Pharma Market Access Insights - from Petauri Evidence

Global Pricing and Market Access – Strategies for Success in an Evolving Landscape

• Petauri Evidence • Season 8 • Episode 4

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Uncover the forces driving change in global pricing and access
In this expert-led discussion we explore the latest trends, challenges, and strategic considerations shaping global pricing and market access (GPMA).

At Petauri Evidence, our Global Pricing and Market Access Team are growing to meet the increasing complexity of global launch and access, bringing together fresh perspectives and decades of real-world experience. In this episode, our experts, Clare Foy and Adam Brown, are joined by two new additions to the team, Catherine Beecher and Sam Davies, who bring extensive expertise from both consultancy and industry.

Ben Spurr (Head of Partnerships, Petauri Evidence) hosts the panel discussion with Clare, Adam, Catherine, and Sam as they explore the key issues facing Pharmaceutical and Medtech companies as they prepare for global launch, navigate payer expectations, and develop value-driven pricing strategies.

This episode was first broadcast as a live webinar. Learn more at: https://petauri.com/insights/webinar-global-pricing-market-access-strategies/

Discover our global pricing and market access services at: https://petauri.com/gpma/ 

To explore your pricing and market access strategy with our experts or to put your question to the panel, email evidence@petauri.com

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- [Narrator] Welcome to this Petauri Evidence webinar. At Petauri Evidence, we deliver market access and HEOR support throughout the product lifecycle to bring new treatments to patients across global markets. Follow us on LinkedIn for more great content from our team. We hope you enjoy the discussion.- Hi, good morning, good afternoon, wherever you're perhaps joining us from today. I'm delighted to welcome you to today's Global Pricing and Market Access Webinar, Strategies for Success in an Evolving Landscape. My name is Ben Spurr, I'm Head of Partnerships here, and today I'll be guiding discussion with our panel, who I'll introduce imminently in the next couple of minutes. By joining, hopefully some of you or most of you are familiar with who we are. But just so we're all on the same page, we are Petauri Evidence. As a brand whilst we're quite young, forming in April of this year. We are the culmination and merging of two well-established heritage teams who, hopefully, again, you are familiar with, Mtech Access and Delta Hat. Our passion and reason for doing what we do is to collaborate with our clients, with you, with our partners, helping accelerate access of your life-changing products to patients, hopefully with a real drive to improve patient outcomes. As part of Petauri Evidence, we are of course part of and proud to be part of the Petauri group. Some of you may also be familiar with our Advisors, Kinect, Max, or Advance teams. And again, if you've got any questions after the event, please don't hesitate to reach out to me. More than happy to collaborate. I'm aware some people join the call, also work across the Petauri group, and obviously again, great to have you with us. Perhaps a quick overview of how today will work and how we'll use the remaining time together. So first of all, thank you. Thank you for joining but also for sharing the questions before the event. What we've done as a team is bring those together into themes, into questions, and we attempt in some way to address as many of those as possible over the next perhaps just shy of an hour. Fully invite you to use the chat function within Teams. We'll be monitoring that if you're able to, if you feel obviously the desire to contribute, and where possible, if there's anything that we can clarify, of course we will. Where possible, if there are additional questions, we will address those, but rest assured, if we're unable to do so, we will at the end of the event get back to you on a direct basis. So perhaps enough from me, everyone's joined today to hear the discussion. I would like to hand around the virtual room to colleagues, to Clare, Cathy, Adam, and Sam, to introduce themselves before we jump into our first question.- Thanks, Ben. I'm Clare Foy. I'm a director in the Global Pricing and Market Access team at Petauri Evidence. I have over 20 years of experience in global consultancy and also some pharma experience from my early career. My main area of expertise is understanding payer requirements, including hearing insights from our network of stakeholders around the world. I'll pass to Cathy.- Brilliant, thank you, Clare. Hi there, everyone, I'm Catherine Beecher. I'm also a Director in our Global Pricing and Market Access team. I'm a relatively recent joiner to the Petauri team, but I have over 27 years of pricing and market access experience, mainly in consulting with a brief stint in industry as well. Similar to Clare, I love working on projects where we get to hear the payer perspective. We help you navigate the intricacies of different global markets, trying to really support, capture, and deliver on the value of your product. So really looking forward to the discussion. I'm a newbie. First pricing webinar, so looking forward to the interaction.- Hi, everybody, I'm Adam Brown. I'm also a Director in the Global Pricing and Market Access team at Petauri Evidence. I've been in consulting in global pricing and market access around about 20 years now. Similar backgrounds, obviously, to the team here. I'm really looking forward to this, and it's really good to get to engage with everybody, so I'm hoping for a good session.- Yes, and finally, lovely to see everyone. I'm Sam Davies. I'm also a director in the Global Pricing and Market Access team. I have around 13 years of experience across consulting and industry in affiliate and above-market roles. So hopefully can relate to many of the challenges and opportunities that you all on the webinar are facing today. But yeah, really looking forward to the session.- Lovely. Thanks, team. So let's jump right in. I suppose first question actually to Clare. I think some of the overwhelming themes coming out of the pre-submitted questions were, what was we, as Petauri Evidence, the themes that our clients started to see what are those most significant global trends that are currently shaping pricing and market access strategies?- Yep, this is a good question. There are so many things I could talk about, but here are a few thoughts. So first of all, the complex stakeholder environments, both pharma and medtech companies face the challenges of multiple diverse HTA bodies and other reimbursement decision makers. There are obviously differences across countries and regions, and it can be quite confusing and challenging. There are constantly changing requirements and processes, so including new requirements, such as the joint clinical assessment, the JCA, which came into force in January this year initially for oncology products and advanced therapy medicinal products, but with obviously more products to be included in that process in the future. And all of this means there's a need for engagement and collaboration between healthcare systems, HTA bodies, and industry. It's so important to align on evidence needs, including trial design, establishment of unmet need, and justification for access and price so that we can get those interventions to patients. A second thought would be the pressure... the financial pressure. So rising drug spend from health systems, there's obviously a pressure to manage that spend and this means that manufacturers are facing a higher burden of proof to justify appropriate pricing and access. But, of course, at the same time, we have to contrast that with the pressure on companies to remain competitive, to invest in new product development, to keep up with higher manufacturing and distribution costs and more stringent evidence requirements, as we just mentioned. And, of course, they differ across countries too, so it just makes it very complex. Furthermore, companies have to make important strategic decisions. They need to know which products to invest in, where they want to launch them, and in what indication, obviously balancing with patient needs. So there are advances such as AI, which are being used to identify new targets and increase efficiency in manufacturing. And all of those things mean that patients are expecting faster access to new therapies. But, of course, there may be pushback from healthcare systems regarding access and pricing. So very complicated network of different considerations there. I could also talk about the affordability and value demonstration of therapeutic innovations. So if we think about affordability and access to high-cost interventions, things like cell and gene therapies, it can be very challenging for companies to demonstrate value and justify the high prices for these innovative therapies. And, of course, it's also difficult for healthcare systems to prioritise funds for these, but they are important interventions and offer massive benefit to patients. So, of course, it's a fine balance and involves a lot of collaboration and discussion across all the different representatives involved in that process. I suppose thinking about other interventions, there are similar challenges for products like GLP-1s, which can have very broad indications now in diabetes, obesity, MASH may be coming, and that can mean there are huge numbers of patients that would like to have access to these treatments and potentially a large budget impact arising from that. So companies really have to stay competitive, they have to demonstrate value to payers and patients, and all of this can be a very fine balance. I suppose the final thought that I would add to this is new policies. So there's things like the Inflation Reduction Act in the US. Of course, many new policies coming into force all the time, and it can be very hard to stay up-to-date with the shifting landscape, to anticipate and react to things like significant policy change that require actions from companies.- Yeah, thanks, Clare. So I think building on that, one of the hottest topics right now is the US government's push towards most favoured nation, or MFN, pricing. I think this has the potential to significantly shape up how pharmaceutical pricing works, not just in the US but globally. In simple terms, MFN pricing would link US drug prices to the lowest prices paid in other wealthy countries, so really introducing international reference pricing, or IRP, into the US. And if implemented, this could really reshape how companies plan product launches, manage pricing, and approach access strategy across international markets. In terms of the immediate financial impact of MFN pricing, the US has long been one of the biggest markets for pharmaceutical companies. So if MFN does tie US pricing to lower international benchmarks, it could quickly and significantly impact revenue. And, you know, to offset US revenue losses and mitigate lower price exposure, companies may try to raise products in EU markets, but also that again could trigger pushback and further policy changes. There may well also be considerations for withdrawing products from lower-price markets if prices can't be raised to prevent those prices being used to set US levels. Ultimately this kind of revenue pressure can really hamper investment in R&D and ultimately, slow innovation across the board. I think the other major impact we could see on global market access would be in terms of product launches and the sequencing of those launches. And ultimately to avoid setting a low benchmark that could be referenced back into the US, companies may choose to delay launches in lower-price countries, prioritise those higher-price markets, or even choose not to launch in certain geographies altogether. And again, this could significantly limit access in markets with tighter price constraints, and especially in those lower-income countries. I think we're also likely to see some companies reconsider ex-US launch plans. So in those countries, that might qualify as MFN reference markets, which could have a global effect again. So whilst this policy is driven by the US administration, I think the ripple effects could really reshape how and where new therapies are introduced globally. Now I think it's important to note that this policy is still evolving, and whilst technically active, it does face legal challenges and lacks some clarity on how it will be implemented. Industries raise concerns around the feasibility, the fairness, and any unintended consequences. But I think what is clear is that the US is no longer a passive participant in global pricing, and that shift is already sending ripples through the international landscape. In terms of, for you guys on the call today, as we think about that broader impact of MFN pricing, I think it's clear that market access teams will need to take an even more globally coordinated approach when launching products. This will mean including the US when conducting IRP exercises and potentially rethinking launch sequencing and early wave markets entirely. You know, for example, prioritising those high-price markets ahead of the lower-priced ones. I think at the same time, managing exposure does become critical, so companies should really be thinking about how you model MFN-linked US reference pricing and how that could affect global forecasts and revenue as well. So a key part of that is minimising the visibility of lower international prices that could be referenced back into the US. But I think finally, it's important to note that this is still evolving. And I think one of the key considerations is really just to keep abreast of everything that's going on, continue that scenario planning. This is a moving target, but I think definitely one to watch. So even some small steps now can make a big difference in the longer term depending on how prepared companies are for whatever policy changes lie ahead.- Lovely, thanks, guys. There's a recurring theme there of impact and the so what and maybe wanted to bring that into the next theme, but what impact will HTA collaborations, like the JCA and Commonwealth collaboration, ultimately have on pricing and market access in the future?- Yeah, that is a such a good question. Let's start with the Commonwealth HTA collaboration. The arrangement was made in 2021, and this is an initiative of, I think, eight HTA bodies from Australia, Canada, New Zealand, and the UK. So far the organisation has prioritised exploring opportunities and challenges to share across HTA partners. They're also conducting horizon scanning to support better system preparedness, and they're focusing on science and methods development. So far they're not doing any joint assessments. That could change. But as of January, as we said earlier, joint clinical assessments are mandatory in the EU for oncology and advanced therapies. Orphan drugs will be subject to the process from January 2028, and then all products will be part of it from 2030. The focus of the JCA is actually on clinical and safety data. There isn't any economic evaluation because that has to be done at national level, of course. And in theory, national HTA bodies won't replicate the clinical assessment made by the JCA. But of course they may require their own analysis. They may obviously need additional information to make pricing and reimbursement decisions. The rules are that HTA agencies can only request studies that won't yield the same data that have already been assessed as part of joint clinical assessment. But we know it's a legitimate concern for companies preparing for this challenge in terms of it's almost a new hurdle. They've got to prepare for the joint clinical assessment and then their national assessments as well. One positive thing about this centralization of clinical assessments is that it allows companies to access multiple EU markets simultaneously. It has the potential to reduce duplication and could accelerate time to market because JCA has done in parallel with regulatory assessment, and that means it might make national pricing and reimbursement decisions more efficient. However, it does have implications for pharma. They may not want to launch in all markets simultaneously, and many reasons could be behind that, including launch costs. They might not have the resources. And pricing implications, of course, launching in multiple countries at once could accelerate price erosion driven by international reference pricing. And I think there's another really big challenge for companies, especially smaller ones again, that are submitting their products for joint clinical assessment. This is the consolidated PICO. That stands for population intervention comparator and outcomes. The requirements from all 27 member states in the EU for PICOs will be submitted, and companies must then gather the necessary data to satisfy all of those countries in a short time. They only have 100 days to do that, and it may necessitate analyses that were not part of the trial design, so companies will need to undertake systematic literature reviews and indirect treatment comparisons. Those things are really time and resource-intensive, and it puts a lot of pressure on companies. And of course, I think the main thing we're trying to say here is these things must be factored into strategic planning. So trying to predict what would be required, prepare accordingly. You have to do that before your product is required for a joint clinical assessment so that you've got the time to gather the evidence that you need.- Great, thanks, Clare. You talked at the beginning of your kind of response there of that kind of true global spread of those collaborations from a true kind of global strategic perspective. Cathy, maybe heading towards your thinking around what are those kind of key considerations when developing that global pricing strategy that ultimately does support successful launches in those key markets that we've talked about, whether that be ex-US or within US, and how would you define a true global pricing strategy, and how do you align the strategy cross-functionally?- There's sort of a lot to unpack there, but let me talk about that. I think a global pricing strategy probably means different things to different people, you know, and perhaps that changes over time, over the time of a product's development, but I think for sure it has a number of different layers to it. I think for me, at its highest level, a global pricing strategy sort of defines the value of a product. What is your product, you know? What is it? Is it better than what's out there? Is it the same? You know, what are you benchmarking against? You know, is there a benchmark, and if there isn't, what is your justification going to be for the price level that you're setting? So it's a sort of a conceptual framework, if you will, for kind of articulating the value of your product. And that can be sort of formed from the very earliest stages and is actually a tool that you can use internally cross-functionally to guide the interactions and think about what the clinical data would need to look like to support that, you know, what evidence gaps there might be as you see the product coming together. And I think the next layer down really is thinking about, okay, that's our goal, that's our target. You had, you know, a premium versus this comparator or benchmarking against similar products of a similar size of population. You know, how does that look in each individual market? Because, as we've heard, you know, there's very different systems. Sort of cost-effective is based markets, clinical benefit markets, you know, budget impact markets, Based on the key countries that you need to think about, what is the likelihood of being able to support and achieve that price in the different countries? What is the... translating that concept into an absolute dollar or euro value in each of those key markets. And as we've heard from Sam, there's a bit of a shift in the earth's axis that, you know, maybe there aren't going to be so many free-price countries where you can just dictate that. Maybe ultimately, you know, markets like the US could have some level of control there as well. So when you have a vision of what price might be achievable, absolute price I mean, you can then start thinking about what does that look like globally. Like there's of a corridor of prices that you would like to achieve, the target, and at what level, because obviously there is the list level that is publicly available. And then, you know, in many instances, you would obviously also thinking about the net level. You know, dictating that corridor and then thinking what that means for the launch sequence, your global launch sequence. Again, Sam was talking about that. That is something that we do already, but actually, is there going to be a big change in how you would think about that? So again, ongoing discussions cross-functionally about how feasible, applicable the strategy might be and what one might need to do to prioritise or deprioritise countries is really important. So defining that launch sequence is another layer of that, of that strategy. And even at the very nitty-gritty level, the strategy, even though it may be blurring into kind of more tactics, but I do think there's a strategic component here is sometimes it's very simple. Price per year, and there's one formulation, and that's your price. But sometimes there are also considerations about how you translate that target comparator price to a price per pack or a price per particular SKU, and are you flat pricing or linear pricing, and where can that be done how you want it to, and where are there rules that prevent you from doing what you want? So just really getting into the weeds of how you would actually set the price for a pack in a given market. I think also, if I'm not going on too much, I think there is a component about your negotiation strategy. You know, knowing what you want to achieve and knowing the data that you're likely to have to support that, how do you go about achieving that? In some markets it's very much driven by your cost-effectiveness model or what have you. In many cases it can be part of a negotiation. Where do you begin knowing where you want to end up and what's most important to you? Is it, you know, fast access because you've got competitors coming on your tail very quickly and you want that first-to-market benefit? Is it securing price because it costs a lot to develop or because you have subsequent indications launching and you want to optimise the value as long as possible and as much as possible? Is it about just broad access because you truly believe that this is a product that should support access? So knowing what's most important and where you are willing to make concessions is again, I think, part of that strategy. And sometimes that does lead to a lot of internal discussion and interaction and negotiation internally between functions, but between the global and local teams, where they know they're the ones that have to go and actually implement the strategy at the end of the day. So I do think there's a lot of layers, a lot of components, but to me the strategy is this living, breathing, evolving thing. You can start very early on the back of an envelope and have conceptual ideas about what you want to achieve, and you use that to plan the data and the interactions. As Clare noted, you know, that's getting harder and harder if you have to think about all the potential comparisons in all of the relevant markets in the EU. You know, you need to plan around that, and it enables dialogue and discussion with the regulatory teams. And then, as I said before, making it through to the local level. So for me the strategy is your kind of framework. To have that that you're thinking about things in the right way, and in our experience that the companies that really do do joined-up planning, evolve that strategy over time, have joined-up conversations across functions and ideally with the support of people that can provide insight from external perspective, not just internal. I think those are the companies that have the most success in actually translating the strategy into reality.- Thanks, Cathy. You spoke very nicely there about that like cascade of stakeholder involvement and communication. That real need to communicate to the right audience at the right time about value throughout. I wanted to maybe bring the next question up to earlier in that process and maybe focus on one particular key audience that we've certainly started to see as a real key protagonist in this and maybe, Adam, what role do we see as that early payer engagement playing in shaping a really successful global launch?- Yeah, it's a really good question, and obviously with us in market access, it's a really important one, and it's something that we focus a lot on. So to understand the opportunity to engage in the mechanisms, how you do it obviously differ quite a bit across markets, but obviously preparing for access and reimbursement should really be at the front of mind when designing clinical trials. The broader evidence generation strategy and is really a launch critical strategic imperative. So early payer and stakeholder engagement really helps de-risk the launch, improves alignment with individual markets, and ultimately helps secure optimal pricing and reimbursement across markets and helps move that relationship with payers and other stakeholders from being reactive to strategic. So making market access a driver of value rather than a barrier. So I think the important things to consider, I suppose the first thing early engagement will inform, is really a fit for purpose clinical and evidence generation strategy, so it helps align payer and decision maker expectations. The early dialogue may help identify things like what clinical endpoints are important, what comparators, what patient populations are most relevant for demonstrating values of payers. And these may be and often are different or supplementary to those required for regulatory approval. Early engagement really helps reduce potential evidence gaps so it can inform things like target product profiles, the phase two, phase three trial design, and other evidence generation activities to ensure that the data really does support key indications and value claims and that it's appropriate for HTA reimbursement and also formulary inclusion. So I think a bit more about clinical endpoints. So payers may not accept things like surrogate endpoints or some PROs unless they're properly validated. We know that from places like France and Germany, where there be challenges around the use of surrogate endpoints. There may be some endpoints that payers consider more clinically meaningful than those required for approval by regulators like EMA, FDA, and so on. The comparative selection is really important as well. So reimbursement agencies can be quite strict about the relevance of comparators to that particular market. So really understanding the clinical practice and individual markets and engaging with payers to understand what their perspective is can be critical for ensuring that access is possible across different markets and is optimised. Similarly with patient populations. So payers are going to prefer patient populations that are represented of their marketing under consideration. So some countries even require clinical trials to be conducted in that market. Japan's a good example. Other things to think about are understanding how payers may look to narrow the reimbursed population. So perhaps to patients with an unmet need in order to justify premium pricing. So early discussions can really help steer the trial inclusion criteria accordingly to ensure the trials are designed and perhaps sufficiently powered to detect differences in those relevant subpopulations that may be subject to restriction. And also early planning has helped support in planning for future indications. So it helps companies understand and plan for the development access pathways for potential follow-on indications or line extensions. Other things to consider are, it can really help anticipate managing access barriers, so other potential hurdles or restrictions, such as line of therapy, treatment duration, and it'll help develop mitigation strategies. So obviously proactive development of strategies, things like patient access programmes, or risk-sharing agreements, or perhaps supplementary evidence packages are things that should be considered and to plan for these future potential risks. One thing that we've seen as well is you really need to understand and differentiate between, obviously, the different regional needs. So payers in US, Europe, Asia, they often have different priorities. So ensuring that you have early multi-regional engagements supports that better global strategy integration and allows for country-specific planning. So tailored payer engagements really help shape the country-level pricing, reimbursement, and access well in advance of launch. It can really help early engagement, can really help speed up market access. So we've seen that companies that engage early tend to face fewer delays post approval'cause they are better prepared to meet those needs of payers. It will reduce the likelihood of rejection or request for additional data, which can often delay reimbursement. It can also improve readiness for things like early access schemes, things like in France, the early access programmes and compassionate access programmes, formerly ATU. The UK, the Early Access to Medicines Scheme is another one where if you prepared early, you can get the evidence ready and prepare really for these individual market considerations. So ultimately these are, obviously, this isn't exhaustive, but they're just some of the main considerations, and we've seen firsthand what it can really do to prepare well to engage early, and you'll often see quite a stark difference between those companies who have prepared early for the payer hurdle versus those that haven't. So yeah, thanks.- Thanks, Adam. Yeah, you painted a good picture of those basic series of critical success factors, which, whilst not exhaustive, clearly are going to be, to those colleagues who are joining today's discussion are unique to whatever environments that they're working in. We've also painted quite a lot of permutations, but, Cathy, without you unpacking another larger question, but I'll maybe throw it to you anyway. Given all of those complexities and all those kind of permutations of capturing the kind of full value, and particularly for innovative kind of therapies, such as whether that be cell or gene therapies or treatment for rare disease, how could attendees on today's call consider that in their own role of thinking about those key challenges and pricing within those therapy areas?- Yeah, no, thank you, Ben. It is true that, you know, there are a number of really exciting, innovative products coming to the market right now. You know, whether it's, you know, products that are the first of their type, they're changing a paradigm in a disease, or if they are, as you say, those sort of cell and gene therapies. You know, there's so much potential and promise, it's super exciting working on them. But of course there is, on the flip side, there's just a lot of challenge as well in terms of, you know, the evidence base and the affordability piece. And I think I'm going to talk a little bit about, you know, how I sort of see that playing out. But of course some of the solutions are more sort of financial. I think Sam is likely to be able to kind of comment on that as well. So I mean, to me, you know, without stating the obvious, I think for these rare, often rare diseases, the sheer volume of data available is somewhat limited. We have, you know, smaller population to deal with from the beginning and trials, it's very challenging sometimes to recruit patients. The trials tend to be smaller, single-arm, often open-label. The data is just a little bit less robust and not certainly not fitting the normal standards for some of our evaluators. But obviously they recognise that you can't change that. It's not like they're going to require you to do the same sorts of studies. But I think by the same token, you have to kind of think about the ways that you can make the data as relevant and as appealing as possible and try and fill those gaps. I think some of the kind of very tricky pieces, of course is the durability component, like some of the promise of these products is that, you know, it could be a once-and-done therapy, but ultimately do we have the data to support that? Or even if it's a, you know, a significant impact is that benefit maintained over time. And these are the questions that really do contribute to uncertainty. And that's something that payers really don't feel comfortable with, and you've got to work as hard as you can to kind of try and reduce that uncertainty as much as you can. I mean, on a sort of slightly nuanced level as well, the fact that you are just changing the paradigm, it's harder to then zero in on a particular strategy or what I talked about before about the overarching conceptual value of your product. You know, if there's a comparative there, it makes more sense. But if you are truly setting a new line in the sand, you've got to think very carefully about what's the relevant level. It costs a lot to develop some of these products, you need return on that investment, but you also need some justification and different ways of triangulating in on the value that can be supported. And I think when you think about that, you also have to think from the payer's perspective in terms of affordability and sustainability. I think there's two parts to this. One is, yes, it's a rare disease, there's very few patients. We should be willing to pay a lot to kind of cure this horrible genetic condition, but there are quite a number of rare conditions that we should be funding because the impact is so horrible. And therefore, from a payer's perspective, they need to sort of find budget for all of these rare, relatively small-impact diseases on their own, but they amass for the payer, and they have to cover them all. In addition for some of the gene therapies where, you know, the investment comes upfront and the benefits are reached long-term, that obviously requires different thinking and different approaches, which Sam is going to talk about. And those different sort of upfront payment or sort of deferred payments is very important for markets where perhaps there isn't one central payer and that actually the payer that invests for a particular patient may or may not see the benefit longer term. So I think that is important considerations. And I think ultimately, therefore, it's kind of the, it's kind of we're repeating ourselves, you've got to start early, you've got to think about the challenges that you're going to have for your particular product and your particular disease. It's important to think about the ways that you can improve the value and the quality of the data, even if you're not going to be able to deliver the outcomes that payers, based on their rules and regulations, might require. Can you add additional elements? Can you expand it? Can you put it in context? Is it a condition where caregiver burden is super important, and maybe that is factored in for some evaluators and maybe not for others, but in this instance maybe that's incredibly important. So work to see how you might do that with lobbying, with stakeholder engagement, all of those things. Like, think for your product, what could make a difference? Again, this whole idea of planning for the uncertainty, trying to fill the gaps, and just being open and recognising that you might really need to go talk to the payers early on to get their buy-in, to get their solutions. You know, just be open and transparent about the challenges you're facing, and then you might be able to bring the product to market in a way that the payers are comfortable with. They've bought into the strategy, they've helped you solve some of your problems. And I think some part of that is related to the agreements that you might well make. I think payers are a little bit wary of outcomes agreements in certain contexts, but obviously in this sort of area they have to be open to consider the outcomes or the financial type agreements. And I think, Sam, you wanted to talk a little bit about that based on your experience, right?- Yeah, absolutely. So I think when we talk about these innovative pricing agreements, with which Cathy's done a great job of introducing, whether these are outcomes-based, stage payments, managed entry, it's important to remember that that success doesn't just depend on a contract or a scheme itself. It really depends on the ecosystem around it. And I think there are a few critical enablers that really determine whether these agreements can work in practice or not. I think firstly, you need a really solid data infrastructure and real-world evidence system in place, and you know, that's to track outcomes, trigger any payments, and validate that long-term value piece, which again, Cathy introduced as so important. Without that reliable data, even the best design agreements can fall apart really due to a lack of evidence or accountability. I think secondly, operational capacity is really key. These agreements by design are complex, you know, especially when there are outcomes-based payments involved. And I think many successful models rely on third-party administrators, specialised platforms to manage that data collection, help with contract execution, and ultimately, monitor that performance. I think thirdly, a regulatory and policy support is really key. It needs to evolve alongside these models. I think some markets are starting to introduce frameworks for conditional reimbursement or multi-year payment models, but again, these are still early days. Having those clear supportive policies are essential to give all stakeholders confidence in these type of technologies and the indications they're treating. And I think finally, defining the right outcomes is absolutely critical. You need those endpoints, which are not only clinically meaningful, but they're easy to measure and they're agreed upon by all parties. When outcomes meet these criteria and are aligned with real-world clinical practice, they reduce ambiguity, they build the trust between manufacturers and payers, and it's really easier to scale these agreements across markets. So when designing an innovative agreement, companies really need to ask, is the system ready? Is the data there? The policy, the people in place to really make this a success? If not, part of the strategy has to include helping build that readiness through partnerships, pilots, phased implementation, whatever it may be. Now, if we think about some of the models of innovative agreements that have been successful and already in place, I think one of the first to come to mind would be outcomes-based agreements. So these essentially just link payments to how well a treatment actually performs, whether that hits certain clinical milestones or delivers a durable response. And there are well-published examples of this. Then, as Cathy did a great job mentioning, there are staged or annuity payments. So these kind of spread the cost of high-cost therapies over several years, which again could be a real lifeline for more fragmented or smaller payers or insurers. And again, countries like Spain, Italy, Brazil are already putting this model to great work. Next there are things such as coverage with evidence develop or more managed access agreements, and these really allow patients early access to promising treatments whilst at the same time ensuring that data is gathered to reduce any uncertainty that may be associated with the product. And again, that's a well-established process in places like the UK but is gaining more traction in other European markets as well. Another model is more one-time payments with performance rebates. So again here the full cost is paid up front, but if a treatment doesn't deliver on the expected outcomes, a rebate is issued. You know, it's a simpler model to administer and does fit quite nicely into any existing accounting systems. And I think a final example in this non-exhaustive list is some of the examples we've seen with subscription models where payers essentially make a fixed annual payment for unlimited access to a product or a class of products. And this has been used to great effect in infectious diseases and anti-microbial resistance and I think is now being explored in other areas too, given its success. But I think more than anything, these models highlight the point that whilst innovative therapies inevitably, by construction, introduce complexity, they also create a great space for creative and adaptive solutions. Pricing these technologies in a way that reflects long-term value whilst managing affordability and addressing uncertainty does require more than just a strong clinical evidence base, but it needs that strategic planning, early engagement, flexibility, and, I think, most importantly, collaboration with payers and healthcare systems to be successful.- That's great. Thanks, Sam. We're tracking quite well for time, but I'm also conscious people are on coffee breaks or if you have US morning or equally grabbing a slightly later lunch, but maybe time for two more questions. But I think, Adam, perhaps how, in your opinion, how should companies really prepare for or equally respond to competitors in the market?- So when we talk about competitive things like generics, biosimilars with loss of exclusivity, and things like that, because obviously inevitably when generics and biosimilars are launched, most healthcare systems are going to be motivated to prioritise cost containment and optimise the value that they're getting for their money. There are obviously many things that companies can do to try and prepare for this and to make sure that they're ready for these competitive dynamics. So firstly, I suppose the most important thing is really to understand the market dynamics. How are different healthcare systems likely to respond to the introduction of new and potentially lower-cost entrants to the market? What are the key drivers in those markets? Are they purely cost, are they related to outcomes, clinical experience, real-world use of the originator product? What are those drivers? And try and really understand those. And if it is cost, which we do see in quite a lot of markets, understand what are the mechanisms of cost containment that might be applied and how can you prepare for these. What do they look at? Is it pure cost? Are there outcomes-related elements to it? So it's really about understanding what are those individual market dynamics. Also, it's obviously really important for keeping an eye on market intelligence and competitive landscaping. So systematically monitoring pipelines, trial data releases, regulatory milestones, and pricing trends of comparators to make sure that early action can be taken and benchmarking clinical data and identify potential areas for differentiation early really helps prepare for those new market entrants. One thing that's really important to think about is the post-launch evidence generation. So invest in real-world evidence studies that demonstrate the value of the product versus newer entrants and things like registries. And if appropriate and feasible, conducting head-to-head studies or indirect treatment comparisons to demonstrate superiority, if possible. Obviously that's not necessarily always appropriate, but something that could be considered. Other things that are less, I suppose the perhaps added value things that we've seen used quite a lot in the past is things like support programmes being used for patients or healthcare professionals. So developing medical education, data-sharing platforms, and ongoing patient support or healthcare provider support and really demonstrate the real-world experience and value of the product and to differentiate the originator brand. We've seen manufacturers offer wraparound services, so things like adherence programmes, nurse helplines really helps enhance that product stickiness and differentiate beyond just the molecule. We've seen examples of how some manufacturers have developed things like the Pfizer's ByYourSide app for cancer patients. AstraZeneca have a large IMPACT Academy, which is basically a hub for peer-to-peer education for specialist healthcare professionals. Some companies offer nurse-led patient onboarding for things like biologics. So obviously there's a few of the key things to consider. Again, there's obviously a lot more to think about, but hopefully those are some of the things that I think would be most appropriate.- Thanks, Adam. That's, yeah, really good food for thought. Guys, hopefully you don't all jump at the same answer'cause it's always tricky when you all kind of go running round robin for this next question of offering kind of maybe one piece of advice. To anyone who's really on this call, if they were to leave with one nugget of advice from your perspective, but maybe going from kind of Sam, Cathy, Clare, and then, Adam, sorry you've got the raw end of the deal here, but what would your piece of advice for people to leave this webinar with today?- Well, I'll jump in. Thanks, Ben. So I think for me, and it seems to be a recurring theme, and it's really start early. I think one of the most important lessons we've learned through this whole webinar from the pieces is access strategy can never be an afterthought. It really needs to be embedded from the very beginning of development. Payers, HTA bodies want more than just clinical evidence. I think they want to see long-term value, real-world impact. And I think by involving those market access teams, many of whom hopefully will be on this webinar today from the outset, those evidence requirements can really make sure they're proactively built into any development programmes. And again, that gets that consistency and consideration from the payer perspective alongside any clinical, regulatory, commercial strategies from day one.- What he said. That's basically sums it up in a nutshell, but I think it's so right. Thinking early and cross-functionally is key. But I guess if I was going to add a different bit of advice, I guess I would say to always try and think from the payer perspective, just to sort of sanity check your assumptions about the environment and about your product. Are you really seeing it in the way that they will see it? And can you get ahead of that to try and change their mind if it's not quite the same as how you want to see it? And also think about them in their role. Like, I think this is more moving into when you're engaging with the payers and trying to convince them and sort of getting to the negotiation piece, which is a part that I love working on. And it's think from how do they view you as an individual, you as a company, are you consistent? Is your ethos appropriate? Is what you are trying to achieve now align, have you been collaborative in about, think about those kinds of things as well, and think about their objectives. You know, are they managing their budget for this year? Are they managing, you know, a kind of a reduction over the next two years of X percent? Like, are they focusing on a particular therapy? Like, can you support them with whatever objectives they are trying to achieve and get something that you need as well? I think it's very important just to think not only with your own lens in your planning processes. That's my advice.- Yeah, I totally agree with everything that you've both said. I think what I would add is that it's important to be flexible so things can change. Things change all the time. It might be new policies, new governments, new competitors coming to the marketplace. And although we must encourage developing a strategy early, I would also like to stress that it's important to revisit it over time. Keep considering is this still going to work, is it going to hold up. Consider alternatives, pressure test it, and just make sure that you keep your strategy current so that it's going to stand the test of time and serve you going forward.- I'm going to struggle to top any of that. Obviously really, really good stuff. I suppose one thing that I would say is give us a call. Obviously as Petauri we're here, we're here to help obviously and support if it's needed. So yeah, hopefully, I suppose, we've shown that some of us know our stuff, but yeah.- Yeah, we want to help.- Thanks, Adam. Yeah, and I think we've talked a lot about, particularly your point Clare there, that need to be agile and responsive to those ultimately evolving critical success factors that you guys may be confronted with, and ultimately they are governed or influenced by various internal or external pressures. And whilst this discussion certainly may not have been a single silver bullet to any one of you, I think hopefully what we've maybe done is at least challenge your own thinking or hopefully contribute to how you go back into your own teams and consider how you are going to confront perhaps your own challenges as a team. Of course, we have covered a lot in discussion today. If there is anything that perhaps we haven't gone into as much depth as maybe you'd like to explore, please don't hesitate to reach out to us, to contact us. We'd obviously be more than happy to be part of those discussions, but obviously, finally, thank you so much for joining us today. I know the team in way of prep have really enjoyed being challenged by your own questions and thought processes as we've been preparing for this, today's discussion. And I suppose with that, wish you either a good remainder of your day or a good day ahead, and thank you so much for joining.- [Narrator] Thank you for watching. If you'd like to find out more about how we can support your market access goals, get in touch today (email evidence@petauri.com). For more market access insights, follow us on LinkedIn.