Thank you guys for joining us today. To start us off, I wanted to share a stat that we recently learned from our second annual state of patient access survey, which we just presented on in Asembia. We surveyed about 250 high-level pharma stakeholders and what we found is that 80% of pharma companies are now starting market access planning earlier than they did just five years ago. About a third, 30% are starting in phase one and 50% have started by phases two and three. So that’s a really interesting trend that we’ve been keeping an eye on for the past few years. Planning and strategy development are moving earlier and earlier. So we’ll be talking about that today and what you can do in phases two and three. So I’m Jessica Smith, senior writer for our content marketing team, and I’m joined by two of our highly esteemed wonderful market access experts, Carolyn and Sean.
They’ve both been around for a very long time. Sean is the VP of our client partnership team and Carolyn is an advisor on our solution consulting team. Excellent. So what we’ll discuss today is a few different topics that are key when you’re at these stages in the pipeline journey. Every product is different as you know, but there are a few standard areas that you could be working on on this stage. So my first question, Sean and Carolyn, is just I know we have so many clients that come to us and ask how early is too early to start on commercialization and market access research? What should we be doing first and how would you answer that?
Yeah, Jessica, it’s such an important question, especially now with everything that’s going on in this age of the IRA and tariffs being on, being off. There’s a lot of uncertainty and all of that for our manufacturers means there’s even a greater need for certainty than ever as you go into a launch. And we all feel that the clock is ticking. And I love the chart on the left because I think it illustrates really well the point that our survey just talked about and that we’re going to talk about in this call and that is that you really only get one chance to make certain key decisions right to maximize the value of the compound that you’ve been given to commercialize. And it really starts if you sort of go on the upper left with picking the right asset to move ahead with, and then the data that you collect on them to build the story that you’ll take to the market and how you build and invest in the value story and who you target and what you say, that’s all just critical stuff.
And you really, if you don’t have the right data and research behind it, those decisions when you make them, you can really lose the opportunity not only to get to patients faster and better, but to recognize or optimize the full value of the asset. So these are all things you can collect in phase two and phase three to inform your planning and set you up for success on doing the things on the right side, which Carolyn will speak to.
I really want to focus on the right side. And I want to ask a question right upfront. What does preparing for launch actually mean? What should you be doing? It’s going to be different for just about every drug launch. It might be a little bit different, but the six buckets on the right really show the nuts and bolts of setting up your brand and your team for success. Developing your value story is a huge part of your launch as is knowing which part of the value story needs to be delivered to each set of stakeholders. So getting the team to understand that patient journey, both what’s happening right now for patients and then what is your brand going to disrupt? What is your brand going to improve in that patient journey? Predicting the response that payers will have to your product and to your value story and predicting what they’re going to do on their formularies and in their policies.
That’s easier said than done. But we’ll cover that in detail in a little bit. Segmenting your stakeholder into actionable buckets, developing the team to ensure every member of the commercial team embraces the go- to-market strategy, that’s going to be huge for you. Developing your manufacturing and distribution strategy, that could be its own set of hurdles that you need to get through, but having a strategy and an ability to do that before you launch is huge.
That one sometimes feels like a no-brainer because there are already drugs that are being delivered to patients. And so you think maybe manufacturing and distribution isn’t going to be that different than anybody else, but if you’re disrupting the market, it is going to be different and you want to make sure that those set of challenges that you need to overcome that you see long before that you’re faced with them in the real world. So shedding light on that disruption and having that mitigation and strategy in place will help you become launch ready. When’s the right time to start thinking about how you’re going to market your new product and start thinking about what pitfalls you might encounter along the way. It’s going to be individual to each launch and each company, but essentially once there’s a commercial team and once there’s internal or external awareness of the drug being studied and potentially being launched, then an action plan should follow.
Even something as simple as looking at syndicated market reports to get an overview of the treatment class you’re entering or to do some quick research to understand how decisions in the class are being made by payers and treating physicians today. It’s never too early to start planning for success. So I would advise you to start as early as humanly possible.
Yeah, totally agree, Carolyn. And I think a theme that’ll recur throughout our time together is this, based on what we know now, what will it take to succeed in the market when we get to that point? And something Carolyn just said is really important and that is there’s what we know now and there’s the environment as it stands now and then we have to project what that environment will look like when we hit the market and we need to get ready now so we’re ready for launch. And the cool thing is the answers that you uncover at this stage will help you answer that question. So just like our clients told us in the survey that Jessica shared, starting early is really important.
Excellent. Thanks guys. So let’s narrow it down a little bit because I know a lot of our clients can get really easily overwhelmed because there’s so much to do. What steps should they focus on first and at what stage?
Yeah, it can feel overwhelming and that’s totally understandable and there is a lot to do, but taking a disciplined approach at each step really helps. And I think this slide is helpful to show the kind of things that we’re seeing our clients doing at each major stage. And it’s so interesting. Carolyn and I, Chuckle, we’ve seen a lot. We’ve been in the industry for a while and we see these things moving further and further to the left. The things we used to leave until right before launch are getting done sooner and sooner. And so as you can see, phase two and phase three, that second circle from the left is really important. And when you look at what’s there, you can see many of our clients are thinking about things like you see there. And as I think you would agree, these are things that we didn’t see people do until much closer to launch.
And depending on your product and your clinical trial plan, being in phase 2B, you could have a number of years before launch, but you want to be able to influence that trial plan in which you’re collecting to make sure you give the market what it’s asking for. And some of the key questions or standard things that our clients like to know in phase two, and we’re going to revisit these later, but just a really high level, first of all, how big is our patient population based on what we know about our label now? What’s our clinical value likely to be? So what’s our efficacy? What’s our safety? What are the unmet needs and can we quantify the clinical and the economic burden of illness because we need to make that case to payers and they need to have a reason to cover our product. So sometimes it starts with something as simple as how burdensome is the disease.
They may not know, especially if you’re starting a new category or addressing a condition that hasn’t been addressed before. Does the product offset those costs significantly? And if we don’t have those yet or don’t know, what we can do now is be better prepared for launch and launch. Who are the payers that matter in this space and how are they managing drugs now? And your management team is going to want to know how to prioritize accounts. So it’s the 80 / 20 rule, right? 80% of the resources and energy that you put in are probably going towards 20% of the payers in that space. What are the payers going to need to provide access and what can we do to ensure that that happens? But of course, often this early on, I think we’d all agree, they don’t have the team, the funds or the buy-in.
You don’t, our clients don’t have a lot of money to throw at this at first, right, Carolyn?
Absolutely. I mean, we all agree that budget is a huge factor right now at this stage. When you’re in phase 2B, a lot of times you’re being told you can’t spend any money until you actually have a forecast of approval. You haven’t even entered phase three. So asset viability is a very valid concern. There’s often a lot of reluctance to spend significant money. You’re not close to launch. What happens if you don’t get approved? The likelihood of approval is really important to keep an eye on. If likelihood of approval is low, what should you do right now and what might you be able to wait to do? Maybe you can get an early read on the clas. Even if it’s just a syndicated report that shows you how your competition is covered today, are there drugs being used off-label to fill the gaps? Any information that you can get in the drug class and how it’s being managed could be really important today and is often pretty inexpensive to procure.
Who prescribes in this class? Are there specialist requirements? Are patients traditionally treated at a facility or do they typically go to the retail pharmacy to pick it up or get something mailed from the specialty pharmacy? What else can be helpful and is low cost to obtain is some form of prioritization or segmentation of payers and treaters. You want to be able to segment payers and treaters based on patient size and influence and based on member and enrollment and influence as well. If you start to think about your future targets now, you’ll be able to at least begin to steer the ship and keep the team focused in this direction and then pay for more details later as your viability and crisis.
That makes a lot of sense, Carolyn. Let’s dive a little deeper into actually developing your value story. How do you start doing that at this stage of the game?
Yeah, such an important thing. And we didn’t used to be able to think this way or we didn’t used to have to. The world’s changed a lot. So in an ideal world, you could reverse engineer your trial design for commercial success. So we could just tell, just find out what we need and go get it. And we all know in the real world that’s not entirely possible. Maybe our asset just can’t do the things exactly the way payers want them to, but it’s still really important to get an idea of what our stakeholders need, we’ll need to provide patient access at launch and what you can do to differentiate your product that’ll make a difference. And so even though we can’t do it all, we should try. And like Carolyn said, we do it in the bits that we can, but early is good because it helps us get ready.
So some things to consider. First, what comparators and endpoints do you need to get in phase three that’ll result in payers not thinking of us as a me too product? What are the unique endpoints that just blow everything else out of the water? Again, there’s ideal and there’s reality, but I used to do pre-launch advisory boards for clients where we would present the clinical and economic story to payers to solicit reactions. “Hey, what do you think? This is what the product looks like. Here’s the efficacy, here’s the safety, here’s the cost offset, here’s the cost effectiveness. “And payers would often tell us that key elements that would’ve really been differentiating were missing. And by then it was too late. It was really hard. And they would say,” You need to give us something that differentiates this from the current standard of care in order for us to give you favorable access, “which often is either, especially if you’re in a market that’s highly generalized or where the options are less costly.
Carolyn mentioned off-label use. Maybe they’re doing that to fill the gap in the meantime, still maybe cheaper than what you’ll be coming to market with. So there was a common list of things they were looking for, including things around burden of illness. If that illness wasn’t well understood and if your product was going to come into a category where there are no or few prior treatment options, of course efficacy and safety with comparators versus more than placebo. We used to get away with that just doing a comparison versus placebo, not anymore. And then where we can cost effectiveness and cost offset. It’s not that we need to do these things right then, it’s that we need to understand what payers are looking for and then build it in to our trial plan where it’s possible. But the most frustrating thing was many times the things that we’re missing could have been known and controlled for with some research and data collected in phase two and three.
I guess what we want to say is you can do this by identifying and then filling these gaps and feeding that pie presentation that you do pre PDUFA and ultimately the market access value prop that you’ll go to market with.
Here’s a great example of that because Sean is so right. We just ran a PI presentation workshop for a client who’s three years out from launch. They’re bringing a next generation product into a space that was really new to them. What should they be collecting from their trials that will add to their value story? They want us to know that now. What do they need to present to decision makers? They’re only in phase two. When they get to phase three, how do they design their trials so that they can pull out the right endpoints? What would be those things that are going to sway a payer at an institution to make sure that they’re covered and on the pathway? We helped the client put together an outline for the PI presentation and that’s truly all it was. We said,” What do you need to share?
“And we did research to help them understand what they need to share with payers with institutions as the value story. And by putting that outline together, using primary custom market research with actual decision makers, reviewing analog launch value stories and where they were successful and where they had challenges, all they have to do now is fill in the details as phase three begins to generate results that they need to share and start filling in those details. They’ll be able to see right away if they’ve collected everything they need to tell the right value story in their PIE presentation. Nothing is going to be missed and they won’t need to spend any extra money to run a late stage trial to get the necessary data later. So yes, it costs them money to do this upfront, but think of the money that was saved by not having to rerun a trial as a late stage trial.
Yeah, that’s an incredible cost savings if you compare those two. Well, thank you for that. Let’s talk a little bit about understanding your patient population. Obviously once you’re in trials, you’ve already done a fair amount of research into the patient journey and how your patient is diagnosed and it goes through each step of the care continuum. But what do you need to know now that you maybe didn’t focus or hone in on before?
Second, when you’re in the midst of trials and you’ve already qualified patients for a trial, you don’t really know the journey that a patient goes through to be diagnosed because you’re really looking at patients post-diagnosis. So understanding now what does patient go through to get diagnosed? How long does it take? What’s the path to the diagnosis? Are there roadblocks that will cause a hesitation or a delay in diagnosis? What is that patient living through? Are they misdiagnosed a couple times? How long does it take? What are the roadblocks that are there? We had a client recently that they have a product that’s in market today that treats a disease patients don’t like to talk to their doctors about. Now think about it. We’ve all been patients and we’ve all had to have those uncomfortable conversations with doctors, but the client didn’t spend any time thinking about when patients were going to bring up their symptoms to the doctor and what that activity looked like and what that hesitation looked like.
So their whole lunch plan centered on getting an understanding coverage and they got it and they were able to get access, but they didn’t have a plan for how to get patients to talk to their doctors about their symptoms in the first place, how to overcome the taboo. So they had to retroactively try to figure out what the patients go through, what symptoms do they have and how long are they having those symptoms before they go and talk to the doctor and before the doctor can do anything about diagnosing them. And it cost them a lot of money. They had to do very patient-focused research. It cost them a lot of money and it quite frankly costs them the first year of their launch. They might have identified this earlier and if they had identified this earlier and spent money on potentially television ads upfront, far in advance, helping people feel comfortable talking to their doctor about these uncomfortable things.
And I’m sure you can all picture them in your head what would be uncomfortable to talk about, but now they’re playing catch-up and they ended up not having the ideal launch in that first year because of it.
And anyone can fall into that. That trap, especially if your product is for something novel, something maybe that’s embarrassing to talk about, but there’s never been anything to treat. It’s easy to make assumptions that doctors will know or that patients will say the right thing. And it’s only by understanding early on where there are breakdowns in the journey and the causes of those breakdowns that we can solve hopefully earlier. So it’s a great story that we can learn from and there are many, that’s just one. So doing this, and what I mean by this is thinking about the patient journey and doing that select research to uncover those barriers in phase two, three gives us time to understand and solve for those barriers in launch planning and avoid those costly delays or misses. And a relatively small investment in research with something like an analog’s analysis here can help you understand how prior relevant therapies have dealt with barriers or didn’t and what happened and we can learn from that.
There’s wisdom from that. And it really comes down to picking really good analogs. So if we know we’re a novel therapy that’s in an uncomfortable area where patients haven’t had, we can learn from the mistakes of the past and hopefully we can avoid those costly mistakes going forward. So examples of how to guide development of strategies to overcome them. So things we can look at the patient and provider experience with existing therapies and how our new therapy would fit into the standard of care and is there education or awareness raising that needs to be done because nobody’s doing it now and our therapy will be that earth shattering. Is there new or diagnostic testing needed to confirm diagnosis and access therapy as we see in Alzheimer’s, for example, and how to get those tests covered because if the tests aren’t covered, they’re not going to get done and our drug won’t get used.
Centers of excellence and the need for logistics around site and staff readiness, logistics around patients transport as we sometimes see in cell and gene therapy. Health systems and provider networks like IDNs have things like order sets, formularies, pathways that might influence use of our product and understanding those and what they look like now and what we’ll need to change to be favorable to our product is really important. It’s good to figure that out early so we can address those. And then of course patient symptom identification as we saw in Carolyn’s case example a moment ago.
And you might be thinking, where the heck am I going to get all this real world data to do this patient journey analysis? Well, let me help you. If you could access the entire patient journey from physician chart notes to lab testing and results, genetic biomarker identification, diagnoses, treatment decisions, treatment rejections, reimbursement and prescribing challenges, all of the data associated with treating a patient all along their journey. What could you learn? Well, we can help you with that. We can use MMIT’s Norstella link. It is the industry’s first combined real-world dataset spanning your patient’s treatment journeys, not to get salesy or anything, but you need to understand every facet of your patient’s treatment and the challenges your patients have faced along the way to date. If you could use this dataset to find that, to find all of those barriers that they’re hitting right now, you can focus on any part of that, including patient symptom identification, how long it takes to get diagnosed, how many patients are misdiagnosed first, how can influence earlier and correct diagnoses?
These are all things your clinical trials probably haven’t focused on and being able to use a fully connected dataset to do that analysis could be really valuable for your launch strategy.
It’s incredible what you could uncover with unstructured EMR data, particularly when paired with all the other real-world datasets. It’s really something. Okay. So what other foundational work should be done at this stage to help you better understand key elements of the patient journey that you’re going to need to get into?
It’s all about telling a story. We need to communicate what the patient goes through and where things break down, where costs are, where burden of illness is and the why that the patient needs to have unfettered access. They need coverage, they need unrestricted access or the best access available. But in order to do that, we need to understand where those barriers are, whether they’re payer barriers, whether they’re provider barriers, whether they’re patient barriers, or whether it’s just something in the environment, patient lives far away, patient can’t get there. But if we can answer these questions about the patient journey, you can use that understanding to tell that story in your PI presentation and your value proposition. So going deeper, that helps with your planning, including your launch plan, your commercial plan, pricing, contracting, and forecasting. So what are some of the key questions our clients come to us for help with in phase two or phase three?
So one is how many patients are there that fit our label and where are they and where do they get stuck in the journey? What kind of docs are seeing them and where are those prescribers? It’s almost like that feeds a heat map so we can see on the map, we can even see at the state and county level, where are those docs? Where are they relative to key sites of care? How do patients get diagnosed? What drugs are the target patients on now? How are they working out for them? Key thing is their unmet need. Again, we’re building that story, whether it’s the pie deck or the value prop. What’s the clinical or economic burden? And while the pipeline team has probably already done an unmet needs analysis early on, how long ago was that? What’s launched in the meantime and what’s projected to launch between now and then that might change access in the future or at our targeted launch time.
For example, right now, there may be no treatments in the category you will enter, but you need to know and plan for the three pipeline drugs that will have launched that address some unmet need before us or just after. So in other words, maybe it’s us and three products. Two of them are going to launch right around the same time as us. One’s going to launch after. How do we prepare for that? And that should be where the commercial team comes in and how will we handle being second or even third to market? Or even better, how will we handle being first to market? Because we’re the trailblazers, the pioneers. Does my sales team already have a relationship with these HCPs? That’s going to depend. Am I a small? This is our first product company. Am I a medium-sized company where we have a couple products?
We already have a Salesforce, but maybe they focus on completely different disease areas. Or am I a larger top five company and it’s just a matter of reallocating resources. And as you’re building your commercial strategy and your team, you might need to have some specialist that can handle special situations. Is it a CAR T or is it the latest type two diabetes treatment? All that will dictate how you think about your sales team and the resources they need.
All this information about unmet need, burden of illness, current treatment options, you need all this information for your high deck. So work backwards. What do you need to figure out right now? And then what do you need to figure out as you get a little closer and can spend a little bit more money. I hate to always bring it back to budget, but you’re living in a budget and you’re always going to have that budget constraint over your head. You want to be ready to build your value story, forecast coverage uptake in sales and of course set a price that’s going to gain your product the access you need to be successful. You also at this point need management to feel really good and to trust your thoughts about talking about this product on earnings goals. You know they’re going to be and you want them to have the right words to say so that you’re not stuck chasing a dream that is never going to come to fruition.
Setting the right expectations depends on the best projections, using the right resources to project as close to your reality as possible. If you’re bringing a biomarker targeted infused oncology therapy to market, you need to understand how much infusion sites are involved in that treatment decision. Where do the IDNs and institutions fit in? What do payers dictate? What do the IDNs dictate and where are they never going to work together? What are all the ways patients can be covered or more importantly blocked from accessing your treatment? Do payers cover the right biomarker testing? Do they restrict where the patient can obtain treatment or where they can obtain the test? Where do I need to be priced so payers will write a coverage policy that is close to my label? How do you know what to expect?
Those are great points, Carolyn. Speaking of pricing, can we dive a little bit deeper into pricing? When should companies do their first pricing study? I know you like to say they need to do multiple, but
Yes, they need to do multiple. And I love this question because I’m going to talk like a consultant, that isn’t my title. It depends. Are you testing a price you already have in mind or are we starting from scratch? If the latter, you’re going to need multiple research studies to get to the right range and to figure out the concessions you may need to make to get the coverage you need to be successful. The first study should include an analog review. You’re always going to want to look at analogs and some qualitative research on market trends and pricing concerns in your class. And by qualitative, I mean you need to interview payers, you need to interview institutions wherever, and you need to interview where your drug is going to be dispensed. Interview people so that you can understand what their pricing concerns are. You’re going to address a lot of concerns in the value story and you want your value story to address concerns that they have so that when you do talk about price, they don’t already have all these doubts in their head.
You want to figure out what price you’re going to maximize access. Remember, it isn’t about setting the lowest price so every payer will cover your product because if that’s what it was, this would all be very easy. You just price it at zero and everyone will cover it. It’s about maximizing access for your patients. If the market is already flush with prior authorizations and patients aren’t being denied the therapy they need, you don’t have to buy open access. You can live with a prior auth as long as it’s close to your label. I had a client who said they weren’t going to do a pricing study because, and I guarantee most of you have heard this before, the CEO determined what their pricing was going to be already.
Easy,
Easy. Already half the price and sometimes you do already have the price.
Even if your leadership has already said it, even if the CEO says, “We’re going to price it at this and I don’t want to hear anything else,” you still need to know how the market’s going to respond to your price because it’s not going to be the CEO’s fault when you don’t get access. You should at least conduct some rapid primary research with a representative sample of decision makers. We call out a rapid response here at MMIT and it’s very cost-effective. For a very low investment, you can give that research to your CEO and you can say, “Read this. Here’s all the reasons why we can’t set the price you want to set and do it upfront so that you’re not chasing that after launch saying, well, it’s your fault.” And the CEO will say, “I’m the CEO and it cannot possibly be my fault.” And then you can do a pricing study.
Once he agrees that you’re right, you can do a pricing study to determine what the right pricing band actually is for your market. We’re doing a four-pronged pricing study for a client right now in their therapeutic area. The first step is we’re doing some desk research on analog products. We’re then going to conduct some price sensitivity testing with both payers and physicians since they’re in a buy and bill space. So it’s important to note that physicians are going to be out money until they get reimbursed and knowing how much money they can be out and how long they can be out that money with that financial burden is important to know. Then the phases three and four are going to be primary research with payers, institutions, and physicians. We’re going to project price pressures in the future since there is growth planned for the market and six new product launches are going to follow their launch.
So securing the right price upfront, taking the right access at launch before those other six drug launches before those other launches happen, that needs to be done now so that their price maybe is unlikely to be impacted by these new market events. That’s wildly important for us to know that.
So critical. And it’s all about the inflection point. It’s the inflection point of our price at which behavior changes for the bad. So at what point is it too high for payers? At what point is it cost prohibitive for the physician who might be taking a risk on a buy and bill product? At what point, and this is critical, where there’s a patient copay co-insurance, does the patient not go through with filling the script or having the injection because the cost is too high to them. So those various pricing scenarios, ultimately we need to think about what it’ll mean for payer management, patient fill. And we know that’s all driven by patient out- of-pocket cost. And that’s what the graph on the right is trying to show you, all those different factors working together. At what point is the patient cost too high and coverage and restrictions unfavorable, which affects fills and sales become suboptimal.
And that’s where the education of maybe your CEO or someone on your C-suite team who’s made a decision about price, this will really help them feel good about either that they’ve picked the right number or maybe they need to revisit it. We want to understand the impact of various pricing options on what payers will do and ultimately on patient behavior and sales. So in order to know how to price and maximize return, and this is really critical, right early on we have to forecast revenue too because we’re starting to talk to in those earnings calls with analysts or C-suite is they want to know what revenue might look like. You need to know things about your target patient population. What channels are your patients in? Are they Medicare? Are they Medicaid? Are they commercial? Are they health exchanges? Are they Medicaid? Are they VA? What health plans do they have?
So if they’re within commercial or if they’re in Medicare Advantage, what will key payers in those channels do with management given various pricing and label scenarios? We can look at analogs, again, very helpful at this juncture to see what other similar products have experienced in those channels and market research too. And Carolyn gave you a great example of rapid response is one of the ways you can do this quickly and inexpensively in this stage. Knowing what to expect is best learned in phase 2B and three and then refreshed as details become clearer and we can help with both pricing studies as well as analog analyses, the strategic launch report, rapid response as Carolyn has shared.
Wonderful. So you mentioned earlier that a payer and provider segmentation was something that pharma companies should do at this stage, which I believe is much earlier than they maybe expect to do it. Can you tell me more about that? Why is it important to get a head start on this kind of segmentation?
Yeah, absolutely. So you can’t know what every payer and every provider is going to think, do, need, but you can do some research and have a good idea of what national payers need versus what the regional payers need. Remember, there are over 700 payers in the US and you can’t boil the ocean and create over 700 different strategies. So segmenting these payers into something that’s more manageable, maybe you have four categories. So you have a comprehensive strategy that’s tailored to each of these categories concerns and characteristics. Then you can determine an approach based on a clear set of parameters for each segment. I might segment them into early influencers positive versus negative. So you’ve got positive early influencers and negative early influencers, maybe skeptics and maybe followers. There are hundreds of payer attribution parameters. There’s payer size, impact, restrictiveness, time to make decisions, new to market policies.
You have to decide what’s most important by looking at the data for the space that you’re entering because every indication, every class is going to be a little bit different. Pick the parameters that are important to your market and then use secondary data or primary market research to establish your segments. Then once you have those segments, the goal is providing your field teams a strategy for how to approach each segment of payers, each segment of provider orgs, each segment of hospitals or HCPs. That’s your overall goal. Get a plan of action in place for each so your field teams can actually hit the ground running.
We can help with that through custom market research, through the strategic launch report that Sean mentioned earlier. Also, we do a lot of ad hoc analyses for policy and restriction data. We can look at payers and see details like when do payers start actually having those not covered decisions in a class. Do they leave a block for six months? Is it a mandatory block for six months? And then they make a decision to cover or not cover a product. How many direct competitor products need to be in a market basket before a payer will start to restrict access to those products? Basically, what you want to know is how do we approach those payers who are going to give us problems? Do we approach them early or late? You want to be able to understand if a payer isn’t going to write a policy for a while, maybe you’re okay with that.
If their general practice when they don’t have a policy as a five-second PA, you can potentially, as one of my favorite clients says, “Fly under the radar for a little while.” And instead you want to prioritize talking to those payers who have a new market block when there’s no pulse because instead of being subject to a block, maybe you can do your PI presentation with them, you can talk them into having a policy right out of the gate. That’s why segmentation is so handy because you want to hit the ground running and maximize access fast as you possibly can.
So true. And if we do that right, our chances of success are so much greater, especially if we have limited resources. We have to focus where we’re going to get the most return. And if go back to the big picture, what we want to think about is who matters and that’s based on prioritization. Maybe it’s looking at covered lives, timing of coverage, decision-making, and understanding what they’re going to want to hear. And we talked about that earlier in our call, but just remember that’s based on understanding from research what’s going to differentiate our product and giving it to them to the extent that we can from our clinical data, our economic data, and then to the extent that we need to if we need to do contracting, if we do things with price, there are different levers we can pull as far as what they want to hear and then how best to deliver that.
And that’s also based on good market research. So getting an early read on this in phase two, three can really help ensure that we get an early warning of challenges, but also opportunities ahead and plan accordingly.
Excellent. And as you’re building out this strategy, when do you start building out your commercial team? I expect it changes depending on the size of your organization, but can you talk a little bit more about that?
It does change. So if your company hasn’t commercialized product yet, you won’t have hired your team. You’ll probably just have a head of commercial if you’re lucky you have ahead of commercial. We often help our pre-revenue clients figure out how to structure their teams and all of the insights we just discussed, all the segmentation we just discussed really helps when the time is right. Our partner, the Detam Group consulting team has a ton of experience helping new commercial organizations right size their teams and the insights we’ve discussed gathering on the rest of this call that will be key to figuring out the size, the geography and the right time to hire and build out that team. And even in some cases, what level of experience you need for that team.
Yeah, it’s a powerful combination, right? Research data and then a consulting group that really knows the space, has done it a ton of times before that can really help you figure out the way forward. So at this stage, it’s critical to figure out a few things when it comes to field force sizing and account manager, field force sizing. First, we need to think about where do we need to have boots on the ground and in which accounts, which states are important to us? Do we need to have an IDN team, an integrated delivery network, provider health system, team? What about a person focused on hospitals and health systems? Is this going to be something that is inpatient or is it more outpatient? That’ll dictate who we need where. Again, data and insights will drive and determine the types of people that we need in each area.
The other thing to think about is payer and channel mix as we think about the who and where will your drug be used by patients in every channel? If it’s primarily a Medicare drug, maybe you don’t need a contracting strategy, but if you’re going to have a high percentage of commercial patients, then you better have a contracting strategy, especially in a competitive space. Marketing is another consideration. So think about both market access marketing as well as HCP promotion. And that’s really important when we talk about access because a lot of times in addition to clinical messaging, we want to talk about available access so that that’s not a barrier to prescribing and that typically falls under brand marketing and sales ops depending on how your company’s organized. The research you do in phase two or three can help shape these things here if you’re a smaller company that doesn’t have access to these functions in place.
Or like I said before, if you’re a medium or larger size company, maybe you have these folks in place, you just need to reallocate dollars or people to these capabilities to support the launch brand.
You may also need to understand how to work with GPOs, both on the IDM side, the institution side and the payer GPOs. These payer group purchasing organizations have cropped up in the last few years and while they don’t decide what actually is covered, they don’t make the coverage decisions. That’s still the payer’s P&T committee. They do decide what that contract is going to look like and what you’re required to offer in your contract for them to sign up and make it available for the P&T to decide to cover it or not. A lot of it will depend on the drug or the class that you’re bringing to market. What indication is it in? Are there other products in the class that are subject to GPO scrutiny or subject to IRA? Perhaps you might need to negotiate in a very different way.
Excellent. The last topic that we haven’t touched on very much so far is your manufacturing and distribution strategy. What aspects of this should you be focusing on at this early stage and are there any make or break decisions at this point?
Coming up with a distribution strategy is really important and you want to start thinking about that before phase three because ultimately you have to put a manufacturing and distribution plan in front of the FDA. That’s part of the approval requirements. So to overcome potential market issues, you have to understand what’s happening today and what part of the treatment process you’re changing. Are you going to introduce a new distribution channel? Maybe your product is the first oral in a physician-administered class. How are you going to get your product to the retail pharmacies? Which ones do you need to contract with? Is it only going to be specialty pharmacies? Do the dispensing pharmacies need to handle your product differently? Do the pharmacies need to be certified in that handling? Will that be a thing?
How is your market disruption, your market disrupting distribution going to impact prescribers? Will it be good for them or will it impact their financial situation by taking something that’s profitable, a channel that’s profitable in their buy-in bill away from them and having them send patients to retail pharmacies. They may believe that they’re going to make less money and that could impact their profit. So if you’re going to do that, you need to make sure that you’re educating. Education surrounding the change for every player in the market is really important. And while you don’t need to put that education in front of the FDA, you certainly need to have that education in your PI presentation because you need to put mitigation strategies in place.
We had a client with a gene therapy and they were entering a market where the incumbent products were distributed through a specialty pharmacy. The gene therapy was an infused product given through certified infusion sites, not even all infusion sites could do it. Prescribers were nervous about gene therapy because they were nervous that it wasn’t going to be covered by payers, but more importantly, they were being swayed by the specialty pharmacies to continue to prescribe the injectables stating the injectables were superior to the gene therapy because the specialty pharmacy suddenly wasn’t going to be making any money on this if it was only given through certified infusion sites.
And don’t forget that sometimes payers have required distribution channels and it’s really important to understand that. And are there specialty pharmacies that you need to make sure are part of your distribution network? Knowing this early helps ensure you can put the most effective network in place and it avoids issues down the road. We don’t want to go looking for problems. We want to go making sure that we understand things ahead of time and are planning for them. Another great idea is patient satisfaction surveys can help you understand time to fill how quickly … And these tell us how quickly patients are getting prescriptions and refills and how our distribution plan, and we should think about how our distribution plan can help optimize this. If you’re talking about distributing through specific sites of care like infusion sites, they have to be certified and in order to infuse your product, you have to make sure that you’re going after the same distribution channels, the same clinics, and the same sites that your competitors are getting certified because that’s a distribution network that exists today.
And if you go outside of that, you risk payers not covering it.
That’s so fascinating. So many different strands that you have to connect. So all of this being said, we did to cover a lot today. What are y’all’s final thoughts? What’s the very best advice you have for how pharma companies can make smart access decisions early on in the game?
It’s important for the commercial teams or the market access team who are going to take this drug to market. You need to be involved in what the clinical studies are actually putting together, what the endpoints are, what’s going to come out of those studies. You shouldn’t just get a package at the end of phase three saying, “Here’s your stuff. Good luck with your pie.” That doesn’t work anymore. You should have a say and you should understand what those needs are. So you can stand in front of that team and say, “Here’s what I need in order for us to do well, in order for us to hit the ground running, here’s what we need.” And I know this because I just talked to 25 payers and they’re all active decision makers. I know this because I did an IDN study and I know exactly how to get us put on pathways, but I need something from you in order to make that happen and put it in the PI presentation.
Yeah, totally agree, Carolyn. It’s all about confidence and investing smart in research and data purchases. Think back to that chart we started with where there are all those critical decisions that can make or break the optimization of your asset from both a revenue and a patient impact, which is what we’re all about perspective. So starting early on helps you and your management team move forward knowing what it will take to succeed using data and custom and syndicated research to guide your key decisions. And we at MMIT stand ready to help you think about a discipline approach in phase two and phase three, and we’re ready to help.
Thank you so much to both of you, Sean and Carolyn. I really learned a lot and hopefully our audience members did as well and thank you audience for coming and for being interested. And if you have any questions for Sean and Carolyn, please go ahead and send them our way and we appreciate your time.
