CADTH Drug Portfolio Information Session
Good morning everybody. Welcome. To today's. Drug portfolio. Information. Session this is our annual, review, of. The pharmaceutical. Reviews, program, and. Changes. Related, to the work that we do within the portfolio. And across the organization. My name is brent fraser, i'm vice president, of pharmaceutical. Reviews. Next slide. Just a brief outline, of the agenda, today. We'll have opening remarks, by suzanne, mcgern, who's our president, and ceo, of cadif. I will be providing, a brief, overview. Of. The pharmaceutical. Reviews portfolio. Focusing. On a couple of areas, and trevor, will be providing, the, main. Update, on program. Changes, he's the director, of the, drug, pharmaceutical. Reviews, program. We also will have some presentations. Um, by nicole, mittman, who will be talking about real world evidence, deliberative, frameworks, and scientific, advice, and she's our vice president, of, evidence, standards. And she's the chief scientist. For cadif. Heather logan who is the, executive, strategy, lead will be providing, an update on, living reviews. For covid19. Treatments. Sarah berglis, who's manager, of patient, engagement, will be, talking about patient, engagement. And some of the changes, related, to those activities. And randy allen, who is the director, of communications. We'll talk about some of the changes that we'll be making, to the cadith, reports. We'll then have an open forum. And. Wrapping up at the end of the, session. Next slide please. So just some housekeeping. Uh. Items. Please submit, your, questions. By clicking on the q a tab that is in the zoom, control, bar so that's either at the top of your screen or the bottom of your screen. Please note that we will not be taking, questions, during the presentations. We'll be holding them off until, the. Open forum, at the end of the presentations. Also, the presentation. Will be recorded, and it will be posted, on caddis, youtube, channel, later, this week. So i will, uh hand it over to suzanne, mcgiren, to provide some opening remarks. Uh thank you very much brent, um i'd like to welcome, everyone to today's, event as well. I'd like to start with a territorial. Acknowledgement. And. Let folks know that i'm speaking to you today from just outside, of ottawa. Which is on the traditional.
Unseated, Territory, of the algonquin, and ishinobi, people. But i spent most of my life living just north of napanee, ontario. On traditional, land that has been inhabited, by indigenous, peoples from the beginning. Including, the mohawks, of the bay of quinte, and other member nations, and it is still home to many first nation and metis people. These indigenous, nations, committed, to mutual, sharing obligations. And responsibility. As stewards, of the land and the water. Today these responsibilities. And obligations. Extend to all people. Our canadian. Lands are steeped in rich indigenous, history. Traditions. And modern cultures. That are proud and. Vibrant. I encourage, everyone, participating. Today. To take a moment and reflect about the land from where you're participating. And the people that have come before who are stewards, of that land. For those of you new to catholic events. Catholic is one of the pan canadian, organizations. That is funded primarily, by the federal, provincial, and territorial. Governments. To provide, evidence, to support, policy, and health care decision makers. In assessing. Introducing. And managing, health technologies. Including, pharmaceuticals. With the objective, of achieving, better outcomes, and value for canadians. We are commonly, referred to, as a large hta. Producer, health technology, assessment, producer. I'm very proud to have joined katith, recently. This is the first time that i've had the privilege, to meet with this group. For those of you who don't know me. I'm still the relatively, new ceo, and president. Last week i reached my hundredth, day. Mark. My background, that has led me to katith, includes, a career as a nurse, augmented, with a masters of public policy. Over my career i've held numerous nursing, roles in. Almost every sector you could imagine. As well as much of the last two decades, have been working as a civil servant in ontario. With responsibility. For physician, services. Ohip. Health human resources. Drugs and devices. And i've, also had the opportunity. To serve on caddis board. And be the inaugural. Chair of the, pan canadian, pharmaceutical. Align. The pcpa, the canadian, pharmaceutical. Alignment. As well as most recently, when the pandemic, arrived, i was actually spending my time running the, uh. Provincial. Of, correctional, facilities. Certainly was an interesting, time and and has really shaped, um. My thinking about evidence, as i've come to cadiz. I thought perhaps the right place to start today, was just to talk a little bit about, the recent catas symposium. Uh. The theme for the catholic symposium, which just occurred a couple of weeks ago, decision-making. In an age of uncertainty. Ironically, was chosen, well over a year ago, and it seemed very relevant, at the time. It was chosen, during a period of time when it felt like there was a perfect storm. Health system transformation. Was underway. Many things contributing, to the uh. The, uncertainty. Including, discussions. About. National, drug agencies. National pharmacare. Program. Our review of organizations. Like cadith, um inc, about. Uh, how, how did they need to support. Decision, makers into the future. Never-ending. Conversations. As i'm sure all of you on the phone are aware of, about affordability. How did we think about being able to benefit, from all of the promising, and disruptive, technologies. Uh what with the concerns, of affordability. All of these factors, produced a heightened sense of uncertainty. Which, made the theme for the symposium, very. Relevant. In my former, job as a civil servant and. Being responsible, for running programs. Uncertainty. Has been a fact of life. It, it is never a circumstance. Where with a new drug. I shouldn't say never, rarely. With a new drug, medical device, diagnostic. Tool or surgical. Intervention. Do we have all of the information. That we need, to be able to inform. Decisions. Whether you're a decision maker, in a government, a health system. A patient, a clinician. A policy, maker, a manufacturer. Of technology. Or a payer. That's sort of what the world looked like as i, made the decision to move to canada. And then coven, 19, happened. And as we all started, using. The hourly, or often more frequently, word, which has now been determined, to be oxford's, word of 2020. The unprecedented. Circumstances. Of 2020.. It wasn't just that the thieve, of uncertainty, was front and center. It became integral, to every aspect, of our everyday, life. Although there was a great deal of uncertainty, back in march. And early april, there was also a need for quick and decisive, action. And a demand for timely, evidence.
And That demand, took on a new tenor, and that tenor has continued. It's brought into sharp focus, important, dialogue, about evidence. Quality. Timeliness. Certainty. Or often more, often more oft, more often uncertainty. And how we talk about, and understand. Evidence. Particularly. By, the public. I know myself, i was glued to tv, in april and may to watch the governor, of new york updates. In part because, i was so intrigued, by how much, evidence he was able to communicate. Both of what was unknown. What was known, and where they still had lots of questions. With such simple slides, and in a way that was understandable. To people. So when i joined katyth a little over a hundred, days ago. I moved into a place where i'm now leading an organization. That produces, evidence to help decision, makers. Make these informed, decisions. And the role of at the same time that the role of evidence has changed completely. How daunting, it, feels to have a mission, of, consistently. Delivering, credible, scientific, evidence, and management, strategies. That enable the appropriate, use of health technologies. Where over the last nine months it's often felt that we're spending, days where we're flying by the seat of our pants. Even though that we've had the, greatest, leadership. Access to the best researchers. In public uh public health minds. It's still. Very difficult. To be able to make the kinds of sweeping, decisions, that need to be made. When there is. So much uncertainty. So. The virus continues, to transform, our everyday, lives in hundreds of ways big and small. From who we see. Where we work from social distancing. To masking, to washing, our hands. And as i was uh. Sharing at, the session earlier, this week, where we're having conversations. With news anchors talking about when was their last handshake. Was it before, or after. The covet, hit, you know and conversations. About will we remember, how to hug. Conversations. That were imaginable. Less than a year ago. So, i'm at cadith at a point in time where we're faced with. Looking forward. To a world that, hopefully, will have have learned many things, there's things to draw on that were normal before the pandemic. We've learned many things during the pandemic, that we will want to build on, and there's many things in the future that we don't yet know, so we'll be starting our strategic, journey, in the near future. And, i think for all of us we have lots to learn from this experience. I do want to thank everyone, who's on this call. Here at cadif, at other health technology. Groups, pan-canadian. Research, organization. Academics. And most of all. Industry. The industry, has certainly, stepped up during this time period and i think for people who do see. Perhaps. Some. Return to normalcy. In the future, it will come from, the innovations. And the response. Of, uh. Pharmaceutical. Industry, and other technology. Industry. To this. Although, always, talked about, i think truly. A, poorly imagined, future. So thank you all i look forward to hearing the discussion, today, and moderating, the questions, at the end. Please feel free to jot your questions, down as individuals, are speaking. We i will be able to go back to them so as questions, arise please feel free to jot them in but we will not take those questions to the very, end. So at this point, i'm passing, it back to brent to introduce, the next speaker. Thanks suzanne. Next slide please. So i'll focus on the, first two parts of, this.
Update, Related, to the covet 19. Impact, on our reviews, as well as the transparency. Initiative, and as i mentioned, trevor will be speaking, about. A number of the updates, that have been uh implemented, within the pharmaceutical, reviews, program. Next slide. So as mentioned. Many of us were all dealing, with the impact of covid19. Earlier, this year, a decision was made that we would shut down both the toronto, office and the ottawa, office. Fairly early in the pandemic. Fortunately. Though, the drug review, timelines. Have been. Kept up to or, kept up. And we've been able to complete, our reviews, within, our targeted, timelines. We have not had any specific, delays, related, to covid19. However. There were, some submissions. That were pushed out a little bit, because the manufacturer. Had made a decision, to hold off at that point in time. And delay the submission. Some of the rationale. For that, was related, to the impact, of covet 19, on, their. Own. Companies. We didn't have any delays, with respect to our expert committee meetings, and, fortunately, we're able to shift very quickly. To a webinar, format, with our. Expert, committees. The virtual, format, has been, i think. Quite an experience. And, we've learned a lot, through that. Initially, when we had talked about this in the past there was a lot of hesitation. But i give a lot of credit to, our committee members, because they were able to, shift very quickly, to the virtual, format. And i think that they have been a good a great success. We've also started shifting a number of our meetings, into, a virtual, format. Or through teleconference. Our pre-submission. Meetings. Our checkpoint, meetings. To take advantage, of this technology. During this particular. Time. We have made a few accommodations. And support, with for, clinician, submissions, and patient, submissions. That have been uh. Impacted. By covid19. So if there were some challenges, related to the timelines. Which are fairly, tight to begin with but even more so, with the impact, of covid. We were able to, extend. Some of those timelines. So that we could get the information. Included, into our reviews. And as many of you know, um, we had to delay, some of our, consultations. Um. And, as a result, of that. We impacted. The, uh, implementation. Dates, for, some of the changes, that are related, to. The alignment, work that we've been undertaking. For a little over a year now. Next slide. One of the key things i wanted to speak to folks about, is the transparency. Piece and as you know from our previous. Consultations. And webinars. Transparency. Is something, that katith, holds. Very, highly. And, this is one of our key values. And it is important. That, we, reduce. The amount of redactions. Within our reports, and try to be as transparent. As possible. We've had two consultations. On a proposed. Proposed, changes, to, our, transparency. Guidelines, our confidentiality. Guidelines. We've had a number of discussions. With the industry, liaison. Forum. And some individual. Manufacturers. We do appreciate, the fact that industry, has concerns. Related, to some of the changes, that we are looking to introduce. And there were some, concerns. About, whether that could impact, the, percent, of, submissions. That are provided. At a pre-noc. Stage. I think it's important, for both cadith, and the manufacturer. That we try to, maintain. That level, and increase, it because, it does reduce, the gaps. Between. Health canada's. Nlc. Decision. And, our. Recommendations. Coming out of the expert committee, so that minimizes.
The Gap between those two. Points. And this isn't really just katif, that's dealing with transparency. Issues i think almost, every hta. Body, is looking, at making, some changes, to help increase. And enhance, the level of transparency. Within the work that they do. We've seen a fair bit happening, on the regulatory. Side. And, i think you'll see over the coming years. Significant, changes, related to the hta. Work, and all of this really is to support. The evidence, that is used. Uh, to inform, our decisions. And for us to be very clear, about, why it is, that we've made the recommendations. That we've made. What we're looking at for disclosure. Is that all clinical, data. Indirect, comparisons. Prices, that are public, prices. Not sorry, um, not, any negotiated. Prices we don't have access to that information, to begin with. Our economic. Methods, and the outputs, to all be disclosed. And, there is some more detailed, information. That. Will accompany, that when we actually do implement. The changes. What we will continue, to consider, confidential. Is information, related, to market share. Uh manufacturer. Specific, forecasts. Related to the product that's under review. Any specific, implementation. Plans that are provided. To us to, deal with. Some of the more complex, technologies. As well as any data, that, meets health canada's. Definition, of confidential. Business. Information. Next slide please. So in the interim. Uh because, we, we did receive, some very substantial, feedback, on transparency. And so thank you very much to everybody who did provide, feedback. We have been, following, up on a number of points that have been raised. Within those submissions. And, recognize. That we wouldn't be able to, implement. The changes, at the same time that we are implementing, some of the more procedural. Or operational. Changes, related, to the drug review program. So in the interim. What we have done, is adopted, the guidelines. That have been used, for the, non-oncology. Review. Products. And. Following, through, on, that, process. As the interim, step. Redactions. Will occur, after the reports. Have been drafted. And, but i really want to emphasize. That we are still, very much committed, to enhancing, transparency. And we will be making, changes, to how we process, the redactions. And, minimizing. The amount, of information. That is redacted. Within the reports. We will continue, to discuss, some of the options. With industry. As i said, we. Have taken the feedback. And, have a lot of discussions. Internally. And with some of our, partners. To understand, the implication. Of disclosing. Certain pieces of information. Such as, for example the pharmacoeconomic. Price. Which was highlighted, as a key concern. In the manufacturer. Submissions, to our consultations. So we are, seriously, looking at the those impacts, and seeing, what can be done. I suspect, at some point there will be, minimal, redactions.
To Deal with some of those issues, as we had identified. As continuing, to be confidential. But we're also hoping that that will be. To a minimum, as much as possible, as well. So, on the next slide, i will hand this over, to trevor, to provide, an update, on the pharmaceutical, review program. Thank. You. Thanks brian. Uh so i'll provide an update on, some of the changes, to, the drug review, programs, at cadith. A lot of these, really have. Been shared. In, various, forums, and through various, other vehicles. Previously. So not, too many surprises. To most people. But hope to to bring everyone at least up to speed. As to where we are. Right now. So we can move to the next slide. And the next. So in terms of committee, updates. Uh, as you know we we have regular, calls, for nominations. For. Media members whose, terms. Are, set to expire. To fill those positions. According, to our. Standard, procedures. There, so just in terms of an update, in terms of changes to the committees. I would like to thank, um two outgoing members, one from cdec. And one from perk. Uh that is rakesh, patel. For the former, and, uh flea charger, for the latter. And. We are, looking, to fill those positions. And we'll make an announcement, in the the coming weeks. As to uh who will be replacing, those two individuals. Uh so thanks again for their, uh. Exceptional, contributions. Over the last couple of years to those committees. We have. Appointed. Several new, committee members. To. Perk and cedec. Notable, uh, is the, the first appointments, of. Specifically. Ethicists. To cedek. And perk. So sally bean, is the ethicist. From, sunnybrook, who will be sitting on c deck. And, jennifer bell, is, uh, her counterpart. Um. Taking the ethicist, role. For perk for oncology, reviews, and she's uh by ephesus, from uhn. And then, dr andrew, she, and. Dr irene, sadek. Are respectively. Two additional, members who have been added. To the cdec committee, to essentially. Staff, a new subcommittee, of cdec. Which is the. Which is called cpac, or the plasma expert committee. And these two individuals. Have extensive. Experience. In hematology. And, are specifically. Being appointed. Have been appointed, to. Assist with recommendations. Related to our new, process, for reviewing. Plasma, related. Drug products. So we can move on. So just. This information, is available, on our website. But just uh to give you an idea of who the committee members, are. So on the left side and cpec. Jim sylves, of note is the chair of that committee. Um cpec, as i mentioned. Really comprises, the addition, of the, two hematology. Experts. And perk, uh. The chair there remains, uh dr maureen trudeau. And uh obviously, just to reinforce, in case you weren't aware that uh perk. Is. The remit for that committee, is focused, on oncology, reviews. Uh whereas, cdec. Focuses, essentially, on everything that's, not oncology. So we can move. On. So of note, um, we had we will be changing, the, uh the the meeting. Timings. In terms of. When cdec and kirk, meet. Typically, historically. Both expert committees, have met in the same week in fact, on consecutive, days, the first wednesday and thursday of every month. Respectively. For cediac, and perk. Have. From april of next year though we will stagger, these meetings.
Such That there will be, a. A week between, the two expert. Committee, meetings. Uh, so pro concede, will now be staggered. Uh by a week. So a variety of reasons, for this. But really it's allowing, us it does allow us to to make better use of our. Resources. And meet some of the the substantial, challenges. That we run into when uh these these expert meetings. Uh run for for instance more than one day. Um there there tends to be overlap. Um and obviously you can imagine. Um it's not an ideal situation, so, just of note that we will be staggering, the the committee meetings. Um. Starting in april of 2021.. We can go the next slide. So we've talked a lot about alignment. Over, probably, in excess of the last, year. We have. As of october. Officially, launched, our. Harmonized. Or aligned review process. And i'll just cover some of the highlights. In terms of changes to that process in the next few slides. We go to the next slide. So just a little. Recap, of of how we got here. In terms of harmonizing. The catastrophe. Processes, for reimbursement. Reviews. Uh consultations. As you probably aware, were. Essentially, open. From, june. Of this year june 25. To august, 10th. We received. Well over 80. Responses. In terms of feedback, from a variety of. Organizations. And individuals, from, patients, to. Public, payers in industry, and consultants. We obviously took uh. Our time to consider, all the feedback, the the considerable, amount of feedback. Before, finalizing. Exactly, um which are proposed, changes we would go ahead. Uh and implement, brent already covered, the transparency. Changes so i won't go into those. But essentially, the the new aligned, procedure. For. Reviewing. Drugs, for, reimbursement, recommendations. Um. Was. Implemented. In. Late october. We did communicate, this. Preceding. That. On september, 30th. And. I think of note is that, reviews, that have been received. After. The october, launch date. Will, reach the expert committees. For recommendations. To be delivered. Following the april. 2021. Expert committee. Meetings. Go to the next slide. So another change, is. That we have consolidated. All of our various. Communications. Related, to, reimbursement, reviews. So rather than having to subscribe, and receive. Multiple. Uh. Email communications. Related to various aspects, of the programs, and specific, reviews. We're now consolidating. Everything into a, master communication. If you like. That'll include. Essentially the following, information, that's on the slide. But really of note, open calls for. Opportunities. To provide. Input, and participate. In the reviews, for. Patient, groups and clinician, groups. Uh calls for stakeholder, feedback. On draft recommendations. And provisional. Algorithms. Also notice, of our final recommendations. And algorithms. As those are made available. And then we'll include. Um, a major. Updates, to the program, in terms of announcements. Within that, communication. As well. I believe there's no action needed from anyone that has subscribed. To any one of our. Communication, vehicles, we will have transitioned, you. Without having. You. To have you resubscribe. To the new updates if there are any issues then, please reach out, to myself, or the rest of my team. We can move on. So following the same, vein in terms of harmonization. We are consolidating. Our web pages i know this will be good news for a, small number of folks that. Rely, uh rely on this information, and. Have had. The challenge, of navigating, our various. Portals, and web pages to access, this we are consolidating. All of this. Now. This is, imminent. But you can look forward to. All of our reimbursement, reviews, being presented, on a common, web, page or portal. Some key changes, they're summarized, there but we will, have a single, summary, table for all of our reimbursement, reviews this will not be split.
Any Longer between, p coder, and cdr, for instance. Also it'll, contain all the information, you need, for any of our reviews, that are, being conducted. Again. Sort of one-stop, shopping if you like. As well as opportunities, for stakeholder, input, and feedback. We also will have, all of the latest. Templates. That. You could use, for, the various parts of the procedure, and process. Made available, on the consolidated. Web pages. As well as, publishing. Our meeting schedules, for the expert communities. We can move to the next slide thanks. So just an update on the clinician, engagement. Process. Just to recap, where we, do use, our clinical, experts, in our review processes. We do engage. Multiple experts. On each of our reviews. They as, noted on the slide they provide. Various forms of input but particularly, advise, on our, research, protocols. Uh. Helping with, appraisal, of clinical evidence, interpretation. Of that evidence. And probably most importantly. Helping to eliminate. The place in therapy. We also have, expanded. Clinician. Engagement. To establish. Clinician, panels, for. Complex, reviews. Where we. Expand, upon the the core, expert, pool that's retained for each review. To include, multiple, other experts. To advise again on on, the placement therapy, and unmet needs and really anything. Uh, that that. Is related to the review that requires. Expert, input, we. Have the the panel process established. And where possible, in fact, have. Aligned. That process, with. Our counterparts. At ns. So that we're able to, in most cases. Hold. Joint. Clinical, panels for engaging. Pan-canadian. Experts. Together, with ns. We also have now expanded. The ability, for clinician, groups to provide. Input, and feedback, into, all of our reviews, going forward. So this was previously. In place for. Uh the key coder or oncology, reviews. But we now have expanded, this. To allow. Input from any clinician, group for any, product. And will it will also be expanded, to allow this for draft recommendations. Going forward as well which is new. We can move. On. Just a little bit more on the clinician, input process i know this, says. In the subject, of some discussion, and questions so hoping to provide some more clarity, on this. Uh previously, for the oncology, review process. Individual clinicians, were. Able to provide their input. Because we've expanded, this to. All of our reviews, at cardiff. For, reimbursement. Reviews. The.
Volume, Is substantially. Greater. And we'd like to. We've essentially, harmonized. The process, for. Dealing with clinician, input. Such as we're focusing, on. Asking for that, input to be provided. By. Groups, of clinicians, or associations. Rather than individuals. So we're encouraging. Individual clinicians, to work together, with their peers. To provide, joint submissions. Which will. Not only improve, the quality but, it will reduce, redundancy. Um and. You know up notes the administrative. Burden. For the catholic team in dealing with that volume, of input. So really wave. The core, message, here is that we've taken. Um. What was a very popular, process. At p coder and now expanded, that. As i said to all uh reimbursement, reviews. At caddis, and are very pleased to to offer that ability. For for any clinician, to provide input. Into, any review. As i said important, is is to encourage them to work. Together, to be more efficient. And therefore. More effective, in providing that input as a group. We can move on. A little bit about sponsor, engagement, just to recap, where we are with that. Sponsors, will have the opportunity. To review, and comment, on. The, draft reports, those are the clinical and economic, reports for reimbursement. Reviews. Prior to the committee, meetings so this will be, something that is new, on the oncology, side. So we're very pleased, to be able to provide. An opportunity, that has been in place for the non-oncology. Reviews. To all reviews, essentially, now for reimbursement. Recommendations. At cadith. So sponsors, will. Have an opportunity, to provide, comments, during. The review process. And. As you know, we will continue, with our process. Of. Providing. Uh written responses. Uh to those, to that input. Of note checkpoint, meetings. From the picot, process. Because of the, this, and some other changes, are really. No longer relevant. We've replaced. Those checkpoint, meetings. With more rapid, ad hoc, communications. Directly, between. Ourselves. And the sponsors, to clarify, issues, during the review, rather than waiting for. Uh one point, in the review. Um. Also having provided clarity, on the, transparency. Initiative, and and what is considered confidential, and not this really obviates, the. Uh, the discussion, that, usually happened, at the checkpoint meetings about, disclosure. Of disclosure, of information. An important new offering is also the the ability, for, uh sponsors, to meet with and discuss. Uh, requests, for reconsiderations. Of recommendations. Uh with cath. So we can move on. A little bit more about drug plan engagement, so we have made some changes, to how we. Engage, with. The drug plans and cancer, agencies, to harmonize, this across, all of our reviews. And really the key there, is, that we are looking to the drug plans to provide us with. Greater, definition. On what. Might be implementation. Issues for a particular, review. This is getting into the weeds a little bit but, we are harmonizing. This process, in terms of. Where we engage with the drug plans and cancer agencies. And how that. Information, is used in our review process it will be. Moved to be, uh. Sorry. It'll be gathered, early, in the the review, phase so that it is able to inform. The entire review. And. Also this information, will be included. In the review reports, which as i said earlier. Are made available to the sponsors, for their review. And feedback. And then this will continue, through, uh discussion. At the committee meetings. And eventually, will. End up being included, explicitly. In the recommendations. Themselves, which again. Will be provided, to sponsors, in fact. Publicly, to all stakeholders, to provide, feedback, on this and any other information, in the recommendation. There is an implementation. Phase that that could be triggered. To address. Implementation. Questions, or issues that. The committees, are unable, to address due to limitations. That they face. Being required, to essentially, base their recommendations. On. Objective, evidence. The details, are available, in our procedures. On this. But this can be triggered. Subsequent, to a recommendation. Being issued, and will focus, on providing. Implementation. Related, advice, to, the drug lines and cancer agencies. We can move. On. In terms of the clinical review process, the, the top line really, says it all uh, no major changes to that. Process. Suffice, to say, the harmonized, process will mean that the the key milestones, and approach will be, the same for all drug review, um.
Drug Reviews, at cardiff. For recommendations. Um, so. We will continue, to do a systematic, review, as the the core. Vehicle, for assessing. Evidence. On the clinical, side, obviously for for everything except the dictated. Review process. Um. We will as i said, we have harmonized. The, not only the process, and procedures, related to the reviews. It's, themselves. But, we will have, a common template, that will be used for all reviews. As well as the, the same procedures, and milestones. So, this will hopefully, alleviate, some of the. Potential, for confusion, with, multiple, processes, having been used. Previously. As i mentioned a major new. Offering there is the ability for sponsors, to review and comment, to provide feedback, to us. On the draft reports. We did discuss. The potential. For. You know. Aligning, with, the approach, of some other international, hda, agencies, in. In uh, requesting, that the sponsor, file, the systematic, review. To katith. Um, we are still considering. How that that could be implemented. As i said that's, not going to be implemented. Right now. But, just just bear in mind that if, if this change. Were to be proposed, we would of course. Consult. Publicly, on that before, doing anything. And uh if if we were to make any changes. Um, not only for this but as as applies to any changes at the program. Um we we will uh, consul, sorry notify. Um. Any, individual. Organizations, or stakeholders. Well in advance. Of launching anything to allow for for adequate, preparation. So we can move on. So an update on the economic. Review, process. Um so of note here, is the. The. Change, to. Reintroduce. The ability, for sponsors, to file. Cost minimization, analyses. Or cmas. For certain submissions. There are a number of reasons for bringing this back. Including, efficiency. And aligning. With, the approach of. Other hta, agencies. Um. And uh obviously this has been a request. From, numerous sponsors. For some time now so we're happy to be able to bring this back. As an offering, for the, drug review processes. Reminder. Further details, on this are available. From us. On the website and in the procedure, document. But just briefly, to recap, where, a cma. Would be considered. To be an acceptable. Form of economic, analysis. Um they're summarized, on the slide there but it's essentially. Where there are other options, available, and reimbursed. By the public. Payers. That. Treat the same population. As, the drug that, is being submitted for review. Obviously that that's the requirement. The second i think is probably the key requirement. And, it's probably, the most, difficult. To get clarity, on. However, um. For a cma, obviously a requirement, would be that, the new product, is at least, as clinically, effective. As the comparators. Uh whether that's based on ideally, direct. Or. Indirect evidence. Um that has to be a requirement, that's that's demonstrated. As well. And then finally. Um. In terms of the cma. The the new product, would need to. Demonstrate. That, um they're not increasing, the cost burning, burden, to the public payers. As well as, i think going further than that. Demonstrating, cost savings would make a compelling, case for a cma. So i think the top line is what i left. To last. So while we're offering the opportunity, to. Accept, a cma. Where these conditions. Are met. You can appreciate, that. It's, impossible.
To, Definitively. Determine. Whether all these conditions, have been made until you're actually. Finished out of the process. So it's it's really incumbent, on, a sponsor. To. Provide. Enough information. Um, to allow us to determine. That these conditions, have been met during the review process. And uh ultimately, the decision, of whether to do cost minimization. Uh versus the cost utility, analysis, is, at the discretion, of the sponsor. Uh, the top builded again. Our position, is that. The cost utility, analysis, or the cua, remains. Cada's preferred. Form, of economic, analysis. And we would never. Not accept, a cost utility, analysis. Even where, a cma. That may be appropriate. We can move on. So in terms of recommendations. In the format. In the context, of. Harmonization. Or alignment, we will continue to use the recommendation, framework, that. Has, been in place. And in fact is. Common to all of our drug review committees, for for, some years now. Um in the interim, um, nicole mittman, and her team. Are working. On potentially. Updating. The deliberative, process, to harmonize, this for, the drug review. Committees. And. As, this develops, we will of course. Provide, information. Publicly. On potentially, any changes, to that. It's really status quo right now in terms of how we proceed. With the proviso, that there might be some changes in terms. Of the logistics. To harmonize. The committee. Functioning. I guess in terms of the recommendations. Themselves, so randy will present. Um. Some updates, to, to the. Uh the products that we produce. In terms of the format. Of those as well as presenting, some some new products in terms of the recommendation, formats. As i mentioned the aligned, reviews, or the harmonized. Process, will have its first. Recommendations. Being generated, after the april. 2021. Expert, meetings, and from that time. You will notice that the, format of the recommendations. Will change. Uh, for for all of our expert committees. Um some will be. A more dramatic, change than others. But the key is that the the format will be the same. And, it'll really, borrow, on, uh. Two of the the strengths, of. Seek. Cdr, and p code respectively. Summarized, on the slide there but. We will, have a new format for presenting. Um. Conditions. And, reasons or the rationale. For those conditions. For individual, recommendations. Um, in a consistent. And clear, manner. Kind of in the way that you see those recommendations. Coming out from cdc, right now, that will be applied. Across the board for all of our reviews including, oncology, reviews. We also will be, updating. The format, to provide, a clear, greater clarity. So greater emphasis. On, potential, implementation. Issues i touched on this earlier but those will be. Clarified, and highlighted. Distinctly. In our recommendations. Going forward from april. And this really, is building on, experience. Uh. In this realm. Built through the the p coder process through perk. We can move. On. I mentioned this earlier but just to re-emphasize. That uh this this is, new, for us um but we're, very pleased to. Be able to, offer the opportunity, for stakeholders, to. Review provide, feedback, on, draft recommendations. Going forward. From april, so all of our. Craft recommendations. Will be posted, for stakeholder. Feedback, publicly. In the interest of transparency. Um. Because we still have, uh. The confidentiality. Issue to deal with um, we still will provide. Uh the sponsors. Certainly. As well as the drug programs and cancer agencies, with. The unredacted. Versions, of those, recommendations. But, we will. Unfortunately, have to post. Redacted, versions, for. Public feedback. We can move on actually. Uh so updates, in terms, of, reconsideration. Options. Again more details, we've shared this information. Previously, and and more details, are available. Uh through the website and the procedures. But just to recap, uh what the reconsiderations. Are, um. I think the main issue here was to harmonize, the processes. And and. At the same time modernize, and to allow some. Greater flexibility. And efficiency. Uh. In terms of particularly. Avoiding, uh, potentially, lengthy, delays. For anything that's being. Uh considered for reconsideration. Through the expert committees. So going forward we will essentially stratify. Reconsiderations. Into three. Major buckets, or categories. Um, major revisions. Uh will be those revisions, that, could, i think the easiest, example there is. Is imagining, a reconsideration. In fact change, the recommendation. From. A negative, to a positive recommendation. So essentially to change the. The category of recommendation, that would be considered, a major revision. Uh minor revisions. Are really any revisions. To. The conditions. Or anything related to the recommendation, that's not going to change either the. Category of recommendation, or substantially. Change. The population, that that would be eligible, for reimbursement.
Those Would be minor revisions. And then editorial. Revisions. Are, as. The name implies. Really minor edits to improve. Clarity, or correct. Factual. Errors. So. These were developed, over some time, and really, did leverage, some of the feedback we've had. Particularly from sponsors. In terms of how we could, improve this process. Go to the next slide please. So uh these, this just. Clarifies, the differences between major and minor revisions, uh without going into. Even more detail, i think just to highlight, that. Um the timelines, here are for major revisions. We anticipate. Um. Most of the. Reconsiderations. Will be able to be dealt with either through, just making editorial. Revisions which will not need to go back to the expert committee and will be dealt with. In an expeditious. Fashion. Or minor revisions. Which. Ideally. We're targeting. Not taking more than one month to, finalize, those and that is because. This will be able to, be resolved, through a sub-panel. Of the expert committee rather than, waiting to convene, the full committee. As mentioned the the major revisions, will require. A, full committee meeting. And, as per our usual process, we'll still, take between, two and three months, uh to allow for. Uh the engagement. And background, work that needs to be done prior to that meeting. Of note, eligibility. For the major revisions, and minor revisions, is being limited. Uh to the sponsors, and plans. Right now considering, the potential, impacts. In terms of timelines, and delays to access, there. Of note though we will as i mentioned earlier. Regardless. Of. What type of, reconsideration. Might be. Requested. All stakeholders. Will still be provided an opportunity, to provide their feedback, on a draft recommendation. So we can move on. So just a couple of reminders. Uh these are, just. Based, on, some of the experiences, we've had over the last, few months. And just in the interest of allowing, the, process to operate. More efficiently, and more more effectively. We're open to, um, addressing, any inquiries. Um, but just remind. Anyone that's, interested in inquiry. To please provide as much detail. As possible. Um, we do have standardized. Templates, and processes. To assist. With providing, this information. But it typically, does avoid, any delays. In really dealing with inquiries. Effectively, if you provide as much information. As possible. You know for instance hypotheticals. Are really difficult, to deal with so we really do, require, as much detail. As possible, to allow us to. To sort out any issues related to inquiries, uh quickly.
We Have noticed that. Sponsors, have on occasion. Included. Disclaimers. That have, essentially prevented, us sharing, information that's provided to us with some of our. Key stakeholders. Including. The drug plans. So, rather than. Having us. Try to resolve, these on an ad hoc basis, which. Takes considerable, time and resources, we just ask. Sponsors. To please, and not include. This kind of disclaimer. On any of the material they're submitting, to us going forward. Remind it to consultants, to please. Include. Contacts. From the, manufacturer. Sponsor, on all your correspondence. Again this is just going to, make things, operate. More smoothly. And avoid, potential, delays. So please. Include. Any sponsor, or manufacturer. In all of your correspondence. Rather than relying on, on us to do that. Um tracking, uh the request at cath.ca. Hopefully that's all in uh, that's in everyone's contact, list but. Whether you're contacting, myself, or brent. Or suzanne. Or really anyone, in our program. With a question or a query. It's always. Advisable, to copy requests at cadith. To ensure, that. Your your. Message, is not, um. Doesn't fall through the cracks and we can deal with it, in an efficient. Way and avoid any delays, there. And then finally. A perennial. Reminder, but again please. Always. Source, your your templates. From our website, we're. Constantly. Updating, our templates. Um, and, the latest version will all be. Always be available, on our website. For download. So, please rely on these rather than, saving them. Or sourcing, them from, any other. Source. We can move. On. So if you're still awake we could cover some other initiatives. Um, by way of uh reminder, and update so we can move on to the next slide. I'll just take a sip of my own. Coffee. So the provisional, algorithm, process. You may recall, that. The cdic. Process. On the oncology, side was transitioned, to cadith, a. Couple of years ago. And. We have. Integrated, that into our, program, and review processes. To establish. As i mentioned earlier. Implementation. Panels, to address, implementation-related. Issues. But really a unique. Feature, of the the oncology. Side of things, has been the need for. Development. Of treatment algorithms. Or, aka, sequencing, algorithms. So we have established, a process, for. For essentially doing that providing. Advice. On sequencing. In terms of. Algorithms. We're pleased to uh, um. Be able to offer. As we we try to do with all of our processes. Um. The ability, for. Uh stakeholders, to provide, input, into that, process, so this is, i you know we're happy to. Provide this um, in terms of. Meeting our transparency, objectives, and being inclusive, and, fair. Um. To so, any, algorithm. That is being developed, will. Be publicly, announced, and. Will. Have an opportunity, for all stakeholders. To provide input including, patient. Clinician, groups. As well as, notably. Any other. Manufacturers, that might be impacted, by. Said algorithm. We can move on. So the title is mandatory information, sharing i think, that's because this is top of mind really the context, here is our aligned, reviews. We've, spoken about this, numerous, times, in multiple.
Forums. So i won't recap. The the align review process. But, just related, to, um. Our uh, our. Commitment, to, um, evaluate, and potentially. Update that process. After it was launched and put in place, approximately. A year ago. Um just a reminder this allows for parallel, reviews. Of products through. A collaboration, between health canada. Kathi, and ines. We did a consultation. To. Get input on, a couple of proposals. Most notably. The proposal, to move from this being a opt-in, or voluntary. Participation. To being mandatory, in terms of. Specifically. Sharing information. Um, between, health canada. Cardiff, andy ness, if you opt into the aligned review, pre-nfc, submission, process. As well as the proposal, to make some minor revisions, to the, consultant. So, to the consent, consent, letter. And the logistics, related to that. Uh really no, no major issues with that part of it. So we can move on. Um so feedback, that we had in terms of a proposal, to make information. Sharing mandatory. Um if you're participating. In the pre-nuclear. Line review process. Um, generally, uh. There is really positive feedback, in terms of this proposal. And in fact. Numerous stakeholders, expressed surprise. That this wasn't in fact mandatory. And hadn't realized, that that was. The case. Industry has raised a number of concerns, though uh they're, outlined, on the slides, there. Without going into too much detail. Um. Uh they really. Center around. Um. Caution around. Uh what information, is shared, and how that information. Is used. Um. And i think. There's a, persistent. Lack of. A clear benefit. To the sponsors, that. I think outweighs. Their their view of the potential, risk, of uh. Sharing this information. Between. These. Our three, organizations. So we can move on to the next. Slide. So for right now it's status, quo we are still considering, the feedback, and figuring out how we will. Move ahead, um following the consultation. Uh suffice, to say, if we do. Move ahead. With changes, to. To the process. We will. Provide. Ample notification. To all stakeholders. Prior to, going ahead with with any implementation, as i said. What exactly, might change is still to be determined. Um, and we look we're looking for. A lead time of at least six months. Um. Should any changes, uh, be proposed to go ahead. So we can go ahead. Uh so changes to pre-submission, meetings. Um. Again this is not new information, but just to recap. That we are. Including, drug programs and cancer agencies. As observers. In our pre-submission, meetings. That occur between. Cardiff, staff, and sponsors. Um of note. Uh we've had some issues, trying to share the information, that's. Uh discussed, at these meetings, with all the participants, including the drug programs. Um so we will be revising. Our uh. The, the forms, associated, with that essentially, to. Provide, some, some upfront consent, to allow us. To share information, with the drug programs. Rather than us doing, dealing with these. On an ad hoc, basis. We hope to have that. In place. From. December, of this year. So we can move on. So i think that's, it for me. Brent, can i hand it back to you. Sir. Next slide please. So i will be um, passing, it along, to. Nicole. Mittman, who will be talking about, some of the pieces, that trevor had mentioned around the deliberation. Process. For our expert committees, as well as. An update on real world evidence, and scientific, advice. So, over to you nicole. Thanks very much brent, next slide please. So just to. Provide, an, update, on now we approached, or we introduced, this topic at the last. Forum, about a year ago. Where we wanted to, address. Some of the. Potential. Consistencies. Or standardize.
And Really harmonize. The three, expert, review, committees that we have so you are all with respect to this audience, familiar, with perk, and cdec but we also have our health technology. Expert review, panel, for medical devices, and clinical interventions. All three. Panels. Or expert committees, have evolved. Over time with different, uh kinds of competencies. Uh with respect to expertise. And processes. And then also for example, with some of the. Information, that they actually deliberate, on so here was an opportunity, along with the alignment, process. To think about. How we deliberate, here at cadith, and provide, some sort of, consistency. Around, those and provide some. Guidance, and potentially, some recommendations. On how we can harmonize. And so the, idea was to harmonize, and then potentially, enhance, those committees, where, if there are recommendations. In order to improve, the way we deliberate, here at caddis that we could enhance some of those committees. Next slide please. So, the the three, kinds, of uh, or the the work that we. Undertook, was to, conduct an environmental, scan of what our best practices, amongst, other health technology, agencies, and how they deliberate. What we quickly, found. Was that there isn't any best practice, but there are different, perspectives. And different, ways that, different health technology. Agencies. Actually conduct their deliberation. So what we wanted to do is go back to first principles, and review, what are, what are the what's the conceptual. Evidence. On deliberative, frameworks, and processes, and, as a reminder, there are really, two, kinds of pieces of information, that we're looking at, we have the framework, itself, on what, information. Do we use, to make decisions, on. And then there's the process. In terms of either membership, or order, or the way. The way, voting, happens. So we wanted to go back to, sort of first principles, and look at the con the concepts, of how that actual evidence, gets into. The frameworks. And the processes. We also started to review, and summarize some of the key recommendations. And that we have found through our environmental, scan. We also did a little bit of a quality, assessment, of our our. With our, panels our three committees. Our expert committees with respect, to. How they. Look at, information. How they. Understand, transparency. How they understand, how information, has an impact. And together we worked with the center for innovations. In regulatory. Sciences, or cirs. To help us with a quality assessment, of that work. And then we also, looked at, um. Taking that information, back to put together, a draft, set of recommendations. For the committee, based on not only our environmental, scan, but also then the quality, assessment. Next slide please. So we also reached out to uh with some stakeholder, feedback.
And Really, tried to understand, that, uh we've heard that even just understanding, what does the deliberative, process, mean, uh what are frameworks. And providing, some sort of concepts, on that. And really. As as trevor already mentioned in terms of transparency. So, how do we deliberate. Uh how are how, there are decisions, being made what information, is presented. Is some of it implicit, versus, explicit. And some of the stakeholder, feedback, that we've received, have actually highlighted, the need for more transparency. And so again highlighting, that, from a framework, point of view. Uh do we need to be explicit, with the criteria, that we look at in terms of value assessments. Or understand. How that information, is, interpreted, and rationalized. And used in the decision-making. Process. And then from a process, you know understanding. What are the key drivers. In a recommendation. How are the the process by which information, is provided, to the expert committees. Also the order potentially. Of the process the, way that the information, is provided. And thinking about any sort of uh considerations. Along the way of a process that could be harmonized, amongst the three committees. Next slide please. So, we're we are at a, point where we have taken all the information, from the environmental, scan we've taken some initial, stakeholder, feedback. And we're now at the stage where we're thinking about consultation. And starting, to think a little bit around, how do we consider, stakeholder. Sponsor, feedback. In uh, in the. Way that we deliberate, or provide. Our our decisions. And so our first. Model for consultation. Will actually, be. With our patient, groups. And. We're just in the process, of trying to understand. How we can model that well. And the idea would be to provide, some education, sessions, around. Improving, the transparency, of what deliberation. Is, and then also having an opportunity. To discuss. How patient input, is actually, uh, achieved. Uh, or, what kind of information. Would patients, like to see. In our, alignment, process, or in our deliberation. Process. And then we are looking for other opportunities. For. Consultation, amongst our stakeholders. And our sponsors. Uh this again will facilitate, greater transparency. And understanding, of deliberation. And then. We will contribute. To. The, uh, informed. Approach, to harmonizing. And consistency. Of the way that we do things in expert, committees. Next step, please. So that's deliberation. I wanted to talk a little bit about real world evidence and this is a real, topic near and dear to my heart. Next. Slide please. So, this work was launched. Initially. Or at the canadian, association, for population, therapeutics, in 2018. Where the real world, evidence, core, action, team. Rwe. Cat, was formed. There are a number of members, part of that including. Caddis, health canada. Ns. Cihr. Kai hike. And, then also some academics, and some industry members are part of this core action, team. Uh, after the this uh. Uh. Initiative, was launched in 2018. There have been a number of deliverables. And and a couple of publications. Uh, either in a peer-reviewed, format, and a white paper, talking about the process, and what is needed to actually think about, real world evidence. In the space of health technology, assessment. Next slide please. So, uh the core action team has been very busy, of late. We, and here's the membership, again. And we have uh, through a survey, of the membership.
We Have actually identified, that there are three. Areas. That we need to have folk, focus on, and those would be guidance. And then there is around real world evidence, around oncology. Products and real world evidence around non-oncology. Products, and that would be in the drug space and i have very. Grayed, out. Because this has not, yet a working group. Committee. But perhaps, even thinking about a non-oncology. In the uh working group in the, uh, device, space, as well. So we are in the process of putting together our terms of reference and what are the scope of activities, within. Each of those working groups each of those groups. Have a co-chairs. A cabinet member and a health canada member. And part of the work that, folks are trying to look at are what will the. The, activities. Be, uh under the working groups that will move beyond. Necessarily, the membership, for the core action team. We are in the process of understanding. What is the inventory, of databases. So where does rwe. Lie. And strategies, around canada, to access, rwe. We're certainly trying to think a little bit around, improving, the dialogue. Between. Sponsors, or manufacturers. And. And, health technology, agencies. And every health technology, agency we've been in touch with has similar, issues around how do we look at rwe. And. Certainly, how do we, incorporate, rwe. Into the, health technology, assessments, that we do. And we're also trying to build criteria. Uh for and for choosing, rwe. Demonstration. Projects, and that will be part of the, terms of reference, and the mandate, of each of the working groups, is to think about how do we demonstrate, that we can use rwe. For. Either. Our deliberations. For potentially, our submissions. Uh, for potentially. Looking at the way we continue, evidence generation, so, uh part of starting to look at how do we. Choose demonstration, projects and what criteria, are important to do that. As well and then all the while being cognizant, of the fact that this is a similar, problem through health canada. And they're also dealing with issues of how do we look at real world evidence, for, diseases, that might not have formal, or robust, clinical, trial programs. Such as rare diseases, or pediatric, populations. And so making sure that we're always in alignment, with, health canada, and, some of the methods, for example. Or some of the submission, requirements, that they need as well. And then are there optimal, time points, for the use, or for the the, information, around rwe.
So Is it at submission. Is it at uh, consideration. Is it after consideration. So thinking about different ways that that would be that work would continue. And certainly, uh, groups like the institute for health economics, have actually. Started to look at that of, in terms of rare diseases. Next slide please. So here's an opportunity, where, while we're considering. And doing the work with the rwe. Cat. There's also a bigger program around rwe. That we're starting to think about here at cadiz. And they're really, kind of four, objectives. Or four broad objectives, around, how do we provide, guidance, so what kind of evidence, is required, and for those of you who have submitted, you know that we already do accept real world evidence in our submissions. Usually, for, i mean quality of life information, may come from real world evidence, utilization. Information, may come from real world evidence. Certainly health preference data could come from real world evidence. I think that the sticking, point for all health technology, agencies. And regulatory. Agencies, are around how do we look at, the efficacy. Piece or the effectiveness. Piece and can we use, real world evidence, to actually support, some of those outcome, data. You know certainly we use real world evidence from registries, from safety data, so, you know it's really the sticking point is around some of the efficacy. And some of the evaluations. Around that so can we provide some guidance, around that. So we're looking for opportunities. There, uh what kind of advice can we provide. And uh, we you know we have guidelines, for economic, evaluations. Are is there an opportunity, to provide guidance, on submissions. Or potentially. Rwe. At. From an advice level, the evaluation. Already alluded to the fact that the sticky point is really around the efficacy, or the effectiveness. Piece, so are there methodological. Requirements, that we're looking for, or are there requirements. Around, the data that is actually being. Used and potentially, submitted. So, example, is you know how independent, was it. Who did the analysis, and those are all things that are actually inborn. To a randomized, clinical trial program, but may not be, so much, uh. Articulated. Or thought of in. Potentially, real world evidence, or registries. Or cohort, studies so starting to think a little bit around how do we evaluate. The quality. Of the real world evidence that's, received. And then working with other, groups so there are lots of groups with industry, who have also created. Registries, or patient, assistance, programs. Also thinking about academic, groups, they're at registries. There are. Administrative. Databases. There are academic, groups such as decent. And. Other groups across the country that actually have done this for a number of years, so can we collaborate, with them and what kind of information, do we need in terms of, access. Or. Availability. Of the data to help us answer some of those questions. And also just, what what is the uncertainty, we're trying to address, so what methodological. Rigor do we need around that as well. Next slide please. So scientific, advice, um next slide. After a pause during covid, we are open for business, again and we have a number of, projects, already. Under, review. Through our scientific, advice program, so. If folks are really interested in being part of our scientific, advice program. Where we could provide scientific, advice, on, the clinical trial program, we can do that as cadith alone but we also have partnerships, with, health canada. Where you provide the, the advice, from not only a regulatory, point of view but from a health technology, point of view, and we've had a number of projects that we've worked on with nice as well and collaboration. As well so if if. Interested, our program is open for business. And with that that's my last slide thank you. Great thanks nicole. Um i think maybe, one of the positive. Outputs. If you can say that related, to covid19. Is the fact that it's really challenging, the status, quo. And similarly. That is also. Affecting. How we've been doing, some of our reviews, and responding.
To. Questions, related, to covid19. And heather will, provide an update, on some of the activities, that katyth is doing, related, to covet 19, treatments. Heather. Terrific thanks very much brent. Um, good morning everybody and thank you for joining today so i'm going to give you a little bit of an overview, of some of the work we've been doing the teams internally, have been working hard since we launched our covet 19 effort. In april, um so this data is really until, the end of october. So we have a mechanism, on our new covid, micro site to. Enable. People in the external environment to submit requests to let us know how cadif can best use its core competencies. Uh and products and services, to support, um, decision making and the information, needs, during such an unprecedented. Time we've had, now more than 190, requests, literally from every jurisdiction, across the country including some from international. We on our new website. We've had, about 37. 000. Hits on the website a little bit increased, from what's on this slide and we focus, the site based on, themes so treatment infection prevention, control, screening testing. Etc. And, of those we have both reactive. Topics. So where people like you have come and said please help us understand what the evidence. Is on this particular, topic. But the team because they are always monitoring, the external, environment. Also proactively. Identify, things and there really is a mix of those on the site. Um so some of the most, interesting, topics, or i guess downloaded. Topics, and documents, on our site include. N95. Reprocessing. Um with the rem deserve, report. Including, the implementation. Advice panel that we hosted. So there's a large number of them online and i invite you to go to the site to take a look. As part of, our commitment to bringing evidence, to decision makers, and customers, we have instituted, a series of webinars, and so, what you'll see in the middle column, are the lists. Of, an apologies, for the formatting. A list of some of the webinars, that we've hosted. The most. Current one is happening next week and it's on community, transmission. In heating ventilation. Air conditioning, systems. Um with experts, uh from a technical, pe