Market access and reimbursement in Canada – changes at CADTH

What do you need to know about the market access and reimbursement landscape in Canada? What changes can we expect at the Canadian Agency for Drugs and Technologies in Health (CADTH) in 2024/2025?  In this webinar, Clare Foy (Director – Global Market Access, Mtech Access) interviewed Don Husereau (Adjunct Professor of Medicine, The University of Ottawa).

We take a look at the market access, health policy, and health technology assessment in Canada. Clare Foy and Don Husereau explore:

• The market access landscape in Canada
• Upcoming changes at CADTH
• What Canadian payers expect from your value proposition
• Opportunities and challenges when launching new medicines/medical devices/diagnostics in Canada
• How Canada compares to the USA/key European launch markets
• What this means for your global market access strategy

This episode was first broadcast as a live webinar in March 2024. Learn more at https://mtechaccess.co.uk/market-access-canada-changes-cadth/

Learn more about the Canadian healthcare market and launching new pharma and medtech innovations at: https://mtechaccess.co.uk/launching-healthcare-products-in-canada/

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Transcript

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- Welcome to this Mtech Access webinar. At Mtech Access we provide health economics and outcomes research and market access services, from strategy, through to implementation. Get in touch today to discuss your market access goals. First, though, I hope you enjoy the webinar. Hello, welcome everyone to our latest Global Whispers webinar. Please see our YouTube channel for past webinars and look out for more content from us in the future. The topic today is market access and reimbursement in Canada. I'm Clare Foy, director of Global Market Access here at Mtech Access. We have a great mix of audience today across industry and healthcare systems. I'd like to particularly welcome our global affiliate partners who play a key role in the work that we do. For those of you that don't know us very well, Mtech Access is a global specialist health economics, outcomes, and market access consultancy. With a track record and expert delivery, we provide specialist support to pharmaceutical and medtech clients, and we work as a collaborative partner to healthcare systems worldwide. Today we're going to focus on market access and reimbursement in Canada, and I'm delighted to welcome our guest, Don Husereau. Welcome, Don. Could you please take a moment to introduce yourself and your background?- Hi, thanks, and thanks for having me and inviting me to this. Yeah, I'm Don Husereau. I work in and out of Ottawa. I have an adjunct appointment at the University of Ottawa, the School of Medicine. I am originally a pharmacist by training, but I worked with the Canadian Agency for Drugs and Technologies and Health for 10 years where I received substantial training in health technology assessment, health economic evaluation. And I have been, for the last more than 10 years, conducting independent health policy, health services research, and I've been a health economist advising payers on several national and regional committees, and I'm very happy to be here.- Brilliant, thank you. We're really glad to have you. So could we start by talking a bit about the Canadian healthcare system in general, and perhaps you could outline some of the challenges of achieving access for a pharma or medtech product in Canada?- Yeah. Well, Canadian health system's a federated health system. So it's a bit tricky. We have 10 provinces, and we have territories, and they have an independent remit to delivery healthcare, in a similar fashion, under federal legislation that says that there's money at stake if they deliver it using certain guiding principles. Under that, there's no mention of drugs or publicly insured community-based drug funding. But most provinces have sort of recognised the need and have created independent agencies or insurance plans for drugs, but they vary by province by province. So, what we see in Canada is a lot of them have come up with similar systems, or have similar coverage, for example social welfare or seniors, and they've gotten together and created federated alliances for both the review of drugs and the pricing and reimbursement of drugs. Quebec has its own systems of evaluation, but does participate in alliances related to getting price deals. I guess we'll talk about that a bit later. So yeah, when we think of Canada we have to think of, there's no national anything. It's not like the UK, for example. It's a little more maybe like Italy or Spain where you have a bunch of different regions who are trying to coordinate.- Okay. And obviously it's an HTA market, you mentioned CADTH in your introduction. Could you tell us a bit more about the role of CADTH currently in making HTA recommendations?- Yeah, it's an HTA market, and I think that sometimes gets a bit misunderstood because CADTH does review drugs, they look at clinical cost effectiveness, other dimensions. They also review medical devices and procedures, other things. There are some commercialised technologies, like vaccines that are reviewed by other HTA organisations. CADTH now does look at new blood products for our national blood programme. Again, so CADTH is doing this looking at, as I said, clinical cost effectiveness, looking at patient and caregiver experiences, and some other dimensions. I guess the confusion comes in when manufacturers say,"Well, it's an HTA market, it must be like the UK." But in fact we're, we're much more like France and Germany. We make decisions about whether to fund based on clinical effectiveness or judgements that something may have a positive clinical impact. The cost effectiveness is looked at, but unlike the UK for example, we don't make decisions, or recommendations, or change recommendations based on matters related to cost or cost effectiveness. The cost effectiveness is simply used to inform price discussions.- Okay. that makes sense. All right, so we're going to be talking a bit about some changes coming up, but one change that came into play quite recently, in September, CADTH introduced a new type of recommendation, the time-limited drug reimbursement recommendations. Perhaps could you tell us a bit about that?- You know, the time-limited drug reimbursement recommendations was an attempt to deal with probably what I think is attention seen in other jurisdictions as well. A manufacturer has an exciting and promising new technology. It's exciting and promising enough that they bring it to a regulator with early data, sometimes phase 2 data, sometimes not comparative phase 2 data. And there's a lot of uncertainty, sometimes, with these data. I mean, we could have phase 2 data with surrogate outcomes, for example. I think what was happening was, the end result was drugs were coming to market, available, could be a valuable cancer drug, at least something that patients were very hopeful would be valuable, and it was available. But when going through the CADTH process committees might say,"Hmm, it's a phase 2, we're kind of uncertain. And we do see that the manufacturers actually plan a phase 3 trial. What's the rush? Maybe we should, you know, make sure that we're making a good decision because that phase 3 is going to confirm some things that we're really uncertain about." And so they might say "no". Well if you're a patient, and you are excited about a new drug that really might provide benefit for you and you're told "No, this can't be reimbursed because we're waiting for more certainty," that creates certainly a lot of tension. So I think CADTH was responding to that natural tension and saying, "Well, why don't we build something in here that says we're going to make something like a conditional approval. We'll say yes, but we'll say yes pending further information, pending a commitment to a reassessment." So I think it was intended to shore up this gap, that they were saying "no","no" was a pretty blunt instrument for something that actually was quite promising. And now they're saying "yes." But it's not a free lunch. It's "Yes, but we're going to check your knitting later on. We're going to see if you actually are living up to the hype at the time being."- Okay, and have there been any products that have gone through that process yet, and have that follow up evaluation or is it still too early to see how well it's working?- No, there have, I don't have the numbers in front of me, but it's just begun, I think, in the fall. And now I think we're actually seeing even the first, because once CADTH makes a recommendation, I know we're going to discuss this then, how do we negotiate the price of a time-limited recommendation? Well, we do that through maybe a special process of price negotiation. And so my understanding is we're undergoing the first one of those. So, I think there have been at least one, possibly a few, I don't have numbers. The criteria are fairly narrow at present. So, this isn't for anything that comes along with a phase 2, it has to have a bunch of conditions. Number one, it has to actually be given a conditional approval by the regulator. Like the US we have a conditional approval. It's called an NOC/c. But there are other things they have to have, too. For example, they have to have a phase 3 study ongoing that they think will confirm some of the phase 2 stuff. And it actually is also contingent upon that phase 3 study results being available within a few years. I think three. So, it's not every drug that may qualify. It's fairly narrow. I'm sure as they evolve CADTH is, you know, taking feedback. And I'm sure, as things go, they may consider expanding this if this is working out. However, there are some more strict criteria around what qualifies for a time limited-drug review.- Yeah, that makes sense. I think it's areas of higher unmet need, isn't it? But yeah, perhaps from a patient perspective, and they'll be interested to see how things work out and whether that will be expanded, like you say. So you touched a bit on pricing there. Could you tell us, first of all, how pharmaceutical pricing works in Canada overall? And then we'll come onto some changes.- Yeah, well pricing's tricky business. So we've already said that there is no universal pharmacare in Canada, that each province might have different public insurance packages, depending on the province, depending on what they perceive are the needs, and their political goals. But I mean, one thing we need to be mindful of in Canada is that public insurance does not cover anybody, by far. It actually covers a minority of people. There are private insurers, employee-based private insurance that covers a similar number of people. And then there are people that simply have to pay out of pocket. So we have a first level of price regulation, which is we actually have a federal price regulator that looks to see if list prices are excessive. And they perform a whole bunch of tests. So they create a kind of ceiling price for the whole market, for insurers, and out of pocket, and the like. And then, probably more relevant to this conversation, we have an alliance of price negotiation across provinces. So we have the Pan-Canadian Pharmaceutical Alliance. It can take recommendations from CANAS or CADTH or both, or either, and it uses those recommendations as the basis for price negotiations. So CADTH might say, "We recommend you list this drug, but we think you should list it in only these patients, and with a price reduction of a certain percentage." So they will take that and use that as the basis for negotiation as a collective negotiation, so that all provinces can enjoy the same amount of access, or access conditions. And that is going on. And the Pan-Canadian Pharmaceutical Alliance, the PCPA, is now even, sort of expanding efforts as we speak.- And you mentioned that the PCPA had a companion piece to the conditional reimbursement changes. Could you describe that for us, please?- Yeah, well they did have to respond to the, what do we do when CADTH says,"This is a conditional recommendation pending further information." They had no, sort of way of dealing with that. So they created what they call the PCPA temporary access process. And that's, for short, PTAP. And so they take a CADTH time-limited recommendation, and the idea is that they would then convert that into a time-limited negotiation. And you can imagine, it just form follows function, or function follows form. It just says, okay, these negotiations will be subject to a reevaluation. And, you know. So we're going to be renegotiating the price. Again, people can Google "PTAP" and look at all the criteria that are involved, but it just is simply a way of dealing with a recommendation that is not meant to be permanent.- Okay. All right. So if we could turn our attention to some future changes. I think there was a recent consultation led by the Canadian Drug Agency Transition Office, and they were looking at high drug costs, inaccessible health data and lack of consistent standards for prescribing practises. And all that has led to the creation of the Canadian Drug Agency, the CDA. So I was hoping you could tell our audience a bit more about that.- Yeah, well the Canadian Drug Agency is sort of meant to tackle a couple of things at once. So I think in the background there's always been an intent by the federal government to develop a kind of universal pharmacare programme. So I started off by saying there is no universal pharmacare, but some people see this as a real shortsightedness that this was never put into place. So our current federal government has put on the table that this is something that they would like to put forward. In doing so, they sort of gave some thought to, okay, if we really were to do a universal pharmacare, what are some things that would need to be in place to make it sort of optimal? And one of those things was having a Canadian Drug Agency, having a body that could inform this federal pharmacare programme about what drugs should be paid for, and at what price, and under what conditions, and the like. Now, CADTH was already doing this kind of work. So I think what the federal government's response was, was they created what they called a Canadian Drug Agency Transition Office, and essentially came out with a recommendation that we're going to build a Canadian Drug Agency, but essentially we're just going to build it in and around CADTH. You know, in other words, CADTH's core function is fine. That's exactly the kind of thing we want to do. But there might be some other pieces that we want to throw in. So for example, the federal government also funds research, and they fund research that can be particularly valuable in looking at things like post-marketing drug evaluation. CADTH also now does some level of post-marketing drug evaluation. So, one of the things they thought, well, we should potentially bolster that. And we could bolster other things that we do in this space to improve the amount of information and data used to inform drug decisions. And along with that is a thought that we should also probably shore up and improve the way that we fund rare drugs. And so an additional activity, and maybe I'm sure we'll be talking about it, is also looking at what should be our strategy for addressing rare disease. And so all of this is sort of culminated. But the Canadian Drug Agency as a starting point is intended to be a kind of CADTH-like body that's going to ultimately inform a federal pharmacare programme.- Okay, that makes sense. So I know, not these changes, perhaps, haven't really come into effect yet, and as you said it, it might all still be up for some further change, but based on what we know so far, what do these proposed mean for pharmaceutical companies? Do you think there will be anything they'll need to do differently, or any change to their strategies compared with the the current strategy?- Yeah, and I'm sure they're dying to know. (laughing) Do we need to change anything? And the short answer is no. You know, I did say, I think the commitment has been made that they're going to build something upon the existing mandate and functions of CADTH. They're not intending to replace it with something different. So, you know, I think if you're a drug company and you're thinking "I need to get past the CADTH post," well nothing's going to change in the short term. That is for innovative drug companies. Obviously generic drug companies, there might be things afoot. But, so that's one aspect of this. I think what you need to think is, you need to look at CADTH currently and its functions, for example reimbursement review and the post-marketing drug evaluation, and just think it's going to be a bolstered version of that. It's going to be a more robust version of that with sort of more data outreach and you know, more of a focus on rare and the like. So I think that's what you should be thinking about. But really no changes, no announced changes. I think in the next couple of months we're going to get more information from the Canadian Drug Agency Transition Office, or with the federal government about what further change could look like. But again, I wouldn't be changing the way you're doing dossiers currently, I think. There are other changes afoot. CADTH is looking... CADTH has an what's called an aligned review process with Health Canada, our federal regulator. In doing that, they do offer drug companies and opportunity to submit applications to CADTH six months prior to getting an NOC. That programme has been in place for a while, but it does not enjoy 100% uptake. And CADTH now is looking at, and looking at reasons as to why or how they can improve the uptake of that so that CADTH recommendations can be issued at the time of a regulatory decision. And their goal is, wouldn't that be great if it occurred all the time? So, you know, I think one thing companies can do now is get involved with CADTH's Target Zero initiative and look, or just investigate, see how they can improve their own internal processes to get in their applications six months before an NOC, rather than after the fact.- That's great observation, great advice I think. Yeah, I'm sure our audience will appreciate that. You touched on there perhaps some changes with the advent of CDA that might impact things like post-launch strategy. You've mentioned maybe more data requirements. Would you care to speculate on anything that might be required there?- No, I think, you know, CADTH currently is actually, through their post-marketing drug evaluation programme, already looking at sort of answering relevant questions for policymakers using what available real-world data there are. They are currently looking at expanding that, and actually I believe they've already started expanding that to not only working with academic partners who have access to valuable healthcare data, but also industry partners to, you know, because often industry partners have access to real-world data that is not otherwise well known. So, they've begun that work. And they've also now creating an inventory of registries, they want to bolster activity in the use of registries. I think CADTH sees registries as providing, potentially, valuable and reliable data for decisions and evaluations related to real-world data. So, does this change what a company is doing now? Not really, but it does mean that they could potentially be more involved, or that there are opportunities now to share post-marketing data with CADTH to help CADTH answer important questions for policymakers. So, I mean the general gestalten of CADTH currently is that they opened up a little more. I think it's easier for stakeholders to exchange with CADTH, and I think it's easier for industry, frankly, to exchange with CADTH. So maybe one other thing people should be mindful of is, particularly in the last year, and with the new leadership of Suzanne McGurn, we've seen more of an openness. So I think one of the things that industry should be mindful of is if they have in their heads that, you know, it's very difficult to interact with CADTH, I think that assumption might need to be discarded. I think it's a lot easier now to interact. CADTH has expanded the time that they commit to pre-submission meetings, and there are other opportunities. So yeah, I think people should be seeing CADTH as more of an opportunity than a barrier, as it might have been back in the days of older leadership.- That's great. That sounds like a really positive thing. And yeah, I think the more pharma companies can engage with these decision making bodies, reimbursement bodies, and HTA then, you know, we're all trying to do the same thing ultimately, aren't we? So that's great advice. I'd just like to think a bit more broadly now, for a moment. So you'll be aware of the joint clinical assessment coming in in Europe over the coming years. Just wondered how that might impact things in Canada, and in other countries, maybe. Whether the HCA bodies, for example CADTH, might look at what's going on there and perhaps even take note of the reports being published by JCA to see if that has any bearing on decisions in Canada.- Well, it may do. We have to also be mindful that in August of last year, CADTH and some other agencies did get together and say, "Hey, maybe it's a good idea that we start to do things together. We start to share work. We start to have our horizon scanning processes aligning." We look at collective methods. How do we all look at surrogate outcomes? Originally this was just a smaller group of HTA organisations internationally. I think it was NICE, ICER, CADTH, but that's expanded. There's a larger group now, including a lot of the groups in the UK, the Australian government. So yes, while I'm aware there's joint clinical assessment going on in the European context, there is also more international collaboration going on. And in part, sort of catalysed by CADTH and others. I think it's just a logical response. How do you respond to a multinational pharmaceutical company? Well, you respond through international collaborations, right? Let's have, you know, we have... We have somebody who would like to get things to patients, but we're mindful of the fact that we need to evaluate. Why don't we evaluate collectively? So, I think that's also what's going on. So yeah, all the collective stuff that's happening in Europe I think is also being, you see reflectively, it's also happening in the rest of the world now with the HTA organisations. And there's more to come. We're also seeing it on the regulator side, with things like Project Orbis, where regulators are now getting together and saying, let's just do all of this together, because why are we all duplicating?- Yeah, interesting times. Okay, so coming back to the CDA, I think one of the things that the CDA, is expected to impact is the regulatory landscape. Have you got any information you can share with us on how that might look?- I don't. (laughing) Again, there's not a lot of information in relation to, you know, what the CDA is going to impact. I mean, right now I think the biggest impact is, you know, the CDA is engaged. What this has resulted in is there are bilateral negotiations between the federal government and the provinces to discuss, you know, what drugs should we be thinking about in terms of CDA and a federal pharmacare programme. And so whereas the pharmacare programme now has been proposed with two classes of drugs, oral contraceptives and diabetes drugs. That list is planning to expand, both with input from work that's been done by CADTH and others, but also ultimately through a discussion just about money. The way our healthcare system works is there are transfers of payments from the federal government to the provinces, but those transfers sometimes have conditions attached. And they certainly always have the conditions related to our Canada Health Act, which is the guiding principles that I mentioned at the beginning that kind of create a more homogeneous delivery of healthcare across the country. And so they're using those same conversations around transfers to talk about, okay, what drugs do we think are most valuable to shore up in regards to pharmacare? So, sorry, I'm not sure if that answered the question exactly, but-- It's evolving, isn't it? So I think it is just a case of seeing.- It's evolving, yes. And like, I'm not aware of any announcements of the regulators saying that they're going to change anything anytime soon. So, it doesn't seem... Regulators don't usually change things. Nothing happens too quickly. So nobody has to worry that they're going to have a nap and things are going to change. It's the glacial pace of policymaking.- Yeah, sometimes these announcements happen and you think, "Oh god, it's all changing. We must do something immediately." But the fact is it takes time.- No, and often the announcements relate to, we're announcing that we need to plan a plan. So, you know, it's... I think you know, what it does mean, though, is obviously industry stakeholders, or academic stakeholders, or the like, they should be looking to see how they can be involved. Because one of the things that is happening in and around pharmacare, and CDA, and the like, is there's more consultation, more exchange, more opportunities for input going on in and around this. So, people very interested should be looking for those opportunities.- That's great, thank you. All right, so I'd like to ask you a bit about medical technologies now. I think you said that CADTH have responsibility for reviewing medtech products as well. What can you tell us about the process and what are companies that may be listening in to this webinar need to know about?- Yeah, I mean CADTH's original remit was the Canadian Coordinating Office for Health Technology Assessment. It had no real drug remit per se, although it did look at drugs in its early days. But its real initial remit was technology, funded by the federal government, which is interested in appropriate use of medical technology. And that has always been the case. And so CADTH has always actually assessed medical technology, health technology. I mean, the definition of health technology is broad. It's not simply commercialised medical technology, things like stents and the like. It could relate to procedures or processes of care. CADTH has recently done, again, an evaluation for example, of emergency department overcrowding, and interventions that could be done to deal with that. But CADTH is also focused on some high impact technologies more recently. Things like newborn screening programmes and oh, and diagnostic technology. And so there's an interesting difference between the medical technology assessment process and the drug... Or there have been, historically, interesting differences. Notably the medical technology or health technology assessment review process has typically been more like the UK, sort of an internal prioritisation exercise working with payers to say, what sorts of things should we be looking at? Not an application-driven process, like the drug review process. However, more recently, CADTH, which has become very innovative and trying a lot of new things lately, has actually opened this up. And they've done an actual application-based medical technology review, or at least something very similar to an application-based review. They just released, actually the other day, an assessment of Optune, a medical device for the treatment of recurrent brain cancer. And so in doing that, they're experimenting with broadening things. But all that to be said, medical technology, commercial medical technology producers are sometimes under the, sometimes have the misunderstanding that their first stop, like in other countries is to make an application to CADTH. And that's not necessarily the case. It typically, what they need to be doing is going to individual regions or large academic hospitals and working with them. Some provinces, like the province I live in, Ontario, also have health technology assessment processes. But again, they're not necessarily application-driven. In some cases manufacturers are given the opportunity to apply. It doesn't mean that they'll be assessed. So it means that they'd be put into a prioritisation process. But there is no currently real sort of application-driven technology assessment process that leads to reimbursement, except for in the province of Quebec where they have the NS process. And part of that is hospitals in Canada are private, not-for-profit institutions. And they're usually the ones delivering medical, you know, expensive and important and medical technology. They're not beholden. They're given a budget, a global budget envelope, and they're not really beholden to anyone to help administer that. They are administering those funds themselves. So you know, they're not beholden to Canada, they're not beholden to even their provincial funders to run technology in any particular way. Where things get a bit tricky is when a very expensive new technology comes in, something like a proton beam therapy, where the hospital says,"Well we can't carry that with our current budget. We're really now going to have to work with our provincial funders." And at that point the provincial provinces might say,"Well, we need to really assess that." And if they have their own assessment process, they might use that. They also may ask CADTH to help them. So you know, I guess it's important for people to know that whereas CADTH is doing this work, it's not necessarily an application-driven process, and really depends. We did do a kind of overview of the process for the Institute of Health Economics. There's a document that people can access. It's getting a little older now, but I think it still tells you a bit of the story. And so that's, I think, important to know. But it's also important to know that CADTH wants to expand the way it looks at medical technology and is currently looking at application-based approaches.- Okay. All right. So, more changes there as well, but it sounds like engagement and understanding of the different structures can be very helpful. I wanted to come back to rare disease strategy. You touched on this earlier. I think there was a rather large investment last year, one and a half billion, into the first ever national strategy for drugs for rare diseases. And with the aim of that being to improve access and affordability for drugs to patients with rare diseases in Canada. What's been the impact of this so far?- (laughing) Well, that depends on who you ask. Yeah, the $1.5 billion commitment was from a few years back and it's been carried forward, carried forward, as sort of... I mean, it's kind of an interesting conversation. 1.4 was set aside to kind of pay for the drugs themselves over the course of years. And then there was about a hundred million dollars set aside to help bolster the infrastructure required to either evaluate, or look into the development of registries, and the like. So, it's been slow going. I mean, some people will say it's been slow going. Some of those funds have been deferred, deferred 'cause there's nothing really concretely up and running as of yet. However, there has been work being done in the background. There's been extensive consultation by the federal government in terms of, well what does this look like? What do we need? And there are organisations like CADTH, and CIHR, our national health research funding organisation, looking to see how they can bolster this process. I think one way of looking at this might be a rare disease strategy, or a rare disease... It could come out through the guise of national pharmacare where we are now funding rare diseases, or shoring up the funding of rare diseases. So for example, as CADTH makes a recommendation, provinces collectively negotiate. Some provinces sign on quite early. A province like Ontario, it has a lot of people, and so ostensibly we'll have people who have these rare diseases, and they know that they need to provide access. Some provinces might say,"We're not even sure if we have anybody who has this, so we're not even going to implement this'cause it's a very expensive thing." And then a patient comes around and actually says,"Well gee, I need this." So that can lead to some inequity across the system. And I think what people are thinking now is, if anything a federal pharmacare funding, what it could do... Or federal, sorry, rare disease funding could shore up differences between provinces. But again, those things haven't been... The details around that have not been fleshed out. So we still don't have a bonafide... I can't point you to anything and say this is how it's going to work. Discussions are ongoing, however. But industry is involved to some extent for those discussions. We have what's called an implementation advisory group that the federal government has been hosting as a forum for industry and other stakeholders to discuss how could this all work. And so maybe they have to do a little more, It's been a bit slow going, in the context of, I think they've gone beyond their target for where they wanted to be at. However, my understanding is progress is being made.- Okay, that could be another watch this space. I think there's a theme there in rare diseases, and possibly more broadly about real-world evidence as well, and more and more demand for real-world evidence, both to support previous decisions, and see whether they were the correct decisions, or whether any new decisions need to be made. But also to help make, you know, make decisions about patients with rare diseases who may be relying on registry data and so on. Is that something, has there been many changes in terms of that and setting up systems and processes to analyse registry data and real-world evidence? And is that something our audience might need to be aware of?- Well, there have been. I mean, in the context I did mention before, CADTH has a post-marketing drug evaluation programme. A key part of that is CADTH sort of assumed control of a previous programme called the Drug Safety and Evaluation... Sorry, Drug Safety and Effectiveness Network, which is something from years back that was set up by the federal government as a way of looking at safety and effectiveness. In its initial form, it was sort of a little more focused on pharmaco vigilance, pharmaco epidemiology of safety. Now that it is in CADTH's hands and more connected to drug payer policy, it's shifted. It still has involvement with the regulator in looking at safety questions. But it also, probably more and more, is looking at effectiveness questions. And I think people do see bolstering that type of programme as a way forward with capturing, and looking at, and assessing valuable evidence, that is not part of typical randomised control trials that are meant to pass regulators or, you know, sometimes just meant to pass the FDA and the MA, which, you know, these are bodies that make different types of decisions that have no financial stake in the decisions they make. So it's easier for them to say yes to certain things, where payers are saying, well, we have no idea. So yeah, so there's a real recognition that there's a whole bunch of real world evidence that could help. And now CADTH's doing things like finding out, like what real-world evidence is out there, and like what registry... So they have this project looking at mapping registries in Canada. They're coming out with quality evaluation tools for, here's how we're going to assess real-world evidence, here's how we're going to assess data quality when we do find repositories of real-world evidence. As I've mentioned before, they're also looking how can we work with industry stakeholders so that there is a sharing of those data, that maybe industry has that payers and academic partners don't have access to. So yes, I mean I think this post-marketing drug evaluation, real-world evidence is going to become a bigger thing. It plays into a rare disease strategy as well, where I think people recognise you often have drugs that come to the table again with, you know, regulatory clinical trials that don't answer a lot of questions that payers are interested in. So we're going to see, I think, more of that. Definitely both through the rare disease strategy, and then further on with this Canadian Drug Agency. I'll stop there.- No, I think you're right. I think it's a trend that's going to evolve and change over time. Okay, so we're coming to the end of our time now. I just wondered if you had any closing comments, you know, anything else that you think our audience might like to be aware of, or any sort of inspiring comments or lessons that they can learn?- Well, a few things. I think, as I said, the kind of tone and tenure of CADTH has changed with sort of a much better leadership now. And so, you know, you are seeing a lot of openness. And I think people who are living in the past must now look at where they are now and realise that CADTH is actually trying a whole bunch of new things. There's a lot more engagement. They will be coming out with an improved deliberative process in coming months. You know, looking at international best practises there. So, I think you're going to see more standards and an openness to kind of try and engage and do new things on the CADTH side. In the background of all of that, you're going to see, potentially, this pharmacare, Canadian Drug Agency, and rare disease stuff advance. That's independent of CADTH, in a sense. CADTH's involved with those discussions, but independent of that, working in the background between provinces and the federal government. And you know, that could ultimately result in a large, federally administered pharmacare programme that is maybe filling in gaps. We don't know what it's going to look like. There's no real design. So some people have ideas, but we have no idea. And then, ostensibly, also addressing questions of rare disease and how we can make that equitable across provinces. So yeah, there is going to be a lot of change. I think there's a lot of opportunities for involvement. And there may be, you know, a great deal more of transparency so that companies like medtech companies and pharmaceutical companies who are maybe first time in Canada and they're wondering how does this all work? It might become a little easier to understand in coming years. So, stay tuned for that. And yeah, be aware that though things are evolving, probably evolving, I said it's a glacial pace, but I think, like the global warming situation, glaciers are starting to move a bit faster than they did before. So, yeah, you know, stay tuned, I think, the next couple years. We have a federal election in 2025, so a lot of this stuff could be happening before then. If it doesn't, and we have a change in government, they could also be, you know, they could take the air out of this as well. So there's a lot to keep track of. I haven't mentioned a lot about Quebec. I think Quebec is increasingly participating. They are part now of the the Pan-Canadian Pharmaceutical Alliance, although they're still doing all of their own reviews and things like that. So Quebec is distinct in how they manage a lot of health technology. And so just, I think people need to be aware of that too, that a lot of the things I've been talking about are more generalised with the CADTH, and not necessarily to NS.- That's great. Thank you so much. That was really interesting. It sounds like there's some changes coming up, lots of positive things about more openness and engagement. So, that was great to hear. Perhaps we'll have to schedule another webinar in the future when there's a bit more clarity on some of these changes and we can talk to you about what's happening. Yeah, and thank you to the audience. Thanks for listening to our conversation. If there were any questions that we didn't get to, please get in touch with us and we'd be happy to respond and arrange of follow up with you. Yeah, thank you Don. Thank you everyone, and we'll hope to see you again soon. Thank you for watching. If you'd like to find out more about our work or how we could support your market access goals, please email info@mtechaccess.co.uk, or visit our website at mtechaccess.co.uk.