NICE topic selection, methods and process review explained: Process and topic selection focus

NICE topic selection, methods and process review explained: Process and topic selection focus

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Good afternoon everyone and welcome to our  third webinar to support our methods and   processes and topic selection consultation  for health technology evaluation at NICE. My name is Jen Prescott, I'm a programme director   in the Centre for Health Technology  Evaluation at NICE and I'm responsible   for process and operations for our  health technology evaluation programmes. I'll be chairing the webinar  session today for you and I'm also   joined by six panellists to discuss some  of the proposals we're making to support   your understanding of the consultation  and documents we've provided.

We have a larger panel than we've had on  other webinars but hopefully that reflects   the breadth and depth of the topic selection  and process proposals we'll be discussing today. This webinar will be recorded, and  we'll be having a Q&A session at   the end of the presentation that some of  our guest speakers will do for you today. In this webinar today we are going to cover  aspects of the topic selection process   and proposals for changes to the  guidance development processes. We won't be covering the highly  specialised technologies criteria today   nor methods related conversations and I  would direct you to the other webinars   that are focusing on those  areas at your own leisure.

So, let's move on to the first slide. So, NICE play is a critical role in the  healthcare system in the United Kingdom. The work that we do is vital in ensuring  rapid access to both clinically and   value for money technologies. We want to  benefit patients the NHS and life sciences. We need to ensure that evolving and  improving our methods and processes   ensures that we as NICE adapt to emerging changes  in health care and health technologies within it. Our overarching goal is to improve the  health of people using the NHS and social   care systems and in doing so to support  equitable access for people using the NHS. In our consultation proposals we've  outlined five reasons for the changes   that we're proposing to make in how we both  assess and appraise health technologies.

The first is the recognition that as  health technologies rapidly advance,   so too do the methods and processes of  evaluation and therefore the need for   effective selection of new and important  technologies is incredibly important. The second is that reviewing  our methods and processes   allows us to remain agile and also responsive   to support rapid access to new technologies  that are clinically affected by money. Our methods and processes underpin robust,  consistent and transparent decision making   by our committees that need to evolve as well  as social, societal preferences also change. There's a greater need for alignment  between the work of regulators,   assessors and payers in the United Kingdom   to create an ever more receptive environment for  new emerging and innovative health technologies.

And finally, the fifth area was that  COVID-19 has put a spotlight on the   importance of medical technologies such as  diagnostics devices and new digital technology   and these methods and processes allow  us to level up how we select and how we   manage these exciting new technologies  and their introduction into the NHS. You'll find that through all  of our proposals there's really   clear benefits for patients for faster  access to innovative health technologies   and an easier way hopefully to understand  and ]contribute to our evaluations. For the life sciences industry they  will find a responsive flexible and   predictable way of working with NICE  and of course they will also see   flexibility when the evidence we find  is difficult to analyse and interpret. Through the proposals we  offer more broader support   for a comprehensive evidence base,  including real world evidence.

And then finally for the NHS our proposals  we believe will ensure a fair equitable   and evidence-based access for innovations. And of course in the end as I've mentioned  previously it's important for NICE   to ensure that technologies that are  clinically effective and value for   money will be supported through our new proposals. We're confident that these new methods,  processes and topic selection changes will   support the ambition that has been formally  laid out in the new life sciences vision to   make the UK the best place to discover, develop,  test, trial, launch and adopt new technologies. So, this webinar is focusing on topic  selection and processes. We've already   held the webinar on methods and hopefully  some of you took part in that webinar.

We've also held a webinar on highly specialised  technologies selection and routine criteria and   hopefully some of you also took part in that  webinar also. There's another webinar plan to   take place tomorrow and I'll give you some more  information on that later on in the session,   but just to introduce the panellists and the  speakers we have today. We have Lori Farrar   associate director for horizon scanning and  topic selection, Lee Dobson a programme manager   in our medical technologies evaluation programme,  Mark Rasburn a public involvement adviser   and Jenna Dilkes an associate director  for planning and operations and they   will be talking you through the proposals that  we'll be making in our topic selection update. After their presentations I'll be coming  back with a couple of additional guests.   Paul Dimmock a technical adviser and David  Thomson an associate director within our   commercial liaison function and I'll be  hosting a Q&A session with all panellists,   but please do as we're moving through the  presentation if you have any, questions please   do start to filter those through in advance of  starting the Q&A session. So, over to Lori first. Thanks Jen and good afternoon everyone. So,  I will take you through the overview of the  

topic selection proposals that's  been part of this consultation.   So, first up I'm going to give you a snapshot  of what we're going to cover today. Number   one the topic selection manual, the criteria  for identifying selecting and routing topics. Within that is also the eligibility criteria  that we received a fair amount of comments from   the consultation that took place in the autumn  last year. The creation and membership of the  

topic selection oversight panel known as the TSOP  and lastly the transparency of decision making,   publishing the topic selection  decisions and the challenge process. So, first off, the topic selection  manual, sorry, next thank you. So, you can see on the left hand  side here that the manual covers   in detail these areas of the identification of  topics, the eligibility and selection criteria,   the routine considerations, topic  briefings, the TSOP panel again   and communicating selection and routing  decisions and timings and engagement   of the process as a whole that has been missing  and was a requirement from stakeholders. So, on the right hand side of the slide here we've  just got four snapshot boxes that kind of really   hones into what the four key areas that came  out of the consultation held in the autumn last   year and that was clarity on the types of health  technologies that are appropriate for evaluation. More questions about the panel and how and  how they select the topics and propose refined   criteria on the highly specialised technologies  evaluation programme but as Jenna said in her   introduction the webinar on the refined routing  criteria for that programme was presented last   week so if you missed it you can look at  the NICE YouTube channel to look at that.

And then lastly clear a communication  of selection and routine decisions   and how in exceptional circumstances  a routing decision can be challenged. Next slide please. So, firstly I'm going to go through the criteria  for identifying selecting and routing topics. Next slide please, thank you.

So, here this covers two slides this  part about the eligibility criteria   and a lot of the comments that we received from  the consultation last year is that the criteria   were not clear and that you needed more examples.  So through this consultation we've tried to add   a little bit more detail and make these a bit  more clearer for stakeholders to understand.   So, for devices we've added examples, and these  are the highlighted yellow sections of the table   so we've said that this includes wound dressings,  catheters, implanted neuromodulators and apps or   software used to deliver cognitive  behaviour therapy for a smartphone   and then for diagnostics you can see that  there's quite a long list there as well now. I'm not going to go through those  mostly because I think I'll trip   myself up with the explanation of some of  those later on but you can see them for   yourself they're on the screen and now  you see that for medicines there is no   there are no examples there was a requirement or  a quest sorry that stakeholders asked us to be   more clearer on what was meant by a new active  substance or a significant license extension. Now these terms came from the 2019 voluntary  scheme so they're a little bit harder to give   examples of but as either mentioned in  various forums with stakeholders and   you'll see later on through my presentation  that topic selection are working to be   more transparent with their decision making,  so examples of these will become clearer when   we explain our decision making on the  NICE website as we work through these   but for a general a general rule for license  extensions that is not considered significant,   that would be something that may be covered by  a commissioning policy that's available. For   example, the medicines for children policy whereby  a paediatric license extension comes into play.

Next slide please. So, again here the yellow parts show  the changes that have been added so   the interventional procedures we have  added examples to the manual of what   these may be and then we've also added  two new areas on the left hand side the   combination of integrated topics and other  topics that have direct patient benefits. And then you can see on the right hand side that  we've added examples to the manual of what the   eligibility may be to be considered as part of  the topic collection process, again I'm not going   to go through them because they're quite wordy  and you can see on the slide there for yourself. Next slide please. For this slide I just wanted to really try  and show to stakeholders what we actually   mean in topic selection by selection and routing. So, the selection criteria is where technology  has been identified as eligible and that must   then be considered and assessed against the  selection criteria so they almost kind of go   through three hoops if you like, so you've  got the eligibility and then is it of value   to the NHS for NICE to look at this, should  it be selected to progress for NICE guidance.

Each type of technology has  different selection criteria   and all of that is clearly laid out in the manual. And then you've got routing so once we've  considered its eligibility, we've decided that   absolutely there is value in NICE producing  guidance for this it should be selected,   now is the appropriate route and in  which guidance product does it go to. So as you can see on the bottom there, we've got  diagnostics, highly specialised technologies,   interventional procedures, medical  technologies and technology appraisals.   And that there is the is the role of  the topic selection oversight panel,   they look more at the routing and in some cases  they do look at the selection as well where there   are some topics that are not as clear-cut as  to whether they should be selected or not. Next slide please. Well now I'm going to talk about  the creation and the membership   of the topic selection oversight panel the TSOP.

So in the autumn last year when we did our  consultation you will see that we proposed   here about the TSOP and its creation and it  was actually already signed off by the board   pre-consultation for us to implement this. So this was implemented in July last year and  has kind of been going on for a year now. It's   had quite a few changes but we're changing it all  the time as we're taking a quite an agile approach   but the biggest introduction and the change since  last year is the purple box on the screen there   where it says lay member times two, so we have  now recruited and have two active lay members   on the panel and they're already up to speed and  providing a real value to the discussions that go   on in in the panel, and the rest there you can  you can read those for yourselves on the screen   and as part of the consultation we have  also updated the terms of reference   as part of the consultation so that you can see  how that panel will work. There was also a request   in the consultation last year about the inclusion  of patient groups and industry representatives,   we feel the late the introduction of the lane  members are the patient voice so therefore there   is no need to align the topic selection oversight  panel with the committees and having that   and also we the industry members we felt that  this conflicted with nicest social balance   value judgments on three points of inclusivity  and we also feel that there are other forums   that incorporate the views of industry bodies  such as the accelerated access collaborative   which exists to streamline the adoption of new  innovations in healthcare and we did not feel   that their membership was appropriate on the topic  selection oversight panel. Next slide please. So,   transparency of decision making, publishing topic  selection decisions and the challenge process.

So those of you that was in the in the webinar  in in the autumn that we did for the proposals   last year you'll remember that I did a  poll as part of that webinar to ask you how   you felt about the topic selection decisions  and did you agree with transparency and how you   would like to see it so as you can see on this  slide there are variances across our centre.   So, for technology appraisals and  highly specialised technologies   we have that really cumbersome spreadsheet that  is really difficult to be able to find things,   the medical technologies evaluation programme  have a word document that is just a list.   Slightly easier to find perhaps than the TA  HST version and IP have a really NICE web page. So what we've tried to do is  we've tried to encompass all of   the information across those programmes  and what would work for stakeholders. So if we go to the next slide please. It might just be frozen, there you go. So, next  step, so what we're trying this is not absolutely  

what it will look like we are still working  with the developers but we are hoping that   from January 2022 we will be able to have a  better showing of our decisions on the website,   so as you see here that there will be a single  topic selection web page which will have three   free key headings and that's the decision  the reason for the decision and the date. So this will solely be for topics that are not  selected and so that way stakeholders will be   able to easily search on the NICE web page, if you  put in a drug name for example on a NICE web page   it will direct you to the topic selection web  page and you can see all of the information   there. That is something that the medical  technologies word document and the TA HST   spreadsheet won't allow you to, you have  to go and think to find that information. And then on the right hand side you will see an  actual topic web page, so when a topic is selected   the topic web page will be created really  early at that topic selection decision,   it will have all the selection information,  the routing information and we should be   able to update as we can with the most  updated scheduling information as well.

So there's a lot of collaboration  going on between topic selection,   the scoping team and the scheduling team  as well to be able to provide stakeholders   with that clear up-to-date and transparent  information on a topic in the NICE process. Next by please. So, challenging a routine decision. So, this is  something that we have gone through, or we do go   through I should say in the process but it's  not something that's been overly advertised. So this is on the routing decision that we  can receive a challenge, so you can see here   that a company or another stakeholder can  seek to challenge the routing decision.   They must submit rationale for the  reconsideration to NICE at the topic   selection email address that's there within  14 days of the notification of the decision.

Now within that we want new detail   or new data I should say that will consider  to change the panel's mind. We don't need a re   representation of stuff that has been considered  and discussed during the scoping phase. The challenge is then  reviewed by NICE and the panel   and then if it's applicable we will take that  for ratification to the NICE executive team. Following that the company is notified  of the outcome of the reconsideration,   the rationale is provided, and the information  will be published on the NICE website so that   stakeholders can clearly see what's happened  in that process and once that's happened there   is no further challenge, that decision  is then final again everything is in   this consultation document for you to review  and to comment as part of the consultation.

And then I think that that is my last  slide for today so I will hand over   to my colleague Lee Dobson to go through  the process elements with you. Thank you. Thank you Lori, thank you very much. Hi, this afternoon I just like to talk about the   overview of the proposals that we have  in the process part of the consultation.

Many of you will remember that back at  the beginning of the year we went out   for a principles consultation and these  proposals are really based upon the   consultation comments were received as  part of that consultation and we really   have built upon the feedback that you all gave  us in order to help us improve our processes. In the next slide I just want to explain  the three areas that we've covered as part   of our process consultation. So, the first of  those is alignment. What NICE has tried to do   here and has been working on for the last  a couple of years is actually creating an   aligned, unified process for all of our  technology guidance on pharmaceuticals,   highly specialised technologies, devices,  digital technologies and diagnostics   so ideally we have one process that all  our stakeholders use and engage with. And a part of that is to try and create, learn  from all the best practice in these different   groups and in these different programmes, and  trying to create the best process that we can.  

Currently our stakeholders have  different experiences and have different   rights and abilities in these different  programmes, and we want to really create a single   unified experience for our stakeholders which will  hopefully make a clear process for them as well.   It will also be efficient  for both NICE and allow us to   use those resources to help develop  this process a lot faster in future. One of the other areas we're focused on are  new ways of working not just about alignment   but how we can improve the process, how we  can make it faster, how we can make sure   we reach decisions in the best way and create  the systems in place that allows us to do that   and lastly, we've also looked at our  commercial and managed access processes.   Looking how we can ensure that we  have a good process in place to   come to good commercial decisions and  get best value for money for the NHS. And also, I have a process to get  access to patients for technologies   where the evidence space isn't yet strong  enough to give a clear yes on that technology.  

So, if we just start by looking at alignment.   When we went out for the principle's consultation  most of the proposals that were in there were very   positively received and very strongly supported by  all the consultees which was really good for us. Now those that wasn't a strong  support or there was questions we   actually sort of engaged with our stakeholders  in this period, tried to often explain in a bit   more detail what we're trying to do and  we've basically gone out and listened. One of the key things that was raised was  for our guidance for medicines we couldn't   have an option to go from the first  committee meeting straight to final   guidance without a second committee meeting,  without a consultation and we propose to extend   that to devices and diagnostics guidance  and digital health but it's clear from the   consultation that we didn't really explain when we  would use that and so we have gone out and talked   to our stakeholders we have explained that we will  be using that only where the guidance is positive   and stakeholders are in broad agreement  with that guidance. I've also sort of   piloted that scenario on our first piece of  medical technologies guidance which is for   a technology called plus sutures. So we have gone  out and explained that a lot more detail and that  

that still remains within the consultation  as well, so we have gone ahead with that. Some of the other proposals  that we had on alignment,   one of the key things in the  next slide is about terminology. So a lot of our stakeholders will be involved  in guidance for pharmaceuticals or for devices   or for diagnostics. I want to make sure that   we as NICE actually use the same  language in all those processes. They all have the same steps and stages,  and our organisations can all interact in   the same way and whether they're involved  in their guidance for a pharmaceutical or   a diagnostic their involvement is broadly the  same, it's very easy for them to engage with us   and help us develop the right guidance, so we've  used common terminology across old programmes.

One of the other proposals we had  was that the guidance consultation,   when we have a consultation may in some  cases be less than 28 calendar days. We did get a lot of feedback from our stakeholder  groups that they definitely needed that time,   and they wanted that time to make sure  that they could fully be able to comment   on our guidance so we have retained that 28  calendar days which is what it currently is. The one thing we have added in there which is  again taken from one of our pharmaceuticals   programme is that the first seven days of  that 28 days, the draft guys will be with   the main registered stakeholders in  the evaluation before it goes public   and that allows them just to prepare for  when the draft guidance does go public   and prepare their sort of stakeholders  and organisations for that going live.

One of the other areas where we have tried to  bring together the process is the appeals process   which currently happens in technology appraisals  and HST and the resolution process which is   the similar process that happens for medical  technologies guides and diagnostics guidance. So both of them now have a factual error  checking stage and then the appeal and   resolution is broadly similar as well, so  we've kind of made all the stages very similar. One of the other areas that  we've also looked to align is   for our professional organisations, that in  all of our guidance programmes they can provide   written submissions of evidence that  currently doesn't happen in every programme   so we've brought that in as well to make  sure that each stakeholder basically   can provide evidence in all of the programmes that  they want to be stakeholders in and we obviously   we want evidence and actually value that. I think  next I'm going to hand over to Mark Rasburn, Mark. Yeah, thanks Lee, so the changes we're  speaking about today will have an impact   on all of our stakeholders such as  aligning technology as Lee just mentioned   but we wanted to highlight a few changes that  improve our patient and public involvement. So, in this slide we picked out a few of the  key changes in the manual that we feel will   improve our patient and public involvement  offer. The first change is the introduction  

of patient experts providing patient evidence  across all of our programmes so for those who   have been involved in our technology appraisals  or a highly specialised technology appraisal   this is something you'll already be aware of,  but we wanted to extend this practice across   all of our non-medicine's programmes so we're  able to kind of standardise best practice   and increase the patient voice  throughout all of our work programmes. The second change is the introduction of  the summary of information for patients,   so this is something that was  actually pioneered by our colleagues   over at the Scottish Medicines Consortium  and it has been voluntary option at NICE   over the past 12 months which some  companies have volunteered to help   pilot so it might not be something that  you're unfamiliar with but its purpose is   to help patients understand industry submissions  so that they can better engage in the appraisal. So it's essentially a plain English summary and  the benefits of this summary is that it provides   a better understanding of the evidence which makes  it easier for patient organisations and patient   evidence to write evidence submissions, it helps  with the technical engagement and involvement at   committee meetings and there is a summary, sorry,  the summary is on a template which we provide   and there are guides to companies and guides  for patient organisations to help them get   familiar with the process and what it actually  looks like. The third change on the slide is   extending our written submissions across all  HTA programmes so similar to patient experts   written submissions were already in place for  most of our programmes but we're expanding this   to our diagnostics programme, so again standardise  our patient and public involvement approaches. The fourth change is the move to virtual meetings.  So in the manual we propose committee meetings are   primarily held virtually and usually open to  members of the public and stakeholders and we   feel this change will support our commitment  to openness and transparency as it enables   stakeholders and the public to see first hand  how the evidence is evaluated and interpreted,   the decision-making processes  which happen at the committee   meetings and how the consultation  comments are taken into account.

Now we first introduced this practice as  a necessity due to lockdown measures early   last year, but we found that it enables greater  patient involvement of those who may not been   able to attend our face-to-face meetings so for  reasons like health reasons, work reasons or   caring responsibilities which may have restricted  their ability to travel to one of our offices. It also increases public attendance so we're  able to cater for more observers. And in the   same way to committee members and patient experts  it reduces the need to travel to meetings and in   one of our committee meetings we actually had  over 90 public attendees which is something we   wouldn't have been able to accommodate for  had we've been meeting in a physical space.   Now we are aware we're still learning about  virtual meetings so we're constantly reviewing and   learning best practice for these meetings but the  initial evaluation across all of NICE's programmes   it shows it has had a positive impact  and it has shown to have benefits to   our patient and public contributors, and  I'm sure most of all the stakeholders. The fifth item we've listed is a  running theme throughout the manual   and that's the support offered by the public  involvement programme, and this is for patient   organisations and patient experts. The first big  change is that we've introduced monthly meetings   with patient stakeholders and these meetings  are designed to talk through the HTA process,   the support available, what information the  committee needs, share best practice of how   they can strengthen their impact and answer  any questions that organisations may have.  

We're also offering patient stakeholder  feedback on their participation,   so this is a process to systematically collect  feedback from committee members about the impact   of patient evidence and this information  is then shared with the patient stakeholder   to let them know what the committee found helpful  and how it actually influenced the decision.   So not only does this help to increase  the transparency of the decision making,   it can also help identify what information the  committee require to improve future submissions.   And the last thing we wanted to highlight  is that we're extending our exit survey so   where previously we routinely asked individual  patient experts about their experience on the   appraisals once it had ended we've now developed  a survey for organisations and this is to help us   to formally monitor their experience, identify  any successes they've had along with any issues   and that will help my team to continuously  review the patient and public involvement offer   that NICE provides to ensure we're able to adapt  and support organisations where I necessary. Now I will hand over to Jenna,  the next slide, thank you. Thank you Mark. So I will be taking you through  a few more slides focusing again on those new   ways of working that Lee mentioned earlier  and also on commercially managed access.

Looking at the new ways of working proposals that  we made in the first consultation and we received   lots of comments and some of the main issues  raised were around our proposals on the removal   of the technical engagement process which was  part of our process that we introduced in 2018. In the proposal we made in managing company  submissions with significant base case   incremental cost-effective ratios and that was  a proposal where we would potentially pause   after companies submission if we identified that  significantly higher ICER to enable discussion   and also on our proposal for the removal of  fast track appraisal processes for low ICERs. Our responses to the comments that we received,  we have not continued with the proposal to remove   technical engagement but what we have said is  that technical engagement should no longer be a   mandatory stage of the process and instead we have  described how it can be used as an adaptive step   so, flexibly to enable us to still unlock  those key challenges ahead of committee   where required but where we could  perhaps flexibly adapt our process   and perhaps not use technical engagement where  we've identified it would be appropriate. We have also continued with the proposal  to remove the individual process for   highly cost effective technologies but have  retained and described incentives for using   this approach within the standard process so, we  will continue that proposal to remove that option   but like I said we will still, you know we are  approached with that flexibility we will look   at our standard process and use it adaptively  when we've been approached with that proposal. We're also going to rename the  remaining fast track appraisal   approach to cost comparison just to  more accurately reflect what it now is.

Next slide please. I just wanted to highlight that when we were  considering new ways of working and the process   proposals that we were making we really had  to consider the key process element, speed,   cost, dependability, flexibility and quality. So, in any process if you're focusing on one  area for example if you focus on the speed of   your process there is that risk but you're  going to affect your ability to be flexible   or perhaps the quality of your process or if  you're focusing highly on the quality of your   process you're going to affect your ability to  be to be speedy or to be flexible with that.   And we need to really consider all  these elements and make sure that   it was critical to build and document the  process it's rigorous enough for clarity yet   flexible enough for a range of responses and this  is a quote that's taken from our chairman Shar.

We're really aware of managing  that tension regarding speed versus   inclusion engagement and robustness and we heard  this quite clearly from industry that whilst they   really do think we're already quite fast, if we  focused on speeding up and getting ever quicker   they were concerned that we would compromise  that robustness and integrity and the quality   of our work and their preference was  to manage optimal appraisal timing so,   that's working with industry to  recognise as optimal submission timings. We have to really think about flexibility  and what that actually means for us   and I just wanted to focus in on that word  and when we say flexibility, we don't mean   creating a bespoke process for all the types of  technologies and all the topics that we look at   and in fact doing that is not efficient at all  and does lead to a reduction in productivity. Instead, we wanted to think about  that targeted flexibility so,   perhaps imagine that 80/20 rule and the idea  that 80% of the topics that we look at would   follow that standard you know that dependable  process but 20% we could afford that flexibility,   adaptability where required and  where it's identified as necessary. So, while we've been looking at all these key  process changes and proposals and thinking about   these different elements the idea is to think  about where we can most correctly apply the   flexibilities and using those approaches like  retaining current time scales for consultation   but perhaps adapting them where necessary  so using that standard process flexibly. Next slide please. There are some other process  review proposals that we made.  

Technical engagement used across all programmes  including HST so I did mention earlier   that we would continue with technical  engagement we're not going to remove that,   but it would be an optional step not  mandatory and now across all programmes. The consideration of not using  a committee meeting to make a   recommendation in the fast track appraisal process   like I mentioned earlier that's now going  to be called the cost comparison process. Managing company submissions again mentioned  earlier when the company-based case ICER is   significantly higher than the threshold and we  also increased utilisation of the multiple HST   process and we are going to continue to  include this as an option and we don't   expect to see this process very often we think  it will be used rarely but it is good for us   to have that as an option, perhaps in the  area of reviews when we are reviewing our   HST's and we have similar products and  where that would create efficiency for us. The explanation of use of treatment eligibility  criteria used by NHS England improvement.

We have also maintained our ability to  route directly to clinical guidelines. We still think there's a case be  made for this process so we will   still have that option to move through  to our clinical guidelines programme. Earlier and wider identification of patient  and clinical experts, so we want to make sure   that we're doing the most we can to have  the appropriate engagement and input from   patient and clinical experts so we're going  to make sure that we look across from scoping   through to appraisal for our experts, you know if  appropriate and also if we're struggling to find   experts both patient and clinical experts. We'll  then look wider across the institute and look at   what other programmes have done, who they've  used, what knowledge, what they've managed to   access and whether that would be appropriate  for us to engage with as well. We included a   new process for reviewing biosimilars due to  loss of market, exclusivity and we where the   originator intervention and perhaps was a negative  recommendation and it's possible that review   doing that rapid review of the biosimilar  may result in a positive recommendation.

Terminating MTEP topics where a company  submission has not been received so,   similar to how we work now  in technology appraisals,   we feel we should really be able to draw a  line under that when we haven't received a   company submission for MTEP topic we should  be able to terminate and publish that. Next slide please. So, the final key theme for process review that  I wanted to go over was commercial and managed   access. So, we had a really overall positive  response to our recommendations which is great  

and our proposals but some of the issues raised  were we had a request to formally extend these   processes from pharmaceuticals but also to include  devices diagnostics and digital technologies. We had a mixed bag of responses regarding a  proposal to delay and be flexible regarding   the budget impact test, so this is a proposal  to perhaps pause the publication of the   FAD, draft final guidance if there are  budget impact test issues to work through.   And there was some concern on the idea  of scoping topics at guidance review   so these would be topics which  have been through managed access,   and we propose that we may want to re-scope  before we start the review of these topics. So, what was our response, so we have  developed an aligned single approach   the guidance we've used that  balances our desire for flexibility   but manages to change the treatment  pathways post the collection process. We've confirmed where flexibility might be applied  post first committee meeting so that's with the   pause if we're considering budget impact  test issues but also to allow for commercial   discussions and we've added detail on the  entry criteria and the process for assessing   proposals for managed access, including those  opportunities for devices diagnostic and digital   products. And I just wanted  to highlight that we have been  

very careful our technology diagnostic with  our descriptive learning in the manual for   commercial managed access to make sure we have  that flexibility and that adaptability programmes. Next slide please. And the final slide for me today is just to  highlight that there are still a couple of issues   that couldn't be resolved in time for this unified  manual but that we will still be working on. So,   these are the proposals for straight to  managed access process so instead of having   to go through the you know the standard process  being able to demonstrate through to rapid access   and also a proposal on how to  manage technologies with multiple   indications for example the immunology drugs both.

Both of these proposals are very complex  they require some complex discussions and   quite complex solutions, and we need to make sure  that we're engaging fully with the stakeholders,   and we have significant buy-in and we've managed  to look through and manage all the risks that may   be associated. So, these two proposals will be the  subject of our first modular update developed over   autumn and winter this year and with the idea  that we aim for publication in 2022. Thank you. Okay, thank you to all of the speakers in the  webinar so far today and we have some time for   Q&A session although unfortunately time is running  rather short but the team have been working very   busily in the background I think answering some  of the questions in written format so that's great   to see but we do have time to answer some more  questions so if I just ask the panellists just   to pop their cameras back on just so that you're  ready to go should I target you with a question. Okay, maybe if we just go right back to the to the  beginning and Lori thinking about topic selection.  

We've received a question just  asking about the challenge route. How would a challenger or a stakeholder know what  was considered at the topic selection oversight   panel in order to provide new evidence if  they would wish to challenge a decision? Well I guess this is a good question and maybe I  wasn't quite clear on who can challenge, so the   challenger would be the company or the person  that has suggested meaning the stakeholder that   has suggested the topic so it's not just companies  that we liaise with and that we consider topics by   so they would have direct contact with the topic  selection team who have regular communication on   what's happening with the topic and the outcome  so you would know through direct communication. Thank you Lori. Lee there's a couple of related questions in  terms of some potential new additions for the   medical technologies programme. I think this  is in question to the inclusion of there's a   pathways lead in the manual, an adoption lead in  the manual as well and adoption support resources.  

Can you confirm if they're new  additions from a programme perspective? Thanks Jen, no they're not actually. We're just  making them available to all the programmes so   the resources that they're using now so often  for medical technologies guidance and diagnostic   guidance we do often have additional adoption  resources that are in there to help sort of trust   so, whichever the clinical organisation using that  technology and adopt it, they're often sort of not   needed as much for pharmaceuticals but those  resources are always there available and the   pathways leader normally involved in ensuring any  guidance that's published is linked in with our   pathways as well so, it's just creating the same  options for all the programmes not necessarily   adding specifically to the  programmes. Okay, thank you Lee. Jenna, a question for you.   Will products exiting managed access now go  through a full reappraisal including re-scoping?   Assuming this might link into the current cancer  drugs fund review process that we have versus   the managed access review process we  have for highly specialised technologies. So, you may wish to help me with this Jen  if hopefully if I'm getting this correct,   but I believe that we are considering  this approach and this process at the   moment and we'll be providing  an update on that in due time.

Yeah, absolutely Jenna. I think it's key  here is that alignment and consistency   piece that we have a single process  for reviewing managed access products. Mark, there's been a question about PIP support  for organisations that might wish to influence   the data or outcomes selected  for managed access agreements.   Are the lay members trained in how  to have meaningful input into this? Yeah, so part of my team's work is we have public  involvement advisers who are assigned for each   topic. So, they provide kind of the advice  and support for all of our lay members   across the board at NICE so specifically for  health technology assessments they'll have   an assigned adviser whose job is to make sure  they're able to participate in all the work,   be able to understand what the documents mean,  where they can have an impact on the committees   on the managed access and identify if there's  any issues or barriers to involvement and address   those, so simply yes there's that support from  designated person who can provide that tailored   support whether they need a lot of support or  very minimal we are able to kind of provide that. Great, thank you Mark.

Lori, a question about charging actually. We've had a webinar attendee ask are NICE  planning to increase the charging fee   if technical engagement is utilised  in the medicine's evaluation process? Well at the moment the charges for all TA HST  evaluations are as per on the website and there is   at the moment no aim to change those charges but  when we do a charging review in the next year or   so that may result in a change to the charge but  I cannot confirm or clarify if that will happen   and what that may be at this stage, so at the  moment there is no changes to any of the charges   but please do look out for further information  or consultations as we go for a charging review. Thanks Lori and just in reference to  the medical technologies programme   there isn't a current charge is there  for companies progressing through that? No, there's not no. The charging only  applies to technology appraisals guidance   and highly specialised technologies guidance. David and Jenna I was hoping I could  approach you both with this question   maybe David with your commercial perspective  and Jenna with your process perspective, but   could you provide more details on how the  optional technical engagement could work and   when will it be decided if  to use it and what terms? Shall I kick off? Sorry I didn't say who to go first, so  Jenna if you go first and then David please? No problem so of course probably I should have  stated that when we considering perhaps making   a technical engagement optional or not using it  within a process we would always discuss this   initially with the relevant company  that's involved and we would always   make this a decision that we've made in discussion  and making sure that we're communicating   appropriately so, it will be  something that will be decided   when it's been identified as appropriate and when  we've had these discussions in advance as well. And with the commercial hat on Jen,   I think we are exploring how we may use technical  engagement where to help manage the uncertainties   commercially or through managed access earlier  and spark some of those conversations earlier.

You'll see from the process going  around commercial managed access   we're pushing to get conversations and decisions  happening a bit earlier in the process rather   than after committee although potentially  allowing some time after committee for   i's to be dotted and t's to be crossed  so I think there will be a commercial   and managed access element to the decision  as to whether to go to technical engagement.   I'm assuming however and Jenna you may  be more appropriate to comment on this   there may also be decisions made on the basis of  the data being presented and uncertainties and   trying to get better hold of that data, get  improved data in before we go to committee. Okay, thank you David, Lee a question for  you maybe? We've had a couple of these as   well in a similar theme. Will the modular  updates be subject to further consultation? Yeah, I think there's so much for us  that we could possibly have covered in   the in the consultation, but we couldn't  obviously include everything, so I think   we don't plan to update the processes and  methods manual as a whole next time but   come along with these modula updates. I think  we'll be coming out to consultation engagement   with our stakeholders as well to make sure we  can get those modular updates right as well,   so we'll be further engagement even after  this particular manual is published.

Thank you and Jenna sorry, targeting you with  another question, process is so wide-ranging   isn't it? Could you explain how NICE is working  to align timelines with project orbis and what   new ways of working might be introduced to  support this and Lori if you also want to come   in on this as well from a topic selection  point of view as well but Jennifer first. Absolutely so we do have engagement with system  partners regarding project orbis so we are always   in discussion with the MHRA and but also with  NHS England and with our partners at the SNC   in discussion. You know we're making sure  that we're speaking to companies and asking   for early engagement from them, we really you  know want to hear from them on their plans and   make sure they contact us early with any changes  or information that they can provide us. We're   assessing whenever we're made aware potential  projects orbis topics confirmed or you know even   in advance of application. We're assessing  the scheduled comment schedule that we have   against expected maximum authorisation to  make sure that we're as quick as we can be. We're speaking to companies  if we feel there's maybe some   flexibilities that we can make  to our processes slightly quicker   so like we've discussed today there's adaptability  of our processes and managing that in the best   way in agreement with companies if we feel  that we could perhaps speed up the process.

But we were also discussing with NHS England  when there perhaps is a large gap between the   process and final publication and  marketing authorisation and we're   having discussions with NHS on where that  might be apparent and what can be done. Thank you. Oh sorry Jen just to echo what Jenna said.  Jenna and I have both been working quite  

closely with companies and system partners  as she's outlined here on trying to find out   the best data that we can and in addition to that  all of that information is fed to the innovation   observatory so the National Institute for  Health Research Innovation Observatory is   also known as the NEREO up in Newcastle and we  kind of let them know any early intel that we   get for them to be able to pass the topics  for us to enable them to move quite quickly   and swiftly through the topic selection process  but I guess as with anything engagement is key   from companies as well so please if you do  know of anything and you have that early   indicator internally then please do get in touch  with either Jenna or I because that really does   speed up the conversations and help us and help  you and speed up access through the process. Thank you both, so Lee and there's  a question around the manual really.   Around what we've published on the processes and  there's a question about whether we'll supplement   the manual maybe with other documents published  around the process. The question reflects on  

the manual being quite focused on methods and  doesn't perhaps provide enough guidance on some   of the key process options such as fast track  and so on so, what are your thoughts on that? Yeah, I think we have focused on creating   the process side of the options and  the steps that we have available,   but I think one of the areas that we weren't able  to sort of get into the document before published   it was some diagrams an explanation of the  milestones and the time scales and the routes that   that the technologies will follow through these  options as well. So we'll have that for the final   manual, I'll just hold our hand up and say we  weren't able to get that into this draft stage,   but it will be. I understand the kind of the point  that's been put across, but it will be much more   explanatory and hopefully we'll give it  give a lot more clarity in the final manual. If anybody's got any ideas or suggestions for  how we could do that it'd be great to see those   through in the consultation as well.

David perhaps one final question for you, Jenna  talked about the new process for loss of market   exclusivity. Do you want to just give us a  quick flavour of what that might look like   and why we've implemented that or why we're  proposing to implement it I should say? Wow in five minutes! So I'll be brief the top line  is that where the problem we have is that where   products lose their marketing exclusivity and the  originator product hasn't had a NICE approval,   there is no funding mandate in place for those  biosimilars to be used if they are cost effective   and no way for us to find out from NHS England  as the commissioner to find out if they're cost   effective so we were trying to find a solution  to that that was pragmatic, that reduced costs   to all sides and the intention overall is to is to  have a pragmatic relatively quick process similar   to the FTA process where there's some committee  input but not a full committee meeting so that   any decision can come with a mandate. We are just  been on a call this morning with the commercial   medicines unit at NHS England to think about  how we really align with their processes but   yeah we're looking to make a recommendation based  on the original appraisal but looking at whether   evidence base or pathways changed or simply  whether costs change and if cost has changed   is the only thing that's changed significantly as  a result of bison was or generic products coming   then we may be able to make a recommendation that  comes with a funding mandate. We are working out   some of the procedural detail behind this at  this point in time. I think the other thing to   say one of the key things that came through in  the consultation on the very similar piece was   around the scope and clarifying the scope in the  consultation document, so we are considering that   generic and biosimilar products are included  where the originator got negative guidance.   We are considering that we may be in a position  to review optimised recommendations where   there's a biosimilar involved with the view  to potentially widening the original decision   and we are not in a position at this point  in time to review drugs that haven't had a   submission made to NICE because we just  have nothing to work, So Jen back to you.

Thank you David so we've only got a few minutes  left of the webinar so just to come back to   the webinar that we're going to be  hosting tomorrow for those of you   that want to return to listen and for  maybe colleagues and friends and peers. So, we have a webinar that's focused on  some of our methods proposals particularly   the modifiers that we're proposing to introduce  and that will be held tomorrow between 2 and 3   pm and there's still chance to register if you  haven't done that so far and the link is there   but you can also find that on our website  as well through our consultation webpage. And the final thing just to say as well is thank  you for coming today and for listening to the   webinar and for entering your questions  as well they're all really informative   but please do share your views through the  consultation and of course those views where you   might disagree with the proposals but also if you  do agree with proposals it would also be helpful   to see where there is that consensus agreement  as well across our stakeholders if we have it. Well, thank you very much please do go  to the website and take a look at the   consultation documents. It closes  at midnight on the 13th of October   and thank you for your attendance  today and we'll see you soon. Thank you.

2021-09-15 03:33

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