Early planning key to successful access and product launch – transcript

Mike: Hello everyone. I’m Mike Ward and welcome to Conversations in Healthcare, a video series brought to you by DRG part of Clarivate. In this series, we are speaking to opinion leaders to explore the challenges industry faces when trying to develop treatments to provide the most benefit to patients.

It’s well established that the cost of development is rising, and yet the ability to pay for new treatments is more constrained. A significant proportion of approved treatments that are shown to be safe and effective, actually still fail to fulfill their anticipated potential. The most common reasons for missing these expectations are limited market access, under estimating market needs, and suboptimal product differentiation. While there are externalities which contribute to this that companies have no control over, thorough planning and disciplined product launch execution can mitigate the risks of commercial underperformance.

To discuss these product challenges and potential solutions, I’m delighted to be joined by my DRG colleague, Alison Kneen. Alison is a Senior Vice President at DRG Abacus part of Clarivate, and the not for profit center of innovation and regulatory sites. She’s responsible for Global Market Access and regulatory policy strategies and solutions. Alison, I hope you and those you care about are keeping well. Thanks very so much for joining me.

Alison: Thank you, Mike. I’m certainly delighted to be here and everybody keeping well, as I hope our listeners are, as well.

Mike: Great, thanks very much. Alison, as we know, within the life sciences ecosystem, no company, not even the largest multinationals has all the answers when it comes to successfully launching a medicine. What are the most common challenges biotech and pharma companies come to you with for help?

Alison: Absolutely. Good question, Mike. Really, it’s a very transient and fast changing landscape out there. Most commonly, the challenges that our clients have are basically, how do we know what’s happening in the marketplace? What do I need to do? Most commonly, really, it’s about what is the evidence that I actually need as a company to get over the national reimbursement hurdles, and how do you communicate the value of your product, whatever it is, or your innovation? Who are the stakeholders involved and the timelines, etc.? That’s where we’ll typically look at a product and say, “What’s happening with your evidence?”

Quite often, we do evidence gap analysis, where we’ll say: this is what the standard is for your in-focus country that you’re focusing on. This is what the requirements are. Here’s where your evidence stacks up or perhaps there may be areas that are slightly weaker.” We will then advise the client on what they need to do, to actually overcome that hurdle. That would be one of the bits on the evidence side. Then of course, they’ve already alluded to it–it’s all about how do you communicate once you’ve got that evidence and what do you do to best capture it?

What we typically do is we will make our global access advisory team who will actually map out all of the timelines and the different stages, of what a product or a client needs to do to actually get into that marketplace. We typically call that our roadmap to access.

Mike: Looking more specifically at some of the challenges that you just mentioned, in your experience, what are the key questions that companies need to ask themselves, to ensure that they’re actually gathering the right amount of evidence, either to demonstrate that their therapeutic solution will be considered cost effective, or for example, inform a go/no-go decision in that clinical development.

Alison: It’s very much about understanding the landscape in that market that they’re operating within. Making sure that they’re really up to date with the policies and the methodologies of how their product is going to be assessed. That’s all about really understanding how the health technology assessments at country level, will operate and what methodologies those regulators are actually using, because the scope is changing. I’ll give you an example of that, Mike, if I may.

With digital therapeutics, for example, if we go to the U.S. market, highly developed, they’ve got their methodologies and process set out for looking at these products coming into the marketplace. However, if we move across to Europe, within the EU5, they started to develop the methodologies of how they will assess these products and new innovations coming to market. But they’re not all through federal law yet. The challenge for the client is understanding, number one, what the methodologies are and that they’ve got the right evidence to support how their product will be assessed, but also really understanding the timing as well of that.

That’s just one bit on the landscape on the environment side of things. If we focus in even further on pharmaceuticals, for example. I mean, in the last two years, there’s been a big shift to lots of rare and very specialist diseases coming into the marketplace. Quite often that throws up a challenge, because if you’re having to get your evidence together to get your product assessed, you really need to understand what is the established standard of care. That’s really one of the first steps, when it comes to one of the rare and specialist diseases, because on that standard of care, that’s the basis of how we actually would then go about building the health economic model.

The start of really saying, okay, with the evidence that we’ve got, how are these patients normally going through the health care system at country level? What are the challenges? Where are the lever points? Because that’s how you start to build your evidence and your health economic argument, which is really crucial to get into the marketplace. That would be one of the first areas that we look at. We have a very specialist health economic team that do that.

One of the other areas is looking at the other measures. For example, our clinical outcomes assessment team, very often are having to develop patient related outcome measures, as a standard that they can be measured against, because that doesn’t exist for that product because it is very rare and specialized. With a cracking team, as you probably are aware, that actually specialize in this and really can help companies shape where they want to be, and make sure that their product is actually being seen in the right light, and that they’re very early on the product life cycle. Really early like phase one, when the clinical trials are still going on, that they’re starting to actually collect that right data.

What we’ll always advise clients is, engage early. If you’re going to use a consultancy, start planning really early and even if you’re not using a consultancy in the house, in the client’s own metrics launch team, within the pharma company, start as early as you can planning because it can never be too early. Keep re-evaluating the market as you go, because the landscape and the policy and regulation we’ve just sort of discussed and talked about, keeps changing. You need to make sure that you’re entering the market at the right time, with the right information so that you can get the right assessment out the other end.

Mike: You highlighted there the ways that you and your team can help. Can you give us some specific examples of what you’ve done instead of highlighting actually what the outcomes were of the assistance?

Alison: I briefly mentioned the clinical outcome assessment team. We actually did a really interesting piece of work–actually, only a couple of months ago–where we helped define a patient-related outcome measure for a blue chip pharma company. It was a disease area where there hasn’t been a lot of work. There wasn’t really a lot of support for it, and it wasn’t really classified as a high unmet need. But for that patient emotionally, because we’re looking at alopecia areata, that really is a big issue if you’re a patient. We were able to work in partnership with the pharma client, to develop what is now seen as an internationally recognized patient-related outcome measure. That’s one of the things that that particular team has done.

We have many instances of things. If we look at some more of the traditional type things that we do as well, where you’re looking at reimbursement and what will the reimbursement pathway be–this was actually quite an interesting one. I got called into the backend of a meeting as happens to all of us every now and again, and I overheard something that I thought, “oh,” ears picked up. The company actually had told all of their stakeholders internally and externally, because they were just about to be acquired by a larger pharmaceutical company. They had communicated that they had an ultra-orphan drug coming through, which was going to go through mice’s highly specialized technology route.

Really, the communication to the internal and external stakeholders, because this was then in the public domain, and was fueling the shareholder price of the company. That was then being seen as a highly innovative product. Really, prime for investing. Unfortunately for them, they had misunderstood that there was a difference between orphan drug status and ultra-orphan, and also that the route to reimbursement which has very strict criteria for a highly specialized technology. They didn’t actually meet the criteria. They wouldn’t be going down that route, because it had just recently changed. Again, coming back to really understand the landscape and the market and the timing.

What we were able to do with that was we were able to do quite a bit of analysis, because obviously, we specialize on regulatory both in the consulting arm of the business that I represent, and also the not-for-profit side of the business. We’re able to do a bit of analysis and actually say, it’s actually not going to make a difference on how your product is reimbursed. This has recently changed. We were able to work out a very robust communication plan for them. The outcome was that everybody won. The drug was reimbursed, they got acquired by the larger drug company, nobody lost face, and the share price maintained. That was a win for all parties. That’s quite often what it’s about. It’s all tradeoffs and making sure that all stakeholders win because everybody wants the best decision.

Mike: Alison, you’ve mentioned the Center of Innovation Regulatory Science (CIRS), a couple of times. Could you explain–it’s a not for profit within Clarivate. Would you mind explaining what it does and how it kind of gives you that view or that transparency on what sort of various regulatory stakeholders are thinking?

Alison: Yeah, absolutely. Happy to do so. Well, as you say, this is our not-for-profit side of the organization. This is where we work. We have grants for example coming in from the Bill-Melinda Gates Foundation, etc. This gives us the opportunity to use our experts. And it is a bespoke group of experts that we have within CIRS that don’t work on normal consulting projects. This allows us to work very closely with the global regulators. All of the HTA (Health Technology Assessment) bodies, for example, are pretty much represented throughout the world, within the CIRS group, and are actually members of that group.

What it’s really about is the academics coming around the table, and really looking at: Have they got the best methodologies? Are the processes as robust as they can be to make sure that each country is being able to help their patients and their constituents get the best product at the best time at the right price? Value for every sector of the healthcare system.

We’ll work very much hand in hand, but it also gives us the opportunity to work in less established markets as well. For example, at the moment, we’re doing a large piece of work looking at the emerging markets, and how we can actually help them through the CIRS group, to get the methodologies and processes right, so that they can assess product pharmaceuticals, digital solutions, devices, and medical devices in the marketplace. If they’re doing that equitably for their people in that respective country.

For us, it gives us a wonderful insight as well. It keeps us sharp and at the top of our game. We can see and understand what the regulators are thinking, before it very much comes into policy. The other bit of what’s really important with CIRS and what they do, is that they’re not only to look at what the methodologies are at this point in time and analyze is it being successful, or is this being super-duper and the rest need to engage that way? But it’s also about being able to be ahead of the chase and see what’s happening in the market and advise strategically, so that governments can shift their healthcare policies at the best effect.

Mike: Earlier on, you talked about how at a very early stage, you were helping businesses develop a strategy. I just wonder, at what point in an asset’s development timeline should companies start evaluating this potential value proposition, and which stakeholders should they be engaging with at that point?

Alison: Well, we’d say as early as possible. Basically, from phase one, when you’re starting and you’ve got your clinical data coming through, that’s when we would start engaging at the very early stage on the global value dossiers, where we’re looking at the clinical evidence. We have a large team of scientific medical writers, all who have PhDs. Actually, I think we’re one of the most robustly qualified medical writing teams actually within consultancy. We will look in very fine detail at that evidence, as it exists at that point in time, and start pulling out what we would call, “the aspirational value messages,” for that product or innovation.

Of course, as you get more clinical information becoming available prior to launch, you will have to tweak it and modify. Then, we’ll take that early information, and then we will test it with key stakeholders and decision makers. We have tests with clinicians, we have tests with national payors and local payors. We may even, on occasion, test with patient organizations as well, to make sure that we’re getting what are the true unmet needs from all of the stakeholder mix, that we’ll be making the decisions on moving forward. Then, of course, the closer you get to market, you finalize your global value dossier for your affiliates. You test again, and quite often we’ll run workshops and stuff with the internal stakeholders and the affiliates, to make sure in case we have to tweak the value messages, particularly for a country or affiliate area.

Mike: What are the best ways for companies to communicate, say for example, that value to the various stakeholders that you’ve just identified? What tools are available for people?

Alison: Well, we’ve got a plethora of tools! It’s like, where do I start and where do I finish? I think the secret always in communication is: keep it simple. Keep the messages as simple as possible. We’ve all got the Marketing background, where we know if it’s visual, we’ll retain X amount. If you hear it, it’s another–you know, the whole bit. We’ve got lots of different methods to use in different areas. We do a lot of iPad models, so we’ll actually put health economic models onto iPads, so that we can communicate–this is what the model actually shows and here are the key messages from that. [Text Wrapping Break][Text Wrapping Break]That’s one way to communicate very simply. We can do it not only just with health economic models, but sometimes also these tools can be used to communicate value, for example, in tenders. Maybe in an area where there’s national tenders, like say, with blood disorders, so affiliate contracts that lasts for two to three years. Companies will often need to be able to go through a lot of complex data and cost calculators, to be able to show the benefits of the drug from the clinical studies, but also the benefits if you use so much of this treatment and so much of that treatment, and what would the financial outcome be for the national body making that assessment?

We do all the traditional things as well, of course, like flash cards and leave pieces, smart decks as well, which has become actually, in this awful time that we’re living in at this point in time, with the pandemic, we’re having highly visual and very creatively designed smart decks. When you’re having to connect over the internet, rather than face-to-face, it is becoming ever more important. We’ve got an absolutely top-notch design team in-house that are very, very skilled at doing that. In fact, one of our clients, they don’t actually allow us to put any slide decks out for any work that we do for them, unless it’s gone through our design team. That’s how popular they are. They’re certainly in big demand.

Mike: In some of the examples that you’ve shared, there clearly is a lot of interaction. You said, how you have been in meetings, the relationship with these decks, etc. What does engagement between your team and clients look like? Are these all discrete, one-off arrangements or are there off-the-shelf opportunities?

Alison: Well, on the consulting side, we do very much bespoke work for clients–everything is totally bespoke to that client. Because each client will have a particular need and something that they want particular to their product, so that’s very bespoke. But having said that, within the wider DRG Clarivate, we also have an awful lot of product solutions as well, which are off-the-shelf. We’re quite well renowned for some of these excellent insight reports that we have, etc. There are lots of other products as well. [Text Wrapping Break][Text Wrapping Break]But on the consulting side, which I look after, it is totally bespoke. What we do is, to ensure that we get the best possible people and the best possible solution for that client, we work in a matrix structure, which is very similar to our clients, generally, but we have very specialist teams. We have a unique and specialist health economic team, a health technology appraisal team, a systematic review team, a global access advisory team, and a valued communication team–which will include programmers to help us with platforms, in doing the iPad models, etc., and also, our quite famous design team. We have these specialist teams which can all input into the particular requirements for a project for a client.

What we do is we look initially when a client comes to us, whether it be directly because it’s repeat business–because we do a lot of repeat business–or it may be through an RFP, for someone that we haven’t worked with before. We will allocate for each project a project lead: a strategic advisor, who’s an absolute expert in that area that they want to look at, whether it be launch excellence, or it may be a therapy specialist for a very rare disease that we need to put on to it.[Text Wrapping Break][Text Wrapping Break]And each project also has a project manager. The project manager is quite a key role. What that does for the client, it means that you’ve got a core team, who are always there as a point of contact. The project manager is very much like the facilitator, to join all of these specialisms together to give the bespoke solution. They’re almost like a conductor of an orchestra. You bring in your violins when you need–which would be maybe your health economist, to do your model. You will then bring in your global value communication section, when you need to do your GVD (global value dossiers), to assist in communicating the value etc. It goes on like that.

That works incredibly well for us, because one of the key comments we’ve had back from clients, is they like the strategic advisors on the project, because the strategic advisor will spar with them quite often and say; okay, so you’re considering doing this, but really have you considered what the outcome may be, and should you perhaps look at it from this view or another view? We get really good feedback on that. It means that you’re getting as a client, a true expert rather than a generalist consultant, to give you the solution. That is important, because as we discussed earlier, you really need to be at the top of your game, because it’s a very fast-moving landscape, and especially on the CTOR side, where it’s very technical, methodology driven, etc. You’ve really got to be up to date.

Mike: As a final question, that increased focus on your evidence-based value, that therapeutic approach you now have to show. It’s still a relatively new phenomenon. How quickly are these value assessment strategies evolving?

Alison: Very quick, very quickly indeed. I’ve been in market access for a long time. You can probably tell by the white hair. I think for about 30 to 34 years now. At market access, I was actually in the first team that was ever conceived market access in the days of Astra, which then became AstraZeneca, because I came in from the pharmaceutical side into consulting. My goodness. All I can say is the changes had just been, market access as a relatively new phenomenon in the last 10-15 years, but my goodness, how things changed. But having said that, while methodologies and things changed, the core bits of market access are still there. They just sometimes reinvent them and call them something different.

You might get a little bit of change in terminology, but the core bit at the heart: it’s getting value, and making sure the value of your product meets what the policies are in the methodologies of that company and addresses what the unmet need is for the patient. What gets us out of bed in the morning, Mike, what really gets me out of bed in the morning is making that difference, and making sure that I can get the best possible solution to the clients, so that a patient can get the treatment that they need. That for me is what it’s all about.

Mike: Alison, thanks so much for taking the time to talk to us today. The insights that you were sharing there around product launch, market assessment, etc.–they’re going to resonate with a lot of our listeners. They’re going to find that very, very valuable. [Text Wrapping Break][Text Wrapping Break]If after listening to this broadcast, you’d like to listen to future Conversations in Healthcare, follow our LinkedIn page because there we will be posting alerts to future episode releases. In closing, I’d like to thank Alison again for joining us, and thank all our listeners for tuning in. Until next time, stay safe and healthy. I’m Mike Ward. I’ll see you in the next episode.