E14: USA - Ross Margulies

Introduction So welcome back to the Payer Exchange. Throughout this season, we've explored these changes from the perspective of health plans, commercial organizations and those working alongside employers. We've looked at how different parts of the healthcare system are adapting, what this could mean for pharmaceutical manufacturers, and not just local US, but global impact. So to finish the season, I really wanted to step back and ask a broader question. How do pharmaceutical companies make global strategic decisions while the policy landscape undergo seismic shifts literally beneath their feet? This is why I am so pleased to bring Ross Margulies from Manat Health into this season. He has spent much of his career helping manufacturers navigate exactly these kinds of challenges. Now, I've known Ross for many years professionally as we've supported multiple pharmaceutical manufacturers during CMS drug price negotiations, right from the beginning in fact. And personally, over this time, me and Ross have become great friends. Just a few weeks ago we met up in London for lunch and it was just really an amazing experience. In this episode, I'll be discussing with Ross Global Launch sequencing, International Reference pricing, MFN policy, and how is it that decisions made in Washington are increasingly influencing pricing and market access strategies far beyond the US borders. This last and final episode will be pulling all the threads together on U.S. policy and the effect on geopolitical landscape across the globe. It is maybe the most important episode you're going to listen to in this season. Speaker 2 Hello and welcome. Today's episode we have a really special guest. We've discussed with payers, we've discussed with providers and health plans, employers. Today we're really talking policy and it gives me great pleasure to introduce a great friend, a great professional colleague, Ross Margules, lawyer, Washington based firm Manat. Ross is great to have you today. Speaker 3 Omar, it is always so fun to be with you and I'm really excited for the discussion today. It's a really fun time to be having these these conversations around drug pricing and MSN. Introducing Ross and his work in US drug pricing So Ross, let's first give it a little brief intro. So we, this is a just so for the listeners are aware of this. This is we're doing like a season of US deep dive and we've spoken to payers, we've spoken to health insurers, provider policy and really yours comes into the policy bracket. Just a little bit about yourself and you and your firm and what you do so that we can launch into some of these key themes. Speaker 3 Yeah, sure, absolutely. So I'm, I'm trained in practice as a, as a healthcare attorney. You know, my clients are across the healthcare spectrum, although I spend a lot of my time focused on the drug supply chain and the life sciences industry specifically. And my practice is sort of sits at the intersection of policy and, and law. And so, you know, my clients tend to come to me to be their ears and eyes in Washington from a policy perspective, how federal agencies, how Congress are making changes that require them to be, you know, thinking ahead, responding and interacting in ways that continue to push their business forward. And so those range from sort of both legal questions to policy questions to strategic market access questions. And I've been doing this for about 17 years now. I'm currently at Manette, which is a hybrid sort of policy legal firm and I work with a bunch of lawyers and non lawyers, including clinicians and data analysts working with our clients to sort of do exactly what I do. So it's it's a really fun time and I think as we're about to dive into the topics we're going to discuss, you're going to see sort of how how busy we've both been, I think. Speaker 2 Yeah, that's awesome. Thank you. That's just really great experience. Your wealth here to tap into for this podcast today. MFN, GUARD and GLOBE So the first theme, we've just been a riding theme through all of our guests and discussion is MFN looking at Guard and Globe and different perspectives, particularly how international pricing models are kind of coming in to the US and sort of offence legally affecting drug pricing state federal policy. And the first question is, I guess when it comes to concepts like MFN or the frameworks garden Globe are being debated in Washington. How are these impacting on pharma and payers broadly speaking in the US today? And how does navigating this kind of, I guess, almost reference pricing effect coming like it's a global effect coming into the US? How does that work from a day-to-day when it comes to the payers in the US and well payers and farmers I should say? Speaker 3 Yeah, it's a, it's a great question. And I think in the last year in particular, we've seen a really significant shift in the psyche and and positioning and thinking of both payers and and manufacturers. You know, the concept of incorporating some form of international reference pricing into U.S. markets is not brand new, although it has taken on a certain strong significance in the second Trump administration. But going back to the Obama administration, there have been a series of proposals to incorporate international prices. We saw that again and the first Trump administration and then, and then again now as we're in the second Trump administration, they have really leaned into, you know, this, this concept of, you know, I think it is rooted in core populist beliefs that of fairness and, and this belief that the US may pay too much for, for drugs. And in the last year, we've really seen, I think a shift in that shift being a recognition that international reference pricing is probably here to stay as a, as a concept, right? And that it's not going to live or die with one political party, right? We, there's a lot of uncertainty around the upcoming November elections, whether Democrats take the House, whether Democrats could take both houses, the Senate, the House and Senate. But sort of irrespective, I think the political outcome in November, I think most of our, my clients tend to think that the idea of incorporating some form of international reference pricing is probably here to stay. You asked sort of, you know, what, what does that? How's it impacting them? You know, from a, from a manufacturer perspective, you know, I think the initial impact really has been some degree of sort of freezing and waiting period. In other words, I think a lot of manufacturers feel like this time the, the, the pace of change is phonetic. Everything feels very uncertain. And, and I can say a lot of our clients are holding international launches, trying to understand exactly what is going to happen here and, and trying to avoid a situation where, for example, they go into a negotiation with Germany or, or launch and, and, and the UK. But UK maybe a bad example. They launch, they launch and Japan and, and have somehow triggered a series of significant future price impacts in the United States. And so there's, there continues to be a lot of uncertainty right now. You mentioned sort of the frameworks like Globe and Guard as to whether or not those models will ultimately move forward or they'll survive the legal challenge. And so I think manufacturers right now really are in a bit of a wait and see period, although the action they have taken in many cases is pretty impactful and that they've actually made a decision at least temporarily to to not launch in certain ex US jurisdictions. You know, I think payers are probably a little further behind. I think they're waiting to see whether or not these concepts old, whether or not international reference pricing ultimately becomes embedded into pricing structures, but I think they are, they certainly see this as an opportunity for cost savings going forward. Speaker 2 Wow. I mean we have had, but we've spoken and we've worked actually with clients where this is really playing out. The idea that you might launch in a European country the net price that used to be confidential kind of isn't confidential. We can discuss that a little bit. And then it transfers and sort of haunts its way back to the US and of course, the revenue generation of the US become significant impact as they want to launch in Europe or some European countries to say is can you see if we say the international reference pricing is here maybe for the foreseeable future. Can you see on the domestic side within the US legal and constitutional hurdles around this or like is Garden Globe being challenged legally even to this point? The legal challenges facing MFN In the same way we've seen we're going to talk about CMS drug price negotiations and they're also, I guess being challenged as well. But that's been, you know, progress through how does that play out? And so and does that only add to the kind of uncertainty? And you know, drug companies can't just cause a launch forever, right? Like going to have to do something like they've invested in the R&D, they've invested in clinical trial. We are seeing drugs being launched, but they're kind of struggling with the context of how to navigate that launch now. Speaker 3 So let me begin with the boring legal answer, although I'll try to make it not boring, which is there's a real big distinction between when Congress has authorized something and when a federal agency is acting using existing authority. I think it's important to know that to date, Congress has not authorized CMS or any other agency to utilize an international reference pricing framework. So today the, the models that are being proposed are being done using what's known as demonstration authority, which is a sort of broad grant of authority or broad but not limitless grant of authority from Congress to the agency to run sort of demonstration tests that write experiments to, to test whether certain changes to how Medicare operates can improve the program. I think Garden Globe, if they are so Garden, the current status of Garden Globe is that they are, we have proposed rules and final rules have now arrived at what's called the Office of Management and Budget, which is really the last step before those rules would be finalized. There's always some degree of possibility they're not finalized, but my personal expectation is that those rules will be finalized sometime this year. I think there's a great deal of legal uncertainty as to whether or not those two models Garden globe will survive a legal challenge and I am highly confident that they will be subject to legal challenge. So, so that's that's point 1.2 is Congress may have an interest in legislating on international reference pricing. And that's a very different legal question. If if Congress authorizes CMS to incorporate international reference prices either in how they generally pay, pay for drugs or for example, another concept would be incorporating international reference pricing into the drug price negotiation program. Legal challenges are still possible on constitutional grounds, but I think the chances of those laws surviving legal challenge are much higher than Globe and Card would be. Speaker 2 From a manufacturer's perspective, would they view Globe and Guard as mandatory even if it's not statutory in place? Speaker 3 Yeah, so, so there's sort of an interesting, there's an interesting dance currently playing out if Globe and Guard go into effect, they are and they survive legal challenge. They are designed as mandatory models. So any manufacturer subject to the model would be would be subject to the model. But there's a really big footnote there, which is simultaneously the Trump administration has been negotiating what I'll generally call most favored nation icing agreements with manufacturers. They started with the largest 17 manufacturers of which they've entered into agreements with all of those now, and they're now entering into agreements with a smaller subset of small and mid sized manufacturers. Our understanding is that those manufacturers if they execute those agreements and and and there's a number of different commitments as part of those agreements including some pricing commitments in Medicaid would be exempt from Garden Globe. So we may enter a very interesting situation where if BLART Garden Globe are finalized, let's say this fall and they survive legal challenge, a portion of US manufacturers will be subject to those rules. How manufacturers are responding to MFN But a large portion including the largest manufacturers, which which constitute the largest, you know, a significant ports of drug spending will actually be exempt based on voluntary pricing commitments they've already made. Speaker 2 Generous. Or is that another one? Speaker 3 No, no, you're right. So, so that's right. So the, the, the, the 17 manufacturers plus this other group of manufacturers currently negotiating now are agreeing to a series of voluntary commitments. 1 is what you just referenced generous. This is a voluntary model where you would offer international reference price in Medicaid, but there are additional commitments. They want manufacturers to offer drugs direct consumers through this Trump RX website and they want manufacturers to commit to perspective MFN that is going forward, manufacturers are committing to launching products at an aggregated net price in the US that is no greater than the most favored nation price overseas, which is which is also pretty significant. And in exchange for those commitments, those manufacturers will receive both some degree of tariff relief to the extent that it applies, as well as we understand Globe and Guard exemptions. Speaker 2 So one of the things we're seeing play out is how the stakeholders of this are trying to dance to avoid the scenario. Yeah. So for example, a drug company manufacturer says, OK, we're going to delay launch in Europe so that whether it's the 19 OECD basket from Globe Guard or the the eight countries, the G7 minus US. Speaker 3 Yeah, in generous. Speaker 2 Denmark, Switzerland, right, generous. So what you do is you say, OK, so I'm not going to launch in those markets yet. I'm going to wait. I'm going to launch in the US, There is no reference price to compare and aggregate and the launch in the US today. And I'm going to sit and wait maybe 2-3 years and launch later. And we've seen some manufacturers even come out and say, oh, we're not going to Germany or we so #1 does that get around this whole reporting? And in theory, does that obfuscate any notion that there'll be a cheaper drug price in the US? Because if there's no cheaper European price, then you can just launch whatever price you want. Speaker 3 One, I would say my first reaction is I think I've been struck by how how unique every single manufacturers circumstances, right? That, that it depends widely on how many products you have, where you manufacture, what your tariff exposure is and the size of your patient population, right. So that there's a different story for companies launching rare disease products versus companies launching, you know, a new GLP. One, there's, there's a, you know, major difference for companies that have one or two drugs versus companies that have 75 commercialized products. But I guess the short answer such a question is yes. I mean, I think some companies will be able to, you know, engage in strategic launches that enable them to avoid the broadest effects of current MFN agreements. The international impact of US pricing policy The other piece that's happening that I think is really important to pay attention to. We already saw it happen in the UK. It's currently potentially happening in Germany. Is, is the concept of adjustments occurring and the prices paid by those international countries, Right. And you're, you're closer to what occurred within the UK. There's a process that's currently occurring in Germany today. You know, it's interesting within the Trump administration, there are really two schools of thought and they're pretty evenly divided there. There is one school that is very comfortable with this idea that manufacturers in the US should receive less money for their products, right? That reimbursement should be lower. There's another group of people who are not comfortable with the idea of ice setting, but they're very comfortable with the idea of using the USS Strategic and international strength to force other countries to pay more. As you, as you might imagine, you know, pharma companies are, are hoping that the latter is really where the pressure ends up going, right. In other words, is there some world in which it's not necessarily that the US is spending significantly less on prescription drugs, but European countries in particular start to pay their quote, UN quote, fair share? Speaker 2 Totally. And I get and we get that and you're right in the, in the UK and England for example with NICE, they have adjusted the cost per quality threshold, they've raised it from 20 to 30,000 to 25 to 35, sort of 15 to 20% increase. They've also agreed to spend more, like doubled nought .3 to nought .6% / a certain number of years on GDP on innovative medicines. And that wasn't because of any argument about who should be paying more or less. It was because of tariffs and trade deals. And we actually didn't want tariffs on pharmaceuticals in the UK. So you're right, the US were able to use other broader and overarching methods in negotiation for us to affect our internal pricing dialogue. And we've seen already, in fact, the US trade relations I think have opened up a legal section, three O 1, I think in Germany. Speaker 3 That's right, yes. Speaker 2 It's quite extraordinary, like for, for an external country to say they're opening a legal kind of challenge on an intern, a country's own internal pricing policy, it's quite remarkable. And so they've done that to Germany and people are asking how they can do it to other countries. So how is that going? I mean, I'm just trying to see where that takes place. Like this is all just pushing isn't it? From different methodologies. Just trying to get other countries to pay more. That's what this is about. Speaker 3 Again, I think that is there is there is one school within the Trump administration, you know, it's being led by the Department of Commerce and Secretary Levnik that that really is focused on that piece, right? My assumption is there's going to be push and pull on both sides, right? I think some of those efforts internationally will be successful in increasing the prices paid by foreign countries. But I also think. It's likely that there's going to be bleed over of ultimately lower international reference prices to some extent into US pricing. Speaker 2 OK. And before we go to CMS drug price negotiations, which I'm sure we'll have lots of stories we could share, let's just look at the reporting of these prices. Reporting international prices under MFN So we know that let's say you're a pharmaceutical manufacturer and you do launch in European countries and we know there's this Method one reporting and Method 2 reporting. So the way in which CMS actually get the prices the the I guess what were confidential net prices, but get the net prices to transmit back to the US for MFN Guard globe generous through method one, it's using data systems like for example, I think Evasana have a Navalny IQEMIDS. The idea being that they track not just list price, but some net prices may be aggregated, may or may not be correct. And CMS use those commercial software to say right, we've can see that you're doing 2030% discount European countries. So we're going to apply that here. This pressure test that we is that good. Are we good with that? Speaker 3 Yeah, yeah, that's exactly right. So the method one is essentially manufacturer, you're not required to report anything to us. We're gonna rely on these third party data sources. I'll just say a note, I think this has been a boon for those, right. I think like many of our manufacturer clients didn't necessarily have subscriptions to all of those resources. And now I felt sort of their hand for us being like, well, if we're gonna at least consider the possibility of method one, we should probably understand what what prices are listed in those databases. Speaker 2 And by right now I'm thinking, well, there is a method 2, which is a more voluntary open your books. So if you kind of, you know, say you don't like method one or you, you go and buy your IQVIA Midas, look at the reporting or ever sign an avelin and you go, whoa, whoa, these guys are way off. What we'll do is method two, we will come and we'll open our books and we'll, I guess it's auditable factual tracing and say actually our net price looks more like this. So can you not use method one? Could you please use method two? If I, I'm trying to simplify, but is that kind of what we're talking about? Speaker 3 That's right, yes. Speaker 2 And under the method 2 and under method one, is the calculation the same or is like method one more about like the second least expensive and method 2 is more an aggregated or is it a similar? Speaker 3 It's it, it, no, it's the same ultimately it's the second lowest price of that grouping of countries. But the, I mean the difference really is, you know, I think there's a great deal of uncertainty for manufacturers and loss of control associated with method one, right? Relying on 3rd party data sources that may or may not be accurate. Whereas you know the the both upside and down side of of method 2 is that it's it's your true net price in those international countries. Speaker 1 Got it. You know, today's conversation highlights just how quickly market access strategy is changing around the world. One of the ways we help our clients navigate that uncertainty is through Vapora's innovative contracting tracker that combines nearly 2000 publicly reported agreements from healthcare systems around the world into a single searchable evidence base, helping teams identify emerging trends and make local strategic decisions with greater confidence. You know, it's a resource we rely on ourselves every day. And if you'd like to access this resource, drop me an e-mail or message me on LinkedIn or visit vapora.com. Speaker 2 For details of our innovative contracting tracker, let's go to our second theme, IRACMS drug price negotiations. The IRA and Medicare drug price negotiations It's been a pleasure to work with you with various clients and present at conference. We've seen round one, I pay. We've seen round two, I pay. We've been on many journeys together. Now I pay 3. What's interesting about I pay 3 is a couple of things. Number one, we're bringing in Part B medicines physician administered within the hospital as opposed to just the kind of Part D that we're kind of outpatient self administration. And the second thing is we're moving and I'll probably get you to explain this a bit better to our audience. We're moving from kind of CMS interpreting what the guidance is to a more formalised rule making of that guidance, which means there's slightly more of a legal shift on the procedure and the methodology of how CMS will be negotiating and guessing. Probably more legal counsel and presence and maybe less deviation and exploration and or interpretation, but more a rigid standard framework. So let's just explore some of those themes that I I outlined, which is really coming with IP3. Speaker 3 Yeah. Let let me start with the move of the program again, back to boring lawyer stuff from the move of the program from one driven by guidance to 1 driven by regulation. And, and there are your correct nuances and an important considerations as we move to a program that is bound by and driven by regulation versus one that's driven by guidance. And, and, and just to update the audience, we're currently in that rulemaking process, right? So CMS has proposed a series of regulations and we're currently in the 60 day comment period for those regulations. And you know, we're working with dozens of manufacturers that have, you know, a stake in those regulations and they're submitting public comments. I think overarching the most important piece here is I think it's a fair assumption that once CMS finalizes these regulations, although they'll update them probably every year, that the program is going to become even more solidified. You know, that said, I don't want to under, I don't know, overstate the significance of this moment because I think the headline story from the proposed rule was CMS is largely putting into regulation the program that was finalized over the first two I pays. So we had some shifts between I pay 1 and I pay 2. But really CMS has been remarkably consistent, you know, in the actual negotiating room, CMS sits with copies of their of their guidance in front of them and they really are driven by that guidance. And so while the while the program has been technically driven by guidance, it's, it's felt very regulatory driven, it's felt very rule based. And so I actually think one of the more interesting pieces here is that the proposed rule really has not proposed a major shift in terms of how the agency has governed the program and will govern the program forward. It feels like it has entered into sort of it has it has institutionalized fairly quickly and and that CMS has clearly come up with a lot of internal processes and procedures to try to make the negotiation work in as non arbitrary as a way as possible. How CMS negotiations could evolve Do you think how will that play out in the negotiations because when we've both supported manufacturers, we've had legal counsel usually with the manufacturer and occasionally maybe maybe a bit late or not always necessary with CMS. Do you think that this changes that or not? Speaker 3 I, you know, I actually do, I mean, CMS is largely in, in, if you recall and I pay 26. The first I pay CMS sent legal counsel to most of the meetings. Some of that I think was driven that we were also at the early stages of litigation in the drug price negotiation program, which we may talk about, you know, in I pay 2 and I pay 3. Legal counsel has been absent from those meetings. It's not that they're not involved, but they're not in the negotiating room and most of our clients tend to still send an attorney with them, although not all. We me as a as a lawyer's advising client for this process still lives and breathes and dies by the guidance and it will be helpful for me to have something drafted in regulatory text. You know, there continue to be constantly issues of uncertainty that come up as an in advising clients as to what CMS is obligated or not obligated to do with respect to the program. And I do think it'll be helpful to have actual regulations to work with, but I'm not necessarily certain it'll change the overarching structure of who attends the meeting or how they operate. Speaker 2 And just on that legal challenge, I remember like many of the manufacturers or maybe all of them also in parallel had a legal challenge to this whole procedure. Legal challenges to the IRA Have they all materialized? Have they been thrown out or are they still ongoing? Speaker 3 So litigation is ongoing, although you know, to date none of them have been successful. There are, but there are a handful of cases that continue to work their way through through the courts for now. That's where the Federal Circuit court lever or federal appeals appeals court level, you know, I would say most board observers are not terribly optimistic that any of these challenges will ultimately materialize in a way that strikes down the entire program. I do think there continues to be a possibility of legal challenges on specific issues. And I'll just give you an example of one. While I mentioned the current proposed rule for the drug price negotiation program, you know, largely puts into regulation the program as it operates today. One of the proposals that's gaining a lot of attention is a proposal for the treatment of fixed dose combination products, right with with, you know, in particular products where there's a subcutaneous version of an intravenous product, often with the addition of a of the active ingredient hyaluronidase. CMS has proposed that if a that will fix those combination products are generally treated as separate drugs and not negotiated together where hyaluronidase or another active ingredient has been added. And the only effect of that addition is to change the route of administration, say from IV to sub Q that that product will be grouped together. I think CMS is likely to finalize that proposal and I think CMS is likely to proceed, you know, to be to be legally challenged on that proposal. And I think a court could consider arguably a more narrow challenge to certain drug place negotiation policies, even if it's unlikely that the entire law is found unconstitutional at this point. Speaker 2 Got it. Yeah, that was that was a great answer actually because I've spoken to a few payers that have been knocking this one around and without necessarily a solution on it. The other thing I mentioned was part BI mean in the US you've got the whole Part B of fundamentally tied to provide a buy and build economics rather than the traditional Part D kind of pharmacy benefit. I can, I've been hearing, I mean you'll see this when we, we have spoken to payers in the system who have got all sorts of issues with this and maybe small providers, GP OS, other people now being drawn into this whole Freakonomics of if you like of the these drug price negotiations. Medicare Part B and negotiated pricing How do you see this playing out when it's now affecting this kind of buy and bill and injectables and going to ASP? The MFP almost is becoming an ASP and the danger of organisations either going underwater or struggling with that kind of reimbursement. Speaker 3 Yeah. And I'll say, you know, one of the, you know, one of the potentially more promising challenges to the drug price negotiation was one actually brought by the infusion centers, right? So, but you know my, I continue to believe that this issue has gained less. I think most providers continue to be not fully aware of what is coming for this third by pay, right. The fact that there are going to be highly high volume Part B drugs where they earn a significant margin today, where they will be, where they will, that margin will be significantly reduced and I think there's growing awareness, but it's slower than you might expect. We're still waiting on see, you know, even though we're just around the corner. CMS has continued to kick can down the road on how they are going to effectuate or make providers whole on Part B drugs under the drug price negotiation program. Really fascinating that they've been able to push this that long. It actually wasn't included in the proposed rule for, for I pay 3 even though I pay 3 will be the first year that that Part B products are being negotiated. And it may be that until the prices are effective January 1, 2028 that really or or leading up to that that we don't see major provider activation. But I do think there are a lot of really unique considerations as we move from negotiating just pharmacy dispense products to physician dispense products. I think it's likely there is going to be right. So, so when a when a provider prescribes a pharmacy dispense product that's been negotiated, I don't think we believe necessarily that there's really any significant impact to prescribing behavior. The maybe there has been some impact to formulary behavior, although frankly I don't think we've seen that it's going to be different when we have the prescriber buying and building the product and being reimbursed at MFP. So, so I think one major change here to watch for is are we going to see a real change in prescribing behaviour and physicians retreating away from prescribing drugs with MFPS? Speaker 2 And do you remember, Ross, when I mean, often in the negotiations, this kind of idea of a system effects, right, That look, if you negotiate a really low MFP that's so low, then you're actually going to have formularies move away and almost penalize the MFP product. You just spend nine months negotiating in favour of better rebate products. And I don't think that really panned out. And we spoke to health plans and payers and formularies, it was quite clear that if they started penalizing MFP products, they would lose their Medicare business. Like in fact I remember some of our payers have said that CMS have actually rejected bids for the first time now based on plans trying to move and literally doing other things like moving from a co-pay to Co insurance model and raising premiums and kind of hiding MF PS and some of that. If when it comes to the intravenous like what you're saying is physicians may penalize MFP intravenous drugs, right? Speaker 3 I mean, if there's two, you know, if there are two competing products, the clinician views them as clinically comparable and one has an MFP, you know, arguably I, I could see strong incentives for the prescriber to move away from prescribing the one that has a lower reimbursement differential, right, The net where the net between what, between the buy and bill is, is lower. Speaker 2 They might the survival of the organization if it's small all it might be out you know in some of it might be not a large teaching academic unit. It may be like a small out in the rural yeah regions and they will struggle. They may well struggle. We're going to sort of wrap up with some of the lifespans and future of MFNI know we've covered some of this already. The intersection of MFP and MFN One of the popular questions we've had and people have been feeding me questions already going, oh, you're going to have policy and payers. The intersection of MFP and MFN has cropped up a few times. In fact, some of our payers didn't even know the answer to this. If a product has been through the negotiation with an MFP, whether it's Part D or Part B and then it's suddenly is subject to MFN guard globe, is there a carve out? I think is there a statutory carve out which says, look, the fact you've been through MFP means you're actually safe from Garden Globe or is that not the case or do we not know? Speaker 3 No, that's not the case. I I you know, my understanding is that products that have been negotiated can still be included in models like, for example, Generous or Garden Globe. Speaker 2 Right. So it doesn't protect them in any way. Speaker 3 No, I think what what you are protected from is having that inner that MFM price incorporated into the drug price negotiation or a renegotiation. Speaker 2 Right. So what you're saying is say you have an MF that's been negotiated, if an MFN would kind of give you a lower price that won't then override it, your MFT price just protected from that part of the equation? Speaker 3 Yeah, yes, that's got. Speaker 2 It got it. OK, that makes that makes sense. That makes sense. And as we wrap up what tell me, how are you kind of advising pharma clients now as they're planning their longer term US and ex US launch strategies? Rethinking US and global launch strategy What are you telling them or how are you advising them? And they can't always necessarily watch and wait. What is, what is where, where is the direction? And, and I get there's a heterogeneous model depending on the drugs, depending on the disease areas. Broadly speaking, you know, say you have an oncology drug or rare disease or let's say it's something like AGLP, one kind of map broadly how that might play out when you're supporting or what companies might be doing. Yeah. Speaker 3 Well, well, I mean, I guess I think the most fundamental piece is we're building it into into the models in the market access plan, right? I'm just to give an example, I'm working with a client right now putting together sort of a memo on they're launching their first product in the US later this fall. And they sort of asked for soup to nuts, right? From a, from a federal payer perspective, what do we need to do from a, you know, Medicare coverage, coding, reimbursement, life cycle management, all of these pieces. And, you know, two years ago, discussions of MFN and the guard and globe and, and, and even, I mean, three or four years ago, drug press negotiation would not have been a part of the plan. They have to now, right? So, so now, you know, companies need to be thinking about launch indications, launch sequencing very differently than they did a few years ago. Companies need to be thinking about market sequencing right where they're launching different than they did, right. I mean, I mean, one helpful thing frankly, is, you know, at least right now is, you know, now that these models have come to light and we understand, for example, the Market Basket of countries and you know, how CMS will select the price from those market back to their countries. Companies are able to start designing or building around these constraints. Although I think one big limiting factor is it's a little, you know, I don't think we're in a stable period. You know, we don't know if Globe and Garb are here to stay. You know, we don't know if generous is here to stay. We don't know if Congress, the next Congress may wish to legislate on MFN. Could Congress legislate on MFN? And so I will say it's a really difficult time to be a manufacturer and plan for these things, right? Because it's very hard to plan around uncertainty. You know, the last thing you want to do is, is not, you know, is wait to launch in Germany for three years only to find out that you could have launched and made your product available to patients and, and save lives or, you know, reduced harm and, and, and you would have been fine, right? So I do think that that's keeping a lot of C-Suite folks up at night, right? Which is this just total lack of uncertainty as to where all of this is going. But I guess my key point is no organization should be going through planning of a product and not taking into account these important factors. Speaker 2 Yeah, totally. And one of the legal things that's come through which could be very interesting is some markets like Spain recently is looking to put through legislation which says these confidential discounts legally and contractually. Are confidential, you can't share them with anyone outside. So if you come to Spain now and you want to give a discount, you can't just go and tell the US president what they're just like. It's meant to be a two way protection because some of the countries are seeing that they're not going to get launches there because the view is well, the confidential price isn't confidential. And I think traditionally right manufacturers if they go around giving discounts to European markets, the confidentiality is to protect the manufacturer. They don't want to tell other countries what discounts they've been giving. So if markets suddenly start doubling down on this confidentiality and legally if you go to Spain, come and give us 30% discount, that's great because we want access. We're never going to pay AUS price. It's never going to happen. But this is a contractual obligation. You can't go and share it now with the US and you're going to sign that contract. So we get access and to kind of block an MFN route. How does that look now if you then want to go and do a voluntary reporting if you signed a deal which says you can't share our contract? Speaker 3 I mean, my, my understanding is that most of the agreements to date, there's an NFN agreements, you know, containing clauses that recognize that a manufacturer may in certain instances, you know, be compelled from reporting, right? In other words, can't report and create exemptions for that, which seems to suggest the Spain model could be a really good model. But I also had this suspicion that U.S. Federal policy makers, commerce, are going to be really unhappy with that move, right? And that long term, that's probably not a sustainable model, right? If every country just passed, you know, like makes these prices not disclosable, there's going to be something that comes next, right? I just can't imagine that's how this all this all Nets out. Speaker 2 Totally, totally. So Ross, I mean, I'd love to speak with you for another hour. I think this is going to be a special episode because I think yours is going to be the longest because we've covered the most content. You have been totally awesome, Ross. Anything exciting for you now? The next over the next sort of sick we've had, we're coming halfway through the year now. What comes next for US drug pricing policy? What does the next six months look like for you? Are you coming and coming over to Europe? I'm. Speaker 3 Coming over to London in in in in 12 days. Speaker 2 I've got your dates in my calendar. Speaker 3 Yeah, got our got our little flat booked and made of ale. Wonderful and, and and we'll have to eat some spicy Indian food together. Speaker 2 I'm, I'm gonna, I'm gonna take you out and test your waters, I think. Speaker 3 Yes, yes, I love that. Yeah. And, and I guess I would just say, I mean, it is that I, I don't anticipate the pace of change slowing. I do think it's really important to watch the outcome of the midterm elections because I think Democrats and Republicans have slightly different perspectives on MFN. And then I think one of the really but, but, but, but divided government is, is, is a high likelihood in 2027 to 2029 or 27 to 28. And I think the question will be, is there a bipartisan path towards some sort of broader drug pricing reform that incorporates MFN? Speaker 2 Ross, I think you're going to probably be the most popular episode. We'll definitely have to have you back. Thank you so much for giving us your time, your expertise. I look forward to working with you again. I look forward to presenting with you again and I'm definitely looking forward to seeing you in London soon. Speaker 3 Same my friend. We'll see each other soon. OK, Take care for having me. Speaker 2 Thank you. Thank you. Closing thoughts Bye bye Ross. That was just. Speaker 1 Brilliant. We could have kept going like we have to bring this to a close because, in fact, this might even be one of our longest podcasts. I need to go back and have a look. Yeah, Ross is amazing. In fact, thanks to all of our guests across this season. Speaker 2 For being so. Speaker 1 Generous with their time, their unique insights, perspectives and really shaping, I think maybe a different direction. I sense our payer exchange going because really we've gone from interviewing different payers across different seasons to maybe this deep dive, this US deep dive, whereby we've kind of gone and explored right down to the root what's happening in the US and then the global implications of that. Now when we started planning this season, the objective was simple. Understand how changes in US pharmaceutical policy might influence the future of market access. Now, having listened to all four conversations, I think the discussion has become much broader than that. We've heard from a regional plan, speciality pharmacy, self insured employers and policy expert from the legal perspective for manufacturers through some of the biggest changes the industry has seen in decades. Each looked at the same challenge through a different lens with some common themes. But we kept coming back to some key issues. How do we support innovation while keeping healthcare affordable? How do we demonstrate value beyond price alone? And how do organizations make good decisions? While the policy landscape is still evolving? Those questions are confined to the US. They increasingly influence pharmaceutical manufacturers, payers and healthcare systems around the world. So where next for the payer exchange? Well, let me tell you, Season 4 is already in pre production. We're planning our return to Europe for an entire season focused on one healthcare market that's changing rapidly. And I'm delighted to say we'll be welcoming back one of our most popular guests from our very first season. Until then, thanks for listening. Thanks for joining me on the payer exchange. And may I just add, if you would like to participate, maybe you're a current or former payer, maybe you're involved with policy, maybe you've heard and you want to be part of the conversation, please contact me on LinkedIn or on vipora.com and I'd love to engage with you until then, despite from me, thank you very much, Omar Ali, Head of payers at Vipora. Every conversation in this season explores a different perspective on the challenges shaping pharmaceutical market access today. Together, they reflect the kind of discussions we're having every day with payers, policy experts, and life science organizations. Speaker 2 Around the world. Speaker 1 You know, at Vapora, we're all about access strategy. We help pharmaceutical companies bridge the gap between the value of innovation and the realities of healthcare funding. Through our global payer network, evidence, data and strategic market access expertise, we support better decisions, stronger partnerships, and ultimately better patient access to your innovative medicines. If today's conversation has inspired questions about your own challenges in market access, pricing, value based and innovative contracting, or you just simply like to continue the discussion, we'd be delighted to hear from you. Visit thepoorer.com to connect with our team. Discover more episodes of The Payer Exchange and more specialist on Demand content.