NICE topic selection, methods and processes review explained: MedTech focus
Good morning, everyone, thank you for joining us today, and welcome to the webinar for the consultation on health technology evaluation topic selection processes and methods with a particular focus on medical technologies today. My name is Sarah Byron and I’m programme director for devices diagnosis and digital here at NICE. I’ll be chairing this session today as well for you. So many of you will know we've had previous webinars on this consultation. Four of them in particular on topic selection, methods, modifiers and highly specialised technologies and from stakeholder feedback we've also recognised that it's really important to also focus on the medical technologies and highlight the areas that are relevant here today and which is why we've included this fifth additional webinar and so welcome thank you very much for joining us. During this webinar I’ll be joined by three presenters from NICE who will walk you through the relevant parts of topic selection processes and methods and then at the end we will open the question and answer session and where we'll be joined by five more panellists to give you a really great breadth of the expertise and knowledge at NICE in order to answer your questions. They are looking at this review of the consultation there are a few reasons why we've done review of all the technologies and that is the rapid advancement in health technologies means that we also need to evolve our methods and processes and there's a need for a greater alignment with health payers and providers to create a more receptive environment as well for health technologies coming into practice and we also want to make sure we remain agile and flexible and responsive to the needs of both the life sciences industry and the NHS system as a whole team. And I think in particular it's really relevant to say for medical technologies obviously
with the COVID pandemic has really put a spotlight on the benefits of value that these technologies can add to the system and to patients and we're very much keen on championing these we have a couple of programmes for guidance in NICE running for over decades we've got a lot of expertise really keen to contribute to this agenda within medical technologies. Focusing on the consultation today and very much to the manual you'll see throughout the proposals there are very clear benefits that we've added in and particularly for three areas for patients, for life sciences and for the NHS so you'll see that there's prompt access innovative health technologies and we've made it easier for patients to contribute to evaluations as well. In the life sciences we are developed methods more responsive and flexible and we're looking at greater flexibility where we know that evidence generation is difficult and also further support when we need broader types of evidence and putting that all in place as well and also the healthcare system itself we're looking at a fair and equitable evidence-based access to these innovations and really helping them to identify those technologies that are clinically effective and represent value for money, so we hope that throughout these proposals we recognised the benefits of this but also please know that this is not the final offer of the end of our work and we are obviously working on a five-year strategy that many of you will have seen but also very much looking at the new health care system in its response and recovery to COVID and looking how we can develop our proposals and processes methods further as well. So today's
conversation and discussion is based on the manual of the consultation and this is the last large review we'll do of all the programmes together but in the future and over the coming year there will be more work and that you will see and we'll be very grateful for you to engage in and how we refine things further and keep on evolving and with the new technologies that are coming forth into the system. So today as I mentioned I’m joined by three presenters Lori Farrar associate director of topic selection, Lee Dobson who's a programme manager for processes in the medical technologies evaluation programme and Ian Watson our senior technical advisor for methods and they will present the highlights from the manual for you for medical technologies and then we'll come back for a question and answer session at the end. I hope you enjoy hearing about what we've been doing, so Lori Farrar I’ll hand over to you, thank you. Thank you Sarah, good morning everybody so as Sarah said I am Lori Farrar and I’m now going to talk to you and give you an overview of the topic selection proposals. You will hear me say
next slide please throughout so next slide please. So I have three areas of focus today the first one being a very quick snapshot and overview of the topic selection manual that complements the proposals paper that's out for consultation at the moment, the criteria for identifying selecting and routing topics specifically I’m going to hone in on those medtech criteria specifically and then the transparency of decision making and the publishing of our topic selection decisions. Next slide please. As I said number one the topic selection manual so it's just on the left hand side of the slide, sorry I was trying to get my left and my rights right then, on the left-hand side as you look at it the manual covers in detail the identification of topics, the eligibility criteria and selection criteria, our routing considerations, topic briefings the TSOP known as the topic selection oversight panel and communicating selection and routing decisions and the timings for engagement.
In particular today out of this I’m going to focus on the clarity on the type of health technologies that are appropriate for health NICE health technology evaluation and showing the clearer communication of selection and routing decisions. Next slide please, next slide please. Throughout the consultation that took place in the spring of this year we received a fair amount of comments to say that more clarity was needed and with examples of what is, what is actually eligible for the different types of evaluation that we go through in the health and in the centre for health technology evaluation, so the bits on this slide and the next slide that are highlighted in yellow are the additions that we've added to provide you with some examples of what would be eligible or not eligible to come through topic selection. I’m not going to go through them in detail just because there's quite a lot there so I’m hoping that through me speaking now that's giving you enough time to be able to read those and also, it's all listed in the consultation and within the manual that's on the NICE website as well and then next slide please. And you'll see there is also so some further information on combination or integrated topics on what the criteria is for that and the examples added so that's just to say that the criteria is more that there is more than one type of type of topic either sequentially or simultaneously to achieve or enhance the intended effect so the example that we've added is using several medicines with distinct mechanisms of action to form a combination regimen and using a medical device with an app or software to deliver the medicine. So I’ve gone through that in detail just because it's an it's an addition and then other topics that have direct patient benefits with the criteria to see that they must be going through some kind of regulation or be regulated as a medicine or medical device or have direct patient benefits, and again there are some very clear examples there of what we mean by this.
Next slide please. Well here is so that was all of the eligibility criteria and now we're now going to go for the selection for medtech I will call it just so that we I don't get tongue tied in the big long title there, so this is to show that it's an assessment of the cost and effects to the on the system is needed so for example this is because there is uncertainty or because the topic is expected to be significantly cost incurring or cost saving and it has benefits that are likely to be highly disruptive or lead to a stepwise change to a care pathway in the UK. These benefits are supported by evidence, knowing the technology's effectiveness compared with current practice in the UK health and care system or an appropriate reference standard and information about the expected resource impact of adopting the technology that is directly applicable to the UK health and care system and with advice from experts that confirms the benefits are meaningful and likely to be realised when adopted in the UK healthcare system. Next slide please. In some exceptional circumstances topics that do not fulfil the selection considerations may be considered this might be done to stop an ineffective activity happening to address a particular issue of safety or to stimulate appropriate research, now obviously that can come with some ambiguity of what exactly does that mean and in some cases we can't fully at this stage be able to explain or put some more robust criteria on that but you know if you have ever have a product that you think that might fit some of this criteria and these wordings around this then please always do get in touch with the topic selection team and we will discuss that with you and no doubt that as more information becomes available and scenarios like the similar scenarios do present themselves we will be able to show the transparency and our considerations of that in the topic selection web page which I’ll go on about a bit later on in my slides. Next slide please. So, I realised that this is quite a heavy slide and it's not quite easy to read so it's a I’m not going to spend long on it it's just a very quick snapshot of the eligibility selection and routing process for topic selection. So it does include here interventional procedures, medicines and then the medtech at the bottom so if we go to the next slide please where I’ve honed in on the medtech so this here is just a snapshot of the bottom of that slide so just what's missing is how we receive the how we receive notifications of topics so that's either through UK pharma scan which can be relevant for medtech if it's an integrated topic with what we do ask is that if the lead is a medicine it goes on UK pharma scan but if the lead is the med tech then it would be entered into HealthTech Connect and that's a separate system that we use to identify these topics and through journals and clinical notification. So as it comes through it gets assessed against
the eligibility and the selection criteria it's a very top level does it mean that does it meet the criteria yes or no, if it's no then NICE guidance is not required and if it's yes a topic briefing is developed. Now what we mean by topic briefing is that this is a medtech innovation briefing in most cases which is the entry entry-level advice output for new and innovative devices, diagnostics and digital technologies and MIB is used to select topics for guidance and all published MIBs do go to the topic selection oversight panel who approve the MIC in its first place so all MIBs do go through the panel as well before they are published and that that update has been made in the manual already to show that the kind of what we mean by a topic briefing so in the case of medtech it is a is a MIB that we use so we've clarified that in the manual that you'll see in the updates so that topic briefing is developed and then it goes to the to the TSOP panel which we've kind of discussed before and they kind of look on the value for in NICE producing guidance to the NHS and then it's got its routing options which are on the far right hand side and it's diagnostic guidance, medical technologies guidance, PA guidance or it could be that there is no guidance developed at this time so in the cases of medtech we don't always do guidance but in majority of cases there is a MIB that is available. Next slide please. Well here is just a further hone in on the process so you can see that we've gone from topic briefing to TSOP and then you've got the guidance so there is just some clarification there on what the guidance is and what it does, so for diagnostics there's a full assessment of diagnostic and monitoring tests including digital and it's a cost-effective analysis and multiple technologies can be considered and compared. And then you've got for medical technologies guidance it's a full assessment of devices and digital health technologies, it's a cost consequence analysis so either cost saving technologies and it's a single process designed to be faster. And then you've got TA so I’ve kept TA in there to mention here because as we said in the original proposals that that came out in the autumn of last year for topic selection is that we can root medtech to technology appraisals in the in this case though that it will have a technology appraisals and guidance output but it will be considered by a med tech committee to give that consistency in looking at that evidence and ensuring that there's that that it will be considered for its guidance and then NICE guidance not required it's not always the end of the line as I’ve said before there is a MIB is published, NICE advice where there's no recommendations and there's a single or multiple technology process.
The next slide please. So here is sometimes when I’m talking about selection and routing what do we mean so this is more clarification of what I’ve just been through in my previous slides so the selection criteria is that it is about a technology that has been has been identified as eligible and they must be considered and assessed against the selection criteria and each technology has different sets of selection criteria and what I’ve shown you today has been the med tech and so it's been through that it's past that eligibility test and then it's now is there value we shall select it and then the next decision is that routing which can go through the topic selection oversight panel that you've seen on my previous slide, so once the technology has been selected we will determine the most appropriate guidance for development and just a note at the end reiterating what I said before what the NICE guidance includes. Next slide please. But this is about the transparency of decision making and the publishing of our topic selection decisions. Next slide please. It's a very quick snapshot the snapshots aren't really intended for you to read them I realise that they can maybe look not overly accessible but on the top there we've got TA HST so we have a very a very long-winded spreadsheet that's very hard to be able to search and it's not searchable if you want to put it on google or the NICE website but that contains all of our decisions that we've made for TA and HST. MTEP there have a word document that is updated again similar to TA and HST you can't search it in in any kind of field so it's really difficult for you to be able to find out information on what's happening and technology and whether NICE are looking at it and then in IP's we've got a little we're a little bit better where we have a NICE dreamy web page and that kind of has the topic and the decisions and stuff what's going on with it but what we would really like to do if we can go to the next slide please, is to have one topic selection web page that has been the whole point of this exercise is first for alignment across the centre for all so that's medicines and med tech so we will have one page we can't show you a snapshot because it's in development right now we're talking to the developers but we will have one topic selection web page where it will mostly talk about topics that that aren't that haven't been that haven't been selected or if they're not selected at this time but if things have been selected then they will automatically have a web page that will fit in the guidance and development pages that you can see there on the left hand side, so we're working with the developers on that and the plan is that that will be able to be published in the new year so January, February 22 that is in line with the with the manual being published so we will have that and you'll be able to see all of that and the reasons that we will use on the website and everything are all included in the consultation documents for you today. But that's enough from me and I’ll hand over to my colleague Lee Dobson who will go through the processes with you, thank you.
Thank you very much Lori, good morning all. My name is Lee Dobson I’m a programme manager in the Medical Technologies Programme I’ve been working on the consultation and the changes to the to the process. One of the key themes of the process is first to align the process that we have for medicines, devices, digital and diagnostic technologies just to try and give the same experience to all our stakeholders for all the evaluates that NICE are doing on these different technologies. Over the last sort of 10 years we've sort of tried to these programmes have evolved
differently so if stakeholders are involved in a medicine evaluation and then involved in an evaluation of a device or a diagnostic all the language that we use is different, all the processes are slightly different and nuanced as well and what do you want to try and do is create the same experience for all our stakeholders who are involved in helping us getting guidance out, new and innovative treatments out to NHS patients. So a lot of work has gone in to try and align these processes and start using the same language for the same things in these processes and also take the best practice from each of the processes and make sure those options those options to make things faster or more flexible are available for all technologies that we evaluate as well. So we have extended some of those options to the to the other types of technology evaluation. And what we'll try to do is create a much more flexible process as more and more innovative treatments come to NICE and hopefully come to our NHS patients as well. So I just want
to highlight here some of the improvements that that means for our medtech evaluations. The first of those is that we will have the option to actually publish guidance quicker where the technology is actually recommended for adoption, currently in the medtech evaluations no matter what the recommendations are NICE will always go through a full public consultation and come back and consider those comments and make revisions to the guidance and go towards a publication and but what we have found looking at the guidance is where the draft guidance was wholly positive the consultation hasn't changed that recommendation and so all we are really doing is sort of delaying the time it has taken to get these recommendations out and these treatments to patients. I just want to be clear this is only where the draft recommendations are to fully recommend the technology all technologies in the multiple technology evaluation so it's only in those circumstances where we have the option to not have the consultation but we still have the option to do a fact check and make sure the facts within the guidance are right and we'll still have the appeal or resolution process end of that but hopefully this will help us get guidance on positive positively recommended technologies out to patients faster. The one thing we've also sort of taken from the technology appraisals programme is making sure that we have wider involvement from the professional groups and the patient care organisations, to allow these groups to submit evidence and evidence statements to the evaluations of devices and diagnostics as well that doesn't happen in some cases but we want to make sure that those options now available for all our technology guidance programmes.
One of the other options we also now have is to have a sort of a process called technical engagement before we have the first committee meeting so when we have complex and difficult topics we can go through and iron out and discuss the issues, the key issues through the evaluation before we get to committee and we can involve our key stakeholders in that process as well, so we don't need that for every topic but it will help us make sure that when we do get to committee they're in the best position to be able to make positive recommendations if that's the right outcome on the technologies. We also want to make clear there are a lot more digital health technologies coming to NICE for our consideration and coming to the NHS as well and the vast majority of these will be developed as medical technologies guidance or diagnostics guidance so that will be the normal route for these types of technologies. And also over the last 10 years the medical technologies committee and the diagnostics committee have built up quite a wealth of experience in evaluating medical devices and diagnostics and digital technologies as well and so in the future they will be the main place for evaluating medtech in all its forms but if it requires a technology appraisal then we will most likely use the medical technologies and the diagnostic advisory committees and their experience to produce that guidance and we also give us capacity to be able to do that as well.
So these are the sort of key benefits that we are bringing in through the process changes that are in the consultation. I’m now going to hand you over to Ian who will help talk you through the methods changes that are relevant to medtech. Thank you very much Lee and good morning everyone my name is Ian Watson I’m the senior technical advisor for methods and I’m going to just talk through some of the proposals that on the methods side and how they relate to medical technologies, devices and diagnostics so if we could have the next slide please? This slide gives a brief overview of the breadth of the proposals for the methods that we present in the consultation paper. Under those five headings that you can see here so valuing the benefits of technologies, understanding and improving the evidence, structured decision making, challenging technologies and alignment across programmes so as you can see there's a broad range of methods changes and improvements and benefits and they're all very much developed in a technology agnostic fashion that is they they're not they're developed to apply equally to all types of technologies within the relevant evaluation context that they're being considered in. But of course there are some of these that are particularly relevant to medical technology so I wanted to touch on those in a little bit more detail in the following slides so if we can move on to the next slide, the first area I wanted to highlight was the topic of modifiers and when we refer to modifiers this is referring to those factors that can change the considerations or decisions or recommendations that our tech committees make in the context of the evaluation.
When considering a modifier or a factor to take into account we must recognise that any modifier that allows us to consider a more costly or a higher estimate of cost effectiveness or value for money that has the potential to impact on others elsewhere in the system, others other people elsewhere in the NHS that is in displacing their health. And that has the potential to conflict with our general ethical principle or normative principle that is that all health benefits are of equal value except in exceptional circumstances and so as a result our modifiers must be applied cautiously in those exceptional circumstances and when supported by evidence and rationale. And that's the basis and so this emphasises the importance of modifiers but also a note of caution in how we apply them to make sure that our recommendations are fair and evidence-based. And there's a number of modifiers that we take into account, and I wanted to focus today in particular on two of those so the severity of disease and uncertainty is a consideration. So moving on to the next slide, to pick up on the severity of the disease we present a proposal based on the evidence that society values particularly highly health benefits that arise for people with particularly severe conditions, severe diseases and as a result of that evidence we present a quantitative modifier to take into account the severity of the disease that is to apply an additional weight to the health benefits gained in severe diseases and that's done through a QALY weight so a weight applied to the health benefit, calculate based on the amount of health that is lost as a result of the condition that is the term QALY is shortfall either in absolute or proportional terms. So we present that as a quantitative modifier.
So specifically for the context of medical technologies where we're considering a costing caring technology one that would be considered through the technology appraisal process that modifier can be applied as a quantitative modifier as I’ve described and as is described in the consultation. For cost-saving technologies so those that receive medical technologies guidance the concept of a quantitative QALY way isn't applicable it's not relevant, it doesn't make sense in the context of a of a cost-saving scenario, so as a result that quantitative modifier can't be considered as I described but nevertheless it's still it's still right that we give the committees the scope to recognise the severity of the condition as a relevant consideration but rather than applying it as a quantitative modifier it can be considered qualitatively in the round within the deliberations of the committee. And exactly how that's going to be implemented in practice is a task for the next stage of the methods review so this current stage that we're moving into now to explore how we how we best we can implement that in practice in in the context of an actual committee meeting. So as I say the severity remains relevant but is considered qualitatively in the context of over cost-saving medical technology. The diagnostics the relevance of disease severity is somewhat different compared
with treatment intervention so I mean importantly a diagnostic it sits somewhat upstream within a pathway of care and has the potential to influence the pathway and the treatments and the health outcomes both for people who have a particular condition and those who don't and as a result of all of those factors together the QALY shortfall or the amount of health lost when measured at the point of use of the technology may not reflect the severity of the disease in the same way for a diagnostic context as it does for a treatment intervention, and as a result of that the severity modifier we describe will not normally be applicable in diagnostic evaluations. Moving on to the next slide then please. There's the second modifier of consideration is that of uncertainty so as we know uncertainty is a critical consideration across all evaluations across all health technology evaluations because as we know uncertainty and evidence means that there is risks for patients and the NHS. That's for patients who are having a particular technology and for those who are not having the technology but whose health may be displaced by additional spending on a particular technology so uncertainty is important, and it remains critical and so we retain our view that the committees will normally be more cautious about recommending technologies when they're they are less certain about the evidence. We also present a clarification and a codification of our practice that it's appropriate to accept greater uncertainty in some circumstances where we know that evidence generation is particularly difficult so as to not provide a block or disadvantage or impede those technologies and those innovations where we were we know that evidence generation is particularly challenging, so some examples of that for rare diseases, for technologies for children and also for innovative technologies and that clarification is relevant across the board.
Beyond that as we align the methods across the across the different evaluation programmes, the alignment emphasises that we must consider uncertainty proportionately to the context of the evaluation and that includes a number of contextual considerations but one of those that's relevant to medical technologies is that we must consider uncertainty proportionately to the type of technology in evaluation and population. So that is we look at a medical technology as though it is a medical technology and don't apply it's a different sort of standard so recognising the challenges that are associated with medical technologies devices and diagnostics and I think that's an important part of the alignment so while we do align the text of the guide we retain that flexibility to remain proportionate to the context of the different types of evaluations. Moving on to the next slide then please, the next topic or topic area that I wanted to talk about was how we support a comprehensive evidence base and how that's relevant in the context of medical technologies.
One area that's particularly important I think here is real world evidence and we know that there is a broad range of applicability for real-world evidence across different types of evaluations so knowing that while in some context you might be talking about relative treatment effects there might be other sort of more process or usability outcomes where real world evidence has real value and we want to support that and we want to champion the value of that type of evidence and so we provide some guidance on the appropriate use and the development of high quality evidence to make sure that we're getting the very best evidence to inform our evaluations. In the context of evidence on costs we present some proposals around apportioning costs in certain circumstances and this may be relevant for example for high-cost devices or diagnostics with multiple uses for example, where we permit non-reference case analyses in defined circumstances where costs can be apportioned between different uses or technologies or different settings so as to reflect the reality of the use of a particular technology in the NHS. We also alongside that present some guidance on acquisition costs for medical technologies and how that should be calculated and that will form part of the final methods, some additional guidance to be developed and presented potentially through submission templates for example alongside the final stages of the methods review. We also present additional guidance on broader sources of evidence which again may well be relevant in the context of medical technologies such as for example surrogate outcomes and expert solicitation and finally I talked a little bit about alignment in the context of uncertainty and the severity modifier but there's also some further pieces of alignment that are relevant in this context so the ability to consider unpublished and post-marketing data in all types of evaluations and we also present some alignment of terminology for cost comparison methods. I think it's important to note that that's not really a change in the actual methods but it's just simplifying and aligning the terminology so it's a little bit clearer how it's applied and the relevance of it.
And with that, I shall hand back to Sarah for the Q&A session. Great thank you very much Ian and thank you Lee and Lori as well for those questions and today's presentation sorry and so now you'll have seen there's been some questions added to the Q&A and we'll be opening it now some of those have been replied to so please do have a look if there's any questions in there you want to know the answers to and but we'll also be taking more Q&A now and I’ll also introduce four more panellist members as well to help answer all these questions and so Mark Rasburn is a senior public involvement advisor, Rebecca Albrow is associate director for diagnostics assessment programme, Paul Dimmock the technical advisor in medical technology evaluation programme and finally Brad Groves he's an associate director in our commission and managed access and programmes and so welcome to all of you the new panellists and I’ll start with the first few questions. So Paul, this one's first one for you. How will if it's needed the health tech
connect notification process be changed when the updated topic selection proposals are implemented? Thanks Sarah, thanks for the question Mark, this the health tech connect notification process will remain mostly similar to what it is now. There are plans a foot on the beta version of a new portal through the innovation service via NHS England and the access accelerated access collaboration is planned so health tech connect will transition across to the IS service very soon and that will incorporate all the updated topic selection proposals and that will implement most of those through that process so, there will be a change but currently health tech connect does match what is proposed in the TSOP process as well, thanks. Thank you, Paul and the next question, we have is, the recommendations for medical technology guidance differs significantly from technology appraisals or recommendations. Why has there not been alignment of this cross programmes to aid simplicity with the interpretation of the system as a whole and to prevent confusion across the various life sciences sector? Thank you very much for that question and at the moment obviously we're out for consultation on the manual and there will be an implementation phase considering all of these aspects and how we'll implement it and but also there will be further work in the medical technology programmes gaining insight to how guidance is interpreted as well and so that is an area that we will continue to cover and review so thank you for that question. The next question this one is for Becky, Rebecca Albrow. A little unclear if a diagnostic ends up going through the technology appraisals programme does it always end up under diagnostic guidance and if so does it have the funding mandate attached? Thanks Sarah so, I think this is something that we would take on a case-by-case basis with discussion of the with the Department of Health and so we would be using similar methodologies anyway as outlined in the manual and then there would be a decision made during the topic selection process when we do engage with wider stakeholders, to understand whether this is something that the system is comfortable with publishing with the funding mandate applied or not, and of course there is currently the option as well for the diagnostics guidance that's cost saving to be eligible for the medtech funding mandate as well so, there's various different routes as to how the diagnostics may have a funding mandate applied at present. Thank you Becky and the next question for Ian I think this will be for you. How do
companies access the guidance on appropriate world evidence approaches? So some of that guidance is provided in the manual so obviously it's a draft manual at the moment so the final manual will present some guidance but of course this is an it's an evolving area real world evidence there's a lot more that we can do and we have a team dedicated to this at NICE and so they they're also presenting evidence standards and frameworks and further information on how real world evidence can be used across NICE and their work is ongoing and continuing so, they'll be able to continue to provide further support. I suspect there may also be scope for additional methods guidance so I think Sarah you referred to earlier the idea that in the future we may be developing more dynamic, more modular updates to our methods and there's the potential that if we need further guidance at in the form of methods guides updates then that real world evidence topic could come through a modular update. That process how we go about those modular updates is still in development and it's something we hope to be able to explain a bit more later on but yes there will be a number of sources so through the methods get the final method guide that we present, through additional information from the from the real world evidence teams that NICE and the potential to build on that longer term as well. Thanks you Ian, thank you very much and see the next questions that we've got. Ian, I think this next one's for you as well. Until all of the wider work on real world evidence generation and assessment is brought together and noting what section 3.3 of the
draft evaluation manual says about general principles, can you say a bit more about how you would currently and pragmatically do any structured quality assessment and data if, for example, a company presented evidence which was mainly from device registries? Oh yeah thank you, that's an it's an it's an important topic this isn't it so we do need to think quite carefully about how we approach that. I think there's I think very much the answer is horses for courses. I think so in the context of the different types of evidence that we are seeing, the different types of evaluation that we're seeing and also the different uses of those different types of evidence or sources of evidence within an evaluation it's appropriate that we assess and evaluate the evidence appropriately to that context so for example evidence on the effectiveness of a technology might be evaluated differently to evidence on its costs or its use in practice so, we need to make sure that is flexible and proportionate and appropriate so each context will be relevant. So, the that's the role very much for our academic groups and
for our committees and our committees have a lot of experience of this and this is one of the real benefits of using in the context of medical technologies the medical technologies evaluation committee have their expertise to make those assessments as I say proportionately and flexibly according to the need of the particular evaluation and the context that you're looking at. Thank you. Paul I think this one's next for you. When health tech connect transitions to the innovation service portal will company information transfer automatically or will a re-registration process be required. Thanks for the question Ben. This is something we're considering actively there are obviously large data protection GDPR issues around that. We would hope we will be able to
move them across with obviously everyone's buy in, the company buy-in and all the other stakeholders but that is to be decided I think we're going to engage with all the stakeholders who are on health tech connect and give them a flexible process so they can easily transition across or elect not to. Thank you and let's see which ones we've got. So we've got one question here, I’ll summarise. About why we're differentiating between sectors surely technology is a technology it is it's the value and benefit there's in question and there's similarly thin evidence in all sectors? Now that's really good question, thank you for that, I’ll take that one so and the rationale behind that is that although in terms of HTA they're outcomes they are still in very different ecosystems and there are various factors that we have to take into account during the evaluation such as usability of medical technologies and various impacts on the assessment also need to bid in the assessment which means the specialist expertise we developed are still meaningful and really useful in evaluating these technologies to make sure that our guidance actually translates into the system as well so that we've captured all the relevant factors of it and so we're continuing with those expertise and we think it's an attractive offer to industry as well to have people that understand the kind of entire life cycle but also the pathway of how these technologies fit into both the regulatory side and the adoption as well. And, next question, I think this would be for you Ian. Will the revised submission templates include further guidance prompts or requirements
beyond what is currently described in the draft process manual? Thanks, it gives me a good excuse to talk about something I wanted to raise actually that so, the plan for now that the major task for now be as well as responding to the consultation which we'll place very soon is to develop a an integrated and somewhat sophisticated implementation plan to make sure that we can implement all of these changes to the methods process and topic selection very swiftly, very smoothly and seamlessly and to make sure that all stakeholders so industries, submitters and patient groups and academics as well are supported and are clear in what is needed and that's what we're developing now as I say so, I will be developing a number of tools, resources and plans to show how we can implement these methods changes and indeed the process changes in practice and we'll be doing that over the coming months and it will coincide with and extend both before and after the final methods and process manual is published at the end of this this this review. So that will include things like templates and submission templates for example alongside other resources, the guide itself of course hopefully we'll be able to arrange some sessions for stakeholders and other resources such as decision support unit resources all in an integrated package that's full range spans the full range of the updates so that's something I’m quite excited about and hopefully it'll be very valuable for all stakeholders. Thank you Ian, right and the next question, we'll take Ian off the hot seat and Becky this one I think you could answer this one for us. So what about diagnostics and medical technologies which are costing caring but the quality outcomes may not be appropriate. For example those technologies which benefit the healthcare system in ways such as pathway efficiencies like appropriate use of isolation and veteran control and patients efficiencies and do NICE not approach such technologies? Difficult question, it depends what we mean by costing incurring whether that's just the acquisition cost of the technology or whether they are costing incurring once you've mapped out the whole pathway so the examples that are given could potentially also be associated with patient benefits and not just system benefits so, we do take each technology on its own merit.
We can still use QALYs and for some of those examples, for example appropriate use of isolation may result in less patients being infected and transmission of a communicable disease so, we look at them all during topic selection and we'll decide which method to apply. You could be costing incurring and not drive much qualities but it depends kind of how much you are costing caring by and how much current practice costs once the entire pathway has been mapped out so, really I think the key message is to present really what your value proposition is too NICE at that first stage to allow us to understand whether it's going to drive any patient benefits, is it system benefits alone, where they were could there be cost savings in the pathway, where could there be increases in costs and then that allows us to ensure that you do go down the correct pathway for evaluation. Thank you Becky, that's helpful. Yeah absolutely I think some of the technologies that are system benefits sometimes we still want to check that the QALYs are it's still getting effective and the QALYs don't decrease as well so there are some examples of triage tests I think that things like category as well and so it's very helpful question, thank you. And see
so the next question Ian, sorry you're back on the hot seat again. Could Ian say more about the decision support unit resources please is we referring to a NICE DSU or external DSUs? I’m aware of ICSs establishing DSUs across the Midlands regions perhaps elsewhere. Yeah that one's easy. I was referring to the NICE decision support unit the NICE DSU, thank you. I think we've answered that one.
Next one is for you Ian as well. On the methods side how do these methods and approaches feed into the costume analysis, they're undertaking the mechanical guidelines programme? They're small but significant differences in terms of technical engagement resources cost estimation and will see will the clinical guidelines be updated to remain meaningful in this area? Yes, I suspect that perhaps actually refers to processes more than methods. We do have differences in the processes of FL technology evaluations and clinical guidelines and that's for for good reason the different types of programmes, different types of assessment and guidance operate in different ways and for different reasons so I think NICE does have an ambition to continue to integrate how we work across the institute and part of our strategy of course is to continue to do that so, this as you said at the start Sarah this is not the end of the story in any of these areas there will always be continuing development and I think this is something that we could potentially see some real benefit for thinking about how we integrate between health technology evaluations and clinical guidelines but I for now there I do think that a lot of the differences in how we interact with different stakeholders are relevant and it's appropriate to champion those benefits. The benefits of how we work with companies, with industry with patient groups within the health technology evaluations is really valuable towards those towards those evaluations so I think that's important to retain those benefits. Likewise, in how we go about estimating resources was part of the question as well, again that's it's relevant to the context of the evaluations and the circumstances we see.
So, I think we feel at least I feel very confident that the methods and processes that we present here in this consultation are the right ones for the health technology evaluations so not withstanding the potential to develop those ongoing and integrate between ourselves and the guidelines teams, I think what we've presented here is really beneficial for the health technology evaluation context. Thank you, Ian, that's very helpful so I’m just looking through the questions I think we've answered all the ones that come through and we've done also ones in the Q&A in the chat as well. We are coming towards the end of our time are there any further questions, please do put them in now and we'll pick them up. So seeing any appear. So thank you, I think in that case we'll move on to the final slide and
just explain as consultation is running, it will close on the 13th of October next week and so you have any further comments and please do add those into that and review so that we can take them on board and refine our methods and processes more. If you have any questions and you can also email us a message methods and process nice.org.uk and they can also help with any questions you may have on our consultation and so once again thank you very much for joining us today and we hope to hear from your comments very soon. I hope you enjoy the rest of day, thank you.
2021-10-14 07:28
