The State of Patient Access: Navigating Policy and Pricing Pressures

Hello everyone. Welcome to today’s webinar, The State of Patient Access: Navigating Policy and Pricing Pressures. We’re excited you could join us. My name is Annie Falcone and I’ll be moderating today’s event. Before we get started though, let’s go through some quick tips to make sure your webinar experience is the best that it can be. At the bottom of your screen are resizable and movable application widgets. Feel free to move them around to make the most of your desktop space. The slides will advance automatically during the presentation, and if you need to enlarge them, simply click the enlarge slides button in the top right corner of the presentation window. And if you need technical assistance, click the help widget, which is in the bottom left corner at any time. And as the presentation gets underway, you may submit questions using the Q&A widget. We’ll answer as many questions as we can at the end of the presentation, but if a more informative answer is needed or if we run out of time before we answer your question, we will follow up via email.

And after today’s presentation, you will receive a link with on-demand access to the webinar so you can watch it again at any time as well as share the content with your colleagues. So we are thrilled to be joined today by our speakers, Hannah Baxter, partner at The Dedham Group and Andrew Rouff, Senior Consultant Advisory Services at MMIT. So to kick off, I would like to ask each of our speakers to provide just a quick introduction of themselves and of their work. Hannah, why don’t you start us off?

Absolutely. Thank you, Annie. And thank you everyone for making the time to join this afternoon’s discussion. My name’s Hannah Baxter. As mentioned, I’m a partner with The Dedham Group. The Dedham Group focuses in life science consulting, and I spend my time primarily focused on market access strategy. So looking forward to sharing the insights from today. Andrew? Great.

Thank you. Andrew, why don’t you introduce

Yourself? Of course. Hi everyone. Andrew Rouff. I’m a senior consultant at MMIT’s Advisory and Insights Organization. So market research and insights type work. Looking forward to being here today.

Great. Thank you so much for being here, and I will hand it off to Hannah to get us started.

Excellent. Thank you so much. So to start the discussion, a lot of this is all going to be framed around the key question and prompt that we’re assessing and what we’ve been discussing is what’s really keeping pharma up at night. And what you see here are these four key points are really the agenda of what we’ll be talking through today. So what Andrew and I have done is we ran a survey with industry, both pharma and biotech, and we’ll go through some of those panelists on the next slide. But ultimately, we’re trying to understand what are some of the core pressures that we’re seeing that industry is facing. And these four are some of those key topics coming out of that survey result. So first is affordability and access sustainability. Second, policy volatility. Third is the rising price sensitivity. And then fourth is how pharma is turning to AI and real world data to help optimize control.

So we’ll be talking about these four points throughout our discussion today. And as mentioned, please feel free to drop in any questions. We’re happy to address as we go through at the end, but we’re really looking forward to touching on these topics and what the survey results are. So to briefly pause at what the panel on the survey was for this assessment, as I mentioned, this was run with industry. So what we’re really representing across these findings are a split between biotech and pharma. And then as you can see here, many different roles and functions. And I think what’s particularly interesting about the results to these findings is that we’re really talking about what different roles, functions, those who touch market access related challenges, as well as patient access considerations are really facing and what’s causing some of that pressure and constraint that different teams are actively identifying solutions for.

So with that, the first section that we’ll talk through some of those overall and high-arching themes of what is keeping pharma up at night. And what we’ll see is it’s not just one thing. We’re looking at a collision of multiple different factors and tactics all coming into play, especially within 2026. So yes, there is affordability considerations that patients are facing. We have increasing policy risk, which we’ve been preparing for in prior years, but now really in execution move 2026, all with rising payer management controls and consideration and all the while the rapid development of AI. So we see not only these pressures coming from the industry that we’re in, but then also how AI is really taking shape and how ultimately pharma and biotech as well as customers and stakeholders, whether that be prescribers, payers, PBMs, are also leveraging these tools.

So to look at some of the responses that we received regarding this question of what’s really keeping pharma up at night, you can see the results to this question. And I did allude to these things already and a big part of the discussion today for the agenda. But you can see when you look at this data top down, what I think is particularly interesting about the responses here is how small that spread is from the high at that first option at patient affordability down to that last one of AI data capabilities. We’re only looking at about an 11% difference in what’s considered and ranked high from this perspective of what is keeping you and your organization up at night. And I think that this is that trend that I mentioned where we’re really looking at all of these pressures right now in a collision zone where we are dealing with affordability, policy and management.

So all of these challenges aren’t so much unique anymore. We’re really seeing the year of 2026 being a year of execution, which Andrew will talk a little bit more in the policy section about. But overall, when you see these types of bar charts, you usually only look at the first one to two categories. And here what we’re seeing is there are numerous challenges that industry is facing and causing access challenges, which we’ll explore more in our discussion.

Thanks, Anna. So the state of market access in 2026, manufacturers are moving away from monitoring policies, most notably towards execution, specifically regarding the Inflation Reduction Act. So when the IRA was announced in 2022, we received an influx of questions from manufacturers. What is this? What does it mean for my organization? What does it mean for my competitors? Is this going to change? Is it going to be approved? There are tons of questions. However, similar to these examples, they were very high level monitoring based, not quite sure what to make of it yet, rather than talking about what their changes are actually going to be. Fast-forward today, 2026, and we’re in a very different place than we were back then. Today, the questions are much more related towards execution. You see here there’s been a large increase for how manufacturers are investing towards their changes from the IRA, from large increase in how they’re investing in it now.

And the questions have changed much more drastically towards the execution front rather than the monitoring phase. So some drivers of this include revenue from price negotiations. Because CMS negotiations are negotiating drugs, drug prices with the manufacturers. This is revenue that’s taken from the manufacturers. So manufacturers need to understand this decreased revenue for how they’re planning of drug life cycles. So historically, the loss of exclusivity when a drug finishes patent is the finish line for when drugs lose the finish line for their drug portfolio.

However, now because of these CMS negotiations, this lifecycle is increased, so it’s a little faster, one, two, three years sooner than it would’ve been otherwise. Well, lastly is portfolio and pipeline prioritization. The IRA is specific towards Medicare. So manufacturers need to understand how their Medicare line of business is going to be impacted and be able to adjust accordingly based on all these negotiations as well as other things impacting. Most interestingly for this, although it is specific towards Medicare, we have seen from a lot of research that we’ve conducted that the changes are not specific to the Medicare line of business. Although CMS is only negotiated from a Medicare perspective, we have seen changes on the commercial book of business as a result, specifically payers asking for increased rebates on the commercial line of business to account for the decreases they’ve seen on Medicare as well as increased utilization management, things like that.

So manufacturers need to understand that it’s not just the Medicare side, but need to look at their broader portfolio and all lines of business to truly be able to understand what the IRA means for their organization. Similarly, it’s not just the drugs that were selected for CMS negotiations that will be impacted, but rather if you have a competitor that was selected, or even if it’s just a competitor’s portfolio that was selected, so it can impact things like portfolio contracting, things like that. Essentially, nearly all manufacturers are impacted by IRA regardless or not if their drug was selected for CMS negotiations.

So which components of the IRA have the largest impact from a manufacturer perspective? To take a quick step back, the IRA is broken down into a few different components from a pharmaceutical perspective. Number one is what I was just talking about, CMS drug price negotiations. Number two, there is a limit for how much manufacturers can increase the price of their brands from a year-over-year basis. Number three is Part D redesign that caps out-of-pocket costs at $2,000. While four is a cap on out-of-pocket costs for insulin at $35 a month. You see on the left side of the slide here, the results speak for themselves. The two top portions were far and away the ones that were most alarming from a manufacturer perspective, so CMS drug negotiations as well as inflation rebates. This was particularly interesting. We have seen anecdotally the Part D redesign is also a very large component we’ve heard from the payer perspective.

Payers are very concerned about this because if the out-of-pocket cost or cap is at $2,000, payers are going to be on the hook for the rest of the payment. This was a large component that was alarming from a payer perspective. And we have also seen anecdotally from manufacturers, this is one of the components that is heavily monitored. However, the results really speak for themselves right here. The two portions that were far and away the most with 46 and 43% were the CMS drug negotiations as well as limiting the rebates. What strategic actions are manufacturers taking as a result of the IRA? What they’re really doing is shifting their prioritization away from the Medicare line of business to account for these changes. So adjusting their investment strategy for new products or indication to limit Medicare exposure, reprioritizing different therapeutic areas, understanding that the Medicare line of business will be hit because of IRA and then adjusting their strategy accordingly.

Interestingly, these results are actually very much aligned in what we’ve seen from a payer research perspective. Payers are doing this exact same thing from their side because of the IRA. For some examples, we know that UHC as well as Elevance are getting out of Medicare for certain geographies while it gets as extreme as some payers like Cigna getting out of the Medicare line of business entirely as a result from the IRA, as well as other factors. But IRA does have a very large component to how payers and manufacturers are reprioritizing and trying to limit their Medicare exposure.

Well, it’s interesting to note here as well when we’re talking and thinking about this concept of Medicare exposure and responses to the IRA is also thinking about that pharma consideration as well as early pipeline planning, because Medicare obviously makes up a large insignificant population when we look at different therapeutic area categories. So it’s also impacting how manufacturers think about early investments, strategic planning for access considerations, whether it’s acquisition or internal development of therapies. There’s a big consideration now of what will that Medicare exposure be, and how do we start planning earlier in the life cycle development process, the trials, the phases to make sure that when we are approaching those stages of launch, what could this realistically look like? To Andrew’s point, there are big considerations around the IRA impact, but then also how do we think about making this affordable for patients and how do we make sure that access will be secured?

Just given the changing dynamics that we’re seeing within Medicare, this is now a big considerations that needs to be brought into that lifecycle planning consideration.

So as a reminder, from the IRA, we’ve seen manufacturers move away from monitoring towards execution. But if we take a further step back and talk about a different policy, most favor nations under TrumpRx, we are still in the monitoring phase at this point. Just to set the stage, most favor nations is part of TrumpRx that benchmarks US drug prices to international benchmarks to make sure that US consumers are not paying more than their international counterparts. It’s very preliminary, was announced earlier this year. There’s been a lot of media, a lot of press about it. We’re seeing a lot of questions similar to we did from IRA in 2022. Is it going to change approval? It still has not formally been approved yet, but it has been announced enough and there’s enough discussions to really pose a lot of questions from a manufacturer perspective. So again, we are in the monitoring phase at this point, but we do see some hints for how manufacturers are planning to deal with this if it were to go through as it looks right now.

And what we’ve seen is that manufacturers relying on these moderate channel specific tactics rather than enterprise-wide like we’ve seen for IRA. So on the left, moderate tactical adjustments, rebates, messaging, just very tweaks, as well as structural changes to different channels. So Part B versus Part D of Medicare. One on the right, geographic specific contracting messaging, increasing commercial rebate reliance. Very small tweaks is how manufacturers are anticipating what they’ll do as a result because of most favored nations. But again, it is in the monitoring phase right now. Perhaps in three or four years, we’ll be showing a similar slide that shows in 2026 manufacturers were monitoring with small tweaks. However, in 2029, the picture is very different. We’ll continue monitoring and researching, but that’s the tips for right now in 2026.

So then as we get into this next section here around specialty drug pricing sensitivity, what we’ll talk a little bit about is we’ve gone through some of the IRA considerations, and then now we’ll transition to, this is the year’s pull through as Andrew was saying, we’ve seen these pressures rising from a system level, and it is really impacting how pharma is thinking about setting access strategy. I think pricing and how we think about price strategy has always been a traditional lever of factor that needs to be strategically considered. But as we were talking about earlier, we’ve really seen how the collision of challenges, what we’re seeing in 2026 between policy and management is also further shaping how we need to think about price and access strategy. So in this first slide, what we do is explore some of those concepts and understand across pharma and biotech right now, to what extent have we seen the overall impact be rising on sensitivity and how pharma is setting access and commercial strategy planning?

And what we can see here is not surprisingly, the pressure has been increasing. How we think about price sensitivity is no longer just based on those traditional factors. And we’ve seen that over time continuously price is becoming more and more of a factor. But I think what’s interesting about what we’re facing this year relative to others is again, that consideration for how we think about price at such a big category, but it’s evolving. So years ago it started out just really thinking about WAC and the list price, and then we moved more into net price and rebate architecture and how do we try and optimize what that can be to support a product. But then again, it’s moved because of system level factors, the changes that we’ve seen in the lives as well as management. It’s really also thinking about formulary design, access, utilization management.

So it’s incorporating additional factors to really think about how do we focus on access as it relates to that pricing strategy? And I think the second point here is that as we’ve been talking about the rising pressure from policy and how that’s shaping what the different constraints are, but it’s also that, again, it’s not just traditional considerations, but structurally different elements are changing, whether we’re talking about what reimbursement thresholds can be or what some of the book of business considerations are. Overall, the playbook of how we think about access and what those factors are causing and increasing to that sensitivity and how we think about strategy is evolving.

Next slide here, we talk about what are some of those factors that are contributing to that increased portfolio price sensitivity considerations. So when we look at all of these pressures in one list, so to say looking at this top down, you can see what was cited to be most contributing to some of those pressures that’s causing that increase, kind of top down. And what’s interesting is when we look at this, the first two data points here when we’re seeing value-based care and alternative payment models being cited, as well as government pricing and policy, is these two factors are being driven from the outside in. These are forces that pharma and biotech have to react to, wait to see what truly gets passed, and then figure out solutions. Yes, this can be proactive planning, but again, it comes back to this concept of there are system level pressures that is further increasing how we can think about strategic responses.

When we look at the next couple, heightened utilization management, provider level cost pressure and biosimilar, this next sect of factors are more operational in nature of how they pose access barriers or challenges. These types of factors, whether we’re going to talk about payers setting the management, providers needing to align to what the payers are implementing from a specialty drug management perspective, or even the competition between what we see with biosimilars and changing cost dynamics, these factors are more of that day-to-day experience. Access is really being determined at that point, and there’s a lot of strategy that can be done ahead of launch, during launch, and then post-launch as well that can set this. And then the last two factors here, affordability and budget impact, as well as patient out-of-pocket burden. These two are more so active levers that can be strategized towards and prepared towards.

So again, as we were talking about on the prior slide, price sensitivity, how high cost to biologics are, the number of innovation that we’re seeing from products, whether we are talking specialty, even a different category, cell and gene, or even different category of more specialty light or over-the-counter, we’ve seen rapid shifts and how pharma is thinking about these pricing sensitivity is really being shaped by these external forces, as well as how to actively work and partner with different stakeholders to try and ensure access.

When we move into the next slide here, what we did was assess now the pharma’s concern around patient access as it relates to these high cost specialty drugs. In the prior two slide, we’ve talked about how pharma is feeling more and more the pricing considerations due to IRA, the changes that we’re seeing in how we need to structurally think about pricing. And then we further talked into those system level pressures are falling ahead of what providers, payers, and biosimilars might be pushing. But here’s the ultimate result as well as what does this mean for patient access? And you can see here that overall the sentiment is high. We see here the results are either extremely concerned or very concerned. And I think what this tells us is there’s a lot of true management and mechanisms that are being deployed right now that’s really shaping what access to specialty drugs looks like.

And this will only further increase. But some of those considerations that we’re already feeling is changes of what we’ve seen from PA denial rates with increasing biologics, greater competition. We are seeing different health plans, PBMs all reacting and starting to really control what appropriate medical therapy looks like for patients in different categories. The same thing can be said with therapy management. As we look to areas where there might be competitive pricing, very similar clinical profiles, we’ll see greater step therapy management as what we’ve seen growing. Even in traditionally where there haven’t been step edits, we are now seeing those step edits in other categories. We also have formulary exclusions and how there might be soft steerage towards a formulary alternative. Again, it’s another way in the tactic that we’re seeing that is shaping and starting to cause barriers to products. And then lastly, copay accumulators as well, taking away that value of what we can deploy.

As I mentioned earlier, that can be a lever. So overall, when we are seeing the results to this particular question around some of the concern around what patient access looks like, it is high. So what we’re navigating is yes, from the pharma and biotech perspective, the pressures, the considerations, the strategy is evolving, but at the same time, patient access is continuously being strained as well from some of these similar pressures. I

Can just comment the accumulator and maximizer side, the last bullet that Hannah was just talking about is particularly interesting. It’s a large trend we’ve been monitoring since about 2017 when they started being implemented, and they are growing year over year almost every year without fail, these accumulators and maximizers. And they’re interesting in this context because they’re just a downstream trend of the pricing pressure that Hannah’s talking about. So pricing pressure impacts all stakeholders throughout drug development continuing throughout pharmaceuticals from the patient, payers, as well as manufacturers. The pricing pressure from a patient perspective of difficulty affording brands, results in manufacturers developing their copay support programs, which are oftentimes the most expensive part that a manufacturer puts together to help patients get access to their therapies. Payers then respond with these accumulators and maximizers to make this copay support not actually count to the patient out-of-pocket costs.

So this game of back and forth, it’s very interesting, generally speaking, as a trend within market access that gets tons of attention from our clients. Again, we’re talking about it all the time. Many reports, it’s one of the most common topics that we talk about. And just seeing it under this perspective that Hannah’s talking about as a downstream effect of pricing pressure, it shows there’s a lot of these different downstream trends that come up just from a very broad topic like pricing sensitivities.

Thanks, Andrew. And I think too, when we think about some of the considerations around restrictive mechanisms as well and ways we’ve seen some of the responses from payers as well, just quickly came up in the Q&A I saw, is the use of how health plans are thinking about ways to support or understand utilization management that really supports medical necessity. So that might be something like partnering with a medical benefit manager or an oncology benefit manager, an entity with real specialization in trying to understand the clinical nuance in experts with interpreting appropriate management. So we see payers still leaning on some of the traditional tactics of deferring to guidelines or journals or NCCN where relevant in oncology, but overall health plans are looking to try and optimize and understand ways to better manage categories that’s really ensuring that the medically necessary products are available. But if we’re in a competitive category that obviously changes some of those dynamics that might be pressure points.

So in the next slide, which is a good transition point of talking about how access has really become this part of this discussion around pricing strategy and access considerations is what we’re looking at here is responses to what statement best reflects the current reality to how pharma and biotech is thinking about setting price or pricing strategy. And you can see on the left, is it being driven by access? Is it access alone? Or is it still purely just based on price? So obtaining and thinking about a strategy is still just purely price dependent. And I think what’s interesting is to see the spectrum of different responses here. So you can see that about 16% cited that the current access reality for some is still purely price dependent, which makes sense. Certain categories are really driven by the net economics and how we’ll see price. But what’s interesting is the more and more responses we see over time that has shifted towards the left of things that might be a bit more access dependent and how access and the implication of price might really shape access.

So you can see here some of the other options that were cited was pricing and contracting might equally be important or contracting and value demonstration might outweigh price. And then last one, non-price controls are driving. And I think it comes back to this point of the reality of access right now is being constrained by some of the management tactics. And what we can see here is how pharma is thinking about that in that lifecycle planning. So when approaching pricing considerations and strategy, what it means for access is getting more and more brought into that equation. And if ultimately patients are not able to get products or a prescriber is facing too many barriers from a patient, we might have a perfect price, we might have a perfect strategy, but at the end of the day, if access is not going to be available, it might be a non-starter.

Again, it comes back to those factors that we had mentioned where sometimes it’s at the point of prescribing where pricing sensitivity is particularly high. And I think we’re seeing that really come into fruition here when we look at this data where pharma is increasingly considering how do we balance the appropriate pricing strategy with the access goals that we need to achieve to get products to patients.

So one of the last slides in this section when we’re thinking about this concept is where is access heading in the next three to five years? And again, this is all within this section of following IRA, thinking about those considerations of policy, really straining what different options might be that historically had relied on, is we’re seeing overall that access headwinds are no longer just obstacles that need to be navigated. The fundamental changes that are happening right now in the industry, which is going to shape what access looks like, especially due to the changing policy that we’ve seen this year. So of the responses that’s being flagged is one at 46% is performance will increasingly determine access. And I think it comes back to that point on the prior slide of really to demonstrate and maintain access, a strong clinical value proposition, really understanding the patient population, understanding what medical necessity means for a product and how that can be positioned and leveraged to obtain access and maintain open patient coverage is going to be a driving factor.

While there might always be pricing sensitivity at the end of the day, making sure that there are therapies available that are efficacious and safe is the priority. So how do we think about access by way of understanding those subpopulations of populations that we can really target and demonstrate that medical necessity? Second here is the contracting sophistication will outweigh list price. And I think this is an interesting one, and I think this might be therapeutic area dependent or category dependent more so than others. But when we think about contracting sophistication here, it’s what is this population going to require? What do these stakeholders demonstrate? What do we see from a site of care perspective? So when we’re thinking about from a strategy perspective or a pipeline team, what is the relevant contract considerations as we think about the channel customers? How do we make sure that it is going to be available in the right channels and we can support the product and make it economically viable for ultimately the prescribers?

The third option here is operational and data capabilities will drive access. And this will get into a little bit in the next section a bit more, but we are seeing greater use of AI. So whether that also be from providers, how they’re using it internally to help with operations or if we’re seeing it with payers, how they’re trying to leverage EPAs, there’s numerous considerations that’s also coming out of changes purely in operations now with emerging interfaces, platforms, more and more data will continue to drive access as well. So overall, what we’re looking at as a result here is that how we think about sustaining patient access and maintaining coverage in this new environment and highly competitive are ones that can really better understand and navigate what clinically meaningful looks like and how to really understand that niche population for that product that you are positioning, maintaining it through its life cycle, and then also the pricing considerations.

How do you sustain the product and make it economically viable for different channels, but maintain that financial sustainability, and then also make sure seamless integration into stakeholders’ operations as well as understanding the data that blows back around strategy.

So now we’re going to take a little break in the presentation. So far we’ve been talking about manufacturers’ reactive strategies towards policies like IRA, most favor nations, as well as pricing sensitivity. But in the survey, we also wanted to understand some of their proactive measures, what they’re doing to get ahead, most specifically regarding AI in real-world data. So real-world data is nothing new. It’s been around for a while. Manufacturers use it throughout the entire drug development continuum. However, with the recent innovations in AI, real world data becomes much more powerful than ever before. AI has the capabilities to look at more data sets than ever before with a different type of sophistication that allows for this real-world data to be used in use cases that otherwise would’ve been just too difficult or really were not being optimized to the best of their abilities. So for this first slide, just to set the stage a little bit, what it shows is that AI is really being utilized by manufacturers today within pharma.

AI is being implemented in nearly every industry. If you read the news, all industries are using it one way or another. Pharmaceuticals are not exempt from this. Manufacturers are using it today and do expect this to continue for the foreseeable future. It’s just to set the stage, it is being highly utilized. It’s being implemented as we discussed today, and it’s one of the top topics that manufacturers are looking at today. So how are manufacturers looking at AI? The answer becomes a little more complex from that. From a real high level perspective, they’re not putting all of their eggs in one basket, but rather are diversifying across all of their market access operations and strategy just to understand how AI and real-world data can be used to help support their everyday work. So if we put this into a couple of different archetypes, specifically from operations and strategy, operational side, so digital provider enabling tools, deep EHR payer system integration, automated PA line evidence generation, these do just the operational side of what you’d expect.

They make things more operational, operationally simple, sophisticated, faster, things like that. So digital provider enablement tools and deep EHR integration allows for physicians to prescribe drugs easier than ever, ensuring that the access that is in the policy is being met from a real-world data perspective. If you have one step at it, you don’t want physicians requiring two steps prior to being used in the real-world data. By using AI to look through the real-world data, you’re able to target physicians, make sure that they understand the correct policies, how the drug should be prescribed, and from EHR integration just removes barriers to make sure that prescribing becomes easier than ever from an AI operationally sophisticated perspective. Strategy is nothing new. Manufacturers have been strategizing since the beginning of time and they’ll continue to strategize, but AI in real-world data allows them to do some of these similar tactics they’ve done forever just in a much better capacity.

The one that sticks out to me is patient journey orchestration. All manufacturers need to understand the patient journey for every drug that they plan to launch or have already launched, understanding when a typical patient is diagnosed, when they go on therapy, how long they stay on therapy, if they’re switching, things like that. With AI, you’re able to understand, maybe segment these patient populations much more so than you would’ve done in the past. So for a concrete example, maybe you see that 40% of patients take five years to be diagnosed for a certain therapeutic area. However, AI may be able to actually point out that 5% of that cohort are actually diagnosed just within a couple months. What makes these patients different? Maybe something’s going on that you can tailor to make that more patients become diagnosed sooner. By AI being able to tweak and segment a little more, your entire patient journey as well as market access strategy could change drastically just because of this new insight.

The two bottom portions, predictive access analytics, continuous access monitoring, ensures that you’re preparing for access, preparing what your access is going to look like based on real world uptake, real world data from other brands or analogs. What continuous access monitoring ensures that once you launch, you see where the access is, what it should be, what’s coming in from a real world perspective, just to continuously monitor the access environment as you launch.

That’s interesting curious when we look at the responses to this, I think most manufacturers and the industry as a whole have moved past AI as a concept and now not the question or not asking the question of whether to invest in AI and the underlying data, but better, how can we invest in it? What makes the most sense for my organization? Really thinking about the infrastructure that could support the capabilities that they’re trying to build to better support efforts as well. And I think what’s interesting is what we’re seeing in terms of the top down areas that they’re looking to invest. First is digital provider enablement tools. And I think going back to some of the earlier concepts we talked about, how to support prescribers at the point of prescribing and trying to obtain and support access at that point of prescribing is a big opportunity to help secure access and ultimately patient access and affordability as well.

So that falling towards the top. And then the second being scalable real world evidence engines. The point we just mentioned on where is the market heading in the next three to five years? I was talking a lot about the clinical nuance. How do you differentiate the product, really develop a strong clinical story? And as we see more competitive spaces, more products, the nuance in the data and demonstrating that alignment to a population and warranting access, again, can be supported by real world evidence. So I think it’s interesting the top two falling to the top here is very much aligned with some of the pressures we’ve been talking about today that pharma is facing. Again, how do you support at the point of prescribing, whether it’s due to access, price sensitivity, making sure the product’s readily available, but then also developing that unique clinical profile and supplementing that with additional data.

So like we were saying before, these operational risk strategy are two archetypes, but we don’t need to stop there. If we break this down into a few different categories, specifically strategy again, as well as pull it through, field reimbursement, patient support, and contracting, we see, again, the key takeaway is that manufacturers are using AI real world data from a broad wide variety of different types of capabilities. It’s very diverse in how they’re pursuing it. So payer strategy in this case, account targeting, payer strategy, account targeting, patient HCP identification and targeting, identifying payer policy misalignment. So making sure you’re targeting the right people at the right time with the right messaging is real one that you can use AI and real world data to help make sure that you’re targeting correctly. From a pull-through perspective, the second one, field reimbursement are from the bottom portion in green.

Targeting field and pull-through resources. Self-explanatory and similar to what I was explaining before, ensuring that physicians are prescribing based on the policies that are published and are not creating more steps, creating more diagnostic requirements than should be necessary. Making sure you identify these physicians as well as target them with the right messaging. The top portion that’s green from field reimbursement and hub operations, helping just field reimbursement as well as patient support to be able to help patients that are rejected from a PA. If you can automate your hub operations with AI or automate with real world data and AI to just make hub operations more efficient, it makes things much easier for patients who are rejected from a PA, need help navigating the entire market access platform from their perspective. Patient support, similar to that. The last portion, contracting is particularly interesting and noteworthy from our perspective.

When we were talking about AI for the last few years, real from a high level perspective, contracting was the one area that constantly came up from our clients. When you talk about maybe four or five years ago, where do we think AI is going to have the largest impact? It was generally the contracting side is what we heard. From one, AI is able to write contracts in a very efficient manner. So just the logistical side of writing a lot of these contracts can definitely be helped, but also understanding what type of contracting to pursue. Value-based contracting, volume-based. Maybe there’s no need for contracting when you have it in place. Patients already want to take the drugs. Physicians are prescribing well. There’s no need from a contracting perspective because the payer doesn’t want to create a bottleneck from that side or the exact reverse scenario is true.

There may be a small demand in that you do need some strong contracting from a payer perspective to ensure that patients have access to your brands. This was the top area we heard. Interestingly, it’s not number one on the list, but it did bubble to the surface from the survey. So it is being utilized from a manufacturer perspective. Maybe not as much as we would’ve though initially, but it is definitely being used as one of the high areas for AI as well as real-world data. So with that, thank you everyone for your time. So far, we’ve talked about payers’ reactive strategies towards policies as well as pricing sensitivities and their proactive strategies for AI and real-world data. And with that, I’ll pass it back over to Annie to run some Q&A.

Thank you so much, Andrew and Hannah. That was a great discussion. And I would like to shift to some questions from the audience today, so let’s jump right in. Someone wanted to know what are some examples of contracting sophistication? Hannah, do you want to take that

One? Yeah, I can jump in with that one. Thanks, Annie. I think it’s a great question in terms of contract sophistication. That can mean a lot of different things. I think it’s also how you approach the analytics to understand some of the nuances. But I think ultimately at the end of the day, it’s thinking about when you look at a therapeutic area category or the consideration within a class, what are the trends that we’re seeing? Is it driven by a competitive class? Is it due to already competitive rebating? Are contracts being offered? To Andrew’s point, we’re seeing more and more data. Could it be driven by anything that’s data related if it’s tied to value at all? So I think there’s a lot of different ways we can think about contract sophistication. And I think it will vary class by class because we do see a lot of high sophistication maybe within oncology where there is high competition, there’s a lot of nuances going on, there might be a lot of carve-out considerations, or it might need to be more baseline and really better understand one large health system and what a direct contract could be and how you can shape that to release to support.

So I think it comes down to the analytics that we’re going to run within that class, really understanding where the patient volume is, where the prescribers are, and breaking that down to really make sure that the value that we are going to give away is going to be really maximized by the customers. Otherwise, to Andrew’s point, it might be a contract strategy for the sake of a contract strategy, which is not what we want.

Great. Thank you so much. Another question that came in, someone wants to know if pharma is changing their Medicare investment, what does that look like? Andrew, do you want to try that one?

Sure. Yeah. So we talked about this from the IRA section, changing their Medicare strategy because of the IRA. So IRA is Medicare specific. So what does that particularly mean? It means a lot of things. One is understanding just the payer mix from different brands within an organization and from the broader organization for all their brands combined. If you have a few different brands that are highly exposed to Medicare, you’re much more impacted by the IRA versus a competitor who maybe is much more in the Medicaid or commercial line of business. The large organizations are going to be in all lines of business from different brands because generally speaking, they’re pretty diverse, but different therapeutic areas that you’re targeting are going to put your organization at a higher or lower risk depending on exactly what you’re looking at. So first of all, it’s just understanding your payer mix from a brand perspective as well as an organization perspective.

Similarly to that, so I mean there’s other areas to think about too. It’s just from Medicare perspective is you’re targeting, we talk about things like the pill penalty. So right now under the CMS, biologics are more preferred from that perspective because they take longer. It’s a little nuance for the drug negotiation under IRA, but the ones that are biologics that are not oral pills actually take longer for you to make the list for CMS negotiations than the oral pills. So again, from a broader strategy, maybe your organization may be more inclined to go for the biologics.

Andrew, you froze there. Oh, here it comes.

It’s going to depend on their particular situation, what therapeutic areas they’re playing in, things like that. But those are just some high level examples.

Okay, great. Thank you so much. Another question that came in, someone would like to know what are the leading indicators that a pharma team should watch to know when they’ve crossed from price and contracting into a primarily UM-driven access environment? That’s a big question. Hannah, do you want to take that one?

Yeah, so it is a big question. So I think it’s an interesting one to think about of when we see that. I think because of the number of specialty therapeutics available and as the categories become more crowded, I think the precedent of what we see with existing products is the best indicator. So if we are looking at a category and we see a lot of formulary placements, even differences amongst tiers, it might be a non-preferred versus a preferred tier, or if we’re seeing a formulary exclusion, but our prior authorization is there. So I think when we think about pharmacy benefits, some of the giveaways are purely based on what we see with formulary strategy. And then I’d say for medical benefit, it’s a different consideration as well. It’s how do we maintain providers and buy and bill if that’s what the current route is to get the product to patient.

But the consideration there is is there more utilization management based on alignment to the clinical trial that might be acting as a soft barrier? So I think it’s understanding the payer management and how that translates into the prior authorization policies or even understanding the formulary. I think those are indicators. The more step edits we see as well, it’s really asking the question of was it due to the clinical validity? Was there something within the trial or a competitor that really supports and validates that step edit, or could it be driven by price? So I think it’s really having a good understanding of what the competitor’s access looks like and then getting down to the bottom of it in terms of do we think it’s driven by a contracting or pricing play or is it due to the data itself for the product?

Got it. Thank you. This is kind of a big question too. Someone asked with AI and RWD investment on the rise, capabilities like predictive access analytics, payer, EHR integration, and patient journey orchestration, which use cases are actually delivering measurable access impact today? This is such a big question. Andrew, do you want to touch on that one?

Sure. I can give my perspective and then Hannah, maybe you can chime in too, because it’s a very good question. AI is new. So we’re seeing a lot of these use cases come in right now. Which ones are actually working? A little bit of a TBD, to be honest. It’s been around for a few years now. We see a lot of questions, a lot of work going into AI. I mean, I think a lot of what we’re talking about, there have been some success from a contracting perspective, from patient pathway perspective, things like that. But I think the jury’s still out. Which one of these really revolutionized the field, really changed all these different strategies from a manufacturer perspective? I think in, I don’t know how many years, five, 10 years or so, we’ll look back and the story will change drastically. Say this is what contracting looked like before AI, this is what contracting looked after AI.

That was a clear success story. But from my side, I don’t really think we have a clear answer into that now. Hannah, I don’t know if you have different thoughts.

Yeah, I agree. And I think a consideration too is we might see differences in investments and what the timeline looks like, whether we’re talking about AI as one concept or real world data as another concept. Because I think we could see pharma integrate AI more seamlessly, again, as we were talking about earlier, where it makes sense strategically based on the operations that they’re trying to better enhance. So for one very large pharma company, that might look very different versus a mid-size or smaller, even biotech. So I think the use of AI will see. I think there’s a lot of use cases. We talked about some of them today, but I definitely agree with Andrew’s point that in terms of the key leading driver, I think it’s really understanding the data and how do we protect patient data as well and a lot of considerations there.

And then I think with real world data, that’s a different consideration of trying to interpret all that we can understand from it and leverage it for a strategy. So I think we’ll see differences and probably a quick timeline with how quickly we’ve seen both of the fields advance. A lot of use cases, it’s just trying to find the optimal balance for the intention of the pharma company or manufacturer trying to use it.

Great. Thank you so much. All right, we have time for just one more question. Someone wanted to know what about the impact on Medicaid? What is pharma doing to manage access within this large payer? I don’t know who wants

To take that one. Again, same thing. I can try it. Sure. Yeah, so we talked about IRA particularly because it’s a large policy that’s being implemented right now from a Medicare perspective. So the logical question is what about Medicaid? The other major line of business. Medicaid statewide or it’s state-run. So it’s a little bit of a different picture in that there’s not going to be necessarily one policy that’s going to impact everything. Although it could be in theory, it’s more going to be state implementation, state policy, things like that. We have seen Medicaid unwinding over the last few years. That’s a large trend in which patients are having difficulty staying on Medicaid and becoming uninsured or going to health exchange. So the real question though is what is pharma doing to manage access within this large payer? It’s statewide, it’s brand-wide. It’s not necessarily one broad trend that I think we could point to.

But I mean, the question is correct. We see tons of work into, we’re more interested in Medicaid right now, what are we doing from Medicaid perspective? But a lot of those answers are going to be unique towards this state, towards that state, things like that. Yeah, there’s probably more I could think of, but I don’t know if, Hannah, if you have anything to add to that.

Yeah, no, I think that makes sense. And I’d say too, in terms of thinking about the other books of business and channels as well, I think we’ll see changes by way of the Medicare population as well. I think based on year to year, we see changes in what Part D looks like, Medicare Advantage, traditional Medicare. We’ve seen changes in the enrollment for the different Medicare plans. So I think we’ll also see different pressures come out of what does that look like for the different subsets of Medicare moving forward? Where are these health plans seeing constraint when they are trying to run a Medicare Advantage plan? So I think there’ll be considerations both for the Medicaid and Medicare populations that will be impacted by recent policy that we’ll have to monitor very carefully. Because again, coming back to when we think about patient access, it’s really considering the payer mix that we’ll see for the different products and how we need to support the different populations.

And Hannah, I am going to ask one more question because someone wanted to know, what’s the impact of all these changes based on the aging US population? By 2030, one out of five will be over 65.

Yeah. And I think it comes around to what do these solutions look like for the different books of business and how do we maintain open access? And I think it’s also, there’s a lot of different factors at play. I think there’s a lot of considerations coming from CMS and private health plans of what sustainable access looks like moving forward. With the changes of how drug prices set, it obviously offsets the other stakeholders in the ecosystem. So we’ll see pricing sensitivities continue to shift, not just from a pharma perspective, but also how a health plan maintains and needs to sustain plan liability. So I think there are considerations that we’ll have to account for in the ecosystem as a whole that we’ll see change, not just from a pharma perspective and how we need to strategize, but also from these other entities from CMS. We’ve seen a lot of changes already from the PBM reform of other players coming into the space to open up new ways to support access and gain a foothold to support employer groups, for example.

So I think we’ll see a lot of change across the ecosystem as a whole because there is a rising population obviously. And as Medicare is such a large chunk of that population, it will be very much an ecosystem trend that we’ll have to monitor.

And on that point, I think just to chime in too, because I think a lot of what we were talking about earlier is manufacturers deprioritizing their Medicare line of business because of IRA and things like that. What Hannah was just saying, I think what the heart of the question is asking is that maybe that’s not possible in the future. I mean, eventually Medicare is a big line of business already. It’s only growing for the question of the aging population. So maybe the strategy isn’t to deprioritize Medicare, but rather optimize how you’re going to work in Medicare. So again, if there’s CMS negotiation, those drugs are targeted by the highest spend under Medicare. So maybe you’re better off in more rare disease rather than one that’s more of a systemic or chronic disease in which you’re charged every year, but rather just a little bit of higher spend may make more sense from that perspective.

Great. Thank you so much. That was so informative, and that is all the time that we have for today. So I would like to thank our speakers, Hannah and Andrew, for a great session.

Optimizing what you’re going to have to do in Medicare because of the aging population.

I got a little bit of a blip there. Okay. One final though. Yeah, right? We appreciate you sharing all of your insights today and your expertise with us. And I’d also like to thank our audience for joining us today. Today’s webinar will be available on demand and you’ll receive an email soon with the link so you can re-watch at any time or share it with your colleagues. And we hope to see you again very, very soon. Have a great day.

Thanks everyone.

Thank you, Annie.

Bye. Thank you.