Good morning. Thank you for joining us today. This webinar is the second in this series, so if you haven’t had a chance to watch the recording of the first one, developing your commercial strategy in phases two to three, you can access that recording on the registration page for this webinar. I’m Mary Jo Laffler, the executive editor of Scripp, and I’ll be serving as your moderator today. I’m joined by two market access experts, Jason Rodman, VP of Client Partnership and Carolyn Selly, Solution Consulting Advisor. Today we’ll be focusing on what pharma companies should do to mitigate market access risks in the time period immediately before FDA submission until after your PDUFA date, the pivotal pre-launch period. We’ll be discussing five of the largest risks and what you can do ahead of time to reduce those risks and have a successful fearless launch. So my first question is about the importance of forecasting.
What is the risk of getting your brand’s uptake curve wrong and what happens if uptake is a lot slower than you predicted?
Thanks, Mary Jo. Of course. Happy to field that. And really the first risk of launch that comes to mind is that your brand’s uptake will never reach the peak that you’ve planned. And if your brand doesn’t hit that adoption peak, competitors may capture market share that you can never recover. Everybody knows that payers and PBMs watch that uptake very closely. If adoption is weak, the brand has less leverage in future negotiations. A slow launch suggests that the market, including prescribers and patients, do not see that compelling advantage over existing therapies. Payers may interpret this as a low initial adoption as an indication that the drug is not clinically or economically superior. The approach here is really to have an evidence-based peak uptake, not a hope and a prayer.
Jason, you’re so right.You need to develop a cohesive launch strategy. Think YOLO. You only launch once. If you get it wrong, you’ll be chasing your competition for years. Wouldn’t it be better to have them chasing you? Let’s explore a couple of real world scenarios together. Let’s talk about those blockbuster drugs all of us wish we were on when they launched they would’ve made our careers right. Drugs like Humira, Dupixent, Keytruda. What did they do right? They didn’t become a blockbuster by chance. They understood the market. They knew what payers needed to hear, what providers need to see and what patients needed to know before they launched. They didn’t wait for something to go wrong before addressing the potential problems. They predicted what could go wrong and developed a mitigation plan. They headed off potential barriers by addressing the unspoken concerns out of the gate. Even if you’re not predicted to be the next blockbuster drug, by following in the footsteps of these products, by knowing and predicting all of your unknowns, you will be able to maximize your market potential.
If it’s your first brand on the market, there may be an overwhelming amount of unknowns. Your organization is going to be drinking your own Kool-Aid. Everyone’s going to feel great about your product that you’re bringing to market, but your job is to predict and illuminate the potential barriers for your organization so that the effects of that Kool-Aid are normalized. I always recommend first launch organizations build their launch strategy with a market access consulting firm. For instance, the Dedham Group, my personal favorite consulting group. These experts work alongside us at MMIT every day. They helped those blockbuster drugs launch. They’ll be able to advise you on how to navigate and mitigate the barriers to success and help you know the unknowns of your launch. First and foremost, don’t fall into the trap of overestimating your opportunity. You need to be hyper aware of market conditions when you launch.
What’s the competitive landscape? What’s the opportunity in the market? What is your product’s differentiator? How does your brand stack up against the other patient options?
Yes,
Even off-label options. Look at recently launched drugs as analogs. MMIT has a strategic launch report solution where we can trangulate what happened with drug launches like yours in payer policies, in the real world using claims and EMR data, seeing what payers responded to and what fell flat during their PI presentations. We even look at what the Wall Street analyst community predicted for the analogs and whether or not their predictions played out. Use the analog history to identify what they did right and what went wrong and how they course corrected or not to help determine the likely trajectory of uptake during your drug’s launch.
Okay. So how difficult is it to set your brand’s value propositions accurately and what happens if you get it wrong?
That’s a great question. It is so easy to overestimate your brand’s value. As Carolyn mentioned, your team believes in this brand and all it can do, but you have to take the time to think about the payer perspective. So hopefully at this point you’ve done research to better understand your product differentiators in time to get the clinical data on them. Pharma does tend to assume that they know how payers will respond to an obvious differentiator like a novel mechanism of action or a new route of administration. But without that research, you don’t know for sure. Brands need to understand the existing payer coverage and perceived value of a new formulation in terms of fewer side effects, et cetera, whatever those current pain points are in this indication.
Jason, you said it. I mean, we all know it’s all too easy to drink your own Kool-Aid. I mean, your drug is your baby, but even if you’re the first drug in a market, you’re still going up against whatever the standard of care is and that’s what doctors want to prescribe. Doctors are treating the illness with something today. Know what it is and how well it works. This means looking at real-world data like claims, EMR notes, and perhaps even lab data to see what’s happening today. Look at that entire patient journey. Analyze access based on the four Ps, payer, physicians, patients, and pharmacy. Examine what’s happening, find the trends. Identify the current standard of care, what’s being approved, what’s being prescribed. Look at those physician notes to see if there’s an unmet need for your potential patients. How are you going to address those gaps in care?
How can you identify what will happen in a payer P&T meeting when your product is discussed? Essentially, you need to know what the argument will be from the payer side and be able to mitigate them with planned evidence-based objection handling. One of the solutions that we have that I really love is our simulated P&T session. We bring real-world payer decision makers or IDNs if your drug is administered in inpatient. We bring them together and let you watch a virtual P&T session. Blinded, of course. You’ll learn how payers will view your drug at launch when you’re not around to correct their perception. That’s invaluable information. If you can understand what the objections to patient access might be, you can handle them upfront in your PI presentations long before that P&T meeting is even scheduled. Will you have to educate payers? Will you have to start a grassroots movement?
For grassroots, the brand that immediately comes to mind is Meibo. We’ve all seen the commercials. The dry eye market is crowded, very crowded with inexpensive OTC products. Why would a payer cover a new prescription brand? Bausch and Lomb created a wave of change and ensured that the payer, the patients, the prescribers, and the pharmacies recognize their differentiation and benefit. What about launching a pharmacy benefit product into a medical benefit space? Suddenly your target prescriber may be making less money because they’re not administering the product. How are you going to persuade a prescriber to change? You have to know the right catalyst and transform their behavior before that prescriber has an opportunity to do something else.
That’s a fantastic point, Carolyn, because this is really where you have to look at access as a quality perspective. If you get this wrong, you’re going to be finding out very, very quickly from your market and from your uptake. Access may be in place, but it could be terrible, too restrictive, too many hurdles for patients to actually obtain the therapy that they need to get access to. You do need to know what is relevant to those payers’ patient populations. Is it improving the overall cost of care, having more options than the current standard of care, or having really well-thought-out PAPS patient assistance programs in place? A lot of the solutions that MMIT has address some of these questions such as rapid response, rapid IDIs, or Engage. These allow pharma manufacturers and brands to directly survey the landscape on what and how they are approaching some of these open questions.
Thanks. So once you’ve gotten through that, how do you make sure that you are getting the most out of your contracts with payers? When do you offer a contract and when do you not?
That’s a great question. So those are really around understanding where and how your contracting strategy is put into place. If that contracting strategy is off, your payer uptake will not be as expected. When you underestimate the amount you have to spend on contracting, it can have a tremendously negative impact on your gross to net. So the question is, are you missing potential market share that could be impacted by contracting or are you overpaying for not enough benefit?
Those are great questions. Even though you’ve already priced your product at this point, it’s the contracting impact that’s going to have that biggest hit on gross to net. If you priced your brand too low, you may not need to contract, but you’ve probably left money on the table. And some payers may not even cover your product without a rebate, which means you may have to go even lower. But if you priced it too high, you’re likely facing rebate across the board. While I would always argue higher is better than lower, finding the right price is by far the best thing you can do. Before this point, and if you watched the earlier video, you should have done your research on payer expectations. Do they need some type of contract to at least cover your drug? Are they willing to put your drug in a preferred position?
What would it take to get to that preferred position? In some cases, you might need to pay for access that is written to the label and not restrictive, blocking your potential patient’s access to therapy. If most of your coverage is PBM based, because it’s retail pharmacy, you’ll likely have to pay to play. You might want to set your price slightly higher so you can offer a rebate across the board. As you get closer to launch, you need to lock in what you’re willing to do in contracting and start planning your conversations with payers and PBMs around contracting and rebating. Here is where you may want to work with a consulting partner. Again, I’m going to suggest the Deham Group, they do this every single day. They help you understand what your competition is doing and how you need to negotiate for access. You know, Jason, most manufacturers cannot possibly have the manpower anymore in account management to hit all 720 payers out of the gate.
Talk to us about how you would build a strategic plan of attack and hit the ground running with your account managers. How do you decide who to talk to and
When?That is a fantastic question. So let’s talk a little bit around payer segmentation. Most of everybody I would hope has heard this term, but let’s really dive in a bit to understand what is critical to figure out which payers are most important for your brand. Where is the patient potential? What do most payers need from you to cover to your label? So basically, as we look at this, you do need to know what the value of contracting is for each payer segment. How much do I need to pay for label access? Is preferred to access just a higher rebate. It is important to understand how they are currently managing access within the space that you’re launching into. And this is where MMIT’s policy and restriction data really comes in helpful to understand what’s in place today. What are the restrictions and what is the utilization management criteria amongst other therapies in the market that you’re facing?
What’s the geographic distribution of payer and PBM lives? Do you know which payers have most of your patient population? Conversely, are there areas of the country with better access than others and why? All of these answers inform your strategy and they allow you to see for payers and PBMs who will receive the largest return on investment. So figure out who you need to talk to now. Almost all pharma companies have downsized their account management teams at this point so you already have likely a smaller team than you would had you launched five, 10 years ago. And there are more payers now, so prioritization is really key. Prioritize those payers where you think you might have a restrictive policy. It’s so much harder to change that policy than to get an unrestricted policy written right out of the gate.
Sure. I think that does sort of lead us to how can a pharma team prepare for the unexpected issues that might come their way?
That’s a great question. There’s so much that can go wrong, but they can all really be categorized into some likely and kind of predictable buckets and prepared for in advance.
While nobody can be fully prepared for an unexpected issue, you can certainly be prepared enough that you can quickly pivot to adjust and you should already have a mitigation strategy in your bag of tricks. Let’s take label misalignments, for example. You have no control over that. Maybe your label was intended to be X, but you got Y. If the label is narrower than you’ve expected, you’ll need to quickly understand how payers are going to regard this change. Are they going to be willing to cover your brand off label or do they need to see more data to do that? How does the new label change the number of patients that are now fit for your drug and what insurance they might be on? Maybe your label now has a required diagnostic test that you didn’t prepare for, or your drug will be subject to a REMS program.
What do you need to do to educate providers and payers? How well is the test covered? How burdensome is the REMS program?
That’s a great question because this is where MMIT’s rapid response programs allow you to have these very direct, very specific, very purpose-fit discussions and market research with the market that you’re looking to launch into. These really help to validate your assumptions and have a lot more clarity on how the market is responding to them specifically around new products that have come to market since you last looked, some of the new laws and regulations, some of the very macro events that are helping to shape the coverage landscape and payer and provider behavior and those uncontrollable macro events, nobody has planned or anticipated them. So let’s understand how they’re being impacted by regulation, how they’re being impacted by shifting market dynamics to ensure that your launch can be as successful as possible. Expect that your competitors will not execute perfectly and most importantly, be ready to capitalize when they don’t.
I love that, Jason. Let’s talk about underestimating the demand for your product. More demand you think may be good, but not if you failed to anticipate it. Take the RSV market. They didn’t make enough in the very beginning. What happens when distribution fails and there isn’t enough product to go around? Doctors stop prescribing. They stop requesting it because they can’t get it and they know they can’t get it. This particular manufacturer had a three-month period where they were playing catch-up and guess what happened next? Shortly after a competitor’s product was approved and you can bet they capitalized on that previous disruption by talking about it with every payer they saw. Another example of product shortages that could have been anticipated, weight loss medications. When Wegovy faced shortages, it wasn’t hard to anticipate that doubling up on Ozempic was going to happen next. The Wegovy shortage caused a ripple effect in the diabetes market.
The good news is that Novo Nordisk already had a mitigation strategy in place and they were able to recover really quickly.
Thanks. Certainly with Script, we cover a lot of brand launches and approvals and see firsthand how many companies seem to be taken by surprise by various issues at launch. Some of the things you’ve mentioned are really just the sense that they’re scrambling to make up lost round. So really, why are so many launches chaotic?
I think for any of us that have been through lots of drug launches over the years, that chaos and that kind of unexpected launch timeline, this is a big risk for so many launches. For whatever reason, manufacturers seem to get caught blindsided when they get an approval and it’s like, let’s hurry up and scramble. But honestly, it really shouldn’t be a scramble. We all know that we have to do our prep work. We do have to understand our market and understand our vendors. That’s kind of table stakes at this point. What is oftentimes not thought about with as much rigor is who are you working with? Who are your partners? How are you going to activate them? How are you going to leverage them to the best of their ability? And at what point? How are you going to truly activate and operationalize that launch?
Yeah, you’re so right, Jason. I can’t say this enough. Always remember YOLO, you only launch once. You never get a second chance at the first year of launch. Don’t show up late to your own party. If you engage your sales reps too late, you might run into problems. They’re not equipped to promote your brand. We had a client who decided not to implement one of our promotional tools, our Formtrack and Veeva, natively integrated into Veeva all ad until six months after lunch because they just knew they weren’t going to get policies before then. But then three days after launch, they got three critical contracts in place. The sales reps had no way of detailing the wins with their HCP accounts. That was a huge hit and they could have made up so much of their launch strategy by that point. If you engage payers too late and your PI presentation doesn’t address the real issues, then you’re not going to get the coverage that you’re looking for.
If you engage physicians too late, if they don’t have information on the value prop and the drug and the unmet need and who their patient population is, they don’t know when to prescribe it. Doctors don’t just automatically prescribe new drugs. In fact, they do just the opposite. They usually stick with the standard of care and then do a lot of research before they prescribe even a new drug for even the very first time. If you can mitigate that need for them to do a ton of research by handing them all of the research and talking to them about it and telling them when they can prescribe it, then you’ve beaten the game and you’ll start generating that demand much earlier. Sometimes access is grassroots driven, especially in the rare disease space. You have to be doing enough physician engagement ahead of time that doctors are excited and enthusiastic about your launch.
Keep engaging with physicians because that makes the momentum happen. Our drug is coming. We’ve submitted. We’re getting our PDUFA date. It’ll be ready to prescribe by this date. And guess what? Here are all the benefits of our drug and why it’s worth the wait. For physicians, early disease state education is more important than pharma companies realize, especially if your therapy is a disruptor. You might have new physicians that have never thought about this disease state before being able to prescribe your drug. You need the physicians from your trials or other key opinion leaders to be advocates for your brand on networks, public speaking engagements, even just prescribing for their patients so payers are consistently seeing the requests. That way, a physician is ready to prescribe it and can generate the demand that the payer needs to put it on formulary to write a policy for it, especially in a rare disease space because you’re going to get payers who say, “I’m not going to write a policy for it until I see demand.” For first to market drugs, the only way to become the standard of care is to maximize prescribing before your competitors come out.
So don’t rest on your laurels just because you’re first to launch the others are coming.
That really sounds like very good advice and you guys have shared a lot of great information today, but I wanted to check sort of all this being said, what are your final thoughts if you want to share? What’s the best advice you have for pharma companies heading into this pre-launch period?
Absolutely. Yeah. I think there are a couple of key things that are most important for me thinking through these. It’s really how best do pharma companies design and anticipate the uncertainty. No launch is going to be perfect, but we have so many great analogs of when things do go on a path that’s not quite planned or the unexpected macro events happen where the pharma manufacturers have risen to the occasion and they have truly separated themselves from their competition because they have been responsive and engaging when uncertainty happens. At the end of the day, you aren’t alone. You have so many vendors and partners that you can lean on, not only the Denim Group, but within MMIT and the solutions that we have to help give you the best chance and the best strategy to ensure that your launch is ready for the uncertainty that you’re going to face.
The most important thing for you to remember is YOLO, yes, because I said that five times, but that market inertia is real. It doesn’t matter what treatment you’re launching, it’s a change, a disruption to the status quo and it’s up to you to find and use the right catalyst. By knowing everything there is to know about your market today, what’s happening, what’s missing, by understanding who’s going to benefit the most from your differentiation and making sure they’re ready to be your agent of change by educating whoever needs to be educated and persuading those in charge of your patient’s treatment decisions, you can set yourself up for success and maximize your launch, but don’t forget to measure your success every step of the way. Don’t assume anything is working. If your strategy isn’t maximizing your potential, you need to have a pivot strategy at the ready to deploy without skipping a beat.
I’m going to say it again because I want to really say this a hundred times during this presentation so you remember you only launch once. If you remember nothing else from this, think YOLO. Yo only launch once. Set yourself up to be the front runner rather than having to chase your competition.
Thanks. Good advice is worth hearing over and over again. And I want to thank you guys both for sharing your insight and thank everyone for joining us today. If you have any questions, please send them our wives contact information here and thank you very much.
