Pharma Market Access Insights - from Petauri Evidence

Communicating value to US Payers: Insights for Pharma and Medtech

• Petauri Evidence • Season 8 • Episode 2

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What do global market access teams need to know about the US market? What do US payers expect to hear from Pharma and Medtech companies? What kind of value messaging resonates in the US? How do you prepare for launch in a market as diverse as the US?

In this Global Whispers episode, Louise Maddison (Senior Consultant – Global Market Access, Petauri Evidence) interviews some of our colleagues from Petauri Advisors who are either former payers, or former industry market access leads in the US. Louise puts your questions to:

 - Rory Davies – Vice President of Value and Access, Petauri Advisors, with extensive past experience in Chief Clinical roles at Cigna, Flipt and WellDyne
- Dan Vanderpoel – Executive Vice President, Strategic Payer Marketing; Head, Client Solutions, Petauri and former Manager, Trade Relations at Humana
- Shana Gunderson Hua – Vice President of Value and Access, Petauri Advisors and former Medical Affairs Executive Director at Genentech and former AVP of Pharmaceutical Strategy and Contracting at Cigna and Express Scripts (now Evernorth)

We explore what global market access teams need to know about market access and payer engagement in the US. We  explore how and why value messaging, pricing, and launch strategies are developed differently for the US market, compared to other key launch markets, and what this means for global teams preparing for US launch or taking a US-developed proposition internationally.

Learn more at: https://petauri.com/insights/communicating-value-to-us-payers-insights-for-pharma-and-medtech/

This episode was first broadcast live as a webinar in March 2025. 

Learn more about Petauri Evidence: https://petauri.com/petauri-evidence/

Learn more about Petauri Advisors: https://petauri.com/petauri-advisors/

Meet the ACE team: https://petauri.com/about-us/ace-team/

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- 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.- 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. Topic today is communicating value to US Payers, insights for pharma and MedTech. I'm Louise Maddison, senior consultant at Petauri Evidence We have a great mix of audience today across industry and healthcare systems and I'd particularly like to welcome our global affiliate partners who play a key role in the work that we do. For those that don't know us well, Petaur Evidence is a global specialist health economics outcomes and market access consultancy. With a track record in expert delivery. We provide specialist support for pharmaceutical and MedTech clients and work as a collaborative partner to healthcare systems worldwide. In June last year, we joined Petauri. Petauri has brought together some best in class companies with recognised experience in market access, medical affairs, payer marketing, and more. In particular, Petauri has connected us with new colleagues in the US with a wealth of US market access experience. Petauri recently launched the ACE team, which is their Access Customer Experience team, an in-house team of former US access decision makers with experience across all areas of US healthcare, including Medicare, Medicaid, and commercial. I'm delighted to be joined by a few members of this team for this webinar today. Today we focus on communicating value to US payers, insights for pharma and MedTech. I'm delighted to welcome our guests from Petauri Advisors and the A team, Rory, Dan and Shana who brings a mix of experience as former US access decision makers, as well as insight from pharma and consultancy. Welcome, all. Pleased could you take a moment to introduce yourselves, your backgrounds and current roles within Petauri Advisors. Dan, I'll let you start first.- Excellent. Thanks Louise. Hello everybody. My name is Dan Vanderpool. Spent my entire career in the world of market access pharmacist by education and then after graduation, started working for one of the US payers named Humana. Spent about a decade there, really focused in the notion of trade relations, which is rebate negotiation as well as formulary development. More recently, over the past decade or so, I've spent my time focused on strategic payer marketing as well as payer strategy work here in the us. So- Delighted to be here with everybody. Rory.- Hey Dan, Rory Davies. Also a pharmacist by training. I've spent my career doing different things. I've worked in in hospital settings, I've worked in in retail pharmacies, but I've spent the bulk of my career in managed care. So I was the pharmacy director for a state health plan, worked at a couple of different PBMs. I was in a leadership role at Cigna, one of the largest payers in the United States when, when Cigna acquired Express Scripts, one of the largest PBMs in the United States. My team was responsible for a number of things, but primarily it was how do we decrease costs on prescription drugs within the United States. My team also, because we were really, really good at that, we also focused on total cost of care evaluations, do medications, offset medical costs when given in certain situations. So my, my background's mostly payer in the commercial space and and not necessarily Medicare. Sharon?- Yeah, thanks Rory. So I would say similar to Dan and Rory, I am also a pharmacist by background and also spent quite a time bit of time in the Medicare as well as commercial and payer spaces. So I also come from a payer background, having worked at Cigna, really supporting some of the benefit designs, particularly around complex areas like oncology. Also spent time at Express Scripts as well and at both Cigna and Express Scripts was in more of an industry relations role where I was negotiating rebates with drug manufacturers and really supporting a lot of the unique medical benefit products in spaces such as value-based contracts, gene therapies, biosimilars. I am coming most recently from a biopharma perspective having worked at Genentech and while I was there I did support medical affairs as an executive director in a cross portfolio role. Really engaging with payers, PBMs, GPO type entities around market access conversations, really supporting the value that products bring to patients and optimising outcomes. So most recently I did have my own consulting business, really supporting more of the oncology care delivery side. So certainly looking forward to sharing some unique insights today on this call. So Louise, back to you.- Thanks. Sure. So I'd really like to start by talking about the US payer landscape in general. Could you outline what we mean when we talk about payers in the us Sam?- Yeah, happy to Louise and it's a very interesting term as we say, payer in the United States because I think most commonly when you hear that term, especially in webinars like this, where in the active work that we're doing with pharmaceutical companies, most commonly we will refer to payers as managed care organisations in the United States, largely developed by health plans as well as pharmacy benefit managers or PBMs. But if we take a step beyond that, those are typically the administrators of the payment system within the United States. I think it's important to acknowledge that the actual financier of them or or the person that's actually paying them most commonly in the United States are the employer groups of individuals less than 65 and or CMS, the centres for Medicare and Medicaid services for our seniors as well as for our Medicaid populations here in the United States. So important distinction there to say, are we saying literally who is the payer, meaning the person funding it that be CMS and employers or are we remaining payers as the people administering these benefits? Those being more the managed care organisations.- Okay, thank you. And is there common themes between those two buckets in terms of specific needs and requirements when we're communicating value?- I, I think when, and and I just want to add a little bit to to Dan's comments. So when we, when we think about payers in the commercial landscape, so think of people that are employed that are getting their health insurance through their employer, there are different buckets within that landscape as well. Does the payer or the health plan take on risk and and manage the entire benefit medical and pharmacy? Or has the employer decided, you know what, I'm going to go with my medical coverage over here, but I'm going to take all of my pharmacy coverage and put it over here'cause I trust these other groups to manage it better. And when you think of medical management within the US getting your drug at your doctor's office, going to see your physician going to the hospital, the the management is regional and national dependent and there's lots of regional and national players and those regional national players need some different things than, than you would expect, but there's lots of them. When you think about the commercially insured, I get my insurance through my employer. When you think about the pharmacy management piece, there are three really big players. So those big players are pharmacy benefit managers, Optum, CVS and ESI. And between the three of those, they, they generally manage about 80% of commercial lives in the US and they tend to need something a little bit different than the health plan and, and those other payers. So it's, it's a really interesting dynamic within the commercial landscape of the options employers have to choose from. Do I decide to use Cigna or Aetna or or UnitedHealthcare to manage everything? Do I just trust them to manage my medical side of the house and then I'm going to carve out my pharmacy side to somebody else and let them there. So it's really interesting dynamic world and all of these payers, they all want something similar but, but they also want something different as well. And, and and and that's just kind of the nature of the US healthcare system for employees and employers.- Yeah, I think those distinctions that Rory mentioned are really important because it links back to your question Louisa, as we think about value communication, it becomes incredibly important to understand which of those facets the US payer is that you're speaking to. And how do we then change the way that we're thinking about value communication to them? Do they take risk? Are they simply a third party administrator? Are they actually managing both pharmacy and medical or is it just one or the other? Each of those dynamics that Rory started to walk us through, Louise do play a fairly significant role in the way that we think about communicating value- To those stakeholders.- Thank you. Shana, did you want to add anything else in?- No, I mean I agree with everything Rory and Dan said just in terms of understanding where there is commonality, just to keep the story simple. I mean at the end of the day I think everyone's really aligned around, you know, safety, efficacy as well as economics. So really thinking of that as an overarching story. But I agree in terms of some of the nuances that Rory pointed out as well as Dan in terms of, okay, which lever is more strong with which particular player within the market? And I think that's where, you know, some of the fun part comes when it comes to healthcare is really thinking about, okay, how do you craft your messaging and how do you craft your evidence in a specific way that resonates with that particular stakeholder.- Thank you. And if we just take a step back because some of our listeners today will be more familiar with the payer landscape in Europe and the bodies there that conduct health technology assessment such as NICE and the GBA as about additional hurdle after regulatory submission. Can we make a similar comparison in the US and could you talk a little bit more about isa?- Yeah, I'll, I'll jump in first and then I'll, I'll pivot to Rory and Shana. So there are definitely similarities, Louise, but also distinct differences. If we think about the similarities, each of those managed care organisations that we had just mentioned do have pharmacy and the therapeutics committees as new products are coming to market and as new devices are coming to market, individuals that sit within p&t committees are reviewing them, we're looking at the safety, we're looking at the efficacy, we're looking at the economics that Shana had just mentioned to do some of that cursory review. So everybody from a US standpoint is looking at that then, which in some ways is the basis of formulary access of those medications. However, as you mentioned, there's a different dynamic of organisations like ICER that do tend to function a bit more like some of the, some of the European bodies that you had mentioned where they're taking a bit of a different approach, more economically faced approach. I do feel like there's varying degrees of interest, shall I say, from a US payer coverage standpoint with respect to the output that they have. I think there's very interesting work going on by those organisations. I think the biggest downfall that I see from a US payer standpoint is typically those analyses that they're running tend to be fairly far in nature from when those products have been approved and launched onto the US market. So that gap between when product availability happens versus when something like an ICER economic analysis comes out is, is so differentiated in timeline that it somewhat negates as much utility as we would like to see otherwise. But that, that said Shana, Rory feel free to agree or disagree with kind of that point of kind how ICER plays into sort of coverage policies in the us.- Yeah, I agree with, go ahead. I no go point Dan. I would say as well as the other limitation I've seen is that ICER just really isn't able to review everything, right? So in the key categories that ICER is reviewing, ICER does become important and we see that because payers are starting to use that information in terms of negotiation leverage, we also see biopharma companies engaging even early, even before ICER releases the report just to provide some background information, you know, where they can, but I still believe at the end of the day that there is some gaps there and so different companies look at other avenues in addition to ICER to really provide some solid pharmacoeconomic information. And Roy please feel free to add,- I'm going to counter just for fun, I'm going to counter ICER does some really interesting things. So the FDA in the United States, the FDA (Food and Drug Administration, this is a safety efficacy body drug is safe and effective then and, and it gets approved, it gets an indication it is not a cost effectiveness body ICER does cost effective research in the United States. As a payer, I've used ICER to help negotiate additional value for manufacturers. I don't generally use ICER for formulary or management decisions. It it, it just doesn't happen. So within a payer, I've got two, two bodies. I've got a clinical body and I've got a cost effectiveness body. My clinical body sits over here and as Dan mentioned, this is a p and t committee. This is a group of independent physicians that make decisions on the drug. If the drug is it, it should be added to the formulary and and most drugs are, are what we consider a may add. You don't have to add it, you could potentially add it. The, the cost effectiveness committee takes that information and this committee has a group of actuary and underwriters that take that in information and then determine formulary coverage. But at the end of the day they're not always the payer, it's the employer that's the payer. So when we think about the, the quality of justice life here, the ICER cost effectiveness research and who the end payer is is generally the employer. And there has been there, there has been some payers in the US that say, you know what, we're going to use the cost effectiveness threshold and we're going to say no when it goes above that cost effectiveness threshold. So these were some programmes that were rolled out 5, 6, 7 years ago and they just haven't gained as much traction. So I would say ICER is important, it's used as a a bargaining chip and used as leverage to have additional conversations with manufacturers and sometimes there's been cases where the price actually comes down for the drug as a result of those ICER thresholds. So I would say yes, absolutely use it. It's generally not used for formulary decision making.- Thank you all for that, that's really helpful. Dan did you have anything else to add?- No, I think we already hit it spot on.- Perfect. Okay, let's talk a little bit more about the evidence requirements, both clinical and economics. So could you give an overview of the type of evidence required by the key payers in the US Shana?- Yeah, that's great. So I mean generally speaking the FDA is a regulated process when it is approving drugs and typically they're focused on the clinical and safety elements. And typically what they're looking at then is randomised controls, clinical trials, really looking for statistically significant improvements in clinical endpoints with acceptable safety payers. On the other hand, while they are not going to consider a product for formulary adoption unless it has FDA approval, I think they go a little deeper from the standpoint that they're going to think about, okay, how was the product actually FDA approved? So as an example, was it under an accelerated approval? Was it with surrogate endpoints? And I think a notable example of that, many of us remember a few years ago from the Alzheimer's space, but I would say more importantly in addition to that, payers are really going to focus more on the economic story. So they're going to think about comparative effectiveness. Okay, so is the new treatment better than those treatments that are already on the market today? Is it worth the cost? And of course what is the real world performance? Meaning do the clinical trials and those endpoints, are they going to translate to my actual population?- Can you explain a little bit more about the pre-approval information exchange as well? That's quite important I understand in the payer aspect.- Yes, thanks Louise. It certainly is. So I would say back in about 2018 there was certainly a framework that really helped provide some additional guidance around, okay, what type of information exchange can take place between a biopharma company and a payer. And so with that framework, what was outlined and what really helped open the door for more conversations was really around areas such as important facets around how manufacturers can share in advance some endpoints around clinical trial design, what could be expected in terms of the population and any information around the patient journey as an example. And then on the other side, the guardrails that were spelled out through this were things that cannot be shared. So as an example, what can't be shared in some of these pre-approval conversations certainly aren't definitive claims around safety and efficacy because the product hasn't been approved yet, there can't be any promotional claims. And then typically there is an absolute information with regards to the financial element in terms of the drug cost itself. But ultimately what these, this framework allowed for is further engagement that can take place again before products FDA approved. And really the goal here is to balance providing the payer with enough information that they can start planning from a budgetary process while still keeping the conversation, you know, clinically robust. So in terms of that overarching theme and it being a successful pre-engagement conversation, of course the conversation is intended not to be a one and done. You just don't deliver, for example, you know, a pie presentation, but it's intended to be an ongoing conversation that can take place between the manufacturer and the payer to really help prepare for that particular launch- Drawing Sheena's- Last last point was, I'm sorry Louise, I was just going to expand upon Shana's last point. It becomes really important to think that PI is not a one and done conversation typically with payers. In fact, if we look at the actual guidance that exists from the FDA, basically if we're communicating any information that has significant or substantial change, it's the obligation of the biopharmaceutical company to go back and further have dialogue with those US payers to talk about any of the change in the information that they may have provided. So it's a really important aspect to think about this as a opportunity to continue to engage US payers all the way up until approval from the FDA. The one other thing that I was going to mention is if I go back to Shana's first part of her answer, I think she did a wonderful job of kind of describing the importance of efficacy, safety and the overall economic value of products. I think the one other aspect that we see US payers taking into consideration pretty heavily is also the demand aspect. As we see a product come to market, understanding what demand looks like, it really does play a strong factor in some of the decision making that they make on both sides of the fence. As cor as Rory described, we have more the clinically leaning element of p&t and we have the more economically leaning element products that are used heavily or demanded heavily by HCPs in the US are looked upon somewhat differentiated versus products that simply are not moving, that are not gaining market share. So I would just add that as an additional piece of evidence that at times becomes a really important factor from the overall decision making that occurs from a US payer- Standpoint. Yeah, and go ahead Rory.- I I just want to expand on on on just the, this this idea of cost, right? New medication comes out. So when, when I was at Cigna I had a team of actuaries that that's just how we operated. We, we had a, a forecasting group that we called the Oracles that are looking at drugs that are going to get FDA approved over the next five years. Over the next year, over the next two years we had some assumptions that we built in that we used to work with manufacturers on is this close to what, what your data says as well, how much cost can we anticipate and then when the drug gets approved, like we, we know what our spends going to be over the next three years, we can anticipate it, we can make changes to that that's not the same everywhere and that's not the same for a lot of PDMs and that's not the same for a lot of regional plans. And so providing some some cost forecasting is going to be important 'cause they're going to ingest that information and make some small tweaks to it because they're not going to have the resources that a, that a Cigna Aetna or UnitedHealthcare does.- Yeah and I love that point too that you and Dan have made just in terms of once the product is approved, I think that's really where the economic story can really come into play most concretely where drug price can be shared and often, you know what manufacturers do try to do and I know I've had the opportunity to deliver these tools, they're called bims or business impact models. And really what it is designed to do is to really help that payer or PBM forecast, okay based on the launch of this product, how is it going to impact my population? And a good BIM when it's designed well has the flexibility to accommodate that particular stakeholder. So as an example, is it a population that skews heavy Medicare as an example or commercial? But by having those conversations it not only helps then the PBM as well as the payer kind of plan and anticipate maybe one, two and three years out. Sometimes it gets used even after well after launch just to do a little bit of a check based on what Rory said.'cause we know forecasting isn't always important and it really does allow that manufacturer in that payer slash PBM entity to have the conversations around why the numbers look like they look and then how maybe those two could come together and potentially think through strategies and solutions to either optimise outcomes for patients or start talking more around areas of affordability.- Thank you. So what would you say would be the things that a company could do in terms of optimising their chances of market access in us with the right evidence?- Yeah, so one area we've already highlighted a bit when we talked about the business impact models, but I do think there's some other great areas to partner around. I think real world evidence is one of those areas. So for example, we know clinical trials are designed, patients are in somewhat of an artificial setting. We know there's inclusion and exclusion criteria for example. And so the we, I think real world evidence really comes to the table is it's able to take a look at a broader population use that may be more reflective of what that population truly looks like with that particular disease state. So as an example, if you have a disease where the average age is of a patient 70 and African Americans are disproportionately impacted and their clinical trial is heavy with Caucasian patients, you recognise then that that you may have a bit of a data gap there. Likewise, where real world evidence can really come into play is really looking at some of those long-term outcomes and really helping to west test, okay, what was predicted or expected from the clinical trial? Is that truly reflected then in the real world evidence? So I think that becomes critically important. I also think that there is becoming a heavier emphasis on patient reported outcomes as well. And I think the reason for that is people are really starting to appreciate that aspects of quality of life, particularly in disease states like maybe depression or migraines for example. That quality of life element can actually impact productivity and that actually has cost implications, particularly if you're thinking about an employed population or a commercial book of business.- Louise, if, if I can, I think Shana said that wonderfully, I would simply add one other element that we're seeing more and more growing in importance and that's the whole notion of evidence generation planning pretty early on in the clinical development life cycle. I feel like oftentimes if we go back a decade or so, there was very much only a focus on what are the clinical endpoints, what is sort of that requirement to get a product approved And I feel like we're doing a better job, but I still think there's more that we should be doing of thinking about evidence generation opportunities in that development cycle to think about US payers and to think about some of the economic values or some of that data that they would find most useful at product approval. So the more that we could do there in that upfront part, thinking about some of the criteria that US payers find most valuable I think would be a huge, huge benefit as we start to think about how are we developing products in the us.- Uri did you have anything to add?- Yeah, I'd like to, I'd like to think about real world evidence in kind of two buckets. So I've got external real world evidence that that gets published. We we're, we're looking at PubMed, we're finding these journals, articles, you guys are bringing us information, farmers bringing us information and then the real world evidence that me as a payer I can generate. So at Cigna we have 15 million medical rides and so what often was the case is I can't make a formulary decision generally on real world evidence. What I can do is I can take that information and then go look at my data, what do we find out in my data? We actually built programmes at Cigna because of this. There was an interesting tidbit that came from a manufacturer that said X, Y or Z is happening within the US population. And we would say, oh that's interesting. Let us go confirm it. Let us go take that information internally, let's validate it and let's see if there's cost savings there. If there's cost savings or outcomes generated within this intervention, we can then capture that as affordability and we can actually take it back to the marketplace and we can say we're going to spend less because of this. And it starts with real world evidence over that that that the manufacturer brings that we validate internally.- Thank you. So if we think about other factors aside from efficacy, safety, cost effectiveness, what else is impactful in supporting coverage and reimbursement? Shana, perhaps you could lead from the pharma perspective in terms of additional things like the billing and coding or patient support services.- Yeah, no thank you for the opportunity. I know we've already talked about the trifecta, we'll call it clinical efficacy, safety and the economic story. But I agree that there are other areas to consider. We had mentioned already real world evidence, we talked about patient reported outcomes but certainly in addition to that like payers and PBMs are going to be thinking about things such as what are the real world implications of how that product is truly going to move across that patient's treatment journey. So just some examples of what I mean by that are, so you can think about a patient who may have a, a complicated diagnostic journey. So think about like comprehensive genomic testing for a precision medicine oncology product. We know that even if the, that product has great outcomes in the clinical trial, if there's a lot of barriers for that patient in terms of even getting the diagnosis or identifying the patient, it's going to limit the outcomes that that product can have. Additionally, I think if products are started in the hospital and then the patient continues the treatment in the outpatient setting, how that product actually transitions across benefit designs and really creating I would say kind of a frictionless patient journey becomes incredibly important as well as some of the heavy monitoring requirements that some of the products have. We know that that cannot only add to increased costs but it also can reduce I think some of the adherence and safety parameters around that particular treatment. So in addition to that, I think there are some key considerations around some of the distribution aspects as well. So one of the things you mentioned, Louise, is thinking about patient support services or even hub services and the idea of leveraging some of these entities are to think about, okay, how can you actually compress the time from when a patient has a diagnosis to when they can actually get on treatment and really make that an easier journey And that becomes critically important. I also think the design of the distribution model also plays an important role, particularly when we're thinking about specialty pharmacy products that are limited distribution. So as an example, you can imagine if a limited distribution product can only be dispensed from one kind of NA national centralised specialty pharmacy, it's going to be a different experience. And if that patient's able to get maybe an oral oncology product through an in-office dispensing pharmacy that's actually integrated with their physician practise where you can marry together that oral agent with the patient's IV treatment as a package regimen. And I know that there's some data out there showing that those two distribution models may actually have a difference when it does come to treatment adherence as an example. And I would say the last element that doesn't get talked about as much but I think is going to become or is continuing to become more important, is really thinking about how biopharma can actually engage with areas such as patient advocacy groups. And I think the area that stands out most for this type of concept is just thinking about how that operates in the rare disease realm. And I don't know Dan or Rory, I'm sure you've got other ideas as well.- Yeah, I might expand just a little bit on, on what Shana had shared and one element that we haven't discussed yet is this notion of how should we be thinking about the US payer marketplace? And we, we spent a bit of time at the beginning of kind of defining who the players are there, but I think it's an important distinction if we think about the audiences that oftentimes biopharma is communicating with. The vast majority of people employed by the payer organisations are thinking about this from a population health standpoint. We're making decisions that impact the entire population, but several of those elements that Shana just mentioned are more patient centric or patient specific. It does become a really important aspect to start to think about there are audiences within payers or even as we think about the extension of managed care into integrated delivery networks and health systems of individuals and entities that are far more focused on individual patients. That's where some of those distribution elements or some of the patient support elements that Shana was starting to speak to become really important talking points to say how are these therapies being supported and what are we doing directly for the patients to help keep them on therapy or help support their journey through adherence and persistence. So just want to make sure that it's, it's kind of understood the vast majority of us in the payer space, we think about the population but it should not be lost that there still is a, a large portion that think about individual patient care.- We, we talk about, I mean the FDA approval is like the first step in the journey. You could actually have an FDA approved drug that has good coverage that nobody uses. So within the US because we're such a fractionated healthcare system, you you, you, you potentially could have a, a provider problem, a payer problem, a pharmacy problem, a patient problem that it, it's, it goes beyond payer. One of the things that that we haven't talked about is, is utilisation management, right? Where we, we get the drug FDA approved, the, the payer looks at the information and says, we're going to make a determination if this is the right drug for the right patient at the right time, at the right dose, at the right site of care. And then when they add that all up, they put in a utilisation management programme such as a prior authorization. So it's in the commercial space they in in the US the, the payers like Cigna are making a determination if they should pay for that drug even after it's FDA approved so they could cover it and still have prior authorization on it. And sometimes the providers don't get the prior authorization, sometimes it rejects the pharmacy. So there is, there's a lot more to market access than just getting the FDA approved drug and then getting coverage. It's what does the utilisation management look like? How does the provider know that there's a PA on this drug? How do they submit that? Does it require a genetic test? Have you done the genetic test? Does the genetic test require a prior authorization? It's, it's a really fractionated system and it's important to understand each one of these key stakeholders and what they need in order to streamline that process for the patient. We have a tonne of prescription abandonment in the US and it goes from non-specialty drugs to specialty drugs to oncology drugs to infusion products. There are challenges throughout'cause we're so fraction in it and you have to understand each one of these key stakeholders and what they need in order to streamline- That process.- Thank you. - So now we've talked a little bit about the evidence requirements. How do you communicate that value in terms of the messaging that resonates in the us especially when you've got all these different audiences to manage Dan?- Yeah, I'll take a stab at that. I think the most important aspect in my opinion of communicating product value is being able to accurately anticipate the objections or the challenges that the US payer audiences may throw at you. So said differently. If we're creating value stories for US payers that are simply the features and the benefits of the product, we're probably missing a really good opportunity to more proactively address some of the things that we are going to payers challenging with respect that to the best of our abilities. Making sure that that development process anticipates those challenges makes for a much better value proposition or value story in, in my opinion that that said, there's only so far that we can go with that. Obviously it still has to stay within the bounds of sort of medically and legally and regulatory approved content. But I still think a really sound value proposition has an ability- To anticipate those things.- Okay. And what lessons can med tech companies and pharma companies learn from your experience? Where have you potentially had challenges that you can learn from?- Yeah, I think I, I'll take a first stab at that and then pivot to Shana and Rory, but I think the diversity of audiences that do exist within the US healthcare landscape is such an important lesson. Rory started to say it is a very fractionated system. So to ensure that MedTech and biopharmaceutical companies do not perceive it to be a single audience or a single audience with similar business motivations or business perspectives is probably one of the most important lessons. Understand that everybody is going to be driven from a slightly different sort of book, if you will, of what if they attempt to achieve in this gigantic universe that is the US healthcare space and making sure that we're having a bit more of a targeted message or a bit more of a targeted conversation with those individuals understanding what it's, that their perspective is not simply having a one-sided conversation to tell me what is the efficacy and safety of a product, for example. The conversation should be able to go much beyond that and much more individualised to what are some of those business- Drivers that that particular audience may have.- Shana.- Yeah, did you want to jump in?- Yeah, I absolutely agree with what Dan said. The one thing that I will lean on just a little bit and Louise, I think it goes back a little bit to your question when you started talking about billing and and coding and reimbursement and while it can be a little bit complex even for a medical benefit product, I really think it probably stands out even more in that med tech space for those companies. I think where they engage, not only is it across a fragmented healthcare system, but based on my experience doing the consulting work, just really thinking about like how they really need to engage across different stakeholders as well. So just thinking about individuals such as those that are really supporting like workflow and technology and really thinking about, you know, some of those aspects around security and data becomes critically important. But really I would say it's that billing and reimbursement and that coding structure is a little less regulated and I would say known and creates maybe a few more hurdles than what we experience on the drug side. And of course if that isn't a well thought out, it just becomes more challenging to actually bring a successful product to market and then to be able to maintain that technology long term.- Thank you. Rory, did you have anything to add?- No, I, I, I think they captured it really well.- Great. Maybe we can talk a little bit about the process and timing for engaging with payer bodies. So how do companies ensure that they have the right evidence and tools to engage with payer bodies in the US and what is that timing for engagement Shana?- Yeah, so I think it's a great question and I hate to say the word, it depends in terms of when to engage. So as an example, we, we talked about tools such as the pre information exchange or PY Dex as an example. And so typically, you know, as a biopharma company engaging with a payer, I really think it's important to start that engagement. It could be, you know, even 18 to 24 months ahead of launch, which sounds really early, but what I mean by depends is that's really important If you've got a product that's either very complicated or expensive or maybe it's a product that's really going to tackle a disease that doesn't have a treatment today. And so there's a longer education process between the biopharma company and the payer just in terms of education around the disease journey, the diagnostics and the economic implications. I think certain therapies stand apart. So as an example, gene therapy I think is a classic one where that early engagement really matters. Part of it is around, is part of it's just even around, you know, what is the financial implications may look like long term. I think it sets the stage as well in terms of like what kind of insights can be exchanged between the, the organisations. I think if a company is going to bring a product to market and it's either a me too product, it's something that people are familiar with, it doesn't have huge cost implications, then I think some of that pre-engagement conversations doesn't need to happen that far in advance. It could be closer to a six to 12 month timeframe.- Right? I would agree with Shana. I think at a minimum we should be engaging payers always at least 180 days before the p DFA date that's been set. And then I think all those other, it depends elements that Shana had mentioned then start to adjust that timeline to say, now is it a year, is it 18 months? What does it look like? And what behoves the biopharmaceutical company for starting to engage some of those conversations much earlier than month, say that minimum of hundred 80 days. I do think this is one of those times too that, that thinks about the direct engagement between biopharmaceutical, med tech and payers. But I think there's so much of those elements behind the scenes that we tend to work on with our partners from MedTech and biopharmaceutical companies as well. And I think we start to see these really nice close alignments and synergies with our HUR friends as well as those of us that kind of sit on the market access side of the fence to really start to think about what is the evidence that's going to move the needle, what do we need to think about, what do we need to communicate, what do we actually need to go try to procure if you'll throughout the development process to make sure that that value story and that value creation is as well rounded as possible for us payer audiences.- Thank you Rory.- My, my wife runs our household under a no surprise rule. We don't want any surprises in our household payers the same way payers don't want to get surprised. And there have been some, some launches over the last 20 years that have actually surprised payers and surprise payers by, by how much things cost and, and how impactful within the population it was going to be. Payers are better at this now, they're not perfect. So operate under the no surprise rule. If you're going to see an A WP change, a WAC change, educate the payer in advance as much as you can about what's going to happen as a payer, you're underwriting your business for three years. So I'm trying to forecast what's going to happen three years from now. I, I can barely forecast what's going to happen next week in the US right now, but I'm trying to forecast over three years of what the spends going to be. And so I'm working with my biopharma partners to try to understand what your, what is your drug going to do today? What's it going to be priced at? What's the impact of my population? What are you going to do next year, the year after with your expanding indications? Really try to operate under a no surprise rule And, and Dan, Dan hit it within six months of P dfa if you're going to make some changes to, to whack or a WP get in front of payers in advance if you can and and educate them on what's happening. New indications or really important as well. It's not a set it and forget it, it's educate the payer and when, when you have opportunities to get in front of 'em. And then if you see changes in the data, and this is something I used to work with my biopharma partners on, like what are, what are you seeing in the marketplace? What are you seeing my peers do? What are you seeing with, with spend and trend? And we actually with within the Sigma population, we adjusted one of our programmes because of hey, this is what we're seeing in the marketplace, this is what your data's showing. Oh we need to go look at that, let's make some adjustments. So get get in front of payers early often. No surprise.- Yeah, I really like what you said Rory. I mean generally when there's a relationship, like you're having ongoing conversations and a lot of times what I found is that it's kind of regular pipeline updates so they know in advance, okay, big picture wise, you know, what do things look like? And then as a product gets closer to launch, you start moving into more detailed pre-engagement exchanges, focus more on one particular product. And then definitely once a product does come to market, that's where you start really focusing on those bims some of the economic stories. And then I really like what Rory said just in terms of thinking about the expanding indications and really starting to share insights as well with payers in terms of, okay, what are biopharma companies seeing out there in the marketplace? So that exchange, that information exchange, really thinking about like how do we optimise, you know, the outcomes of that product in that payer's population is an example. So it really should be an ongoing conversation as opposed to just a start and a stop. And I think in that way I think it's, it's a good foundation in terms of really bringing like two key players together that are really working hard to try to provide, you know, benefits for patients with some of these innovative treatments.- Thank you. Could we talk a little bit more about the changes that are happening in the payer landscape and what our audience should be aware of? Maybe go to Dan first?- Yeah, I feel like Rory hit it early on is we have a fairly fragmented market. We always have. I think there has been an ongoing desire for us to make sure that we can marry pharmacy and me medical a little bit closer in the United States. I think anybody with common sense would understand that it's going to be a benefit if you're managing a patient in totality across what's going on in the pharmacy and the medical side. That said, I feel like this has been a little bit of Groundhogs Day where we've had this same conversation now for 20 plus years. Are we making progress? Yes. Is there more progress that we need to make? Yes, I would say that is one of the things that we're seeing from a US market standpoint is so many of the different players in this space all having a concerted effort to try to say how do we have better accessibility to the data? How do we start to understand the patient holistically a little bit better than saying, I simply understand what's happening when they have a medication dispense study pharmacy. I honestly have no idea what's going on with their physician office or even with infusible medications. That's just not a great system that we've had for years. So that, that might be the first thing that I touch on. But happy to Shane and Rory go- Farther.- Yeah, Dan, I really liked what you were aiming for and so where I'll take it is just thinking about vertical integration. I think it's a story that everyone continues to talk about is some of that consolidation. I know we talked a little bit about the big three and it just feels like everything just keeps getting bigger and the marketplace is, is condensing in certain facets. And I think part of what's driving that is what Dan talked a little bit about is just really understanding the patient more holistically. And part of that's just being driven, I think by more value-based care arrangements happening at a variety of different levels, which are really creating some of this vertical integration. So I think that that's a really important market dynamic that's going to continue to blossom over the next few years and will certainly change the way I think biopharma companies need to think about engaging with some of these different entities.- I I'm going to, I'm going to add a little bit from what we kind of kicked the conversation off with. So, and the, the end payer in a lot of, in a lot of the, in the, a lot of the US right now is employers and employers don't have a lot of line of sight into what they're actually paying for medication and costs keep going up and outcomes aren't necessarily changing and that's a problem. And employers and going, going into 2025 out of 2024 and, and, and some of the federal investigations, there's been a push for, for more transparency and, and you've seen this from, from some of the reports on on gross to net and how how PBMs are, are making money and the shift away from rebates over to specialty drugs specifically within their own SP and some of the cha there. And, and then we see this also push for, for less high whack, high rebate products, right? If we trend that over the last 20 years we're seeing less high whack, high rebate products and there's just an a a sense and a pulse within the employers within the US who are buying this coverage, paying for this coverage that they're demanding more and they're demanding more transparency. They want to know what they're actually paying for goods and if they're not seeing the transparency that, that they want or hope they're going to push for a more fractionated system. And we've seen this actually from, from some large regional plans that are saying, you know what, we're going to start, we're we're going to blow it up and try to try it again. Will they have se success? I don't know. But there is a shift in the US marketplace and, and some of this is as a result of, of some pending legislation, some investigations and just employers generally unhappy with their current arrangement with their PBMs.- Okay. It's interesting. Anyone else got anything else to add there?- I would say the thing that we probably need three extra hours to talk about is policy change in the US and how impactful that is. So I think that's a whole nother series of webinars, Louise, but obviously I think it's a miss if we don't at least mention the fact that policy change in the US is so, so impactful to us payers.- Yeah, I agree. I was waiting for someone to bring up IRA so I wasn't going to be the one to do it.'cause we need a whole new podcast for that. Rory, I was waiting for you to talk about PBM reform, right? Or 340 B reforms. I think all of those potentially huge implications there. And then when I was thinking about vertical integration, you could start thinking about things such as site of care. I think that's, you know, ongoing issues in an ongoing tactic that payers and PBMs are continuing to leverage, right, when they're thinking about cost containment initiatives. So those are just a lot of little tidbits I feel like they're worth at least mentioning on the call, but certainly each one of them deserves its own podcast.- Thank you. So I guess maybe we'll move to some of the questions that have been sent in by our today. So thank you for sending your questions in advance. So we have a few here to share and discuss. So the first question we have is in two parts. So if we consider a new drug coming to market, what could an impactful evidence package look like to communicate value to payers? And the second part of that question is, if that market already has a few competitors, what would payers consider as meaningful to differentiate that asset? So perhaps I should lead ask Rory to lead on this.- I'll take in, I'm going to steal one of shana's answers. It depends. It really does. It depends on the therapeutic class. I think that that that is key. Like we, we have a new pain drug in the US and and the opioid epidemic has, has, has been well documented within the United States and, and abroad. We, we've got a new agent, this new agent, it, it, it, it's a good agent and it's going to see widespread adoption and payers would like to control this, but they're not going to be able to, they're going to have challenges controlling this pro, this specific product. So I, I think it really does depend. If it's a new ACE inhibitor for hypertension, payers are going to go back to their p and t and they're going to say, well, it's a may add. And what may add means is I'm going to extract as much value as possible in order for you to get coverage. And when I benchmark you, I might benchmark you against a a $5 generic product that's, that's widely available. If it's oncology, that's something different. If it's a first in class agent, that's something different. It's for an orphan disease, it doesn't have any other treatments, that's something different. And so it really is a disease state dependent, therapeutic care dependent. And unfortunately I would like to say, you know what you need to bring this package for for this, it, it's just not the case. It really is dependent and, and payers will look at them all differently and they, they look at it from a competitive marketplace environment and, and all payers are going to say the same thing. It doesn't matter about the therapeutic area though. They will say one thing, and this is really common in order to get access, you've got to give me a rebate. Even if underlying they know that you're not going to be able to control spend and trend here, they will come back and say, I don't, I don't care what the data says, you're going to have to give a rebate more to get access for this product.- Yeah, I agree with Rory. We just Go ahead Dan.- No, you go Shana.- Yeah, I mean I think Rory, Rory raises a really good point. You know, new product comes to market, typically it falls within some type of market basket. Rarely are there head-to-head trials, right? So the best you can really do is think about, okay, the design of the clinical trial is that new product coming to market, you know, really was it compared versus standard of care? And then you have to look at the populations and really think hard about, okay, are the benefits from that clinical trial actually going to translate to my specific population? So there's got to be some credibility there that you really believe in the evidence and that it's going to deliver the value that you're expecting. And then of course beyond that, I think it's valuable to have conversations around downstream implications. So cost offsets as well. So again, that comes into line with that affordability picture. So starting to think about things like hospitalisation, ER visits or if it's a commercial population thinking about things such as quality of life measures. And so while those are softer endpoints and considerations, I think sometimes they're necessary to try to differentiate one product from another product.- Does he have a point to raise?- No, Shana stole my thunder. I was going to say economic endpoints, while they may seem softer on the surface, provide tremendous value. So Shana mentioned several of the different endpoints that we're starting to see more frequently in trials. I do think that they're greeted warmly even though they may on the surface look like they're not quite as tangible as some of the clinical endpoints that we're accustomed to seeing.- Okay, thank you. So a second question we've had is how best to test and refine value messaging in the us Dan, could you give some insight here?- Absolutely. And you may find some bias in the three of us because we feel very strongly that testing is best done with former payers. So especially in a safe space. So let's just talk. So as we're developing value stories for us payer audiences, it it is incumbent upon us to make sure that actual payers are looking at those messages. I think that is best done when you have a quote unquote safe space to do that in. So as you think about the three of us now kind of working on this side of the fence instead of that payer side of the fence, it makes for a much different type of testing that we can go magnitudes of depth deeper of making sure that we're not posturing for a rebate or there's some bias in our responses, if you will, as we're going through some of that testing process that we know exists when we're going to be taking some of that to real payers or, or currently employed payers. So what I would say it has been done in a balanced method of saying let's make sure that we're testing through a group like Roche and myself that have had years of experience in this world, but also then testing with currently employed payers to ensure that there's kind of two sides of that story to make sure we're not missing anything. But I feel like it's that safe space testing it, it's so, so valuable anytime that we're creating value messages.- The the payer model, I'm, I'm going to steal Louise, I'm going to steal it for two seconds then I'll give it to Shane. Payer model is changing so rapidly in, in, in 2010, 2011, that the big three ppms that I mentioned earlier that controlled about 80% of the population introduced closed formularies, meaning they were going to start excluding drugs for coverage and they were able to shift a lot of market share over to one product, enter the era of rebates. PBM started generating huge revenue from rebates. Really impactful year 20 10, 20 11, 20 24 was as impactful as 20 10, 20 11. And there were a handful of things that happened in 2024 that that really changed commercial dynamics. And it's really important to understand as a, as a manufacturer coming into the us what those changes are and how they're going to influence coverage of your drug in the future and what strategy that, that, that you should really take on. And the only way you can do it is actually with payers. So you have to understand what's in the marketplace, what's happening. And unfortunately, 2024 does not look like 2015 anymore and you need to come in with a new game plan.- Yeah, I think the only thing I'll add since you know, Dan took my point, was really thinking about, you know, typically when you're engaging with a big entity and call it a payer or a health system, what I find is that often there isn't just one specific decision maker. Often it's a committee and it could be a committee of clinical people wearing clinical hats and it could be a then layered on with a committee that is wearing more of a financial hat. So I point that out simply to say that a lot of times, again, not never one and done conversations with an entity. So think about engaging, not just longitudinally, but you've actually got to engage across multiple different stakeholders.'cause sometimes those stakeholders, even though they influence decisions, those decisions may not always be aligned. So my point to pointing that out is not only, of course, just thinking about what Dan highlighted in terms of really testing messaging against maybe former payers, but also thinking about a little bit of diversity as well in terms of who you're testing that message with. So test it with someone with a clinical hat, test it with someone with a financial hat as as a really simple example.- Thank you. So thank you all. It's been a really interesting discussion today and I thank you to the audience as well for listening to our conversation. We will follow up on any of the questions that we didn't cover today, and we're also happy to help signpost anyone to the right place if they want to continue the conversation. But just for say thank you again.- 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. For more market access insights, follow us on LinkedIn. Okay.