Thank you all for joining us today. In our 2024 market access survey of industry, we’ve found that more than 80% of pharma companies are now starting market access planning earlier than they did just five years ago. About half are beginning planning earlier for all the products in their portfolio and the other half are starting early just for certain products. Now, there are a lot of reasons for this shift from increased competition in various TAs to increase pricing pressure. To talk about these issues today, we have my two friends and colleagues, Ben and Cathy. Benjamin Hinton is a senior market access solutions analyst at MMIT and Catherine Humphries is a senior consultant for MMIT’s advisory services. And to introduce myself, my name is Ryan Witherington. I’m a solution consultant here at MMIT and I’ll be moderating today’s session. So Ben, what’s your take on why manufacturers are focusing on market access concerns a lot earlier than FDA approval during phase two, phase three, or even earlier?
Ryan, that’s a great question. I think it’s important to plan earlier because it allows you to assess a better strategy around the one important thing, patient access earlier. Since it’s fresh, I’ll use the reference for the Boston Celtics who just won the NBA finals this year after passing all of their trials from years past. You can say they had a successful launch. Even though teams are getting stronger and better, highly skilled players and competitive, they knew historically from analog seasons they had a good enough core to pursue the championship with the stars they had and Jason Tatum and Jalen Brown. So just like many pharma companies have a great product, but the real answer is how can you or how can we make it easier for our best players or our clients to dominate and score? In this case, they signed two-way assets that not only could give them a defensive protection against access barriers, but that could shoot threes and create space in the market before and after launch for competitors to ensure their success.
So their market access partner, or in this example, the president of basketball operations was a former coach with great experience, Brad Stevens. He understood they couldn’t really make adjustments midway after the phase three launch of the season as their opponents would end up doing. They actually added both Jrue Holiday and 7’3″ Kristaps Porziņģis early on. So in doing so, they were greatly prepared to utilize their developed strengths throughout the season, having plenty of momentum. And let’s not forget that their team knew how to prescribe buckets. So this targeted plan really enabled them to be in their preferred position as the number one seed. And I’m willing to bet many of you had them picked in your finals brackets to win or in the market access case on the formulary to win. So just like the road to the NBA finals gets more difficult and market access, new treatments get more complex.
The landscape gets more competitive and payers tighten restrictions, which makes the path to a successful launch of patient access harder to achieve.
That’s awesome. And I love the analogy. Cathy, what are your thoughts?
Yeah, great analogy, Benjamin. I feel like manufacturers are definitely facing added pressure to show value for their new brands. So we have government regulations including the Inflation Reduction Act where both price negotiations and a cap on out- of-pocket spending are impacting manufacturers return on investment. And this causes them to consider lifestyle management strategies much earlier, even into clinical development. And second, especially in oncology but other high cost areas such as diabetes, cardiovascular disease, and now we look at it like cardiometabolic disease influencing obesity, heart failure, all those collateral comorbid conditions, kidney disease that go along with that complex number of diseases that are intertwined. But Pathways guidance puts increasing pressure on hospitals and community practices to improve outcomes and reduce spend on oncology drugs. So there’s more pressure to save money through pathways as well as well as oncology. So manufacturers in the end need to develop value props and targeted approaches with payers based on a solid understanding of the market landscape that they’re entering and that takes time and it’s more and more pressure to begin earlier.
Thanks, Cathy. So what are some examples of what clients are learning with early market access? What needs do they have at this
Stage?That’s a great question, Ryan. So what we’re learning is that almost two-thirds of all US products fail to meet launch expectations. Here at MMIT, we actually just published a profound report called the 2024 State of the Patient Access, where we asked over 300 pharma execs what they thought about access planning and which addresses some of these very issues, which I won’t go in depth here because they need to get their hand on this report. Essentially though, what our clients are learning is that there’s substantial benefit in planning early with our data showing more than 80% of pharma execs now have shifted their timelines within the past five years to begin planning earlier in phase three, two, and even as early as phase one in some cases. With market exclusions, weak value propositions, communicating with payers, finding the right opportunity, government regulations and increased utilization management, all of these are value leaks that diminish the return over time and if not addressed, can really impact the launch.
So let’s take a look at biosimilars as our first example. There was a lot of uncertainty with the Inflation Reduction Act passing and the launches of all the Humira biosimilars. So here’s some things to consider. Sometimes when you’re launching into a familiar space or brands may have a ton of data to leverage, it’s a little bit easy. You have a better understanding. Whereas in others, such as the Humira biosimilar space, not so much. We didn’t know would payers prefer a citrate-free formulation? Would they prefer a high WAC, a low-whack, or what type of contracting strategy would they lean towards? How big of a role would interchangeability play? Other times our clients are launching a new mechanism of action into an established class, or maybe they’re launching the first self-administered product into a class that has been dominated before by buy-in bill historically. So utilizing our custom market research, we can gain insights on client value propositions from payers and so they can be improved prior to launch.
Like the example I mentioned, understanding the value to biosimilars of obtaining a specific formulation definitely helped. And even then sometimes there was almost no attraction until CVS partnered with a manufacturer to bring a new biosimilar to market and preferred, which was something that nobody else saw coming. So even if you can be as prepared as possible, sometimes things still can shift, but being the best prepared as you can be can put you in a better position.
Yep. And I totally agree with what you explained there about the biosimilars because many manufacturers reached out to me to ask about the insights that we could deliver on the slower than expected on their part uptake of these biosimilars for Humira. But we were able to show through our index surveys where we interview payers, manufacturers and healthcare providers that as well as our payer message monitor where we’re able to monitor payer strategy as it’s evolving both pre and post launch and then custom research where we help manufacturers understand the impact of the existing contracts for the reference brand in that case and also the shift in utilization by the lines of business for the biosimilars. So there was a lot of intel there that could have helped manufacturers specifically of biosimilars to not be so surprised by that slower uptake of utilization shift over to the biosimilars.
Exactly, Cathy. We could provide insights and scenarios just like the one you pointed out. We can do a side-by-side comparison to incorporate claims and see how payer decision-making impacted patient volume approvals, denials, et cetera. We were able to capture a payer says versus payer-does analysis from a 360 view. My last point here is that we also have a deep Excel file that we can perform analyses like new to market policies and see what they really did versus what they proposed that they did. We also perform reports where we combine the coverage and the claims analysis to further highlight the payer says versus payer does, which I feel like we’ll touch on a litle bit later in conversation.
Thanks, Ben. So Cathy, for you, can clients use early market access research to determine their value propositions and really figure out their differentiators early on?
Yeah, absolutely. We can understand payer coverage and the perceived value in things like new formulations. As Benjamin mentioned earlier, one example I have is for on- body administration as opposed to a syringe or an administration pen, a subcutaneous pen. We’ve monitored that in the neutropenia space for manufacturers to help them understand how interested will payers be in a new kind of a formulation for a different administration. We can use our policy and restrictions data to better anticipate how analog uptake has been, but also just directionally to touch base with payers to pulse payers and say, “What is your interest in a new formulation?” So we use our, as I mentioned, that index survey, that’s a future looking as well as current trends. We also understand different market events and landscape reaction by payers through that survey.
I guess I could say I’ve also worked in areas where there are markets where there’s many step edits or at least number of generics available such as narcolepsy and cholesterol and migraine headache and immunology as well that we touched on earlier. We’ve done trended coverage analysis to see how the advances in the brand such as different formulations or different dosing can actually help brands to coexist with generics and have their place due to having either a better administration, less frequent or just more efficacious or fewer side effects. So allowing for less expensive brands to coexist in the marketplace with the brands.
Yeah, that’s a great point because there are manufacturers sometimes that come up with a novel formulation, but it isn’t necessarily a novel therapeutic agent. So when payers are assessing it, if it doesn’t meet a clinical significance to a certain degree, they may not see it just as relevant. So being able to have analogs that show how one drug comes into a market in a novel space and whether or not payers feel like they presented a unique product, that can teach you a lot about your differentiating factors and help you to tailor to a specific population. Some things manufacturers want to know is if a product was blocked at launch, what was actually happening with those trips? Were they truly being denied? Were they being approved? How does this differ for something indicated in a rare disease or oncology space versus a disease like diabetes or heart failure, like you mentioned earlier, Cathy?
So I definitely think that having analogs can really help you show what are some things to look out for as you start to plan earlier and lean towards the future.
Thanks, Ben. Thanks, Kathy. So Cathy, in your opinion, what’s the earliest that this kind of research can be useful to clients? Do you have any examples of some work that you’ve done where earlier research and market access planning has been really fruitful and beneficial?
Yeah, I mean, you start earlier in the process to really allow you to consider all the potential headwinds that you might face, the differentiating factors that might play into market access. And it’ll help you to be prepared to enter a market, but also in one example, or I can think of a case like a use case across many examples where manufacturers have considered the market they would be entering and whether or not to in- license a product. So this is before the clinical trials are even completed. We have done market research with payers to understand, for example, the shift in utilization from a brand that was taking over for an earlier brand due to less frequent dosing in rare disease and how a biosimilar would compete if it had the same dosing formulation as the original product, not the less frequent dosing. And that can help a manufacturer to better understand based on the value props of their choices in the market, how HCPs will react, how payers will react to the shift in utilization.
So that’s just one example. I think earlier I gave the example of narcolepsy space where you’re considering how the science is actually elapsing the generic availability because there are better value props in these brands, but it’s helpful to understand the market that you’re entering. We’ve also done work with our policy and restrictions data to trend out, do analyses to look at various analogs to help inform inclusion and exclusion criteria, which is at the level of the trial. So we help clients to chart their waters to be more strategic in their approach. As I mentioned earlier, there are a lot of pressures that are weighing on the ability to reach that return on investment and to inform those kind of key metrics, those early launch metrics to set reasonable expectations. So from clinical trial, really you want to try to influence what’s going to be pitched over the fence and at launch to those market access teams as much as possible, given the pressures of today’s environment of healthcare.
I think I could give you an example too of how currently with the Center of Drug Evaluation and Research approving 43 novel drugs per year, pharma companies are recognizing the value of claims lab and EHR data. Benjamin mentioned this earlier where we look at claims plus coverage here at MMIT. This is a very important aspect of early planning to develop a holistic view of the landscape that will be entered well before the launch of the new drug. So real world data generates insights that helps manufacturers identify areas of need to understand those access barriers and the full patient journey to plan for a successful launch.
Absolutely. Yeah. I mean, as you said, we’ve also helped clients to bridge our data from historical claims dataset from another provider and now MIT can handle the whole project and analysis in a one-stop shop. We can do it to assess payer uptake. We can also do it to assess clinical relevancy. There’s a lot that we can do with our claims data and out now that we have our claims coverage all together under one umbrella, especially in lab data as well, the EMR as you said.
So Ben, quick question for you. So as manufacturers are thinking about market access earlier and earlier in the process of drug development and preparing for launch, are there any pushbacks that they’re receiving internally within themselves about completing market access research earlier than FDA approval?
Yeah. So I mean one pushback I’ve seen is that our manufacturers may say our drug is so unique and so there’s no analog to our drug, nothing. But from a payer’s point of view, they don’t always agree. They have a feeling of how they want to bucket it most of the time. So I’ll give you an example. So in a crowded therapeutic area like atopic dermatitis or eczema, when you may have a different mechanism of action, still when it comes to a payer perspective, they might not feel like it may not be moving the needle. So I’m a big fan of a mechanism of action. I’m a pharmacist, as you know. So I know right now a lot of manufacturers are looking at different interleukins or different drug targets. They’re all in different subclasses. And so for one manufacturer, they may be interleukin-31 or another interleukin 24 or 12 or 23, the clinical relevancy is what manufacturers are seeking payers to realize, but payers may view them as just too similar and may feel like they just only need one or two of those within the class within their formulary versus having each different drug target for a specific degree of clinical relevancy.
So this is an example where manufacturers think their drug is unique going to one target. But as I said, from a payer standpoint, they don’t always see it that way. So being able to reset expectations and allow them to have more relevant information directly from the payers through our resources that we have, our relationship with them would greatly help in their strategy as well, definitely help them to gain a better understanding.
Benjamin, that’s so true and that’s a good point that you make that there is no perfect analog. That’s why we advise I work on many analyses where we take a look at the coverage not only new to market policies versus what payers actually did in current a handful or good number of recently launched brands just to see what all the timing at three, six, and nine and 12 months post-launch really happened. So we can understand payer behavior across a broad spectrum of indications at launch based on those new to launch policies, which are very commonly agnostic of the indication to understand the actual payer reaction. We can segment that and give you actual payer behavior by the payer and line of business. But we’ve also talked about the idea of picking analogs and then looking at the launches within benefit type within all these key metrics.
So we might use three or up to six analogs I’ve worked on projects so that we can mirror certain aspects of the timing, the cost of the product, the marketplace dynamics of trials that were pitched over the fence that were real easy and smooth versus challenges and really get into the nitty-gritty of how the different analogs can help you understand the market you’re entering specifically. So while there’s no perfect analog, I think we have a good approach, a sound approach to helping manufacturers that we’ve heard has been really valuable.
Yeah, that’s good. A lot of clients, oftentimes the point is to really assume how payers behave, but our research shows how they actually do behave. We can definitely see if payers are fast or slow adopters when the P&T sessions may be or how likely they are to review this specific class at their next scheduled P&T, especially in the case of biosimilars where they push the timelines back about a year. So will timelines shift according to future launches? How and if payer coverage has any influence on the claims, coding specifics, et cetera. So our research can really put into perspective how payers are reacting and really just better inform manufacturers so they can definitely strategize better. You can also plan with payers through our P&T perspectives. You can also plan with ACPs. Not all practice managers and ACPs review coverage prior to prescribing. So how does notifying and educating HCPs according to payer data influencing prescriber trends?
A lot of these stuff we can get into and uncover for our clients.
Using P&T Perspectives where we actually have a mock P&T committee with real active P&T members who help to review actual scenarios or dossiers written up by pharmacists can be so advantageous. A little spend upfront could give you the real dynamics in play. And then our message monitor I mentioned earlier is where we track payer feedback to the competitive landscape and ahead of many manufacturers think about reviewing this ahead of launch so they understand better the dynamics from a payer perspective before they enter that market.
Yeah, I think thanks, Ben. So if I’m a manufacturer and I’m going to do this market research later on maybe closer to launch as well, why is it so important to do it so much earlier than FDA approval? And I’ll
Hand it
Over to you for this one.
Okay. Yeah, I can give a good example. Something came to mind, so jumped right in there of how ahead of the biosimilar launches well ahead, manufacturers looked at analogous analogous biosimilar markets, even though they were not their own markets. So if you take the case of ocular disease, looking across inflammatory disease, many different indications, but brands that launched into both crowded and not crowded biosimilar spaces to see what was the timing of coverage across an 18-month span could help you better understand in that space with lots of different factors to consider like less frequent dosing, new mechanisms of action, to get a pulse on how payer and prescribers will really react to the risks that could be involved in that space. But doing extensive analog projects can help you understand across oncology, immunology, how did the payers react who may not be considering all of those clinical factors right out of the gate to understand and better mitigate the entry of multiple biosimilars in the ocular space.
So that’s on example of good use of data that exists and analysis that can help you understand the market you’re entering.
Yeah. And Cathy, to your point, I also think too, especially with a new mechanism of action or something like you’re tripling the dose of a product, you really want to understand how payers are going to react to that. I mean, they could say, “Hey, this is way too dangerous. You’re tripling the dose. It may be more frequent for the patient to come in, but it’s too much of a risk to triple the dose. We’re just going to stick with the one and understanding how they’re going to react to that. Are they going to cover that? Are they not going to cover that? And even putting another lens on it, looking from a physician’s perspective. If I’m a physician and I’m going to triple the dose of a product for a patient, that may be too much of a risk for me. I may not be willing to take that risk if they’re not positive about the efficacy of the product.
And I think as a manufacturer, you have to know what’s the mindset of the physicians and the payers going into this market or going into this space or coming out with a new mechanism of action? Is it going to really change the way they behave or the way that they think about this indication?
Yeah, absolutely.
Yeah, couldn’t agree with you more. I think the earlier you can consider those factors, the earlier you can be proactive year approach. So letting prescribers know the safety information, letting the payers know the safety information, the safety benefits, the safety advantages, working on changing their mentality and definitely as far as HCPs influencing their prescriber rhythm, you want to determine the significant factors that exist beyond the obvious ones, those that may play a bigger role than what you may have assumed. So doing market research can definitely help you give you an advantage and give you an Allego. So especially every month matters in a commercial launch. As you know, if you’re three to four months late, you’re already missing out on revenue that you could potentially be putting back into R&D to service and really help impact other clients and not other clients, but other patients rather.
If you don’t have an advanced relationship with payers once the payers and the prescribers start getting footing, you’re really playing catch up on the projections. So if you’re late and you’re not really on top of tracking the full advantage or taking full advantage of the opportunities, you often begin to think about the consequences of being late and having those other challenges down the line, especially, especially in a competitive space. There’s always different shifts that happen as well unexpected.
So Cathy, what are your thoughts on this?
Yeah, I can think of an example where we’re considering a biosimilar where there was already a brand shift. I mentioned this earlier over to a reduced number of administrations and it’s a good example of the complexity of even markets with only two drugs in them and entering into as a biosimilar with the formulation with the more frequent dosing, how do you come to compete in that market? So you can go in with your eyes wide open and understand the utilization shift away from the less frequent dosing brand and then you can better understand where will that market share shift happen for the biosimilar entering that market? Will it be from the les frequent dosing only or will it potentially be due to cost savings taking away market share from that more expensive brand with less frequent administration? So that’s one example, but there are many complex markets out there and really being able to pulse payers and understand their reaction ahead of time will save you a lot of heartache down the road.
Thanks, Cathy. Thanks, Ben. So with all that being said, what are your final thoughts? What’s the best advice that you could give a pharma company that can help to make smart market access decisions early on?
I’m happy to say that to share my thoughts, which are when you’re making these final decisions and adjusting your trials throughout the phase two and three stages, these are chances where you could potentially influence the product and the value props that you’re going to give to those market access teams and the marketing team down the road. So it’s helpful to make as many of the positive changes that you can based on research at this phase. Sometimes clients are concerned because as we mentioned earlier, the drug may not have a lot of budget at this point until it’s closer to approval. However, it’s money well spent to have that knowledge at an earlier phase so that you can be better positioned at the time of launch to work within that as well as possible within the market you’re entering. Those early expenditures early on will save you a lot of money down the road.
Yeah. It’s almost like they say cheap is expensive. So yeah, my final thoughts is that it’s important to know and validate what you do know so that you can know what you don’t know and then pay it forward. MMIT solutions allows you to have a well-rounded approach to the market access landscape and to keep the organization abreast of any competitive intelligence moves or any policy shifts and really just a well-rounded approach to understand the market that you’re getting in, whether it’s with analogs or moving the needle a little bit earlier on so that you can get a better understanding of where your footing is or what I obstacles that you may approach down the line. So that’s it.
Perfect. Hey, thank you, Ben. Thank you, Cathy. This has been wonderful. I’ve learned a lot. I’m sure that all the attendees in the room have learned a lot as well. So just wanted to give a big thank you for all of those that have came today. I really appreciate your time. If you ever have any questions at all, please send them our way. Yeah, thank you so much and have a great day all.
