct level of evidence but sometimes innovators have been driven down an evidence generation plan through other agencies that are contradicting so it's nice to see there's some there's some alignment there one question a follow-up question and I'm not sure who this has come from but how do we how do we then educate the committees that are then assessing these type of technologies because for I'm sure many members, be that clinicians or or they have sat on committees and it becomes very traditionalist in their interpretation of evidence and becomes very purist whereas what's clear from everything I've heard and some of the some of the comments you've made is that we're going to have to get used to more uncertainty with the evidence but not at the expense of making the right decision and that right decision may be you know the risk to evidence generation ratio is is quite low so let's let's just manage that risk with further evidence and I think there is a general concern about the conservative nature of some committees in in this field, anyone from the panel please. Yeah I haven't perhaps I can jump in to start but so so I mentioned the evidence about real evidence framework so this is essentially outlining what good looks like for evidence and acknowledging that there are different research questions that you can ask of data and different data may be relevant for or best suitable for those questions so so it's about we're starting a program that we've started a program on sort of educating and upskilling both staff and our committees and we'll be working with our external assessment groups as well to understand how we can sort of robustly use and responsibly use broader types of evidence it is a journey that we're on to be frank uh we're all learning but it's about being able to make robust decisions responsibly but based on the actual sort of scope of the research question they need answering. Excellent any anything from any of the panellists there. Yeah, I can answer. Sarah and then Andrew. Yeah I think with regards the committee's accepted they're they're used to pulling certainly the medical technology ones there and diagnostics they're used to pulling together all the information so it's a holistic view of the evidence not necessarily a single study and but I think also it's about understanding what they often look at is really about what's the risk of a system what is the risk for the patients and so what we're looking to do in early value assessment is partner up that perhaps we can manage that risk and provide a bit more you know um assurance that actually we can put these into practice and manage that and work with clinicians etc as well so I think that's an aspect of this it's also really important and I think the other aspect for committees obviously is that in final guidance you're looking to make a long-term decision about whether this should be commissioned or not what we're looking at here is although we've done it sometimes before what we're really looking at here is doing more of a conditional one with more of an assurance that that evidence will be generated and then come back into NICE for a final decision on a longer term so I think the remit and the risks that committees are going to be looking at is going to be a different and I think that's you know we're working through that and looking at pragmatism and I think particularly after COVID that pragmatism is really at front of everyone's mind in terms of you know we're not looking about patients having best practice we're looking at long waiting lists and actually what can we do so I think the the remit and everything shifted quite a lot um on all three of those aspects of it.
Andrew you were going to come in with a comment. Yeah um I won't talk about necessarily for the committee side et cetera I'll leave that to you guys at NICE but I want to sort of link this into one of the questions that's come through about comparing this to commissioning through evaluation which which still scars me to this day to be honest. I think the the question was what the time into commissioning was one of the issues with uh with the commission through evaluation um and there's I think one of the aspects about that was the whole evidence generation piece and the time that took and some of the uncertainty around the evidence generation for CTE so I think it's really important that we have this robust real-world evidence framework that underpins the early value assessment and that hopefully should speed up the whole move into a commissioning process. Yeah I think yeah those of you who are familiar with commissioning through evaluation and from we've seen the learnings from that have been taken on board with the early value assessment so I think hopefully the scars will not be reopened, but if you do get a sense that there are similarities that are potentially concerning members in the system and patients alike then please do flag it because it would be foolish to repeat those lessons that we've already learned and I I think this is a question for for Sarah if that's okay, how does EVA fit with the rest of NICE's guidance programs? I think that's the question in the chat that's come up two or three times um so I think we just take that in the round and I'll see if that takes off three or four of the questions. Yeah I know it's a really good question, so everyone EVA is within our medical technology programs the diagnostics one of the medical technologies one and through the pilots obviously running these as pilots of early value assessment but part of all this work is looking at how it integrates into our current guidance processes, how we do it quicker, what can be the learning and read across of it so in that way it'll come out is it'll be looking at NICE guidance that we're giving a signal to the system about what to do so in that sense it's it's sort of NICE's traditional bread and butter type thing but we're also as part of it looking at how this would fit into a NICE clinical guideline, a new living guideline as well so we're having lots of conversations and looking forward about how this will all fit together, so I think in terms of the early value assessment we're really looking giving a conditional recommendation at the system and we have various aspects of NICE that already do that you've got to manage access in drugs and also we've done it ourselves before but after a much longer process so I think through the pilots we're looking at does it integrate into our current guidance we're looking at multiples in their class so we want to make sure that it's it's speedy and it's fair to all of those and agile, we're also really open-minded in many ways think actually should it be something that sits alone should it be separate so at the moment we're looking at how it integrates because we're familiar with that and we're looking at stress testing lots of things but I think at the end of that we realised that actually no this needs to be in order to deliver on its agility and its speed this needs to be something separate and that's also something we're open to so I think it's it's a question we've got a good idea but I think we've also got a lot of questions to answer on that one.
Excellent and and again the phrase that we should be probably landing on and because it's coming across even if it's not the same way this test and learn is very much the order of the day here and there's a couple of questions come in that saying how can companies can we self-nominate how do we get involved so the the the questions are encouraging and to people's appetite for this but it possibly may also be confusing to how they're historically used to dealing with NICE we've had HealthTech Connect we've had self nomination through the IP program we've I've come in and have a chat and we'll see whether it fits MTG and no but maybe that's a MIB so I think we need to admit there is a slight confusion so to get EVA off on the right foot even within the pilots but post pilot just how what what what is the best direction for companies and and and clinicians alike because we want the system to be there's a lot of good stuff in the system that hasn't been given NICE's attention which we perhaps need to anoint for the greater good of the system as a whole so I'll come back to Mark on that one I know you mentioned the Innovation Service but there are are there other routes. Well I think there are but I think the Innovation Service is is the is the right route going forward and so that's why I was sort of um that's why I was proposing that and I think as a system you know we should try and make that work you know we're sitting around the table there with all of our you know national partners um across England, Scotland and Wales, the NIHR the supply chain you know it is a it's a fantastic idea which is built out from the concept of HealthTech Connect which we've which we developed that NICE and you know that's that's been relatively successful in feeding our work programmes as a sort of single source of topics for the system so that that's gonna close in favour of the new NHS Innovation Service we're going to wind that service down over the next year people who are on HealthTech Connect get the same support there's nothing they're not losing out by not by not signing up to the NHS Innovation Service because the same the same team is managing both systems now because so can see all the topics in there so we're going to phase HealthTech Connect out but use all of the learning and the intelligence that we got from building a system like that which is which is truly collaborative, you know NICE being able to talk to partners in Scotland and Wales about about technologies is a good thing it's NICE to be able to talk to supply chain directly with AHSNs about topics coming through and how the best way to get them through procurement these are these are good things these are sort of silo busting, relationship building systems which I think is a good way to go so in order to make that work I think yes absolutely the innovation services is a sort of one-stop shop for advice and information uh and I think I'm gonna I'm gonna be working to make that work anyway over the next six months to a year as it as it takes off. Thanks Mark and I told the audience that you're a font of knowledge and in the spirit of making the Innovation Service work I think for all the audience and people that are participating in in that portal and getting the communication, we'd value your feedback because if you don't feel it's working the uh the ACC and as part of the Innovation Service they want to learn from from this it's not a sometimes a black hole we think of these things but we we've got to make these things work so let's not focus on why it doesn't work let's work on the solution statement to improve it because some of us will have to feel a bit of pain in the first instance for others to benefit when we get it right further down we've talked a lot about process methods how do we get in reimbursement all this and we've we've missed the elephant in the room which is why we are all here and this is a question to to all the panellists how is this going to benefit patients at the end of the day this is why we come to work whether it's industry, clinicians, NICE or or anybody in and around the healthcare system so what in your views is the benefit to the the patient populations and clinicians that are served by them and I'll start with Andrew on that one please.
Sure I mean I touched on it earlier about bringing innovation to patients faster which of course is a benefit to them I probably go a bit broader than that it's not by bringing an innovation to them it's about bringing choice to patients so they they can choose a technology, an approach, an intervention that in conjunction with their healthcare professional that is most suitable for them, both from a clinical, a social, work point of view that way we can really start putting patients at the centre and we can uh you know enable a more personalised approach to how technology is supporting patients. Thank you yeah choice is a really good thought process in this because we we, choice isn't everything being available it's about a suite of things being available that are most beneficial so yeah that's a really good thing for us all to remember when we're working on this, Pall from from your perspective please. So reflecting on one of the key features of of the early value value assessment programme is that we're front loading the evidence generation, so typically we would gone would have gone through an evaluation and then realised actually there are evidence gaps and therefore we can't make a recommendation but this is trying to sort of overcome that sort of challenge so by front loading appropriate evidence generation early on I would think we're more successful, more likely to be successful going through the evaluation when it actually when it goes to the evaluation and that then means we have an earlier access access to to pay for patients with new technologies naturally and I think also there's a lot of new sort of innovative features in the digital health tech space, there's a lot of different type of data that can be collected in in this space so for instance patient reported outcomes so we have for instance devices, variables that collect data directly from patients and this involves getting a lot more richer possibly more meaningful evidence on on on how it interact how technologies interact with patients and benefits the technologies bring to patients so there's an opportunity to capture those aspects as well which I'm really excited about. Excellent and Sarah from from your perspective and historical knowledge of other programmes how how is this going to benefit our patients? Yeah I think I think obviously everything that's been said in terms of quicker access but I think one of my real aspirations as well is a way to strengthen the patient voice the particular medical technologies a lot of the there's a lot of factors in terms of usability so you know sometimes people using these want to know how noisy it is, or one of the things we heard from the diabetes pumps many years ago was that the fact that had an alarm then that the parent could sleep even if a child has got diabetes so I think there's lots of aspects in here that getting be able to get data from the real world and understanding how these technologies actually use how do patients engage with it if they you know we know there's a lot of digital apps now how do people actually engage with those would they if they're given a course of therapy on an app, do they consistently engage with it or does it drop out we know there's a lot of inequity and access to digital as well so other aspects there that we could learn that we pick up does it actually work for everyone, do we need to put in different measures in the system to make sure that people are getting the care they need so I think actually there's a whole range of information that we could get that really strengthens our evaluations I think in medical technology cost effectiveness part but there's this whole other aspect to it that we see in committee a lot and I think really useful to get more information on that and evidence and I think that would really benefit patients in terms of the options and choice they're provided with I think so that's sort of a real aspiration for it as well.
Yeah a very worthwhile human factors and usability the things that you can't capture in a traditional measure but are so valuable it's almost consumer testing isn't it which magazines down and Mark find a word on this particular question to yourself. Yeah I think just accurate for me just listening to that conversation it's just emphasising the need to get you know charities and patient groups involved at a very early stage when we're thinking about topic intelligence and what really you know what really matters really understand that impact of the technology in a broad sense so making sure that our engagement catches that because it's all about the end of the day picking the topics that really matter to patients and that are going to make the greatest difference, the greatest impact so that's something we'll be doing too. Just sweeping up some of the themes in the questions that have come from the audience and it sort of ties into, can we get involved in the process and I hope it's been clear that the best route is to start with the Innovation Service but there's some could you give us a bit of a steer on this and that the other one I think I think it's important to know there is the Office for Market Access, obviously the Office for Digital Health has been out there working with companies and doing some segmenting of where they sit in and the NICE Scientific Advice so I I I think I would encourage you to to just speak to NICE Scientific Advice or the Office for Market Access if you think you've got a technology anyway because whilst we're focusing on EVA today there are a suite of guidances and support that NICE can give to ensure patients get access to some of these these innovations and and sometimes saying we can't help is as important as saying we can help because it means you're you're not you're not chasing a a path that is is not available to you so so please look at all of the other options and and and points of contact that you can do through NICE. Just coming on to the couple of final questions the the this one's probably for all the panel again as well we all seem to agree that this is a good way forward in terms of driving innovation into the hands of practitioners however what challenges do we, you, see on the horizon and what will success look like that we in that question suggest it may have come from one of our colleagues internally tonight so uh we'll well imagine it's an external question in that regard and we're all one big happy family working on this so I'll then I'll start with Pall on that one, so what challenges do you think we see on the horizons and what will success look like? Yeah I don't want to sound negative there's of course challenges when you start to develop a new programme, a new way of working but when we're looking at evidence generation, so evidence doesn't just appear out of a vacuum so developing a good evidence base takes both time and costs money so those are some of the challenges that we need to look at and understand how we can overcome but also I think on the more positive side of things I I think this requires an expertise in developing and analysing this type of data and there are opportunities for NICE to bring that expertise to the table and we'll actively do that there's also I think opportunities to bring systems partners together to develop a compelling case for for these really exciting innovative technologies by setting out what a good evidence base looks like prospectively as I mentioned before and really maximise the chances that supportive evidence base is generated in a timely manner before the technologies are implemented and that again as I said before has an impact on access to patients which is a positive thing. Great thanks for that Pall and just on the subject of front loading evidence and that I think there's a there's a message there for for innovators in regards to just check your evidence plan upstream of product launch because you might be able to intervene and get the answers you need just by adding a particular question in your in your clinical study form so please be mindful of that because that's probably the easier route than doing it post launch or or in in one of these and I think that's why I haven't got as much hair as some of you on the call because that's been possibly attached I've been saying for many years in my former organisation as many others. So Sarah coming on to you being right in the middle of the of the guidance development for
other programs but you know being leading on this what do you see as the challenges on the horizon and in your mind what does success look like building on your former, previous answers? Yeah I think some of the, there are I think in terms of so some operational challenges I think in terms of how NICE improves its agility and how we respond in terms of how we produce outputs, how we present our information so I think there's some challenges in making all that happen I think on the operational side I think also just on the bigger picture there is how do we manage change? So a lot of things are fast paced the system itself is moving you know we're developing a product that needs to dock in and translate, how do we manage all of that, how do you make sure we're championing the right innovations and then another one comes along so I think there's lots of thinking to do and lots of design work in terms of how we make sure that all managers can adopt them and I think the other aspects of it is we as everyone know is we need each component of the pathway to work and that involves all our partners working in that way I think linking all of that up and also things that we are working through at the moment systems like information governance, there are lots of things that we need to resolve and sort but I think one of the benefits of EVA is that we can articulate those challenges, we've got to clear a pathway to say if we can change this this can happen and I think that's the bit that will be really beneficial for EVA when we work through the noise and running the
2022-07-23