Pharma Market Access Insights - from Mtech Access

Navigating US payer evidence needs to optimise market access

• Mtech Access - Powered by Petauri • Season 7 • Episode 23

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What clinical and economic evidence do US payers prefer to drive formulary decisions? How can you optimise your chances of preferential access in the US with the right evidence? How should evidence be generated, synthesised, and presented for the US market?

In this episode, Clare Foy (Director – Global Market Access, Mtech Access) interviews colleagues Nicole Lodowski (Managing Director, Petauri Evidence) and Bob Nordyke (Senior Advisor, Petauri Evidence) about US payer evidence challenges.

We explore the evolving evidence needs for US payers. Nicole and Bob share unique perspectives around their extensive experience of driving evidence strategies for US pharmaceutical and medical device launches. Additionally, Nicole and Bob share a ‘sneak peek’ of exclusive insights from a recent Petauri US payer insights survey conducted to better understand the evidence landscape from the US payers’ perspective.

They explore:

  • The evolving payer evidence landscape in the US
  • Preferences for clinical and economic evidence by US payers
  • Key differences between the US and other global markets with regard to evidence, HEOR, and market access
  • Opportunities and challenges when launching new medicines/medical devices/diagnostics in the US
  • Innovative perspectives on evidence planning and strategy for the US market
  • US payers’ perspectives, with exclusive insights from Petauri Evidence’s 2024 US payer survey


This episode was first broadcast as a live webinar in October 2024. Learn more at: https://mtechaccess.co.uk/navigating-us-payer-evidence-needs/

Explore more about launching in the US market: https://mtechaccess.co.uk/launching-healthcare-products-in-the-us/

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- [Announcer] 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 navigating US payer evidence needs to optimise market access. I'm Clare Foy, director of Global Market Access 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 anyone that doesn'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 work as a collaborative partner to healthcare systems worldwide. Today we're focusing on navigating US payer evidence needs to optimise market access, and I'm delighted to welcome my colleagues, Nicole and Bob. Welcome, both of you. Could you please take a moment to introduce yourselves, your backgrounds, and your current roles? Start with Nicole.- Sure. Happy to, Clare. Good morning and good afternoon to those across the pond or even good evening. I'm managing director within our US Evidence Team of Petauri based in the US. I've been in the pharmaceutical and consultancy world for over 15 years, with roles spanning global and US, obviously based in the US, with a heavy focus in the US, but a lot of the work I've done has spanned global roles as well, and really have diverse experience working in the HEOR space, as well as strategic market access, US payer marketing and medical affairs. And throughout my roles, I've had a deep focus on planning, developing, communicating evidence, hence the role at Petauri to really support the value of innovative therapeutics, both globally and in the US. And just to note again, really myself and Bob both focus heavily on the US, but we really partner closely with Clare and the broader Mtech team and Petauri to work with global clients to distil some of that critical information for the US which will really touch the tip of the iceberg today, but look forward to discussing more detail. Bob?- Hey there. Bob Nordyke, senior advisor at Petauri. I too got several years of experience, coming up on 25 in the pharmaceutical industry, both on the manufacturer side, large and small, and consultancies in health economics and market access roles, have also spent some time working at a US-focused trade association where I was responsible for their pricing, value assessment, and research on innovation. Glad to be joining today.- Thank you, both, really happy to have you with us. Could we start by talking about the US payer landscape in general? It's probably a hard question, but if you could outline what we mean when we talk about payers in the US?- Oh, sure. Where do we start, Clare? So as you're aware, US is one of the most complex health systems in the world and don't necessarily say that in a full positive light. We'll go into a lot of topics today to try to scratch the surface of some of these things, but let's just cover some of the top things to know and we'll sprinkle some other tidbits throughout today. So we do have... Right, we start with a central regulatory approval with the Food and Drug Administration, the FDA, similar to EMA, reviewing the efficacy and safety of a drug. And that's where it all kind of goes awry in the US. We have a complex... Drugs then go to individual payers. So we have a complex mixture of both private and public payers in the US. Over a third of the US population has some sort of public insurance, including Medicare, which is mainly for elderly patients as well as some chronic conditions. Medicaid, mainly for patients of low income, but again some additional kind of subgroups in there that are covered. And then there's sub archetypes of kind of all of these with managed Medicaid, Medicaid fee-for-service, Medicare advantage. There's so many different arms and models, and then there's additional public payers when you get into Veterans Affairs, for example. So there's a lot of different stakeholders at play, and that's just on the public side. And then there's the private side of insurance. Over half of Americans receive some form of private health insurance. Most of them receiving this through their employer, at least partially funded. It really varies by individual employer. We'll get into some of those nuances a bit. And then when you look into commercial payer archetypes, you might hear things like MCO, IDN, PBM. So MCOs are managed care organisations, really your traditional commercial healthcare plans that focus on managing care to limit cost. Things like PBMs, pharmacy benefit managers, provide the drug or pharmacy benefit and really coordinate with healthcare plans to manage that drug cost and that integrated delivery networks, almost a one stop shop, with a payer and integrated healthcare plan and health system within, and a more popular model that's coming with more vertical horizontal integration in this US web that keeps getting bigger and smaller at the same time. And this leaves an important subset of the population out which different than some other countries in the world. The US has quite a large uninsured population. The latest CDC report, I think, about 8% of the US population having no insurance whatsoever. And this is not just adults, it's children. Although, again, there are subsets that are covered under certain plans. So about 25 million individuals in the US don't have any healthcare. There's also an underinsured population that might not have full coverage, and that's a large portion of the population as well. And beyond this, we look at drugs. There's medical benefits. There's pharmacy benefits. And again, we'll get into some of those nuances, especially when we talk about things like IRA a bit more. And then payers, kind of as mentioned, with the complexity of the US. We don't have an HTA, and we'll get into that. We don't have a centralised health technology assessment body like other markets in the world. We try with some of our independent bodies and some models that we're shifting towards, but these negotiation reimbursement discussions are happening on an individual payer basis right now largely and going on behind closed doors with really a lack of transparency, which, again, makes the US a fun place to play in. Bob, I'll turn over to you for any additional perspectives. I'm sure I missed a lot, but just trying to give a small snip of this.- Thanks. Yeah, I will add I guess even a little bit more complexity. Nicole mentioned that a third of the US population has public health insurance. So two thirds have commercial insurance, dominant player in the US. And most of that commercial insurance is actually sponsored by employers. So employers are yet another stakeholder that anybody launching, managing a product in the US market needs to consider, and they're pretty critical stakeholder and importantly have different perspectives on some endpoints, some measures of value than would a health plan. Productivity obviously is going to be pretty important to employers. Hospitals too. If you have a hospital-based product and the hospital purchase decision is important, you need to be thinking about the hospital, P&T committees as as as well. So it's pretty complex market obviously for every product, every disease state. Each stakeholder isn't going to be as relevant as another, so you need to take that into consideration in your early stage evidence generation planning as you prioritise which stakeholders, which evidence you're going to generate for.- Right. Thank you. And we can explore all of the needs of all of those stakeholders as we go through today's webinar. So, Nicole, you mentioned HTA, some of our listeners may indeed be more familiar with the payer landscape in countries that have health technology assessment bodies such as NICE, G-BA, CADTH in Canada. That's now changed as well of course. So HTA is often considered an additional hurdle after regulatory submission. I just wondered if you could tell us a bit more about the situation in the US. Can we make a similar comparison? Do payers conduct similar assessments of clinical effectiveness and economic considerations after the FDA decision?- certainly they do. And with all of the headlines about the IRA and CMS being able to negotiate prices for the first time kind of obscures the fact that we do negotiate prices in the US. Commercial insurers, PBMs, to an extent, do negotiate with manufacturers, and these are private organisations making private decisions, so we don't have a lot of information on decisions made on individual products, but there are formal evaluations. Large and small plans have their own P&T committees, and the evaluations tend to be more on the clinical value of the drug and comparative effectiveness. We'll talk a bit about what is the best evidence to support that pre an post-launch. The AMCP format dossier is, if you're not familiar with that, becomes so, because that is a really nice format that is designed for manufacturers to communicate clinical and economic value to payers. Another set of evaluations, obviously under the DPMP, we just had a start with the first 10 drugs that were negotiated in Part D only. That will expand over time. We don't know yet about the actual negotiation process. Congress has laid out a number of negotiation elements, evidence elements that manufacturers have to submit. How those are weighed and exactly how CMS is making decisions, we're going to have to wait until early 2025, until the initial rational for that first 10 drugs are issued. And then thirdly, finally, and certainly not not least, is the Institute for Clinical and Economic Review. Independent, private, non-profit that has a bit of an out outsize in influence in that they can only conduct about six to eight assessments per year, but US commercial payers do look to those evaluations for information on comparative clinical effectiveness, and they also do use the health benefit price benchmarks that ICER issues as part of the price negotiations with manufacturers.- Yeah, that's interesting, Bob. We sometimes consider ICER as almost a proxy HTA body. Could you just tell us a little bit more about how impactful their evaluations are?- Well, they do centre cost effectiveness and analyses in their assessments. They are significantly expanding the methods and the scope of their patient engagement to gain patient input on the value. My sense, my opinion only is that since these these are cost effectiveness analysis centred value assessments and US commercial health plans don't really understand, don't fully use cost effectiveness analysis to a large extent, that may limit the uptake, the impact of the ICER assessments on coverage and reimbursement decision-making. But like I mentioned, where those value assessments are available, payers will pay attention to them. They will use them throughout their decision-making and negotiation process. So while the impact might be limited in terms of the number of value assessments, the number of drugs that are evaluated each year, ICER does tend to be very selective. They have to be. And they tend to, and quite understandably, tend to focus on products where there is high unmet need, high potential, and perhaps some uncertainties, particularly in long-term impact, long-term outcomes. So if you're planning on launching in the United States, paying attention to an ICER evaluation and preparing for that would be a very good thing to do.- And I think Bob, just to add, we use them as a proxy, quite frankly. It's the best thing available, the most transparent thing we have available in the US. The other way we get at this information in the US is more so... I know primary research is critical in every market, but that allows us in the US to actually get under the hood. We might see some of the prices. We might see how drugs are covered and what prior authorizations are put in place or what steps are put in place. We don't know the why. It doesn't give us the why. So that's where we have to dive into kind of our relationships with US payers to get under the hood and understand why did they make this decision, what were the factors in play, and a lot of times it comes down to price and what various manufacturers are willing to put on the table from a negotiation standpoint.- That's really interesting. And yeah, together, I suppose that builds a picture of how decisions are made and what's important. Okay, you touched on price there. So, we know the US is often the first launch market for pharma and MedTech companies. Could you tell us a bit more about why this might be and what the attractiveness of the US is as a launch market?- Yeah, so some of it probably bubbles back to things we've already mentioned, but it's no surprise that US is attractive. It's large, not the largest market, obviously, in the world, but the large... Population-wise, it's a large market, but even more so the high price potential as we've kind of touched upon a bit. The US has a population of... I think the latest was 335, 337 million, about 5% of the global population, which big but not the biggest as we know, but that alone accounts for, and again these numbers change between what report and what source you're reading, but about 50% of global pharma sales come from the US or revenue comes from the US, so that is immense. Just 5% of the population in the world is accounting for 50% of global pharma sales. And there's a number of things that go into that, and we won't go into some of the political components as much about US pricing, but I know there's strong perspectives, obviously, on both sides about that. But one of the things being there is a low level of price regulation in the US. They're set by the manufacturers, negotiations happen behind closed doors with rebates and discounts, but there's no HTA that's saying really negotiating on a large scale to say this is the bulk kind of overall price that we're going to pay with this kind of volume discount that we're working with. And then with that, timelines are also quicker. You get FDA approval, you could technically be on a formulary right away, especially if you're having some of those pre-approval discussions. Companies can go in often six to zero months, sometimes 6 to 12 months. They're going in having discussions, especially with some of these large cost drugs or big populations, and payers are preparing especially if it's a high need area that maybe it's the first to market or maybe it's a really innovative therapy or going to have a huge game-changing impact from an efficacy of safety perspective. They're having these discussions a lot of times in advance to allow them to proactively plan their formularies and kind of have a heads up that these are coming and allow them to look at that in advance. So we don't have to go through EMA and then NICE, for example, as other you might be used to, or even additional bodies that come into play with some of those. We go FDA, you go to individual payers, and you can be on formulary quite quick. It takes longer with some of them, obviously, but again, some of that proactive planning allows them to be the market really quickly. Yeah, and I think, yeah, just with... Right, I think US tends to... And Bob, I don't know if you've heard differently, I think about a year before a lot of these other global high, kind of developed markets, the US is often, drugs are available as soon as a year before some of these other markets due to the lengthy HTA timelines that can take place and all of the other processes that need to happen before full availability in some other markets.- And I think that tho those social preferences, if you will, for high value placed on innovation and rapid and relatively broad access to those new drugs are essential values reflected in the US market. We often struggle with those, and we argue about those, and sometimes you see results like the IRA, but we still remain that market that places a relatively high value on new innovation and access to that innovation.- Okay. Let's think a bit about evidence now. So it'd be helpful if you could give an overview of the type of evidence required by key payers in the US. For example, how does the evidentiary standard compare with what's needed by the FDA, what clinical and economic evidence, if any, economic US payers like to see from companies to optimise market access? And how should evidence be generated, and synthesised, and presented for the US market?- Sure. I'll take this one and start, Bob, and then turn it over to you. I'm sure I'll miss things, but really I think the first point to say, and hearing that word, Clare, and it's such a common kind of term that's used when you talk about the US is required. There are formal... FDA will require things for regulatory approval. Payers don't have a you must do. There's no government guidance similar to an HTA body of, "You have to have this to reach this level of approval or this level of reimbursement or acceptability." We don't have that. It really comes down to individual payer preference and kind of the way they work and what they want to see. This changes year to year, and month to month, and day to day as things evolve, which again makes it another level of complexity that different payers have different evidence needs and preferences, but no formal requirements. It's not all laid out on a silver platter, unfortunately, but some of this transparency is increasing, hopefully, as we get there. They can vary, as mentioned, kind of widely between archetypes organisations, even individual payers if you talk to two different payers at the same organisation and do in-depth interviews with them. I've heard complete opposite ends of the spectrum talking about the same exact drug and what they'd want to see. So there are so many layers here, and it also varies widely between disease states. There might be more flexibility in what they're open to in seeing with rare disease states where surrogate endpoints might be okay. They just want to see something and have some kind of patient improvement, really establish disease areas. Those surrogate endpoints, they're not going to fly, or things like oncology. They might be okay with some of the surrogate endpoints to start with. They they might be okay with progression-free survival to start, but they'll want to see overall survival if you continue to come back for access and look at as the landscape gets more competitive and more therapies come to market, and you've been on commercially available for three years. They're not going to want to continue to see PFS, and that's where things like real world evidence really comes into play and continuing to generate evidence and value for a product. Same thing with kind of head to head launch. Obviously, they'd want to see comparative evidence at launch. If they're the first to market, obviously, that's not an option. If the other drugs, when they started their clinical trial programme, maybe they come after. It might not be possible. But again, some of that real world comparative evidence or the indirect kind of comparisons do come into play, but not the preference in the US to have some of that indirect, of course, economic impact. While they appreciate, appreciate might be a strong word, the type of economic evidence that manufacturers are putting forward, we know that there are concerns about the transparency and the information that's included in those models often. So I think an important thing to note is that US payers do have a hesitancy towards manufacturer-provided economic data. So wherever there are opportunities to provide clarity, transparency, our latest, and we'll talk about this a little later, but we did a recent payer survey in the US, not surprising, but over half of payers said that they had a low or no level of trust of manufacturer-provided health economic models with issues being transparency, uncertainty, and rationale. Again, not news and nothing that's earth-shattering. We've heard this for many years and years. But I think just as we move the needle and really go to these more price-focused models and a world where we are sharing more evidence, and more evidence is available, and more tools and resources are available with things like real world evidence, how do we continue to move that needle to have more of this collaboration with payers versus us versus them kind of nature? And some payers are more accepted of it. And building those relationships though I think are really important to continue to build upon that trust and get to this kind of next era of information sharing. Bob, what else?- Well, just a couple of things to highlight and, what, caution against. Just because we don't have a central HTA that is expecting or demanding head-to-head clinical trial data. If your product profile supports it, I would encourage you to strongly consider, at the very least, an economic substudy as a part of, alongside, as an adjunct to a clinical trial if you can't get to the commitment of a head-to-head study, because while they're not required in the US, they are typically rewarded. That will change your market access approach and uptake. Another caution I guess and encouragement is around the value of patient-reported outcomes and patient preference information among US payers. Yes, it does not have the same impact in HTA markets, but payers repeatedly say it's a reason to believe the clinical evidence. And certainly, depending on the patient population, the disease state, the product type, patient reported outcomes are very important and payers are beginning to catch on to patient preference information as providing them some insight into both whether patients might be more or less adherent to a particular product. And importantly, as they're thinking about utilisation management across a portfolio, using patient preferences information and provider preference information to better understand how physicians, how prescribers might switch between drugs.- Yeah. And Bob, just to build off of that, doing ad boards, and in-depth interviews, and different research with payers, I feel like I always, more recently, but I'm hearing this, let's tell the whole story. Adherence alone, great. Put that on a slide, go to payers, it's okay, this is nice. But what does it mean to me? So does this better adherence, can we link this to improved outcomes and ultimately cost savings where the payers really are focused? Are we able to tell that story and connect the dots? Patient preference alone, again, great in isolation, but what does this mean for the payer? So does that patient preference towards an oral versus injectable, does that lead to better adherence and therefore better outcomes? And then kind of tying that value story together for payers in the US,'cause, again, those standalone facts, nice, okay, cool, glad you did that study, but what does this mean for me? So I think that's really the important takeaway that we're hearing.- Great point. Okay, I think we've probably considered pharma a bit more than MedTech so far in our discussion. So what are the similarities and differences when preparing for a MedTech or medical device launch versus a pharma product? Who are the key stakeholders there and how should MedTech companies prepare?- Well, the evidence expectations among payers and hospital purchasers have certainly been strengthening over the last say 10 years. And on a path towards evidence generation needs for pharmaceuticals, whether it ever gets there is a question because anybody in the space knows that the development cycles, if nothing else, are so much shorter in the MedTech space, that your ability to generate the evidence is much more limited. One thing that I've seen, just my limited experience, is the value, the importance of relatively small clinical trials. They don't have to be fully randomised, but some prospective evidence generation, which typically has not been done, not all that prevalent in MedTech and devices, but perhaps working with individual health plans, large health plans that may have a technology champion within their organisation, and then establishing a relatively small, observational even, prospective study can really be a beachhead to market access for MedTech.- So how can companies ensure they have the right evidence and tools to engage with payer bodies in the US? Is there any mechanism for submitting evidence? What level of interaction is possible? And how does it differ across all the different payer organisations that you've mentioned?- Yeah, I mean, to get into technical nuance again, there's no formal submission. There's no formal submission process in the way that HTA bodies have a submission, clearly specified document. As Bob noted before, there are various templates and organisations that have put together guidance, one of them being the FDA with pre-approval information exchange, and this is... Bob I think will mention it a bit later, but as we look in, FDAMA 114 was obviously put in place to allow for communication of healthcare, economic information. With this, there are opportunities, and this has been loosened with PIE and some PIE approval and guidance that has been revised and reformed over the years, but manufacturers can go out in the US to have those prior to launch pre-approval discussions, whether that's through an pre-approval AMCP dossier and there is a format for that or pre-approval information exchange where manufacturer field teams can go out and the right individuals can go out and have those discussions with payers. Again, the right stakeholders within payers, and there's nuances around who can engage in those discussions, and what type of information can be shared in what nature, et cetera. But those are really important, especially when there's a large population as mentioned or a large financial impact. So kind of looking ahead, if it's another... If it's the 17th drug to market in a very crowded landscape and it's kind of a me too asset, that might not be as important. They know the area. They know the population is just potentially another modality, or inpatients that are relapsing, or refractory, et cetera. In a new area that maybe they haven't had, what is my patient population? I haven't had a drug for this, so I'm not sure how many patients potentially have this condition or would be potentially on this drug. That would be an important area. Or a drug that's coming to market at a large price, they're going to care about that. Or a huge population, that's another big thing to consider. So that's leading up to launch. And kind of as mentioned before, this allows them to plan for their formularies plan, look at their data, look at how they think they'll cover this to prepare for those. Okay, we have this drug. It gives them that advanced notification. Really the important things there that we hear time and time again, they want to see efficacy, safety, they want to see price. Obviously, some manufacturers don't want to share full pricing information. They might not be aware of it. Where are they going to land and where are they going to fall as they continue to play with various pricing models and pricing methodologies, but they want to see at least some type of economic information and not an economic model per se, but just what is this going to cost me and what will this mean for my population? And then after launch, going out and having those meetings further, providing a full AMCP dossier that we hear payers will use. They always like to look to them'cause it is a comprehensive placement of their information as long as it's done scientifically, properly referenced, transparent, et cetera. Ideally substantiated by things like systematic literature reviews and clinical trial populations, economic models that can be included in those dossiers. Really it's similar to an HTA submission in a sense, but it's a guidance on what information to submit to a payer. There are also things like payer value propositions that might be on the more commercial sense. There's often health economic field team presentations that might have different stakeholders. So there's lots of ways to engage. And, obviously, again, there's guidance around this and a lot of specific nuances, but the most important thing we continually hear is, we've alluded to this, but let's be transparent and scientific wherever possible. Obviously, there are commercial nuances. We want to have some commercial messaging and try to paint that picture, but the more that we can get payers to really trust that communication, the more that they'll take that and really start to collaborate more with manufacturers. And I mentioned this again before, but it's important to collaborate with payers to kind of seek their perspectives around what they will want to see wherever possible. Start to engage early. If you know that you're in phase two, okay, we're planning our phase three trial, what should we include? If you include the right endpoint, you have to wait until post-launch to do a long-term extension. You have to wait until that real world evidence is available to get that endpoint or try to do some fancy analytics in the background to try to make sense of it. But if you don't have the right endpoint that payers and other stakeholders are going to care about, it's really too late by the time you start recruiting for that phase three. So, as early as possible, understand, especially, again, if it's a new therapeutic area. What type of surrogate endpoints might be accepted? Do we have to do surrogate endpoint kind of testing and validation around this? So really the earlier the better, and that's kind of getting into evidence again but... And the last point I'll make is just, obviously, the engagement with payers has changed kind of in this post COVID area, live in person engagement with payers, but obviously medical doctors and healthcare providers as well. It's become different and it's become more infrequent, so you do need to optimise that time that you have with key accounts and really make that engagement in whatever time you do have, especially before launch, as productive and mutually beneficial and collaborative as possible. Bob, I think you had some points to add about PIE and all of that, so if I could turn over to you.- Yeah, and just a little bit of additional background so you understand what you're getting into with pre-approval information exchange. It's still fairly early days, it feels like to us. It's a pretty standardised approach to share information with payers but the... FDAMA 114 was so vague that how it was interpreted by different manufacturers varied substantially. So the information that payers were getting for relatively comparable products may be in the same class from different manufacturers were very different. That was not a happy situation for anybody. It was actual act of Congress in late 2022 that passed the PIE Act. So while it feels comfortable for us on the supply side of the market, payers are still really just getting used to receiving this newer, better, more complete information maybe eight 18 months or so. So be serious about that. I think test it with payers, and get your PIE decks, get your information out pretty early because payers are now getting accustomed to seeing that nine months, 12 months prior to launch. Doing so will help your initial uptake in commercial success.- Great advice on collaboration. I think that's really so key, isn't it? So let's think about the future. What changes are happening that our audience should be aware of? I know we're planning a future webinar specifically on the IRA, but maybe that's something you could start with.- Sure, yeah. We would need at least an hour to talk about the potential, well, the design and the potential implications of the IRA. But at a very high level, to introduce it to those who aren't fully familiar with it. This is new legislation, again, couple of years ago, that allows CMS for the first time to negotiate prices with manufacturers for a fairly limited number of drugs each year, but that's accumulative and it will build up. And the drugs that are eligible are high expenditure drugs for Medicare in both Part D and ultimately in three years, I think Part B, hospital drugs, as well, that have been on the market for several years. Nine years post-approval for small molecules and 13 years post post-approval for biologics. I mentioned this earlier, the actual process by which CMS is conducting these evaluations, the elements that go into the negotiation process is still a bit unknown. There are... Let's see. Out of the negotiation process then come maximum fair prices for the negotiated drugs. And those drugs are going to be existing in large drug classes. And the dynamics of pricing and rebates both in the Medicare Advantage market, but also in the commercial market, are unknown. Imagine price goes down on a leading drug. What are the knock on effects for pricing and access for the other drugs? Those were all TBD. There are also concerns regarding the impact of the drug price negotiation programme on the incentives to conduct R&D for drugs that might be selected for the DPNP say in five years, 10 years. So I think there's going to be a pretty significant shift in incentives to invest in a particular drug class disease state versus another. So there's a lot to say about the drug price negotiation programme. We can hold that for a bit. And I should also mention a couple of the other main elements of the IRA. One are inflation rebates. This is where drugs that have been approved on the market would be required to provide a pretty substantial rebate back to CMS if the list prices for those drugs go up greater than the rate of inflation in any given year. That'll play out largely in upward pressure on launch prices over time. Third large element of the IRA is the Part D redesign, really substantial effort to rationalise the patient participation, the patient cost sharing, the donut hole if you're familiar with the catastrophic phase that has been closed. Out-of-pocket maximum for CMS beneficiaries receiving prescription drugs has been capped at $2,000, and all of this is shifting somewhere around $40 billion of costs from patients and from CMS to an extent to largely payers to the plan, the Part D plan sponsors smaller extent to manufacturers. That shift of cost burden to payers is clearly going to impact access. We're already seeing proposals for deductibles to increase pretty substantially. For PDP, the Part D prescription drug plans have premium increases that are pretty substantial. This is going to play out over the next couple of years, but there certainly seems to be pretty substantial unintended consequences of the IRA.- Yeah, and, Bob, just to add some quantification in some of that. Experts, when they laid out this plan, we've heard things like,"Oh, over 10 years, it'll save 100 billion dollars." And again, we don't know what that looks like. I don't think anyone knows exactly. And as Bob mentioned, I think it's not just like, okay, that 100 billion will come from manufacturers. Those costs will be shared. Pharma's still here too. It's a for-profit business. Some of those costs will be pushed to patients and other wherein have some unintended consequences that people are starting to estimate and model out, but we don't know the full effect of it. The drug prices, again, we've seen the negotiated prices in August of this year. We saw the first negotiated prices, and those came largely in line with what people were modelling, but it's anywhere from, I think 38%, Bob, was the lowest up to 79% of the drug price kind of discount was put in place. So again, and this will vary year to year, and as these compound... And it will have spill over to other markets too. Again, we've talked about this at the start, but US is that leading market, and that's where 50% of the world's pharmaceutical revenues coming from. Will that change as more of these drugs are added to the DPNP? Yet to be seen. So again, meant to have a positive impact, but I think some of the unintended consequences will have downstream and will have to kind of figure out how to work around those. So patient access and patient outcomes ultimately aren't impacted and negatively kind of impacted based on this thing that was put in place to positively increase, improve patient access via pricing and overall pricing and spend in the US. And then, Bob, I know there's some other large things in the US. I don't know if we want to cover those off now, Clare. Obviously, IRA is at the forefront. Other things like biosimilars, still emerging. US is so much lower than especially Europe to uptake these, but they are starting to get momentum, finally. It's taken a long time. I remember, 10 years, ago we were talking about,"Ooh, biosimilars are coming. What do we do about them in the US and how do we plan for them?" It's taken a lot longer, I think, than most people anticipated to really hit, and now it's quite frankly being overshadowed by some other things but not to be missed. It's kind of something that's happening, but no one's talking about it quite as much. And then GLP-1s, Bob, I know you have quite a lot of perspectives about that, but just the markets exploded and taken the spotlight from some other areas and things like rare disease. Three or four years ago, everyone was talking about rare disease and gene and cell therapy. Obviously still a huge cost and a huge concern for US payers, but GLP-1, you can't turn on the radio without hearing about GLP-1s in the US. You can't open the newspaper. It's everywhere. It's one of those drugs that's really exploded and you can't go on social media without seeing ads for it. They're everywhere right now in the US and I know the rest of the world as well. But, Bob, any perspectives around how those will continue to change and impact the market as well?- I think payers are going to have GLP-1s on the brain for the next few years in part because about a third or less of employer-sponsored plans provide coverage for GLP-1s for weight loss, pretty broad coverage for type 2 diabetes. But coverage access for GLP-1s is pretty limited among commercial plans for the Affordable Care Act exchange plans. As of about six months ago, none of the exchange plans provided coverage for GLP-1s. There are movements to allow to force CMS to provide coverage for GLP-1s for weight loss. And I think if that ever comes to pass, then the commercial market will certainly follow CMS coverage. But that is going to have a huge impact on payers' budgets. And like Nicole said, that is going to replace concerns about the cost of cell and gene therapy in payers' minds. They're all over GLP-1s.- That's a great point. Okay, that's really helpful to think about what's coming in the future and some of those trends that are emerging. Let's think now about opportunities for pharma and MedTech companies launching new products in the US. What would you say about that topic?- Yeah, well, I think I touched on this before, but the opportunities I think in the US, despite the craziness with the IRA and how much bandwidth that's taken out of everybody in the US, still a very attractive market for pharmaceutical innovation, again, because we do place high value in the US on innovation. And we, within the restrictions of our insurance system, do provide pretty rapid access to that information. And by drug class, by disease state, this all varies, but thinking very loosely, say if you're in phase two and beginning to think about the US market, there are clear hierarchies. Gaining coverage through CMS can be pretty straightforward. They typically are required to cover drugs that are FDA-approved. But if a national coverage decision is issued, NCD, that's an acronym to keep on your checklist on your pre-launch checklists. If you have an NCD that's either positive or negative, commercial plans will follow NCDs. And it's a bit of a gross generalisation that there are going to be priority payers, priority stakeholders. Everyone is clearly important over the entire lifecycle. Bu at launch, preparing for launch, a very deliberate, focus-prioritised access plan that focuses on the two or three payer purchaser types that are going to be pretty critical for your initial launch and market access should be the centre of your evidence generation planning.- Okay. All right. So what recommendations would you make to a company launching a product in the US for the first time?- Yeah, I mean, I think we've mentioned most of these, but putting a US spin in... Land early, which is no different than the rest of the world, but really there's no cookie cutter approach to any product launch. There's different competitive dynamics, there's different stakeholders, and that's where it starts to get complex in the US, is this medical benefit. Is it pharmacy benefit? Is it a mix? What's the patient population? Do we have those subgroups? If it's a primarily elderly population or it heavily impacts African-American population, do we have that population represented in the clinical trial? I've seen this time and time again. The clinical trial was done in a different market for example. You need to make sure you have that right evidence for the US because US payers do want to see, Does this clinical trial population look like my population? And the US is so heterogeneous. We know that things will... You need to really represent that in the US, so you do need to plan early and make sure that that's reflected, especially if it will be 50% of your pharmaceutical revenue for that asset, for example. You need to make sure that you have that and continue to refine as well. Things change, and again this isn't unique to the US, but refine that evidence. Make sure that you're not just throwing, continue throwing in additional evidence as it comes about. You have real world comparative effectiveness data. Maybe you don't need that indirect treatment comparison anymore that you did five years ago. Continuing to build upon that, and ratify, and have those open and honest discussions with US payers. What do they want? What do they want to see? Is this meeting the needs? Sometimes just going and saying having those advisory boards or just one-to-one discussions in the field with our health economic teams. What kind of data do you want to see post-launch? And having those open, and honest, and transparent discussions I think are really important in the US. Really acknowledging diverse stakeholder evidence needs. Things like CAR Ts for example, And, obviously, this will change as more come to market, but working on this treatment area, we saw that access from payers wasn't really an issue in oncology and haematology. At least to start, again, this will change. It was more on the administrative side and the hospital side. They could only have so many CAR Ts available or there's challenges in the manufacturer process. Patients weren't getting access to the treatment. Every patient that needed the treatment, obviously, was not getting access to CAR Ts, but that was less so on the payer side here and more so on the hospital. So how do you make sure that you have the right systems in place at a health system level and administrative processes and also the manufacturing capability. So I think just noting in the US that just because you do have payer access, it doesn't always translate to patient access in the US, whether that's through an uninsured population or administrative challenges. And again, a lot of these aren't unique to the US, but just keeping that complexity in mind and not just thinking,"Oh we've done this before in a different area. We can just go forward and use the same approach." Things change daily in the US and you need to continue to evolve your strategy.- Absolutely. Okay, and you've alluded a bit to some recent research that you've done in the team. I believe you conducted a payer insights survey to understand more about the evidence landscape from US payer's perspective. I think the report's due to be published quite soon, but if you could give us a few exclusive insights from the research. How did you do it? What were some of the topics that you covered?- Yeah, running up against time, I'll give a one minute overview. So we did a 20-payer in-depth interview, sorry, survey, quantitatively, some qualitative insights with PBMs, IDNs, MCOs, with a mix of pharmacy directors, medical directors, industry trade relations, and actuaries using our deep payer network that we have access to. Exploring key themes, mainly everything related to evidence. What type of evidence do payers want to see? How do they want to be communicated with about that evidence? What are some changing trends and evolutions in the evidence world? Focusing slightly on things, like IRA and ICER and other topics, but really diving into what evidence do they want to see. How are their needs changing? And we'll continue to do these over time to evolve. As mentioned, they change the trends and needs, and preferences change all the time. But the first time we will present, this will be at ISPOR EU in Barcelona in just three weeks. So if anyone's there, come by and say hi to Bob or I presenting our posters. And if not, we're happy to share those after.- Great, thank you. We did have some questions from the audience in advance of the webinar, but we are running out of time so I think we've covered on some of the themes that were raised, but we will follow up with anyone that dropped us a question after the webinar. Yeah, I'd just like to thank you both, Nicole, Bob, that was a fascinating discussion. I think we could've filled another hour, plenty of more things to talk about. Thank you to the audience for listening. As I said, we will follow up if any of your questions weren't covered. And as Nicole said, some of the team will be at ISPOR next month, so please do come and say hi. We'd love to meet you there. And thank you, have a good evening, and a good rest of your day, and we'll hope to talk to you all soon.- Thank you.- [Announcer] Thank you for watching. 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