"Europe's Access Dilemma" (3/5) - MFN Is Already Changing Pharma Launch Strategy. Here’s How to Prepare.

0:00 Welcome to PharmaMinds, the media for committed leaders in pharma and healthcare. Here we take the time to explore the ideas, strategies and people shaping the future of our industry. If you'd like to understand before the rest, subscribe now and hit the bell to stay ahead. The traditional launch sequence we had of starting with US, Germany, UK and thinking of other countries. That's something to be rethought. Some of the bigger American pharma companies, for instance, that were in holding pattern on some of the launch assets in Europe. And certainty is here to stay. And it's really time to think scenario planning, think of flexible go-to-market model, and think cross-functionally preparing early days.

0:49 Because this is not one single person exercise. This episode is part of a special series I'm releasing this autumn on MFN pricing and access to innovation in Europe. Five short episodes and five different perspectives. And the goal of this series is simple, say out loud what nobody wants to say publicly because MFN is something a bit further than a pricing debate. It's a mile for Europe to see itself in the global race for medical innovation. and what happens to patients when decisions are not made.

1:29 And for this episode, I wanted a voice from the consulting world, someone who works across the full spectrum from small biotechs to big pharma, rare disease and blockbusters, and someone who can speak freely without representing any single lab. That's why today I am with Lauren Nath de Touris. She's a partner at CliveAid, but she has also 20... more than 20 years background in pharma between industry, Novartis in Australia, UCB, Keira Kering, and strategic consulting. She now advises companies on the commercial impact of global pricing policies and the launch sequencing.

2:10 Exactly the kind of grounded and transversal perspective this series needs. Hello, Laura. Hi, morning, Nathalie. Very nice to be here with you. I'm very happy to have concrete and practical feedback on what the temperature in different pharma companies on this topic, on this hot topic. And maybe we can start with this. In your day-to-day right now, how is NFN? Is it really the main issue or is it something, another topic getting too much attention. Yeah, it's been clearly a topic that is top of mind for a lot of leaders in pharma.

2:57 As you mentioned, from biotech to big pharma on a spectrum of therapeutic area, from global to local. Just recently, we had a roundtable with a set of pharma leaders talking about early commercialization. And when we asked what would be the next topic they want to look at, Unanimously, they said the MFN impact on the commercial model. And it's a very cross-functional impact. We can see from the top leader of the company to the asset lead, to the country lead on even medical and obviously market access.

3:38 And it's a change that is starting and we can see it's here to stay. Then concretely, for a team preparing... Maybe a European launch today. What does it change in the plan? It changes the status quo that we may have had before, where we were considering launches in the US, in Europe and in other countries. Needing, it's important to have a global strategy, a global alignment on the access and pricing philosophy. However, there was some less. connection between the US pricing and the ex-US pricing to some extent.

4:24 Now it's clearly more linked with the MFN that is this set of reforms that has been announced by President Trump last year and that has a breadth of impact that is still being worked out. And so there is real connection now we will see between the US. and the pricing that will be looked at in Europe and also beyond Europe. And that is reviewing how we launch. I need to consider early on what are the impacts across countries and cross-functionally. So we have leaders that are as early as those phase one, phase two assets, asking what MFAT impact for me.

5:10 Leaders that are also looking at a new indication. What does it impact for me? Launches that are being rethought. So that has very concrete implications already in the launch ongoing of future assets that are due to launch in the coming years. Does that concern everyone? Because you mentioned biotech who told you rare disease, MFN doesn't apply to us. What do you think about this? What do you tell them? Yeah, so there is a spectrum of thinking about MFN. Does it apply for me or not? Lots of questioning. Some people think they may avoid it.

5:51 Realities need to prepare for it and really go deep in the thinking. Even some rare disease assets may be impacted depending on the type of MFN. needs they cover depending on the patient population they cover and the pricing that we are looking at and the revenue generated. So it's difficult to have a cookie cutter approach. The traditional launch sequence we had of starting with US, Germany, UK and thinking of other countries, that's something to be rethought. And we can't just think, oh, because I mean, that type of indication.

6:33 I will be able to avoid it. I really need to go to the drawing board and see what are the implications for preparing launch, for thinking of the commercial opportunity, commercial impact, and how we need to prepare cross-functionally for it. I understand it's going beyond understanding the risks. And what can the commercial teams can do to prepare? Yeah, concretely, there is a need to really plan No. from early days. I really think cross-functional is not just an access exercise. I really need to think early days and it will vary depending if you have one asset or a portfolio of assets.

7:17 Understanding the MFN depending on the... and maintaining or covering the target population that you are looking at. Looking at the countries that you are looking to launch in. And depending on this setup, having a refined understanding, it will be different. If you are looking for a broad-based indication with more limited additional efficacy, there will be more challenges. We need to think early days how we'll be approaching the access and pricing. to the other extent of more rare disease indication in a pediatric setup, where there will be much more value that can be brought to some of those patients when there is not already a molecule in the place.

8:14 And so there will be a need really to customize the thinking on how we think of the value we bring to. customer but also the launch sequencing. From your side, how did you organize your thinking around this? I think maybe you use what your customers or your people on the field say but also how you provide your advice on this? Yeah, two things. I would say the first thing is that the uncertainty of those reforms going to create is here to stay and so it's important. to prepare for different scenarios of the impact of MFN. There is still a range of implications we need to understand, and depending on how, what will be the impact of some of the voluntary unilateral agreements, the impact on Medicaid and Medicare as well, understanding also how the reference pricing will be done from the list of net price perspective.

9:23 And so those scenario planning needs to anchor really the thinking of what is the range of opportunities that we need to prepare for. That's the first thing. And that can mean different things if I'm a biotech or a big pharma. It can mean looking at understanding the impact across my portfolio and identifying where I focus more, where I take. I need to balance my risk and also where I need maybe to take a decision in a gated manner to preserve my resources or maximize the investment.

10:04 That's one aspect. A second aspect when going more into... The preparation of the commercialization, thinking of patient, customer and thinking of go-to-market, is being very targeted, identifying where we want to engage with patients and customers from a patient perspective, which patient population really we are targeting and where we will bring the most value that really can support. having a more differentiated pricing and access negotiation and discussion.

10:47 The second is also in terms of customer, having a really refined understanding of the key customer that we need to interact with from the center of excellence to those KOL so that we can really focus the effort on them. And then in terms of how to win from a go-to-market perspective, Really this idea of bringing more flexibility in how we engage with customers, thinking more engaging from early day, focusing on a more high-touch model with those key customers, maybe more omni-channel ways for the broader base. And also thinking how to go incrementally, how to have more flexible resourcing with the customer-facing organization.

11:37 when thinking geographic expansion. So if I'm a biotech in the US, for instance, I'm going X-rays, do I go myself? Do I think of a partner? Or do I go solo in some of the key country and consider a partner or a contracting organization in some of the smaller geography? And then having the opportunity to really invest as indication of being... a grid or key milestone are being achieved as well. So there is a preservation of flexibility in how we invest.

12:17 Okay, something I've heard also is, it's maybe related to the flexibility, but it's something different than focusing on resources. It's seeing launches globally as the Le Mans race. and not having first-range countries, second-range countries, and third-range countries, but putting all the countries at the same level and starting all together because we need all countries to contribute to the global products. And we definitely need also to give chance to small contributions. Is it something you also see? Yeah, I see there is a reshifting of UCD.

12:57 continue to be a focus on the US, but thinking of the value that can be brought not just from the US, but the broader base of Europe and Asia Pacific countries, and thinking early days of what are the data packages that we need in those different countries and what can be anticipated. And if it's not the case, having candid discussions also about what countries might be deprioritized. And maybe if we can bring them back in the mix, we'll see more as an upside. And that's where we start talking about flexibility. And it's important to have those considerations early days.

13:39 We've seen too many launches where data packages were developed first and foremost for the US market. And then when we arrive in Europe, we realize we need a new clinical trial that are occurring delay, just on some example, by two, three years. or data packages that the team is scrambling around to work with in terms of managing the best. In a world where there is more reference pricing and where there is more connection across the board, this is something that is more difficult to comprehend. It's really important to bring the value more on the power across.

14:24 Okay, then the... What I understand is it's a good sign for patients. It means we will be able to have better data on a better or more precise population. And it engages pharma companies to put the data sets really early and to put at the same table different countries and not only the US from the very early beginning. Yeah, that's the aim. really having those discussions early days and candidly. At the same time, if there is a need also, there are so many resources to prioritize.

15:06 It's important to have those scenarios where there may be prioritization of some indication of some country. Those are decisions to be made depending on the funding that's getting, for instance, if you're a biotech, or if you're in a broader portfolio in a larger pharma company. within some A recent pharma company, for instance, stopping one indication to prioritize investment and maximizing value. That's also something that needs to be considered as well. I would be interested to have also your advice and how you see the opportunities they can face when they say it's better to stop something now or it's better to focus on a range of countries.

15:56 out you leverage and see the opportunities aside. That's where the scenario planning is. If I'm in a biotech that is well-funded or in a biotech that needs to fight for my next round of funding, I need to think of optionality in different ways. In the first way, if I'm well-funded, I may go larger. If I have some challenges, I may need to have more decision-getting approach. The same will be for broader pharma companies. If I have some upcoming challenges, we do see a lot of patent cliff upcoming. I need to think also there of optionality.

16:37 While if I'm more largely at peace or if also I have a leadership in a certain area, for instance, in neuroscience, I could think of, I may accept on one asset. to have less of incremental value because it makes sense in the broader sense of my portfolio and the leadership I'm creating for the next asset. So it's time to really connect the dots across the portfolio and really think. Those are not just one and it's not just a slide deck and just a financial, but really take a step back and think of really the value that is created now and in the longer term and how it can be done in a sustainable manner and really having candid discussion internally, but also with the external set of stakeholders being regulators, payers.

17:40 We even hear some patient association now. that are wondering about the impact of MFN more and more proactively. And it's important to listen to the different players of the ecosystem, because this is not one single person exercise behind the Excel spreadsheet and a nice PowerPoint deck. Okay, then it brings a lot of complexity, I understand, in the way you operate these kind of companies. And you start maybe to see different patterns or different way of looking at the future?

18:23 Or maybe it's too early? It's still early days and I think we are still looking at the different scenarios of what would be the impact of the MFN and it's still generous, it's still being worked out. We still are looking at how globe and world. will be implementing and there is a broader set of mxn impact at the same time we do see a range of leaders some that are very active some that are really thoughtful about the preparation what is nice to see is that there are lots of questions and i see very few that are playing the ostrich if I may say, putting their head in the sand.

19:08 I don't see that much. There is just a level of preparedness that is different from being more active in the scenario planning, from being more careful in some of the investment or some more ambitious in what can be done. And it's good to see that those level of discussion happening. And I understand also it's a lot of creativity in this world of uncertainty and the solution you can propose and can raise. and in the discussions because I also can imagine many solutions maybe are not already proved and will be built step by step and will be on purpose depending on the business context.

19:55 Yeah and we see more and more of those broader Project engagement where we really need to look at what is the opportunity assessment from a multiple view, from a physician perspective, from a payer perspective across many countries, then really understanding what is the optimal way to address the customer and the patient need and what are the different scenarios of go-to model with roadmap country by country. That's the level of detail we see more and more companies going into, going from pharma to biotech. And it's good to see this appetite and this level of preparedness overall.

20:41 There is still more to do, but that creates a positive momentum, I would say. To have maybe some concrete decisions already made. You talked about indications which are stopped because of global portfolio decision. And do you have in mind other decisions like this starting to be made? Yeah, in some instances I have seen some of the bigger American pharma companies that were in holding pattern on some of the launch assets in Europe and considering the different options. And it's good to see that there is more assessment being done.

21:23 in terms of looking also at geographical expansion or how we address the go-to-market in some of the smaller set of geography in Europe or in APAC. There is also, it was already starting pre-MFN, but it's amplified consideration of flexibility in the go-to-market model with partnering externally so that's the the a farmer biotech can focus more on those high touch geography or considering outsourcing part of the portfolio especially those tail of broader miniature product so we see those trends accelerated because they need to further prepare and focus on the upcoming launch of the existing portfolio also that needs to be maximized.

22:20 That's one aspect of those. The second, we like to think also about the people. I've talked a lot about thinking of patients and customer first, but also internally. We see more and more of the cross-functional team coming together. So it's not an ask for access project or ask for a commercial project. It's more and more ask for the asset project. breaking more the silos. There is still some that do that more naturally than others. And seeing also some company or biotech asking us when we will do this project is not just about doing the assessment, planning for the scenario.

23:09 There are sometimes who ask also things this would have a value also for... creating new flexibility in terms of how we approach, how we do commercialization, almost an educational approach to what is being done. Okay. And I would like to take the other side of this position. If a company or country decides to do nothing and to stay on the traditional way, which can be also a decision. Do you have maybe examples or cases in mind where people took that choice and how it goes?

23:55 I had one recent example of a client who said, I don't need to prepare for it. But what was interesting is such a cross-functional and impactful topic that you could see the other team members that brought him along the way. That would be a dangerous thing to just wait and see. So those are less common, I would say. What's interesting also is planning for a range of different engagements in terms of either going more for a targeted patient population that could generate where we can deliver more value to patients, but that also can mean maximizing more value in terms of...

24:45 opportunity and what's interesting there it's uh it flows throughout the life cycle of the products. So we are talking about how we are more focusing in the clinical development, how we have the access align, the label align, the positioning align, the medical align, the market shaping. So it really have earlier thinking about really how we position and focus ourselves. And that's something used to seeing the best-in-class launches or commercialization. Now, almost there is no room to avoid it.

25:26 That's also encouraging. I'm a hopeful person, as you can see, and looking forward to more. There is still a lot of questions that are being there. There are some extreme cases we've seen in other countries, more like the... New Zealand model, for instance, where there are very limited reimbursements and there has been significant delay in some of the launches, there is a realization that we want to move forward into an earlier and not too delayed launch. And what does it mean concretely in terms of access and innovation? If countries don't want to play the game, this game, or do we start already to see some countries?

26:10 I've heard in UK they declare they will wait for generics and will wait 10 years for your drug. Yeah, there is some of those elements in the model we see in New Zealand where there is the most stringent criteria on innovation. And you can see some later launches in countries when compared with some other European or even. Australian countries, for instance. In Europe, we've seen countries putting together a task force, thinking of Denmark, Norway, about what MFL means and what they can do.

26:54 The UK, as you mentioned, often is being looked at with a more stringent HT approach. At the same time, we've seen a wake-up call, and there has been an agreement with the US. In terms of fostering innovation, we've seen the quality threshold moving from £20,000 to £25,000, £35,000 a year. We've seen also some more commitment around the negotiation of V-PAC that are also being mentioned. So that also acts as a catalyst for additional...

27:35 a commitment for innovation which is encouraging as even if more needs to be done. I've already mentioned that here in terms of New Zealand we've seen by having the delay in accessing innovation and in the health care system being very focused on how much is being spent we reach a point to some of the Patients flying to Australia to get sometimes an MRI or also in terms of drug treatment approval, some are delayed by a significant number of years. That's something being worked on.

28:19 I think it's important, like in Europe, we don't take ourselves for granted. And it's important to ensure we provide the right condition of innovation for... access for also new innovation and access to patients. So it's important and it's good to see some of those work up close, but there is definitely more that needs to be done. Okay. And to conclude, if you had maybe one thing to say to a European Commission director who hasn't started planning for this or just wanted to have the confirmation, is there a right? What could you say?

29:00 I would say uncertainty is here to stay. And it's really time to think scenario planning, think of flexible go-to-market model, and think cross-functionally, preparing early days. So preparation is the key in these cases. And see, again, the global portfolio. Yeah, from global to local, and considering the different stakeholders from across the portfolio. And from early to late stage, really, because it has multiple impact. No way to work in silos inside the pharma company. But also at the ecosystem level, we can see more and more.

29:42 OK, thank you, Laure, for this next conversation. Thank you so much. And I think this conversation make you think, make us think and finding solutions. And it's important to understand that many ways are definitely possible. Thank you for listening to PharmaMinds. If this conversation inspired you, subscribe to the channel and share it with a colleague. And for deeper insight and leadership takeaways, you can join the newsletter. The link is below.