WEBVTT 00:00:07.090 --> 00:00:11.346 Welcome to the Payer Exchange, a podcast where I sit down with payers from around 00:00:11.429 --> 00:00:15.739 the world to talk candidly around what is shaping access value and decision making 00:00:15.822 --> 00:00:19.090 when it comes to drug pricing reimbursement in their markets. 00:00:30.090 --> 00:00:33.870 Thank you. 00:00:33.990 --> 00:00:37.137 So, welcome back to the Payer Exchange. Throughout this season, 00:00:37.221 --> 00:00:40.522 we've explored these changes from the perspective of health plans, 00:00:40.605 --> 00:00:43.910 commercial organisations... and those working alongside employers. 00:00:44.610 --> 00:00:48.907 We've looked at how different parts of the healthcare system are adapting, 00:00:48.991 --> 00:00:53.466 what this could mean for pharmaceutical manufacturers, and not just local US, 00:00:53.549 --> 00:00:56.011 but global impact. So to finish the season, 00:00:56.095 --> 00:00:59.410 I really wanted to step back and ask a broader question. 00:00:59.610 --> 00:01:04.168 How do pharmaceutical companies make global strategic decisions while 00:01:04.251 --> 00:01:09.078 the policy landscape undergo seismic shifts literally beneath their feet? 00:01:09.161 --> 00:01:14.055 This is why I am so pleased to bring Ross Margulies from Manat Health into 00:01:14.138 --> 00:01:19.100 this season. He has spent much of his career helping manufacturers navigate 00:01:19.183 --> 00:01:21.470 exactly these kinds of challenges. 00:01:21.960 --> 00:01:24.657 Now, I've known Ross for many years, professionally, 00:01:24.740 --> 00:01:28.828 as we've supported multiple pharmaceutical manufacturers during CMS drug price 00:01:28.911 --> 00:01:33.105 negotiations, right from the beginning, in fact. And personally, over this time, 00:01:33.188 --> 00:01:36.313 me and Ross have become great friends. Just a few weeks ago, 00:01:36.396 --> 00:01:40.460 we met up in London for lunch, and it was just really an amazing experience. 00:01:40.890 --> 00:01:45.580 In this episode, I'll be discussing with Ross global launch sequencing, 00:01:45.663 --> 00:01:48.538 international reference pricing, MFN policy, 00:01:48.621 --> 00:01:53.647 and how is it that decisions made in Washington are increasingly influencing 00:01:53.730 --> 00:01:57.882 pricing and market access strategies far beyond the US borders. 00:01:57.966 --> 00:02:02.857 This last and final episode will be pulling all the threads together on US 00:02:02.940 --> 00:02:07.310 policy and the effect on geopolitical landscape across the globe. 00:02:10.890 --> 00:02:12.940 you're going to listen to it this season. 00:02:21.270 --> 00:02:25.163 Hello and welcome. Today's episode, we have a really special guest. 00:02:25.247 --> 00:02:29.733 We've discussed with payers, we've discussed with providers and health plans, 00:02:29.817 --> 00:02:32.464 employers. Today, we're really talking policy, 00:02:32.547 --> 00:02:35.965 and it gives me great pleasure to introduce a great friend, 00:02:36.049 --> 00:02:39.170 a great professional colleague, Ross Margules, lawyer, 00:02:39.254 --> 00:02:43.325 Washington-based firm Manat. Ross, it's great to have you today. Omar, 00:02:43.408 --> 00:02:47.895 it is always so fun to be with you, and I'm really excited for the discussion 00:02:47.978 --> 00:02:48.757 today. It's a 00:02:48.840 --> 00:02:53.423 fun time to be having these conversations around drug pricing and MFM. So, 00:02:53.506 --> 00:02:57.080 Ross, let's first give a little brief intro. So this is a, 00:02:57.164 --> 00:03:00.422 just so for the listeners are aware of this, this is, 00:03:00.506 --> 00:03:04.962 we're doing like a season of U.S. deep dive. And we've spoken to payers, 00:03:05.046 --> 00:03:08.115 we've spoken to health insurers, provider, policy, 00:03:08.199 --> 00:03:11.079 and really yours comes into the policy bracket. 00:03:11.162 --> 00:03:16.124 Tell us a little bit about yourself and your firm and what you do so that we can 00:03:16.207 --> 00:03:18.540 launch into some of these key themes. 00:03:18.840 --> 00:03:24.567 Yeah, sure. Absolutely. So I'm trained in practice as a as a health care attorney. 00:03:24.650 --> 00:03:28.606 You know, my clients are across the health care spectrum, 00:03:28.689 --> 00:03:34.203 although I spend a lot of my time focused on the drug supply chain and the life 00:03:34.286 --> 00:03:38.880 sciences industry specifically. And my practice is sort of sits at 00:03:38.963 --> 00:03:40.380 the intersection of. 00:03:40.530 --> 00:03:46.612 policy and law. And so, you know, my clients tend to come to me to be 00:03:46.695 --> 00:03:51.973 their ears and eyes in Washington from a policy perspective, 00:03:52.056 --> 00:03:55.597 how federal agencies, how Congress, how, 00:03:55.680 --> 00:04:00.354 are making changes that require them to be, you know, thinking ahead, 00:04:00.437 --> 00:04:05.938 responding, and interacting in ways that continue to push their business forward. 00:04:06.021 --> 00:04:10.833 And so those range from sort of both legal questions, policy questions, 00:04:10.916 --> 00:04:15.877 strategic market access questions. And I've been doing this for about... 00:04:15.960 --> 00:04:20.318 17 years now. I'm currently at Manat, which is a hybrid sort of policy legal 00:04:20.401 --> 00:04:23.649 firm. And I work with a bunch of lawyers and non-lawyers, 00:04:23.732 --> 00:04:28.148 including clinicians and data analysts working with our clients to sort of do 00:04:28.231 --> 00:04:30.778 exactly what I do. So it's a really fun time. 00:04:30.861 --> 00:04:35.102 And I think as we're about to dive into the topics we're going to discuss, 00:04:35.185 --> 00:04:39.076 you're going to see sort of how busy we've both been, I think. Yeah, 00:04:39.159 --> 00:04:43.600 that's awesome. Thank you. That's just really great experiential wealth here 00:04:45.960 --> 00:04:50.825 So the first theme, which has been a riding theme through all of our guests 00:04:50.908 --> 00:04:55.971 and discussion, is MFN, looking at Guard and Globe and different perspectives, 00:04:56.054 --> 00:05:01.182 particularly our international pricing models are kind of coming in to the U.S. 00:05:01.266 --> 00:05:05.620 and sort of legally affecting drug pricing, state, federal policy. 00:05:15.960 --> 00:05:19.962 on pharma and payers, broadly speaking in the US today. 00:05:20.046 --> 00:05:22.720 And how does navigating this kind of 00:05:22.950 --> 00:05:25.266 I guess almost reference pricing effect coming, 00:05:25.350 --> 00:05:27.564 like it's a global effect coming into the US. 00:05:27.647 --> 00:05:31.853 How does that work from a day to day when it comes to the payers in the US and well, 00:05:31.936 --> 00:05:33.570 payers and pharma, I should say? 00:05:34.140 --> 00:05:38.420 Yeah, it's a great question. And I think in the last... 00:05:38.550 --> 00:05:45.490 year in particular, we've seen a really significant shift in in the... 00:05:46.050 --> 00:05:51.411 Psyche and positioning and thinking of both payers and manufacturers, 00:05:51.495 --> 00:05:57.961 the concept of incorporating some form of international reference pricing into U.S. 00:05:58.044 --> 00:06:04.273 markets is not brand new, although it has taken on a certain strong significance 00:06:04.357 --> 00:06:07.807 today. in the second Trump administration. But going back, 00:06:07.890 --> 00:06:13.011 To the Obama administration, there had been a series of proposals to incorporate 00:06:13.095 --> 00:06:18.667 the international prices. We saw that again in the first Trump administration. 00:06:18.750 --> 00:06:24.528 And then again, now, as we're in the second Trump administration, 00:06:24.612 --> 00:06:28.850 they have really leaned into this concept of... 00:06:28.980 --> 00:06:31.980 I think it is rooted in core... 00:06:32.310 --> 00:06:37.003 populist beliefs of fairness and this belief that the U.S. 00:06:37.086 --> 00:06:39.310 may pay too much for drugs. 00:06:40.910 --> 00:06:47.310 And in the last year, we've really seen, I think, a shift, and that shift being the 00:06:47.880 --> 00:06:49.327 a recognition, 00:06:49.410 --> 00:06:53.477 that international reference pricing is probably here to stay as a, 00:06:53.560 --> 00:06:58.308 as a concept, right. And that it's not going to live or die with one political 00:06:58.391 --> 00:07:02.954 party, right. We, there's a lot of uncertainty around the upcoming November 00:07:03.037 --> 00:07:07.037 elections, right. whether Democrats take the House, whether Democrats would take 00:07:07.200 --> 00:07:11.499 both houses, the Senate, the House and Senate, but sort of irrespective, 00:07:11.583 --> 00:07:14.200 I think, the political outcome in November, 00:07:14.340 --> 00:07:19.080 I think most of my clients tend to think that The... 00:07:19.770 --> 00:07:23.634 idea of incorporating some form of international reference pricing 00:07:23.718 --> 00:07:27.821 is probably here to stay. You asked sort of, you know, what does that, 00:07:27.905 --> 00:07:32.570 how is it impacting them? You know, from a manufacturer perspective, you know, 00:07:32.910 --> 00:07:37.310 I think the initial impact really has been some degree of sort of 00:07:37.920 --> 00:07:40.539 freezing and waiting period. In other words, 00:07:40.622 --> 00:07:45.720 I think a lot of manufacturers feel like this time, the pace of change is frenetic, 00:07:45.930 --> 00:07:50.590 Everything feels very uncertain. And I can say a lot of our clients are holding... 00:07:50.730 --> 00:07:51.880 international launches. 00:07:52.380 --> 00:07:55.740 trying to understand exactly what is going to happen here. 00:07:55.860 --> 00:07:59.328 And trying to avoid a situation where, for example, 00:07:59.412 --> 00:08:03.637 they go into a negotiation with Germany or launch in Germany. 00:08:03.720 --> 00:08:10.720 and the UK. UK has made a bad example. They launch in Japan and have somehow 00:08:11.105 --> 00:08:11.917 triggered 00:08:12.000 --> 00:08:16.867 a series of significant future price impacts in the United States. And so, 00:08:16.950 --> 00:08:19.563 There continues to be a lot of uncertainty right now. 00:08:19.646 --> 00:08:23.632 You mentioned sort of the frameworks like Globengarde as to whether or not those 00:08:23.715 --> 00:08:27.517 models will ultimately move forward or they'll survive the legal challenge. 00:08:27.600 --> 00:08:28.620 And so I think 00:08:28.830 --> 00:08:33.191 And manufacturers right now really are in a bit of a wait and see period, 00:08:33.274 --> 00:08:37.574 although the action they have taken in many cases is pretty impactful in 00:08:37.658 --> 00:08:41.227 that they've actually made a decision, at least temporarily, 00:08:41.310 --> 00:08:44.050 to not launch in certain ex-US jurisdictions. 00:08:45.060 --> 00:08:48.497 I think payers are probably a little further behind. 00:08:48.580 --> 00:08:52.980 I think they're waiting to see whether or not these concepts are, 00:08:53.220 --> 00:08:57.830 hold, whether or not international reference pricing ultimately becomes 00:08:57.913 --> 00:08:58.597 embedded in 00:08:58.680 --> 00:09:03.863 into pricing structures, but I think they certainly see this as an opportunity 00:09:03.947 --> 00:09:06.040 for cost savings going forward. 00:09:06.450 --> 00:09:10.745 Well, I mean, we've spoken and we've worked actually with clients where this 00:09:10.828 --> 00:09:15.123 is really playing out. The idea that you might launch in a European country, 00:09:15.206 --> 00:09:19.155 the net price that used to be confidential kind of isn't confidential. 00:09:19.238 --> 00:09:23.879 We can discuss that a little bit. And then it transfers and sort of haunts its way 00:09:23.962 --> 00:09:25.690 back to the US. And of course, 00:09:25.860 --> 00:09:29.654 the revenue generation of the U.S. becomes significantly impacted. 00:09:29.737 --> 00:09:33.473 They want to launch in Europe or some European countries, to say. 00:09:33.556 --> 00:09:37.526 Can you see, if you say that international reference pricing is here, 00:09:37.609 --> 00:09:42.343 maybe for the foreseeable future, can you see on the domestic side within the U.S. 00:09:42.427 --> 00:09:45.575 legal and constitutional hurdles around this? Or, like, 00:09:45.658 --> 00:09:49.099 is Garden Globe being challenged legally even to this point? 00:09:49.183 --> 00:09:54.000 In the same way we've seen, we're going to talk about CMS drug price negotiations, 00:09:55.860 --> 00:09:58.654 as well, but that's been, you know, progressed through. 00:09:58.737 --> 00:09:59.940 How does that play out? 00:10:00.040 --> 00:10:03.548 And so and does that only add to the kind of uncertainty? And, you know, 00:10:03.631 --> 00:10:06.341 drug companies can't just cause a launch forever. Right. 00:10:06.425 --> 00:10:09.733 Like going to have to do something like they've invested in the R&D. 00:10:09.817 --> 00:10:13.275 They've invested in clinical trial. We are seeing drugs being launched, 00:10:13.358 --> 00:10:16.708 but they're kind of struggling with the context of how to navigate. 00:10:17.500 --> 00:10:20.837 that launch now. So let me begin with the boring... 00:10:20.920 --> 00:10:25.020 legal answer role, although I'll try to make it not boring, which is... 00:10:25.210 --> 00:10:28.730 there's a real big distinction between 00:10:28.900 --> 00:10:34.103 when Congress has authorized something and when a federal agency is acting using 00:10:34.186 --> 00:10:38.332 existing authority. I think it's important to know that to date, 00:10:38.415 --> 00:10:40.860 Congress has not authorized something 00:10:41.050 --> 00:10:47.270 CMS or any other agency to utilize an international reference pricing framework. 00:10:47.650 --> 00:10:53.389 So today, the models that are being proposed are being done using what's known 00:10:53.472 --> 00:10:59.070 as demonstration authority, which is a sort of broad grant of authority to, 00:10:59.170 --> 00:11:04.584 or broad but not limitless grant of authority from Congress to the agency 00:11:04.668 --> 00:11:08.810 to run sort of demonstration tests, right, experiments. 00:11:09.430 --> 00:11:15.650 to test whether certain changes to how Medicare operates can improve the program. 00:11:16.630 --> 00:11:18.950 I think Garden Globe, if they are so garden, 00:11:19.034 --> 00:11:21.791 the current status of Garden Globe is that they are, 00:11:21.875 --> 00:11:25.725 we have proposed rules and final rules have now arrived at what's called 00:11:25.808 --> 00:11:30.369 the Office of Management and Budget, which is really the last step before those rules 00:11:30.452 --> 00:11:31.490 would be finalized. 00:11:31.810 --> 00:11:34.971 There's always some degree of possibility they're not finalized, 00:11:35.055 --> 00:11:38.723 but my personal expectation is that those rules will be finalized sometime 00:11:38.806 --> 00:11:42.829 this year. I think there's a great deal of legal uncertainty as to whether or not 00:11:42.912 --> 00:11:47.591 those rules two models, Garden Globe, will survive the legal challenge, 00:11:47.674 --> 00:11:53.140 and I am highly confident that they will be subject to legal challenge. So, at 00:11:53.350 --> 00:11:56.920 So that's that's. Point one. Point two is... 00:11:57.130 --> 00:11:58.967 Congress may have an interest. 00:11:59.050 --> 00:12:02.521 in legislating on international reference pricing. 00:12:02.605 --> 00:12:07.510 And that's a very different legal question. If Congress authorizes... 00:12:07.840 --> 00:12:10.907 CMS to incorporate international reference prices, 00:12:10.991 --> 00:12:14.625 either in how they generally pay for drugs or, for example, 00:12:14.708 --> 00:12:19.351 another concept would be incorporating international reference pricing into 00:12:19.435 --> 00:12:21.640 the drug price negotiation program. 00:12:22.510 --> 00:12:27.990 legal challenges are still possible on constitutional grounds, but... 00:12:28.360 --> 00:12:32.272 I think the chances of those laws surviving legal challenge are much higher 00:12:32.355 --> 00:12:33.900 than Globe and Card would be. 00:12:34.030 --> 00:12:38.433 From a manufacturer's perspective, would they view Globengard as mandatory, 00:12:38.516 --> 00:12:40.670 even if it's not statutory in place? 00:12:41.140 --> 00:12:45.893 Yeah, so there's sort of an interesting dance currently playing out. 00:12:45.976 --> 00:12:49.022 If Globe and Guard go into effect, they are, 00:12:49.106 --> 00:12:54.143 and they survive legal challenge, they are designed as mandatory models. 00:12:54.226 --> 00:12:59.193 So any manufacturer subject to the model would be subject to the model. 00:12:59.276 --> 00:13:03.816 But there's a really big footnote there, which is simultaneously, 00:13:03.899 --> 00:13:09.150 the Trump administration has been negotiating what I'll generally call most 00:13:09.233 --> 00:13:10.940 favored nation policies. 00:13:11.080 --> 00:13:15.427 pricing agreements with manufacturers. They started with the largest 17 00:13:15.510 --> 00:13:20.294 manufacturers, of which they've entered into agreements with all of those now, 00:13:20.377 --> 00:13:21.500 and they're now... 00:13:21.640 --> 00:13:25.850 entering into agreements with a smaller subset of small and mid-sized 00:13:25.933 --> 00:13:28.960 manufacturers. Are... understanding, 00:13:29.080 --> 00:13:33.000 is that those manufacturers, if they execute those agreements, 00:13:33.430 --> 00:13:38.239 And there's a number of different commitments as part of those agreements, 00:13:38.323 --> 00:13:39.156 including – 00:13:39.280 --> 00:13:43.960 some pricing commitments in Medicaid would be exempt from Guard and Globe. 00:13:44.043 --> 00:13:46.877 So we may enter a very interesting situation. 00:13:46.960 --> 00:13:51.794 situation where if Garden Globe are finalized, let's say this fall, 00:13:51.878 --> 00:13:54.300 and they survive legal challenge, 00:13:54.520 --> 00:13:58.820 A portion of U.S. manufacturers will be subject to those claims. 00:13:58.960 --> 00:14:02.697 But a large portion, including the largest manufacturers, 00:14:02.780 --> 00:14:06.987 which constitute the largest significant force of drug spending, 00:14:07.070 --> 00:14:12.700 will actually be exempt based on voluntary pricing commitments they've already made. 00:14:12.820 --> 00:14:14.720 generous or is that another one? 00:14:14.920 --> 00:14:20.782 No, no, you're right. So that's right. So the 17 manufacturers plus this other group 00:14:20.865 --> 00:14:26.444 of manufacturers currently negotiating now are agreeing to a series of voluntary 00:14:26.528 --> 00:14:30.337 commitments. One is what you just referenced, Generous. 00:14:30.421 --> 00:14:35.787 This is a voluntary model where you would offer international reference price 00:14:35.871 --> 00:14:36.720 in Medicaid. 00:14:44.920 --> 00:14:49.914 RFRX website, and they want manufacturers to commit to prospective MFN. 00:14:49.997 --> 00:14:55.421 That is, going forward, manufacturers are committing to launching products at 00:14:55.504 --> 00:15:01.356 an aggregated net price in the U.S. that is no greater than the most favored nation 00:15:01.440 --> 00:15:04.860 price overseas, which is also pretty significant. 00:15:04.944 --> 00:15:10.653 And in exchange for those commitments, those manufacturers will receive both some 00:15:10.736 --> 00:15:11.570 degree of 00:15:14.920 --> 00:15:18.600 well as we understand Globe and Guard exemptions. So, 00:15:18.760 --> 00:15:23.728 One of the things we're seeing play out is how the stakeholders of this are trying 00:15:23.812 --> 00:15:28.740 to dance to avoid the scenario. So, for example, a drug company manufacturer is, 00:15:28.930 --> 00:15:31.790 says, OK, we're going to delay launch in Europe. 00:15:32.110 --> 00:15:36.787 So that whether it's the 19 OECD basket from Globe Guard or the eight countries, 00:15:36.870 --> 00:15:40.892 the G7 minus US. Yeah, and generous. Got Denmark, Switzerland, right, 00:15:40.976 --> 00:15:43.629 and generous. So what you do is you say, okay, 00:15:43.713 --> 00:15:47.616 so I'm not going to launch in those markets yet. I'm going to wait. 00:15:47.699 --> 00:15:51.210 I'm going to launch in the US. There is no reference price. 00:15:51.520 --> 00:15:56.560 to compare and aggregate and i launched in the us today and i'm going to sit and wait 00:15:56.740 --> 00:15:59.460 maybe two three years and launch later. 00:15:59.740 --> 00:16:02.237 And we've seen some manufacturers even come out and say, oh, 00:16:02.321 --> 00:16:03.971 we're not going to Germany. Yeah. 00:16:04.390 --> 00:16:08.712 So, number one, does that get around, this whole reporting? And in theory, 00:16:08.795 --> 00:16:12.938 does that obfuscate any notion that there'll be a cheaper drug price in 00:16:13.021 --> 00:16:16.212 the U.S.? Because if there's no cheaper European price, 00:16:16.295 --> 00:16:19.427 then you can just launch whatever price you want. One, 00:16:19.510 --> 00:16:22.010 I would say my first reaction is I think – 00:16:22.240 --> 00:16:26.520 I've been struck by how unique every single manufacturer is. 00:16:26.680 --> 00:16:33.350 circumstances, right? That it depends widely on how many products you have, 00:16:33.760 --> 00:16:36.918 where you manufacture, what your tariff exposure is, 00:16:37.001 --> 00:16:39.847 and the size of your patient population, right? 00:16:39.931 --> 00:16:44.896 So there's a different story for companies launching rare disease products versus 00:16:44.980 --> 00:16:47.577 companies launching, you know, a new GLP-1. 00:16:47.660 --> 00:16:52.189 There's a major difference for companies that have one or two drugs versus 00:16:52.272 --> 00:16:54.017 companies that have 75 drugs. 00:16:54.100 --> 00:16:59.072 commercialized products. But I guess the short answer to the question is yes. 00:16:59.155 --> 00:17:03.995 I mean, I think some companies will be able to engage in strategic launches 00:17:04.079 --> 00:17:08.973 that enable them to avoid the broadest effects of current MFN agreements. 00:17:09.056 --> 00:17:14.601 The other piece that's happening that I think is really important to pay attention 00:17:14.685 --> 00:17:19.818 to, we already saw it happen in the UK. It's currently potentially happening 00:17:19.902 --> 00:17:22.510 in Germany, uh, is, is the concept of, 00:17:22.600 --> 00:17:27.796 adjustments occurring and the prices paid by those international countries, 00:17:27.879 --> 00:17:31.667 right? You're closer to what occurred within the U.K., 00:17:31.750 --> 00:17:35.404 There's a process that's currently occurring in Germany today. You know, 00:17:35.487 --> 00:17:37.999 it's interesting. Within the Trump administration, 00:17:38.083 --> 00:17:41.893 there are really two schools of thought, and they're pretty evenly divided. 00:17:41.976 --> 00:17:45.347 There is one school that is very comfortable with this idea that, 00:17:45.430 --> 00:17:49.290 that manufacturers in the U.S., should receive 00:17:49.600 --> 00:17:54.224 less money for their products, right? That reimbursement should be lower. 00:17:54.308 --> 00:17:59.125 There's another group of people who are not comfortable with the idea of ice 00:17:59.209 --> 00:18:04.220 setting, but they're very comfortable with the idea of using the US's strategic 00:18:04.303 --> 00:18:05.980 and international strength 00:18:06.220 --> 00:18:13.140 to force other countries to pay more. As you might imagine, pharma companies are... 00:18:13.240 --> 00:18:17.573 hoping that the latter is really where the pressure ends up going, right? 00:18:17.656 --> 00:18:20.500 In other words, is there some world in which... 00:18:20.650 --> 00:18:24.887 It's not necessarily that the U.S. is spending significantly less money 00:18:24.970 --> 00:18:27.580 on prescription drugs. But... 00:18:28.120 --> 00:18:32.480 European countries in particular start to pay their quote unquote fair share. 00:18:32.590 --> 00:18:37.234 Totally. And we get that. And you're right. In the UK and England, 00:18:37.318 --> 00:18:42.535 for example, with Nice, they have adjusted the cost per quality threshold. 00:18:42.619 --> 00:18:46.630 They've raised it from 20 to 30,000 to 25 to 35 sort of. 00:18:47.110 --> 00:18:50.187 15-20% increase. They also agreed to spend more, 00:18:50.270 --> 00:18:54.400 like doubled 0.3% to 0.6% over a certain number of years on GDP, 00:18:54.484 --> 00:18:59.733 on innovative medicines. And that wasn't because of any argument about who should 00:18:59.817 --> 00:19:04.079 be paying more or less. It was because of tariffs and trade deals. 00:19:04.162 --> 00:19:08.358 And we actually didn't want tariffs on pharmaceuticals in the UK. 00:19:08.441 --> 00:19:13.050 So you're right. The US were able to use other broader and overarching 00:19:13.210 --> 00:19:17.159 methods in negotiation for us to affect our internal pricing dialogue. 00:19:17.242 --> 00:19:21.019 And we've seen already, in fact, the U.S. trade relations, I think, 00:19:21.102 --> 00:19:22.830 have opened up a legal system. 00:19:23.410 --> 00:19:26.650 Section 301, I think, in Germany. That's right. Yes. 00:19:27.040 --> 00:19:31.373 It's quite extraordinary. Like for an external country to say they're opening 00:19:31.457 --> 00:19:35.790 a legal kind of challenge on a country's own internal pricing policy is quite 00:19:35.873 --> 00:19:40.493 remarkable. And so they've done that to Germany and people are asking how they can 00:19:40.577 --> 00:19:44.020 do it to other countries. So. How is that going? I mean, 00:19:44.290 --> 00:19:46.793 I'm just trying to see where that takes place. Like, 00:19:46.876 --> 00:19:50.026 this is all just pushing, isn't it, from different methodologies, 00:19:50.109 --> 00:19:53.809 just trying to get other countries to pay more. That's what this is about. 00:20:00.020 --> 00:20:03.726 led by the Department of Commerce and Secretary Lutnik, 00:20:03.809 --> 00:20:06.840 that really is focused on that piece, right? 00:20:07.250 --> 00:20:11.550 My assumption is there's going to be push and pull on both sides, right? 00:20:11.633 --> 00:20:15.446 I think some of those efforts internationally will be successful 00:20:15.529 --> 00:20:19.730 in increasing the prices paid by foreign countries. But I also think, 00:20:19.940 --> 00:20:23.584 it's likely that there's going to be bleed over of ultimately lower international 00:20:23.667 --> 00:20:25.197 reference prices to some extent. 00:20:25.280 --> 00:20:29.577 into US pricing. Okay. And before we go to CMS drug price negotiations, 00:20:29.660 --> 00:20:33.093 which I'm sure we'll have lots of stories we could share, 00:20:33.177 --> 00:20:36.116 let's just look at the reporting of these prices. 00:20:36.199 --> 00:20:40.003 So we know that let's say you're a pharmaceutical manufacturer, 00:20:40.086 --> 00:20:44.691 and you do launch in European countries. And we know there's this method one 00:20:44.775 --> 00:20:49.812 reporting and method two reporting. So the way in which CMS actually get the prices 00:20:49.895 --> 00:20:50.728 of, 00:20:51.020 --> 00:20:53.950 I guess what were confidential net prices, 00:20:54.033 --> 00:20:57.620 but get the net prices to transmit back to the US, 00:20:57.710 --> 00:21:03.320 for MFN Guard Globe Generous. So method one, it's using data systems like, 00:21:03.404 --> 00:21:07.475 for example, I think Eversana have a Navlin, IQEMIDAS, 00:21:07.558 --> 00:21:11.399 the idea being that they track not just list price, 00:21:11.482 --> 00:21:17.330 but some net prices may be aggregated, may or may not be correct. And CMS... 00:21:17.540 --> 00:21:19.859 use those commercial software to say, right, 00:21:19.943 --> 00:21:23.682 we've conceived that you're doing 20, 30% discount European countries. 00:21:23.765 --> 00:21:27.777 So we're going to apply that here. This pressure test that we is that good? 00:21:27.860 --> 00:21:30.835 Are we good with that? Yeah, yeah, that's exactly right. 00:21:30.918 --> 00:21:32.720 So the method one is essentially, 00:21:33.020 --> 00:21:35.885 manufacturer, you're not required to report anything to us. 00:21:35.969 --> 00:21:39.684 We're going to rely on these third-party data sources. I'll just say a note. 00:21:39.767 --> 00:21:43.682 I think this has been a boon for those. I think many of our manufacturer clients 00:21:43.765 --> 00:21:46.880 didn't necessarily have subscriptions to all of those resources, 00:21:46.964 --> 00:21:49.779 and now I felt sort of their hand forced being like, well, 00:21:49.862 --> 00:21:53.077 if we're going to at least consider the possibility of method one, 00:21:53.161 --> 00:21:54.837 we should probably understand what 00:21:54.920 --> 00:21:57.680 what prices are listed in those databases. Right. 00:21:57.890 --> 00:22:01.006 Am I right now in thinking, well, there is a method two, 00:22:01.090 --> 00:22:03.406 which is a more voluntary open your books. 00:22:03.489 --> 00:22:07.120 So if you kind of say you don't like method one or you go and buy 00:22:07.203 --> 00:22:11.291 your IQVM-itis, look at the reporting or every sign of Navlin and you go, 00:22:11.374 --> 00:22:14.948 whoa, whoa, these guys are way off. What we'll do is method two. 00:22:15.031 --> 00:22:19.404 We will come and we'll open our books and we'll I guess it's auditable factual 00:22:19.488 --> 00:22:23.030 tracing and say, actually, our net price looks more like this. 00:22:23.240 --> 00:22:26.603 So can you not use method one? Could you please use method two? 00:22:26.686 --> 00:22:30.417 I'm trying to simplify, but is that kind of what we're talking about? 00:22:30.500 --> 00:22:34.610 That's right. Yes. and Under the method 2, 00:22:34.970 --> 00:22:39.843 And under method one, is the calculation the same or is like method one more about 00:22:39.927 --> 00:22:44.498 like the second least expensive and method two is more an aggregated or is it 00:22:44.581 --> 00:22:48.004 a similar calculation? It's no, it's the same. Ultimately, 00:22:48.087 --> 00:22:52.295 it's the second lowest price of that grouping of countries. But I mean, 00:22:52.379 --> 00:22:54.960 the difference really is. Um, 00:22:55.070 --> 00:22:59.632 I think there's a great deal of uncertainty for manufacturers and loss 00:22:59.715 --> 00:23:03.630 of control associated with method one, right? Relying on... 00:23:04.040 --> 00:23:09.277 third-party data sources that may or may not be accurate. Whereas, you know, 00:23:09.360 --> 00:23:15.157 the both upside and downside of method two is that it's your true net price in those 00:23:15.240 --> 00:23:17.480 international countries. Got it. 00:23:23.680 --> 00:23:28.038 You know, today's conversation highlights just how quickly market access strategy 00:23:28.122 --> 00:23:32.096 is changing around the world. One of the ways we help our clients navigate 00:23:32.179 --> 00:23:33.660 that uncertainty is through 00:23:34.040 --> 00:23:38.419 Vipora's innovative contracting tracker that combines nearly 2,000 publicly 00:23:38.503 --> 00:23:42.823 reported agreements from healthcare systems around the world into a single 00:23:42.906 --> 00:23:47.523 searchable evidence base, helping teams identify emerging trends and make local 00:23:47.607 --> 00:23:50.737 strategic decisions with greater confidence. You know, 00:23:50.820 --> 00:23:53.533 it's a resource we rely on ourselves every day. 00:23:53.617 --> 00:23:56.032 And if you'd like to access this resource, 00:23:56.116 --> 00:24:00.614 drop me an email or message me on LinkedIn or visit Vipora.com for details of 00:24:00.697 --> 00:24:02.780 our innovative contracting tracker. 00:24:04.040 --> 00:24:04.873 you 00:24:07.190 --> 00:24:10.334 Let's go to our second theme, IRA, CMS, drug price negotiations. 00:24:10.417 --> 00:24:13.359 It's been a pleasure to work with you, with various clients, 00:24:13.443 --> 00:24:15.981 and present at conference. We've seen round one IPA. 00:24:16.065 --> 00:24:19.713 We've seen round two IPA. We've been on many journeys together. Now, IPA3, 00:24:19.796 --> 00:24:22.940 what's interesting about IPA3 is a couple of things. Number one, 00:24:23.023 --> 00:24:26.218 we're bringing in Part B medicines, physician administered within 00:24:26.301 --> 00:24:30.302 the hospital, as opposed to just the kind of Part D that we're kind of outpatient 00:24:30.385 --> 00:24:33.227 self-administration. And the second thing is we're moving, 00:24:33.310 --> 00:24:36.890 and I'll probably get you to explain this a bit better to our audience, 00:24:37.190 --> 00:24:42.571 We're moving from kind of CMS interpreting what the guidance is to a more formalized 00:24:42.654 --> 00:24:47.710 rulemaking of that guidance, which means there's slightly more of a legal shift 00:24:47.794 --> 00:24:52.134 on the procedure and the methodology of how CMS will be negotiating. 00:24:52.217 --> 00:24:57.208 I'm guessing probably more legal counsel and presence and maybe less deviation 00:24:57.291 --> 00:25:01.910 and exploration or interpretation, but more a rigid standard framework. 00:25:07.190 --> 00:25:10.600 I agree. Yeah, let me start with the move... 00:25:10.760 --> 00:25:14.312 of the program, again, back to boring lawyer stuff, 00:25:14.396 --> 00:25:17.960 from the move of the program from one driven by... 00:25:18.140 --> 00:25:21.000 guidance to one driven by 00:25:21.230 --> 00:25:28.230 regulation. And there are your correct nuances and important considerations as we 00:25:28.883 --> 00:25:35.883 move to a program that is bound by and driven by regulation versus one that's 00:25:36.158 --> 00:25:39.370 driven by guidance. And, and, and, 00:25:39.650 --> 00:25:44.101 Just to update the audience, we're currently in that rulemaking process, 00:25:44.184 --> 00:25:46.010 right? So CMS has proposed... 00:25:46.190 --> 00:25:50.564 a series of regulations. And we're currently in the 60-day climate period 00:25:50.647 --> 00:25:55.467 for those regulations. And we're working with dozens of manufacturers that have 00:25:55.550 --> 00:26:00.134 a stake in those regulations, and they're submitting public comments. 00:26:00.217 --> 00:26:03.870 I think overarching, the most important piece here is, 00:26:03.980 --> 00:26:08.194 I think it's a fair assumption that once CMS finalizes these regulations, 00:26:08.277 --> 00:26:11.078 although they'll update them probably every year, 00:26:11.161 --> 00:26:15.669 that the program is going to become even more solidified. You know, that said, 00:26:15.752 --> 00:26:19.907 I don't want to under I don't overstate the significance of this moment, 00:26:19.991 --> 00:26:23.397 because I think the headline story from the proposed rule was. 00:26:23.480 --> 00:26:26.240 CMS is largely putting into regulation 00:26:26.390 --> 00:26:30.173 the program that was finalized over the first two IPays. 00:26:30.256 --> 00:26:33.570 So we had some shifts between IPay 1 and IPay 2. 00:26:33.710 --> 00:26:37.090 But really, CMS has been remarkably consistent with, 00:26:37.220 --> 00:26:42.594 You know, in the actual negotiating room, CMS sits with copies of their guidance 00:26:42.677 --> 00:26:46.823 in front of them, and they really are driven by that guidance. 00:26:46.906 --> 00:26:51.257 And so while the program has been technically driven by guidance, 00:26:51.340 --> 00:26:55.214 it's felt very... regulatory driven. It's felt very rule-based. 00:26:55.297 --> 00:26:59.549 And so I actually think one of the more interesting pieces here is that 00:26:59.632 --> 00:27:04.460 the proposed rule really has not proposed a major shift in terms of how 00:27:04.550 --> 00:27:09.589 the agency has governed the program and will govern the program forward. 00:27:09.673 --> 00:27:12.590 It feels like it has entered into sort of 00:27:12.710 --> 00:27:19.710 It has institutionalized fairly quickly, and that CMS has clearly come up with, 00:27:20.090 --> 00:27:23.067 a lot of internal processes and procedures 00:27:23.150 --> 00:27:28.150 to try to make the negotiation possible, 00:27:28.280 --> 00:27:32.016 work in as non-arbitrary as a way as possible. Do you think, 00:27:32.099 --> 00:27:34.753 how will that play out in the negotiations? 00:27:34.836 --> 00:27:37.808 Because when we've both supported manufacturers, 00:27:37.892 --> 00:27:41.517 we've had legal counsel, usually with a manufacturer, and 00:27:41.600 --> 00:27:45.174 occasionally, maybe a bit later, not always necessarily with CMS. 00:27:45.257 --> 00:27:48.887 Do you think that this changes that or not? I actually do. I mean, 00:27:48.970 --> 00:27:51.982 CMS is largely, if you recall, in IPA26, the first IPA, 00:27:52.065 --> 00:27:55.920 CMS sent legal counsel to most of the meetings. Some of that, I think, 00:27:56.003 --> 00:28:00.421 was driven that we were also at the early stages of litigation in the drug price 00:28:00.504 --> 00:28:03.966 negotiation program, which we may talk about. In IPA2 and IPA3, 00:28:04.049 --> 00:28:08.100 legal counsel has been absent from those meetings. It's not that they're 00:28:11.600 --> 00:28:14.794 Most of our clients tend to still send an attorney with them, 00:28:14.877 --> 00:28:16.220 although not all clients. 00:28:16.340 --> 00:28:23.180 We, me, as a lawyer, advising clients on this process, still lives and breathes. 00:28:23.510 --> 00:28:28.679 and dies by the guidance. And it will be helpful for me to have something drafted 00:28:28.763 --> 00:28:32.067 in regulatory text. You know, there continue to be, 00:28:32.150 --> 00:28:37.395 constantly issues of uncertainty that come up in advising clients as to what CMS 00:28:37.479 --> 00:28:41.658 is obligated or not obligated to do with respect to the program. 00:28:41.741 --> 00:28:46.454 And I do think it'll be helpful to have actual regulations to work with, 00:28:46.537 --> 00:28:51.582 but I'm not necessarily certain it'll change the overarching structure of who 00:28:51.666 --> 00:28:54.330 attends the meeting or how they operate. 00:28:54.590 --> 00:28:58.026 And just on that legal challenge, I remember many of the manufacturers, 00:28:58.109 --> 00:28:59.159 or maybe all of them, 00:28:59.690 --> 00:29:03.882 who also in parallel had a legal challenge to this whole procedure. 00:29:03.965 --> 00:29:08.986 Have they all materialized? Have they been thrown out or are they still ongoing? 00:29:09.070 --> 00:29:12.432 So litigation is ongoing, although, you know, to date, 00:29:12.515 --> 00:29:17.345 none of them have been successful. There are but there are a handful of cases 00:29:17.428 --> 00:29:19.470 that continue to work their way. 00:29:19.640 --> 00:29:23.320 through the courts, we're now sort of the federal courts, 00:29:23.480 --> 00:29:28.200 circuit court level or federal appeals court level, you know, I would say most 00:29:28.460 --> 00:29:32.337 Court observers are not terribly optimistic about, 00:29:32.420 --> 00:29:35.280 that any of these challenges will ultimately... 00:29:35.390 --> 00:29:39.504 to materialize in a way that strikes down the entire program. 00:29:39.587 --> 00:29:42.837 I do think there continues to be a possibility – 00:29:42.920 --> 00:29:48.094 of legal challenges on specific issues. And I'll just give you an example of one. 00:29:48.178 --> 00:29:52.898 While I mentioned the current proposed rule for the drug price negotiation 00:29:52.981 --> 00:29:53.757 program, the 00:29:53.840 --> 00:29:57.914 you know, largely puts into regulation the program as it operates today. 00:29:57.997 --> 00:30:01.597 One of the proposals that's gained a lot of attention and 00:30:01.680 --> 00:30:06.034 is a proposal for the treatment of fixed-dose combination products. 00:30:06.117 --> 00:30:08.677 Right. With, you know, in particular... 00:30:08.760 --> 00:30:13.400 products where there's a subcutaneous version of an intravenous product, 00:30:13.483 --> 00:30:17.533 often with the addition of the active ingredient hyaluronidase. 00:30:17.616 --> 00:30:22.846 CMS has proposed that while fixed dose combination products are generally treated 00:30:22.930 --> 00:30:25.864 as separate drugs and not negotiated together, 00:30:25.947 --> 00:30:30.062 where hyaluronidase or another active ingredient has been added, 00:30:30.146 --> 00:30:35.179 and the only effect of that addition is to change the route of administration, 00:30:35.262 --> 00:30:36.640 say from IV to sub-Q, 00:30:38.760 --> 00:30:43.060 I think CMS is likely to finalize that proposal, and I think CMS is likely to 00:30:43.170 --> 00:30:49.207 to be legally challenged on that proposal. And I think a court could consider... 00:30:49.290 --> 00:30:54.078 arguably... a more narrow challenge to certain drug price negotiation policies, 00:30:54.161 --> 00:30:58.424 even if it's unlikely that the entire law is found unconstitutional at this point. 00:30:58.508 --> 00:31:00.968 Got it. Yeah, that was a great answer, actually, 00:31:01.052 --> 00:31:04.944 because I've spoken to a few payers that have been knocking this one around 00:31:05.027 --> 00:31:09.237 and without necessarily a solution on it. The other thing I mentioned was Part B. 00:31:09.320 --> 00:31:13.530 I mean, in the US, you've got the whole Part B are fundamentally tied to provider 00:31:13.614 --> 00:31:17.506 buy and build economics rather than the traditional Part D kind of pharmacy 00:31:17.589 --> 00:31:18.490 benefit. I can... 00:31:18.630 --> 00:31:23.925 I've been hearing, I mean, you'll see this when we have spoken to payers in 00:31:24.009 --> 00:31:27.798 the system who have got all sorts of issues with this, 00:31:27.881 --> 00:31:33.320 and maybe small providers, GPOs, other people now being drawn into this whole 00:31:33.403 --> 00:31:37.551 freakonomic, if you like, of these drug price negotiations. 00:31:37.634 --> 00:31:43.360 How do you see this playing out when it's now affecting this kind of buy and bill 00:31:43.443 --> 00:31:45.810 and injectables and going to ASP? 00:31:48.630 --> 00:31:52.912 of organizations either going underwater or struggling with that kind 00:31:52.995 --> 00:31:57.550 of reimbursement. Yeah, and I'll say, you know, one of the potentially – 00:31:57.750 --> 00:32:02.790 more promising challenges to the drug price negotiation was one actually – 00:32:03.060 --> 00:32:08.856 brought by the infusion centers. Right. So, but I, you know, my, 00:32:08.939 --> 00:32:10.960 I continue to believe, 00:32:11.160 --> 00:32:17.099 that this issue has gained less. I think most providers continue to be not fully 00:32:17.182 --> 00:32:21.408 aware of, of what is coming for this third buy pay, right? 00:32:21.491 --> 00:32:25.560 The fact that there are going to be highly high-volume, 00:32:25.710 --> 00:32:28.628 Part B drugs where they earn significant margin today, 00:32:28.711 --> 00:32:32.907 where they will be where they will that margin will be significantly reduced. 00:32:32.991 --> 00:32:37.270 And I think there's growing awareness that it's slower than you might expect. 00:32:37.680 --> 00:32:41.883 We're still waiting on, even though we're just around the corner, 00:32:41.966 --> 00:32:47.356 CMS has continued to kick the can down the road on how they are going to effectuate 00:32:47.439 --> 00:32:52.780 or make providers whole on Part B drugs under the Drug Price Negotiation Program. 00:32:52.920 --> 00:32:56.299 Really fascinating that they've been able to push this that long. 00:32:56.382 --> 00:32:59.389 It actually wasn't included in the proposed rule for IPA3, 00:32:59.472 --> 00:33:03.840 even though IPA3 will be the first year that Part B products are being negotiated. 00:33:04.470 --> 00:33:09.452 And it may be that until the prices are effective January 1, 2028, 00:33:09.536 --> 00:33:15.515 that really or leading up to that, that we don't see major provider activation. 00:33:15.599 --> 00:33:16.750 But I do think. 00:33:16.860 --> 00:33:20.788 There are a lot of really unique considerations as we move from negotiating 00:33:20.871 --> 00:33:24.187 just pharmacy dispense products to physician dispense products. 00:33:24.270 --> 00:33:27.488 I think it's likely there is going to be, right? 00:33:27.571 --> 00:33:33.058 So when a provider prescribes a pharmacy dispense product that's been negotiated, 00:33:33.142 --> 00:33:38.850 I don't think we believe necessarily that there's really any significant difference 00:33:38.970 --> 00:33:40.010 impact 00:33:40.200 --> 00:33:43.783 to prescribing behavior. Maybe there has been some impact of formulary behavior, 00:33:43.866 --> 00:33:46.207 although frankly I don't think we've seen that. 00:33:46.290 --> 00:33:50.525 It's going to be different when we have the prescriber buying and billing 00:33:50.608 --> 00:33:55.376 the product and being reimbursed at MFP. So I think one major change here to watch 00:33:55.459 --> 00:34:00.109 for is, are we going to see a real change in prescribing behavior and physicians 00:34:00.192 --> 00:34:03.960 retreating away from that? prescribing drugs with MFPs. 00:34:04.110 --> 00:34:08.467 And do you remember, Ross, when, I mean, often in the negotiations, 00:34:08.551 --> 00:34:12.245 this kind of idea of a system affects, right? That, look, 00:34:12.329 --> 00:34:15.510 if you negotiate a really low MFP that's so low. 00:34:15.690 --> 00:34:19.510 then you're actually going to have formularies move away. 00:34:19.620 --> 00:34:23.827 and almost penalize the mfp product you just spend nine months negotiating 00:34:23.910 --> 00:34:28.639 in favor of better rebate products and i don't think that really panned out when we 00:34:28.722 --> 00:34:32.987 spoke to health plans and payers and formularies it was quite clear that if 00:34:33.071 --> 00:34:37.683 they started penalizing mfp products they would lose their medicare business like 00:34:37.767 --> 00:34:42.379 in fact i remember some of our payers i said that cms have actually rejected bids 00:34:42.463 --> 00:34:44.260 for the first time now based on 00:34:44.760 --> 00:34:48.848 plans, trying to move. And so they're doing other things like moving from 00:34:48.931 --> 00:34:53.591 a copay to co-insurance model and raising premiums and kind of hiding MFPs and some 00:34:53.674 --> 00:34:55.560 of that. If when it comes to the. 00:34:56.940 --> 00:35:01.768 intravenous like what are you saying is physicians may penalize mfp intravenous 00:35:01.851 --> 00:35:06.637 drugs right i mean if there's two you know if there are two competing products 00:35:06.720 --> 00:35:10.669 The clinician views them as clinically comparable and one has an MFP, 00:35:10.752 --> 00:35:15.344 you know, arguably I could see strong incentives for the prescriber to move away 00:35:15.428 --> 00:35:20.220 from prescribing the one that has a lower reimbursement differential, right? Yeah. 00:35:20.310 --> 00:35:24.607 Where the net between the buy-in bill is lower. 00:35:24.690 --> 00:35:27.899 It might be the survival of the organization. If it's small, 00:35:27.982 --> 00:35:28.970 it might be out... 00:35:29.190 --> 00:35:32.657 you know, in some of it might be not a large teaching academic unit. 00:35:32.740 --> 00:35:35.090 It may be like a small out in the rural area. 00:35:35.610 --> 00:35:40.080 regions and they may well struggle. We're going to sort of wrap up with some of 00:35:40.164 --> 00:35:44.404 the lifespans and future of MFN. I know we've covered some of this already. 00:35:44.487 --> 00:35:49.073 One of the popular questions we've had, and people have been feeding me questions 00:35:49.156 --> 00:35:52.473 already, going, oh, you're going to have policy and payers. 00:35:52.557 --> 00:35:56.393 The intersection of MFP and MFN has cropped up a few times. In fact, 00:35:56.476 --> 00:35:59.563 some of our payers didn't even know the answer to this. 00:35:59.647 --> 00:36:02.990 If a product has been through the negotiation with an MFP, 00:36:03.300 --> 00:36:05.680 whether it's Part D or Part B. 00:36:06.180 --> 00:36:10.689 and then it's suddenly subject to MFN, Guard Globe. Is there a carve-out? 00:36:10.773 --> 00:36:13.709 Is there a statutory carve-out which says, look, 00:36:13.793 --> 00:36:18.805 the fact you've been through MFP means you're actually safe from Guard and Globe, 00:36:18.889 --> 00:36:23.083 or is that not the case, or do we not know? No, that's not the case. 00:36:23.167 --> 00:36:28.179 My understanding is that products that have been negotiated can still be included 00:36:28.263 --> 00:36:32.206 in models like, for example, Generous or Guard and Globe. Right. 00:36:32.289 --> 00:36:34.680 So it doesn't protect them in any way? 00:36:36.180 --> 00:36:40.932 are protected from is having that MFM price incorporated into the drug price 00:36:41.016 --> 00:36:45.004 negotiation or a renegotiation. Right. So what you're saying is, 00:36:45.088 --> 00:36:48.380 say you have an MFP. that's been negotiated. 00:36:48.720 --> 00:36:52.782 If an MFN would kind of give you a lower price, that won't then override it. 00:36:52.865 --> 00:36:56.873 That's correct. Your MFP price is protected from that part of the equation. 00:36:56.956 --> 00:37:01.320 Yeah. Yes, that's right. Got it. Okay. That makes sense. That makes sense. And – 00:37:02.160 --> 00:37:07.031 As we wrap up, tell me, how are you kind of advising pharma clients now as they're 00:37:07.114 --> 00:37:10.777 planning their longer term U.S. and ex-U.S. launch strategies? 00:37:10.860 --> 00:37:14.100 What are you telling them or how are you advising them? 00:37:14.183 --> 00:37:17.061 And they can't always necessarily watch and wait. 00:37:17.144 --> 00:37:21.834 What is what is where is the direction? And I get there's a heterogeneous model 00:37:21.917 --> 00:37:25.240 depending on the drugs, depending on the disease areas. 00:37:32.160 --> 00:37:35.724 Kind of map broadly how that might play out when you're supporting or what 00:37:35.808 --> 00:37:37.058 companies might be doing. 00:37:37.170 --> 00:37:41.331 Yeah, well, I mean, I guess I think the most fundamental piece is we're building 00:37:41.414 --> 00:37:44.143 it into the models and the market access plan, right? 00:37:44.226 --> 00:37:47.963 I'm just to give an example. I'm working with a client right now putting 00:37:48.046 --> 00:37:53.130 together... sort of a memo on they're launching their first product in the U.S., 00:37:53.220 --> 00:37:57.780 later this fall, and they sort of asked for a soup to nuts, right, from a – 00:37:57.900 --> 00:38:02.426 federal payer perspective, what do we need to do from a Medicare coverage, 00:38:02.510 --> 00:38:03.880 coding, reimbursement, 00:38:04.020 --> 00:38:07.549 Life cycle management, all of these pieces. And, you know, 00:38:07.632 --> 00:38:12.531 two years ago, discussions of MFN and the Guard and Globe and and and even three 00:38:12.614 --> 00:38:17.637 or four years ago, drug price negotiation would not have been a part of that plan. 00:38:17.720 --> 00:38:22.640 They have to now. Right. So now, you know, companies need to be thinking about. 00:38:22.890 --> 00:38:27.650 launch indications, launch sequencing very differently than they did 00:38:27.960 --> 00:38:31.389 a few years ago. Companies need to be thinking about market sequencing, 00:38:31.473 --> 00:38:34.852 right, where they're launching different than they did, right? I mean, 00:38:34.936 --> 00:38:38.832 one helpful thing, frankly, is you know, at least right now is, you know, 00:38:38.915 --> 00:38:41.690 now that these models have come to light, you know, 00:38:41.880 --> 00:38:46.265 And we understand, for example, the market basket of countries and, you know, 00:38:46.348 --> 00:38:50.700 how CMS will select the price from those market baskets of other countries. 00:38:50.790 --> 00:38:55.837 companies are able to start designing or building around these constraints, 00:38:55.920 --> 00:38:59.513 Although I think one big limiting factor is it's a little, you know, 00:38:59.597 --> 00:39:02.163 I don't think we're in a stable period. You know, 00:39:02.246 --> 00:39:05.407 we don't know if Globe and Guard are here to stay. You know, 00:39:05.490 --> 00:39:09.138 we don't know if Generous is here to stay. We don't know if Congress, 00:39:09.221 --> 00:39:11.733 the next Congress, may wish to legislate on MFN. 00:39:11.817 --> 00:39:14.497 And so I will say it's a really difficult time to. 00:39:14.580 --> 00:39:17.209 to be a manufacturer and plan for these things, right? 00:39:17.292 --> 00:39:20.223 Because it's very hard to plan around uncertainty. You know, 00:39:20.306 --> 00:39:22.584 the last thing you want to do is not, you know, 00:39:22.667 --> 00:39:26.652 is wait to launch in Germany for three years only to find out that you could have 00:39:26.735 --> 00:39:31.472 launched in Germany. and made your product available to patients and saved lives or, 00:39:31.555 --> 00:39:34.979 you know, reduced harm and you would have been fine. Right. 00:39:35.063 --> 00:39:39.497 So I do think that that's keeping a lot of C-suite folks up at night. Right. 00:39:39.581 --> 00:39:43.220 Which is this just, total lack of uncertainty as to where, 00:39:43.380 --> 00:39:46.520 all of this is going. But I guess my key point is 00:39:46.770 --> 00:39:50.970 No organization should be going through planning, 00:39:51.300 --> 00:39:55.400 of a product and not taking into account these important factors. 00:39:55.620 --> 00:39:59.927 Yeah, totally. And one of the legal things that's come through, which could be very 00:40:00.010 --> 00:40:04.590 is. Some markets, like Spain recently, is looking to put through legislation which 00:40:04.673 --> 00:40:05.507 says, 00:40:05.770 --> 00:40:09.485 These confidential discounts legally and contractually are confidential. 00:40:09.568 --> 00:40:13.810 You can't share them with anyone outside. So if you come to Spain now and you want 00:40:13.893 --> 00:40:17.292 to give a discount, you can't just go and tell the U.S. president. 00:40:17.375 --> 00:40:21.406 It's meant to be a two way protection because some of the countries are seeing 00:40:21.489 --> 00:40:25.151 that they're not going to get launches there because the view is, well, 00:40:25.235 --> 00:40:27.450 the confidential price isn't confidential. 00:40:35.770 --> 00:40:39.010 to tell other countries what discounts they've been giving. 00:40:39.093 --> 00:40:43.346 So if markets suddenly start doubling down on this confidentiality illegally, 00:40:43.430 --> 00:40:46.951 if you go to Spain, come and give us 30% discount, that's great, 00:40:47.034 --> 00:40:50.105 'cause we want access. We're never gonna pay a US price, 00:40:50.188 --> 00:40:53.597 it's never gonna happen, but this is a contractual obligation, 00:40:53.680 --> 00:40:55.367 you can't go and share it now. 00:40:55.450 --> 00:41:00.075 with the US and you're going to sign that contract so we get access and to kind 00:41:00.159 --> 00:41:01.470 of block an MFN route. 00:41:01.630 --> 00:41:06.350 How does that look now if you then want to go and do a voluntary reporting, 00:41:06.880 --> 00:41:11.191 If you signed a deal which says you can't share our contract. I mean, 00:41:11.274 --> 00:41:14.758 my understanding is that most of the agreements to date, 00:41:14.841 --> 00:41:18.280 the sort of NFN agreements, you know, contain clauses, 00:41:18.490 --> 00:41:25.230 that recognize that a manufacturer may in certain instances, you know, be... 00:41:25.420 --> 00:41:30.733 compelled, from reporting, right? In other words, can't report and create exemptions 00:41:30.816 --> 00:41:34.716 for that. which seems to suggest the Spain model could be a really good model. 00:41:35.020 --> 00:41:39.700 But I also had this suspicion that, that, um... 00:41:39.820 --> 00:41:42.887 U.S. federal policymakers, commerce... 00:41:42.970 --> 00:41:48.004 are going to be really unhappy with that move, right? And that long-term, 00:41:48.088 --> 00:41:49.630 that's probably not... 00:41:50.020 --> 00:41:55.420 a sustainable model, right? If every country just makes these prices not... 00:41:55.510 --> 00:41:59.565 Disclosable There's going to be something that comes next I just can't imagine 00:41:59.648 --> 00:42:02.854 that's how this all nets out Totally, totally So Ross, I mean, 00:42:02.937 --> 00:42:07.044 I'd love to speak to you for another hour I think This is going to be a special 00:42:07.128 --> 00:42:11.182 episode Because I think yours is going to be the longest Because we've covered 00:42:11.266 --> 00:42:14.558 the most content. You have been totally awesome, Ross. 00:42:14.641 --> 00:42:17.940 Anything exciting for you now over the next sort of – 00:42:18.023 --> 00:42:22.726 we're halfway through the year now. What does the next six months look like 00:42:22.809 --> 00:42:25.661 for you? Are you coming over to Europe at all? 00:42:25.744 --> 00:42:30.702 I'm coming over to London in 12 days. I've got your dates on my calendar. Yeah, 00:42:30.785 --> 00:42:34.148 got our little flat booked and made a veil. Wonderful. 00:42:34.231 --> 00:42:37.593 And we'll have to eat some spicy Indian food together. 00:42:37.677 --> 00:42:41.250 I'm going to take you out and test your waters, I think. 00:42:41.770 --> 00:42:45.243 Yes, I love that. Yeah, and I guess I would just say, I mean, 00:42:45.326 --> 00:42:47.207 it is that I don't anticipate the 00:42:47.290 --> 00:42:51.836 pace of change slowing. I do think it's really important to watch the outcome 00:42:51.919 --> 00:42:56.646 of the midterm elections because I think Democrats and Republicans have slightly 00:42:56.729 --> 00:43:00.160 different perspectives on MFNs. 00:43:00.280 --> 00:43:05.877 And then I think one of the really, but divided government is a high likelihood 00:43:05.960 --> 00:43:08.470 that, in 2027,000, 00:43:08.620 --> 00:43:15.620 to 2029 or 2728. And I think the question will be, is there a bipartisan path to 00:43:16.630 --> 00:43:20.306 towards some sort of broader drug pricing reform that incorporates mfn ross i think 00:43:20.389 --> 00:43:23.657 you're going to probably be the most popular episode we'll definitely have 00:43:23.740 --> 00:43:27.461 to have you back thank you so much giving us your time your expertise i look forward 00:43:27.544 --> 00:43:30.948 to working with you again i look forward to presenting with you again and i'm 00:43:31.032 --> 00:43:34.571 definitely looking forward to seeing you in london soon same my friend we'll see 00:43:34.655 --> 00:43:38.205 each other soon okay take care thanks for having me thank you thank you 00:43:46.630 --> 00:43:52.194 had to bring this to a close because in fact this might even be one of our longest 00:43:52.277 --> 00:43:53.310 podcasts i need 00:43:53.410 --> 00:43:57.444 Yeah, Ross is amazing. In fact, thanks to all of our guests across this season 00:43:57.527 --> 00:44:01.403 for being so generous with their time, their unique insights, perspectives, 00:44:01.486 --> 00:44:04.970 and really shaping, I think, maybe a different direction, I sense. 00:44:05.410 --> 00:44:10.563 our payer exchange going? Because really, we've gone from interviewing different 00:44:10.646 --> 00:44:15.472 payers across different seasons to maybe this deep dive, this US deep dive, 00:44:15.555 --> 00:44:20.839 whereby we've kind of gone and explored right down to the root of what's happening 00:44:20.923 --> 00:44:23.410 in the US and then the global economy. 00:44:23.860 --> 00:44:27.517 implications of that. Now, when we started planning this season, 00:44:27.600 --> 00:44:32.309 the objective was simple. Understand how changes in US pharmaceutical policy might 00:44:32.393 --> 00:44:34.822 influence the future of market access. Now, 00:44:34.906 --> 00:44:37.277 having listened to all four conversations, 00:44:37.360 --> 00:44:40.608 I think the discussion has become much broader than that. 00:44:40.691 --> 00:44:42.617 We've heard from a regional plan. 00:44:42.700 --> 00:44:47.761 specialty pharmacy, self-insured employers and policy expert from the legal 00:44:47.844 --> 00:44:53.453 perspective for manufacturers. So some of the biggest changes the industry has seen 00:44:53.537 --> 00:44:55.320 in decades, each looked at 00:44:55.570 --> 00:44:59.345 The same challenge through a different lens with some common themes, 00:44:59.428 --> 00:45:00.790 but we kept coming back, 00:45:00.910 --> 00:45:04.647 to some key issues. How do we support innovation while keeping healthcare 00:45:04.730 --> 00:45:07.734 affordable? How do we demonstrate value beyond price alone? 00:45:07.817 --> 00:45:11.554 And how do organizations make good decisions when they're not going to be 00:45:11.637 --> 00:45:14.943 able to do it? while the policy landscape is still evolving? 00:45:15.026 --> 00:45:17.366 Those questions aren't confined to the US. 00:45:17.450 --> 00:45:20.655 They increasingly influence pharmaceutical manufacturers, 00:45:20.738 --> 00:45:23.450 payers and healthcare systems around the world. 00:45:24.010 --> 00:45:27.406 So where next for the payer exchange? Well, let me tell you, 00:45:27.490 --> 00:45:32.104 season four is already in pre-production. We're planning our return to Europe for 00:45:32.187 --> 00:45:36.396 an entire season focused on one healthcare market that's changing rapidly. 00:45:36.479 --> 00:45:40.571 And I'm delighted to say we'll be welcoming back one of our most popular 00:45:40.655 --> 00:45:44.515 guests from our very first season. Until then, thanks for listening. 00:45:44.598 --> 00:45:46.570 Thanks for joining me on the payer 00:45:49.060 --> 00:45:53.082 If you would like to participate, maybe you're a current or former payer, 00:45:53.165 --> 00:45:57.412 maybe you're involved with policy, maybe you've heard and you want to be part 00:45:57.496 --> 00:46:01.912 of the conversation. Please contact me on LinkedIn or on Vipora.com and I'd love 00:46:01.995 --> 00:46:05.848 to engage with you. Until then, it's bye from me. Thank you very much. 00:46:05.932 --> 00:46:07.900 Omar Ali, Head of Payers at Vipora. 00:46:19.060 --> 00:46:26.060 Thank you. 00:46:32.230 --> 00:46:36.775 Every conversation in this season explores a different perspective on the challenges 00:46:36.858 --> 00:46:39.696 shaping pharmaceutical market access today. Together, 00:46:39.779 --> 00:46:43.663 they reflect the kind of discussions we're having every day with payers, 00:46:43.746 --> 00:46:47.134 policy experts and life science organizations around the world. 00:46:47.218 --> 00:46:50.055 You know, at Vipora, we're all about access strategy. 00:46:50.138 --> 00:46:54.408 We help pharmaceutical companies bridge the gap between the value of innovation 00:46:54.491 --> 00:46:56.750 and the realities of health care funding. 00:47:02.230 --> 00:47:05.241 we support better decisions, stronger partnerships, 00:47:05.325 --> 00:47:09.246 and ultimately better patient access to your innovative medicines. 00:47:09.330 --> 00:47:13.616 If today's conversation has inspired questions about your own challenges 00:47:13.699 --> 00:47:17.621 in market access, pricing, value-based and innovative contracting, 00:47:17.704 --> 00:47:20.837 or you'd just simply like to continue the discussion, 00:47:20.920 --> 00:47:25.570 we'd be delighted to hear from you. Visit Vipora.com to connect with our team, 00:47:25.653 --> 00:47:28.301 discover more episodes of the Payer Exchange, 00:47:28.384 --> 00:47:30.690 and more specialist on-demand content. 00:47:32.230 --> 00:47:33.063 you