Early value assessment: Driving innovation into the hands of health and care professionals event

Early value assessment: Driving innovation into the hands of health and care professionals event

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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 12:29

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