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