NICE topic selection, methods and processes review explained: MedTech focus

NICE topic selection, methods and processes review explained: MedTech focus

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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  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

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