1 00:00:07,090 --> 00:00:11,346 Welcome to the Payer Exchange, a podcast where I sit down with payers from around 2 00:00:11,429 --> 00:00:15,739 the world to talk candidly around what is shaping access value and decision making 3 00:00:15,822 --> 00:00:19,090 when it comes to drug pricing reimbursement in their markets. 4 00:00:30,090 --> 00:00:33,870 Thank you. 5 00:00:33,990 --> 00:00:37,137 So, welcome back to the Payer Exchange. Throughout this season, 6 00:00:37,221 --> 00:00:40,522 we've explored these changes from the perspective of health plans, 7 00:00:40,605 --> 00:00:43,910 commercial organisations... and those working alongside employers. 8 00:00:44,610 --> 00:00:48,907 We've looked at how different parts of the healthcare system are adapting, 9 00:00:48,991 --> 00:00:53,466 what this could mean for pharmaceutical manufacturers, and not just local US, 10 00:00:53,549 --> 00:00:56,011 but global impact. So to finish the season, 11 00:00:56,095 --> 00:00:59,410 I really wanted to step back and ask a broader question. 12 00:00:59,610 --> 00:01:04,168 How do pharmaceutical companies make global strategic decisions while 13 00:01:04,251 --> 00:01:09,078 the policy landscape undergo seismic shifts literally beneath their feet? 14 00:01:09,161 --> 00:01:14,055 This is why I am so pleased to bring Ross Margulies from Manat Health into 15 00:01:14,138 --> 00:01:19,100 this season. He has spent much of his career helping manufacturers navigate 16 00:01:19,183 --> 00:01:21,470 exactly these kinds of challenges. 17 00:01:21,960 --> 00:01:24,657 Now, I've known Ross for many years, professionally, 18 00:01:24,740 --> 00:01:28,828 as we've supported multiple pharmaceutical manufacturers during CMS drug price 19 00:01:28,911 --> 00:01:33,105 negotiations, right from the beginning, in fact. And personally, over this time, 20 00:01:33,188 --> 00:01:36,313 me and Ross have become great friends. Just a few weeks ago, 21 00:01:36,396 --> 00:01:40,460 we met up in London for lunch, and it was just really an amazing experience. 22 00:01:40,890 --> 00:01:45,580 In this episode, I'll be discussing with Ross global launch sequencing, 23 00:01:45,663 --> 00:01:48,538 international reference pricing, MFN policy, 24 00:01:48,621 --> 00:01:53,647 and how is it that decisions made in Washington are increasingly influencing 25 00:01:53,730 --> 00:01:57,882 pricing and market access strategies far beyond the US borders. 26 00:01:57,966 --> 00:02:02,857 This last and final episode will be pulling all the threads together on US 27 00:02:02,940 --> 00:02:07,310 policy and the effect on geopolitical landscape across the globe. 28 00:02:10,890 --> 00:02:12,940 you're going to listen to it this season. 29 00:02:21,270 --> 00:02:25,163 Hello and welcome. Today's episode, we have a really special guest. 30 00:02:25,247 --> 00:02:29,733 We've discussed with payers, we've discussed with providers and health plans, 31 00:02:29,817 --> 00:02:32,464 employers. Today, we're really talking policy, 32 00:02:32,547 --> 00:02:35,965 and it gives me great pleasure to introduce a great friend, 33 00:02:36,049 --> 00:02:39,170 a great professional colleague, Ross Margules, lawyer, 34 00:02:39,254 --> 00:02:43,325 Washington-based firm Manat. Ross, it's great to have you today. Omar, 35 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 36 00:02:47,978 --> 00:02:48,757 today. It's a 37 00:02:48,840 --> 00:02:53,423 fun time to be having these conversations around drug pricing and MFM. So, 38 00:02:53,506 --> 00:02:57,080 Ross, let's first give a little brief intro. So this is a, 39 00:02:57,164 --> 00:03:00,422 just so for the listeners are aware of this, this is, 40 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, 41 00:03:05,046 --> 00:03:08,115 we've spoken to health insurers, provider, policy, 42 00:03:08,199 --> 00:03:11,079 and really yours comes into the policy bracket. 43 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 44 00:03:16,207 --> 00:03:18,540 launch into some of these key themes. 45 00:03:18,840 --> 00:03:24,567 Yeah, sure. Absolutely. So I'm trained in practice as a as a health care attorney. 46 00:03:24,650 --> 00:03:28,606 You know, my clients are across the health care spectrum, 47 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 48 00:03:34,286 --> 00:03:38,880 sciences industry specifically. And my practice is sort of sits at 49 00:03:38,963 --> 00:03:40,380 the intersection of. 50 00:03:40,530 --> 00:03:46,612 policy and law. And so, you know, my clients tend to come to me to be 51 00:03:46,695 --> 00:03:51,973 their ears and eyes in Washington from a policy perspective, 52 00:03:52,056 --> 00:03:55,597 how federal agencies, how Congress, how, 53 00:03:55,680 --> 00:04:00,354 are making changes that require them to be, you know, thinking ahead, 54 00:04:00,437 --> 00:04:05,938 responding, and interacting in ways that continue to push their business forward. 55 00:04:06,021 --> 00:04:10,833 And so those range from sort of both legal questions, policy questions, 56 00:04:10,916 --> 00:04:15,877 strategic market access questions. And I've been doing this for about... 57 00:04:15,960 --> 00:04:20,318 17 years now. I'm currently at Manat, which is a hybrid sort of policy legal 58 00:04:20,401 --> 00:04:23,649 firm. And I work with a bunch of lawyers and non-lawyers, 59 00:04:23,732 --> 00:04:28,148 including clinicians and data analysts working with our clients to sort of do 60 00:04:28,231 --> 00:04:30,778 exactly what I do. So it's a really fun time. 61 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, 62 00:04:35,185 --> 00:04:39,076 you're going to see sort of how busy we've both been, I think. Yeah, 63 00:04:39,159 --> 00:04:43,600 that's awesome. Thank you. That's just really great experiential wealth here 64 00:04:45,960 --> 00:04:50,825 So the first theme, which has been a riding theme through all of our guests 65 00:04:50,908 --> 00:04:55,971 and discussion, is MFN, looking at Guard and Globe and different perspectives, 66 00:04:56,054 --> 00:05:01,182 particularly our international pricing models are kind of coming in to the U.S. 67 00:05:01,266 --> 00:05:05,620 and sort of legally affecting drug pricing, state, federal policy. 68 00:05:15,960 --> 00:05:19,962 on pharma and payers, broadly speaking in the US today. 69 00:05:20,046 --> 00:05:22,720 And how does navigating this kind of 70 00:05:22,950 --> 00:05:25,266 I guess almost reference pricing effect coming, 71 00:05:25,350 --> 00:05:27,564 like it's a global effect coming into the US. 72 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, 73 00:05:31,936 --> 00:05:33,570 payers and pharma, I should say? 74 00:05:34,140 --> 00:05:38,420 Yeah, it's a great question. And I think in the last... 75 00:05:38,550 --> 00:05:45,490 year in particular, we've seen a really significant shift in in the... 76 00:05:46,050 --> 00:05:51,411 Psyche and positioning and thinking of both payers and manufacturers, 77 00:05:51,495 --> 00:05:57,961 the concept of incorporating some form of international reference pricing into U.S. 78 00:05:58,044 --> 00:06:04,273 markets is not brand new, although it has taken on a certain strong significance 79 00:06:04,357 --> 00:06:07,807 today. in the second Trump administration. But going back, 80 00:06:07,890 --> 00:06:13,011 To the Obama administration, there had been a series of proposals to incorporate 81 00:06:13,095 --> 00:06:18,667 the international prices. We saw that again in the first Trump administration. 82 00:06:18,750 --> 00:06:24,528 And then again, now, as we're in the second Trump administration, 83 00:06:24,612 --> 00:06:28,850 they have really leaned into this concept of... 84 00:06:28,980 --> 00:06:31,980 I think it is rooted in core... 85 00:06:32,310 --> 00:06:37,003 populist beliefs of fairness and this belief that the U.S. 86 00:06:37,086 --> 00:06:39,310 may pay too much for drugs. 87 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 88 00:06:47,880 --> 00:06:49,327 a recognition, 89 00:06:49,410 --> 00:06:53,477 that international reference pricing is probably here to stay as a, 90 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 91 00:06:58,391 --> 00:07:02,954 party, right. We, there's a lot of uncertainty around the upcoming November 92 00:07:03,037 --> 00:07:07,037 elections, right. whether Democrats take the House, whether Democrats would take 93 00:07:07,200 --> 00:07:11,499 both houses, the Senate, the House and Senate, but sort of irrespective, 94 00:07:11,583 --> 00:07:14,200 I think, the political outcome in November, 95 00:07:14,340 --> 00:07:19,080 I think most of my clients tend to think that The... 96 00:07:19,770 --> 00:07:23,634 idea of incorporating some form of international reference pricing 97 00:07:23,718 --> 00:07:27,821 is probably here to stay. You asked sort of, you know, what does that, 98 00:07:27,905 --> 00:07:32,570 how is it impacting them? You know, from a manufacturer perspective, you know, 99 00:07:32,910 --> 00:07:37,310 I think the initial impact really has been some degree of sort of 100 00:07:37,920 --> 00:07:40,539 freezing and waiting period. In other words, 101 00:07:40,622 --> 00:07:45,720 I think a lot of manufacturers feel like this time, the pace of change is frenetic, 102 00:07:45,930 --> 00:07:50,590 Everything feels very uncertain. And I can say a lot of our clients are holding... 103 00:07:50,730 --> 00:07:51,880 international launches. 104 00:07:52,380 --> 00:07:55,740 trying to understand exactly what is going to happen here. 105 00:07:55,860 --> 00:07:59,328 And trying to avoid a situation where, for example, 106 00:07:59,412 --> 00:08:03,637 they go into a negotiation with Germany or launch in Germany. 107 00:08:03,720 --> 00:08:10,720 and the UK. UK has made a bad example. They launch in Japan and have somehow 108 00:08:11,105 --> 00:08:11,917 triggered 109 00:08:12,000 --> 00:08:16,867 a series of significant future price impacts in the United States. And so, 110 00:08:16,950 --> 00:08:19,563 There continues to be a lot of uncertainty right now. 111 00:08:19,646 --> 00:08:23,632 You mentioned sort of the frameworks like Globengarde as to whether or not those 112 00:08:23,715 --> 00:08:27,517 models will ultimately move forward or they'll survive the legal challenge. 113 00:08:27,600 --> 00:08:28,620 And so I think 114 00:08:28,830 --> 00:08:33,191 And manufacturers right now really are in a bit of a wait and see period, 115 00:08:33,274 --> 00:08:37,574 although the action they have taken in many cases is pretty impactful in 116 00:08:37,658 --> 00:08:41,227 that they've actually made a decision, at least temporarily, 117 00:08:41,310 --> 00:08:44,050 to not launch in certain ex-US jurisdictions. 118 00:08:45,060 --> 00:08:48,497 I think payers are probably a little further behind. 119 00:08:48,580 --> 00:08:52,980 I think they're waiting to see whether or not these concepts are, 120 00:08:53,220 --> 00:08:57,830 hold, whether or not international reference pricing ultimately becomes 121 00:08:57,913 --> 00:08:58,597 embedded in 122 00:08:58,680 --> 00:09:03,863 into pricing structures, but I think they certainly see this as an opportunity 123 00:09:03,947 --> 00:09:06,040 for cost savings going forward. 124 00:09:06,450 --> 00:09:10,745 Well, I mean, we've spoken and we've worked actually with clients where this 125 00:09:10,828 --> 00:09:15,123 is really playing out. The idea that you might launch in a European country, 126 00:09:15,206 --> 00:09:19,155 the net price that used to be confidential kind of isn't confidential. 127 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 128 00:09:23,962 --> 00:09:25,690 back to the US. And of course, 129 00:09:25,860 --> 00:09:29,654 the revenue generation of the U.S. becomes significantly impacted. 130 00:09:29,737 --> 00:09:33,473 They want to launch in Europe or some European countries, to say. 131 00:09:33,556 --> 00:09:37,526 Can you see, if you say that international reference pricing is here, 132 00:09:37,609 --> 00:09:42,343 maybe for the foreseeable future, can you see on the domestic side within the U.S. 133 00:09:42,427 --> 00:09:45,575 legal and constitutional hurdles around this? Or, like, 134 00:09:45,658 --> 00:09:49,099 is Garden Globe being challenged legally even to this point? 135 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, 136 00:09:55,860 --> 00:09:58,654 as well, but that's been, you know, progressed through. 137 00:09:58,737 --> 00:09:59,940 How does that play out? 138 00:10:00,040 --> 00:10:03,548 And so and does that only add to the kind of uncertainty? And, you know, 139 00:10:03,631 --> 00:10:06,341 drug companies can't just cause a launch forever. Right. 140 00:10:06,425 --> 00:10:09,733 Like going to have to do something like they've invested in the R&D. 141 00:10:09,817 --> 00:10:13,275 They've invested in clinical trial. We are seeing drugs being launched, 142 00:10:13,358 --> 00:10:16,708 but they're kind of struggling with the context of how to navigate. 143 00:10:17,500 --> 00:10:20,837 that launch now. So let me begin with the boring... 144 00:10:20,920 --> 00:10:25,020 legal answer role, although I'll try to make it not boring, which is... 145 00:10:25,210 --> 00:10:28,730 there's a real big distinction between 146 00:10:28,900 --> 00:10:34,103 when Congress has authorized something and when a federal agency is acting using 147 00:10:34,186 --> 00:10:38,332 existing authority. I think it's important to know that to date, 148 00:10:38,415 --> 00:10:40,860 Congress has not authorized something 149 00:10:41,050 --> 00:10:47,270 CMS or any other agency to utilize an international reference pricing framework. 150 00:10:47,650 --> 00:10:53,389 So today, the models that are being proposed are being done using what's known 151 00:10:53,472 --> 00:10:59,070 as demonstration authority, which is a sort of broad grant of authority to, 152 00:10:59,170 --> 00:11:04,584 or broad but not limitless grant of authority from Congress to the agency 153 00:11:04,668 --> 00:11:08,810 to run sort of demonstration tests, right, experiments. 154 00:11:09,430 --> 00:11:15,650 to test whether certain changes to how Medicare operates can improve the program. 155 00:11:16,630 --> 00:11:18,950 I think Garden Globe, if they are so garden, 156 00:11:19,034 --> 00:11:21,791 the current status of Garden Globe is that they are, 157 00:11:21,875 --> 00:11:25,725 we have proposed rules and final rules have now arrived at what's called 158 00:11:25,808 --> 00:11:30,369 the Office of Management and Budget, which is really the last step before those rules 159 00:11:30,452 --> 00:11:31,490 would be finalized. 160 00:11:31,810 --> 00:11:34,971 There's always some degree of possibility they're not finalized, 161 00:11:35,055 --> 00:11:38,723 but my personal expectation is that those rules will be finalized sometime 162 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 163 00:11:42,912 --> 00:11:47,591 those rules two models, Garden Globe, will survive the legal challenge, 164 00:11:47,674 --> 00:11:53,140 and I am highly confident that they will be subject to legal challenge. So, at 165 00:11:53,350 --> 00:11:56,920 So that's that's. Point one. Point two is... 166 00:11:57,130 --> 00:11:58,967 Congress may have an interest. 167 00:11:59,050 --> 00:12:02,521 in legislating on international reference pricing. 168 00:12:02,605 --> 00:12:07,510 And that's a very different legal question. If Congress authorizes... 169 00:12:07,840 --> 00:12:10,907 CMS to incorporate international reference prices, 170 00:12:10,991 --> 00:12:14,625 either in how they generally pay for drugs or, for example, 171 00:12:14,708 --> 00:12:19,351 another concept would be incorporating international reference pricing into 172 00:12:19,435 --> 00:12:21,640 the drug price negotiation program. 173 00:12:22,510 --> 00:12:27,990 legal challenges are still possible on constitutional grounds, but... 174 00:12:28,360 --> 00:12:32,272 I think the chances of those laws surviving legal challenge are much higher 175 00:12:32,355 --> 00:12:33,900 than Globe and Card would be. 176 00:12:34,030 --> 00:12:38,433 From a manufacturer's perspective, would they view Globengard as mandatory, 177 00:12:38,516 --> 00:12:40,670 even if it's not statutory in place? 178 00:12:41,140 --> 00:12:45,893 Yeah, so there's sort of an interesting dance currently playing out. 179 00:12:45,976 --> 00:12:49,022 If Globe and Guard go into effect, they are, 180 00:12:49,106 --> 00:12:54,143 and they survive legal challenge, they are designed as mandatory models. 181 00:12:54,226 --> 00:12:59,193 So any manufacturer subject to the model would be subject to the model. 182 00:12:59,276 --> 00:13:03,816 But there's a really big footnote there, which is simultaneously, 183 00:13:03,899 --> 00:13:09,150 the Trump administration has been negotiating what I'll generally call most 184 00:13:09,233 --> 00:13:10,940 favored nation policies. 185 00:13:11,080 --> 00:13:15,427 pricing agreements with manufacturers. They started with the largest 17 186 00:13:15,510 --> 00:13:20,294 manufacturers, of which they've entered into agreements with all of those now, 187 00:13:20,377 --> 00:13:21,500 and they're now... 188 00:13:21,640 --> 00:13:25,850 entering into agreements with a smaller subset of small and mid-sized 189 00:13:25,933 --> 00:13:28,960 manufacturers. Are... understanding, 190 00:13:29,080 --> 00:13:33,000 is that those manufacturers, if they execute those agreements, 191 00:13:33,430 --> 00:13:38,239 And there's a number of different commitments as part of those agreements, 192 00:13:38,323 --> 00:13:39,156 including – 193 00:13:39,280 --> 00:13:43,960 some pricing commitments in Medicaid would be exempt from Guard and Globe. 194 00:13:44,043 --> 00:13:46,877 So we may enter a very interesting situation. 195 00:13:46,960 --> 00:13:51,794 situation where if Garden Globe are finalized, let's say this fall, 196 00:13:51,878 --> 00:13:54,300 and they survive legal challenge, 197 00:13:54,520 --> 00:13:58,820 A portion of U.S. manufacturers will be subject to those claims. 198 00:13:58,960 --> 00:14:02,697 But a large portion, including the largest manufacturers, 199 00:14:02,780 --> 00:14:06,987 which constitute the largest significant force of drug spending, 200 00:14:07,070 --> 00:14:12,700 will actually be exempt based on voluntary pricing commitments they've already made. 201 00:14:12,820 --> 00:14:14,720 generous or is that another one? 202 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 203 00:14:20,865 --> 00:14:26,444 of manufacturers currently negotiating now are agreeing to a series of voluntary 204 00:14:26,528 --> 00:14:30,337 commitments. One is what you just referenced, Generous. 205 00:14:30,421 --> 00:14:35,787 This is a voluntary model where you would offer international reference price 206 00:14:35,871 --> 00:14:36,720 in Medicaid. 207 00:14:44,920 --> 00:14:49,914 RFRX website, and they want manufacturers to commit to prospective MFN. 208 00:14:49,997 --> 00:14:55,421 That is, going forward, manufacturers are committing to launching products at 209 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 210 00:15:01,440 --> 00:15:04,860 price overseas, which is also pretty significant. 211 00:15:04,944 --> 00:15:10,653 And in exchange for those commitments, those manufacturers will receive both some 212 00:15:10,736 --> 00:15:11,570 degree of 213 00:15:14,920 --> 00:15:18,600 well as we understand Globe and Guard exemptions. So, 214 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 215 00:15:23,812 --> 00:15:28,740 to dance to avoid the scenario. So, for example, a drug company manufacturer is, 216 00:15:28,930 --> 00:15:31,790 says, OK, we're going to delay launch in Europe. 217 00:15:32,110 --> 00:15:36,787 So that whether it's the 19 OECD basket from Globe Guard or the eight countries, 218 00:15:36,870 --> 00:15:40,892 the G7 minus US. Yeah, and generous. Got Denmark, Switzerland, right, 219 00:15:40,976 --> 00:15:43,629 and generous. So what you do is you say, okay, 220 00:15:43,713 --> 00:15:47,616 so I'm not going to launch in those markets yet. I'm going to wait. 221 00:15:47,699 --> 00:15:51,210 I'm going to launch in the US. There is no reference price. 222 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 223 00:15:56,740 --> 00:15:59,460 maybe two three years and launch later. 224 00:15:59,740 --> 00:16:02,237 And we've seen some manufacturers even come out and say, oh, 225 00:16:02,321 --> 00:16:03,971 we're not going to Germany. Yeah. 226 00:16:04,390 --> 00:16:08,712 So, number one, does that get around, this whole reporting? And in theory, 227 00:16:08,795 --> 00:16:12,938 does that obfuscate any notion that there'll be a cheaper drug price in 228 00:16:13,021 --> 00:16:16,212 the U.S.? Because if there's no cheaper European price, 229 00:16:16,295 --> 00:16:19,427 then you can just launch whatever price you want. One, 230 00:16:19,510 --> 00:16:22,010 I would say my first reaction is I think – 231 00:16:22,240 --> 00:16:26,520 I've been struck by how unique every single manufacturer is. 232 00:16:26,680 --> 00:16:33,350 circumstances, right? That it depends widely on how many products you have, 233 00:16:33,760 --> 00:16:36,918 where you manufacture, what your tariff exposure is, 234 00:16:37,001 --> 00:16:39,847 and the size of your patient population, right? 235 00:16:39,931 --> 00:16:44,896 So there's a different story for companies launching rare disease products versus 236 00:16:44,980 --> 00:16:47,577 companies launching, you know, a new GLP-1. 237 00:16:47,660 --> 00:16:52,189 There's a major difference for companies that have one or two drugs versus 238 00:16:52,272 --> 00:16:54,017 companies that have 75 drugs. 239 00:16:54,100 --> 00:16:59,072 commercialized products. But I guess the short answer to the question is yes. 240 00:16:59,155 --> 00:17:03,995 I mean, I think some companies will be able to engage in strategic launches 241 00:17:04,079 --> 00:17:08,973 that enable them to avoid the broadest effects of current MFN agreements. 242 00:17:09,056 --> 00:17:14,601 The other piece that's happening that I think is really important to pay attention 243 00:17:14,685 --> 00:17:19,818 to, we already saw it happen in the UK. It's currently potentially happening 244 00:17:19,902 --> 00:17:22,510 in Germany, uh, is, is the concept of, 245 00:17:22,600 --> 00:17:27,796 adjustments occurring and the prices paid by those international countries, 246 00:17:27,879 --> 00:17:31,667 right? You're closer to what occurred within the U.K., 247 00:17:31,750 --> 00:17:35,404 There's a process that's currently occurring in Germany today. You know, 248 00:17:35,487 --> 00:17:37,999 it's interesting. Within the Trump administration, 249 00:17:38,083 --> 00:17:41,893 there are really two schools of thought, and they're pretty evenly divided. 250 00:17:41,976 --> 00:17:45,347 There is one school that is very comfortable with this idea that, 251 00:17:45,430 --> 00:17:49,290 that manufacturers in the U.S., should receive 252 00:17:49,600 --> 00:17:54,224 less money for their products, right? That reimbursement should be lower. 253 00:17:54,308 --> 00:17:59,125 There's another group of people who are not comfortable with the idea of ice 254 00:17:59,209 --> 00:18:04,220 setting, but they're very comfortable with the idea of using the US's strategic 255 00:18:04,303 --> 00:18:05,980 and international strength 256 00:18:06,220 --> 00:18:13,140 to force other countries to pay more. As you might imagine, pharma companies are... 257 00:18:13,240 --> 00:18:17,573 hoping that the latter is really where the pressure ends up going, right? 258 00:18:17,656 --> 00:18:20,500 In other words, is there some world in which... 259 00:18:20,650 --> 00:18:24,887 It's not necessarily that the U.S. is spending significantly less money 260 00:18:24,970 --> 00:18:27,580 on prescription drugs. But... 261 00:18:28,120 --> 00:18:32,480 European countries in particular start to pay their quote unquote fair share. 262 00:18:32,590 --> 00:18:37,234 Totally. And we get that. And you're right. In the UK and England, 263 00:18:37,318 --> 00:18:42,535 for example, with Nice, they have adjusted the cost per quality threshold. 264 00:18:42,619 --> 00:18:46,630 They've raised it from 20 to 30,000 to 25 to 35 sort of. 265 00:18:47,110 --> 00:18:50,187 15-20% increase. They also agreed to spend more, 266 00:18:50,270 --> 00:18:54,400 like doubled 0.3% to 0.6% over a certain number of years on GDP, 267 00:18:54,484 --> 00:18:59,733 on innovative medicines. And that wasn't because of any argument about who should 268 00:18:59,817 --> 00:19:04,079 be paying more or less. It was because of tariffs and trade deals. 269 00:19:04,162 --> 00:19:08,358 And we actually didn't want tariffs on pharmaceuticals in the UK. 270 00:19:08,441 --> 00:19:13,050 So you're right. The US were able to use other broader and overarching 271 00:19:13,210 --> 00:19:17,159 methods in negotiation for us to affect our internal pricing dialogue. 272 00:19:17,242 --> 00:19:21,019 And we've seen already, in fact, the U.S. trade relations, I think, 273 00:19:21,102 --> 00:19:22,830 have opened up a legal system. 274 00:19:23,410 --> 00:19:26,650 Section 301, I think, in Germany. That's right. Yes. 275 00:19:27,040 --> 00:19:31,373 It's quite extraordinary. Like for an external country to say they're opening 276 00:19:31,457 --> 00:19:35,790 a legal kind of challenge on a country's own internal pricing policy is quite 277 00:19:35,873 --> 00:19:40,493 remarkable. And so they've done that to Germany and people are asking how they can 278 00:19:40,577 --> 00:19:44,020 do it to other countries. So. How is that going? I mean, 279 00:19:44,290 --> 00:19:46,793 I'm just trying to see where that takes place. Like, 280 00:19:46,876 --> 00:19:50,026 this is all just pushing, isn't it, from different methodologies, 281 00:19:50,109 --> 00:19:53,809 just trying to get other countries to pay more. That's what this is about. 282 00:20:00,020 --> 00:20:03,726 led by the Department of Commerce and Secretary Lutnik, 283 00:20:03,809 --> 00:20:06,840 that really is focused on that piece, right? 284 00:20:07,250 --> 00:20:11,550 My assumption is there's going to be push and pull on both sides, right? 285 00:20:11,633 --> 00:20:15,446 I think some of those efforts internationally will be successful 286 00:20:15,529 --> 00:20:19,730 in increasing the prices paid by foreign countries. But I also think, 287 00:20:19,940 --> 00:20:23,584 it's likely that there's going to be bleed over of ultimately lower international 288 00:20:23,667 --> 00:20:25,197 reference prices to some extent. 289 00:20:25,280 --> 00:20:29,577 into US pricing. Okay. And before we go to CMS drug price negotiations, 290 00:20:29,660 --> 00:20:33,093 which I'm sure we'll have lots of stories we could share, 291 00:20:33,177 --> 00:20:36,116 let's just look at the reporting of these prices. 292 00:20:36,199 --> 00:20:40,003 So we know that let's say you're a pharmaceutical manufacturer, 293 00:20:40,086 --> 00:20:44,691 and you do launch in European countries. And we know there's this method one 294 00:20:44,775 --> 00:20:49,812 reporting and method two reporting. So the way in which CMS actually get the prices 295 00:20:49,895 --> 00:20:50,728 of, 296 00:20:51,020 --> 00:20:53,950 I guess what were confidential net prices, 297 00:20:54,033 --> 00:20:57,620 but get the net prices to transmit back to the US, 298 00:20:57,710 --> 00:21:03,320 for MFN Guard Globe Generous. So method one, it's using data systems like, 299 00:21:03,404 --> 00:21:07,475 for example, I think Eversana have a Navlin, IQEMIDAS, 300 00:21:07,558 --> 00:21:11,399 the idea being that they track not just list price, 301 00:21:11,482 --> 00:21:17,330 but some net prices may be aggregated, may or may not be correct. And CMS... 302 00:21:17,540 --> 00:21:19,859 use those commercial software to say, right, 303 00:21:19,943 --> 00:21:23,682 we've conceived that you're doing 20, 30% discount European countries. 304 00:21:23,765 --> 00:21:27,777 So we're going to apply that here. This pressure test that we is that good? 305 00:21:27,860 --> 00:21:30,835 Are we good with that? Yeah, yeah, that's exactly right. 306 00:21:30,918 --> 00:21:32,720 So the method one is essentially, 307 00:21:33,020 --> 00:21:35,885 manufacturer, you're not required to report anything to us. 308 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. 309 00:21:39,767 --> 00:21:43,682 I think this has been a boon for those. I think many of our manufacturer clients 310 00:21:43,765 --> 00:21:46,880 didn't necessarily have subscriptions to all of those resources, 311 00:21:46,964 --> 00:21:49,779 and now I felt sort of their hand forced being like, well, 312 00:21:49,862 --> 00:21:53,077 if we're going to at least consider the possibility of method one, 313 00:21:53,161 --> 00:21:54,837 we should probably understand what 314 00:21:54,920 --> 00:21:57,680 what prices are listed in those databases. Right. 315 00:21:57,890 --> 00:22:01,006 Am I right now in thinking, well, there is a method two, 316 00:22:01,090 --> 00:22:03,406 which is a more voluntary open your books. 317 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 318 00:22:07,203 --> 00:22:11,291 your IQVM-itis, look at the reporting or every sign of Navlin and you go, 319 00:22:11,374 --> 00:22:14,948 whoa, whoa, these guys are way off. What we'll do is method two. 320 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 321 00:22:19,488 --> 00:22:23,030 tracing and say, actually, our net price looks more like this. 322 00:22:23,240 --> 00:22:26,603 So can you not use method one? Could you please use method two? 323 00:22:26,686 --> 00:22:30,417 I'm trying to simplify, but is that kind of what we're talking about? 324 00:22:30,500 --> 00:22:34,610 That's right. Yes. and Under the method 2, 325 00:22:34,970 --> 00:22:39,843 And under method one, is the calculation the same or is like method one more about 326 00:22:39,927 --> 00:22:44,498 like the second least expensive and method two is more an aggregated or is it 327 00:22:44,581 --> 00:22:48,004 a similar calculation? It's no, it's the same. Ultimately, 328 00:22:48,087 --> 00:22:52,295 it's the second lowest price of that grouping of countries. But I mean, 329 00:22:52,379 --> 00:22:54,960 the difference really is. Um, 330 00:22:55,070 --> 00:22:59,632 I think there's a great deal of uncertainty for manufacturers and loss 331 00:22:59,715 --> 00:23:03,630 of control associated with method one, right? Relying on... 332 00:23:04,040 --> 00:23:09,277 third-party data sources that may or may not be accurate. Whereas, you know, 333 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 334 00:23:15,240 --> 00:23:17,480 international countries. Got it. 335 00:23:23,680 --> 00:23:28,038 You know, today's conversation highlights just how quickly market access strategy 336 00:23:28,122 --> 00:23:32,096 is changing around the world. One of the ways we help our clients navigate 337 00:23:32,179 --> 00:23:33,660 that uncertainty is through 338 00:23:34,040 --> 00:23:38,419 Vipora's innovative contracting tracker that combines nearly 2,000 publicly 339 00:23:38,503 --> 00:23:42,823 reported agreements from healthcare systems around the world into a single 340 00:23:42,906 --> 00:23:47,523 searchable evidence base, helping teams identify emerging trends and make local 341 00:23:47,607 --> 00:23:50,737 strategic decisions with greater confidence. You know, 342 00:23:50,820 --> 00:23:53,533 it's a resource we rely on ourselves every day. 343 00:23:53,617 --> 00:23:56,032 And if you'd like to access this resource, 344 00:23:56,116 --> 00:24:00,614 drop me an email or message me on LinkedIn or visit Vipora.com for details of 345 00:24:00,697 --> 00:24:02,780 our innovative contracting tracker. 346 00:24:04,040 --> 00:24:04,873 you 347 00:24:07,190 --> 00:24:10,334 Let's go to our second theme, IRA, CMS, drug price negotiations. 348 00:24:10,417 --> 00:24:13,359 It's been a pleasure to work with you, with various clients, 349 00:24:13,443 --> 00:24:15,981 and present at conference. We've seen round one IPA. 350 00:24:16,065 --> 00:24:19,713 We've seen round two IPA. We've been on many journeys together. Now, IPA3, 351 00:24:19,796 --> 00:24:22,940 what's interesting about IPA3 is a couple of things. Number one, 352 00:24:23,023 --> 00:24:26,218 we're bringing in Part B medicines, physician administered within 353 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 354 00:24:30,385 --> 00:24:33,227 self-administration. And the second thing is we're moving, 355 00:24:33,310 --> 00:24:36,890 and I'll probably get you to explain this a bit better to our audience, 356 00:24:37,190 --> 00:24:42,571 We're moving from kind of CMS interpreting what the guidance is to a more formalized 357 00:24:42,654 --> 00:24:47,710 rulemaking of that guidance, which means there's slightly more of a legal shift 358 00:24:47,794 --> 00:24:52,134 on the procedure and the methodology of how CMS will be negotiating. 359 00:24:52,217 --> 00:24:57,208 I'm guessing probably more legal counsel and presence and maybe less deviation 360 00:24:57,291 --> 00:25:01,910 and exploration or interpretation, but more a rigid standard framework. 361 00:25:07,190 --> 00:25:10,600 I agree. Yeah, let me start with the move... 362 00:25:10,760 --> 00:25:14,312 of the program, again, back to boring lawyer stuff, 363 00:25:14,396 --> 00:25:17,960 from the move of the program from one driven by... 364 00:25:18,140 --> 00:25:21,000 guidance to one driven by 365 00:25:21,230 --> 00:25:28,230 regulation. And there are your correct nuances and important considerations as we 366 00:25:28,883 --> 00:25:35,883 move to a program that is bound by and driven by regulation versus one that's 367 00:25:36,158 --> 00:25:39,370 driven by guidance. And, and, and, 368 00:25:39,650 --> 00:25:44,101 Just to update the audience, we're currently in that rulemaking process, 369 00:25:44,184 --> 00:25:46,010 right? So CMS has proposed... 370 00:25:46,190 --> 00:25:50,564 a series of regulations. And we're currently in the 60-day climate period 371 00:25:50,647 --> 00:25:55,467 for those regulations. And we're working with dozens of manufacturers that have 372 00:25:55,550 --> 00:26:00,134 a stake in those regulations, and they're submitting public comments. 373 00:26:00,217 --> 00:26:03,870 I think overarching, the most important piece here is, 374 00:26:03,980 --> 00:26:08,194 I think it's a fair assumption that once CMS finalizes these regulations, 375 00:26:08,277 --> 00:26:11,078 although they'll update them probably every year, 376 00:26:11,161 --> 00:26:15,669 that the program is going to become even more solidified. You know, that said, 377 00:26:15,752 --> 00:26:19,907 I don't want to under I don't overstate the significance of this moment, 378 00:26:19,991 --> 00:26:23,397 because I think the headline story from the proposed rule was. 379 00:26:23,480 --> 00:26:26,240 CMS is largely putting into regulation 380 00:26:26,390 --> 00:26:30,173 the program that was finalized over the first two IPays. 381 00:26:30,256 --> 00:26:33,570 So we had some shifts between IPay 1 and IPay 2. 382 00:26:33,710 --> 00:26:37,090 But really, CMS has been remarkably consistent with, 383 00:26:37,220 --> 00:26:42,594 You know, in the actual negotiating room, CMS sits with copies of their guidance 384 00:26:42,677 --> 00:26:46,823 in front of them, and they really are driven by that guidance. 385 00:26:46,906 --> 00:26:51,257 And so while the program has been technically driven by guidance, 386 00:26:51,340 --> 00:26:55,214 it's felt very... regulatory driven. It's felt very rule-based. 387 00:26:55,297 --> 00:26:59,549 And so I actually think one of the more interesting pieces here is that 388 00:26:59,632 --> 00:27:04,460 the proposed rule really has not proposed a major shift in terms of how 389 00:27:04,550 --> 00:27:09,589 the agency has governed the program and will govern the program forward. 390 00:27:09,673 --> 00:27:12,590 It feels like it has entered into sort of 391 00:27:12,710 --> 00:27:19,710 It has institutionalized fairly quickly, and that CMS has clearly come up with, 392 00:27:20,090 --> 00:27:23,067 a lot of internal processes and procedures 393 00:27:23,150 --> 00:27:28,150 to try to make the negotiation possible, 394 00:27:28,280 --> 00:27:32,016 work in as non-arbitrary as a way as possible. Do you think, 395 00:27:32,099 --> 00:27:34,753 how will that play out in the negotiations? 396 00:27:34,836 --> 00:27:37,808 Because when we've both supported manufacturers, 397 00:27:37,892 --> 00:27:41,517 we've had legal counsel, usually with a manufacturer, and 398 00:27:41,600 --> 00:27:45,174 occasionally, maybe a bit later, not always necessarily with CMS. 399 00:27:45,257 --> 00:27:48,887 Do you think that this changes that or not? I actually do. I mean, 400 00:27:48,970 --> 00:27:51,982 CMS is largely, if you recall, in IPA26, the first IPA, 401 00:27:52,065 --> 00:27:55,920 CMS sent legal counsel to most of the meetings. Some of that, I think, 402 00:27:56,003 --> 00:28:00,421 was driven that we were also at the early stages of litigation in the drug price 403 00:28:00,504 --> 00:28:03,966 negotiation program, which we may talk about. In IPA2 and IPA3, 404 00:28:04,049 --> 00:28:08,100 legal counsel has been absent from those meetings. It's not that they're 405 00:28:11,600 --> 00:28:14,794 Most of our clients tend to still send an attorney with them, 406 00:28:14,877 --> 00:28:16,220 although not all clients. 407 00:28:16,340 --> 00:28:23,180 We, me, as a lawyer, advising clients on this process, still lives and breathes. 408 00:28:23,510 --> 00:28:28,679 and dies by the guidance. And it will be helpful for me to have something drafted 409 00:28:28,763 --> 00:28:32,067 in regulatory text. You know, there continue to be, 410 00:28:32,150 --> 00:28:37,395 constantly issues of uncertainty that come up in advising clients as to what CMS 411 00:28:37,479 --> 00:28:41,658 is obligated or not obligated to do with respect to the program. 412 00:28:41,741 --> 00:28:46,454 And I do think it'll be helpful to have actual regulations to work with, 413 00:28:46,537 --> 00:28:51,582 but I'm not necessarily certain it'll change the overarching structure of who 414 00:28:51,666 --> 00:28:54,330 attends the meeting or how they operate. 415 00:28:54,590 --> 00:28:58,026 And just on that legal challenge, I remember many of the manufacturers, 416 00:28:58,109 --> 00:28:59,159 or maybe all of them, 417 00:28:59,690 --> 00:29:03,882 who also in parallel had a legal challenge to this whole procedure. 418 00:29:03,965 --> 00:29:08,986 Have they all materialized? Have they been thrown out or are they still ongoing? 419 00:29:09,070 --> 00:29:12,432 So litigation is ongoing, although, you know, to date, 420 00:29:12,515 --> 00:29:17,345 none of them have been successful. There are but there are a handful of cases 421 00:29:17,428 --> 00:29:19,470 that continue to work their way. 422 00:29:19,640 --> 00:29:23,320 through the courts, we're now sort of the federal courts, 423 00:29:23,480 --> 00:29:28,200 circuit court level or federal appeals court level, you know, I would say most 424 00:29:28,460 --> 00:29:32,337 Court observers are not terribly optimistic about, 425 00:29:32,420 --> 00:29:35,280 that any of these challenges will ultimately... 426 00:29:35,390 --> 00:29:39,504 to materialize in a way that strikes down the entire program. 427 00:29:39,587 --> 00:29:42,837 I do think there continues to be a possibility – 428 00:29:42,920 --> 00:29:48,094 of legal challenges on specific issues. And I'll just give you an example of one. 429 00:29:48,178 --> 00:29:52,898 While I mentioned the current proposed rule for the drug price negotiation 430 00:29:52,981 --> 00:29:53,757 program, the 431 00:29:53,840 --> 00:29:57,914 you know, largely puts into regulation the program as it operates today. 432 00:29:57,997 --> 00:30:01,597 One of the proposals that's gained a lot of attention and 433 00:30:01,680 --> 00:30:06,034 is a proposal for the treatment of fixed-dose combination products. 434 00:30:06,117 --> 00:30:08,677 Right. With, you know, in particular... 435 00:30:08,760 --> 00:30:13,400 products where there's a subcutaneous version of an intravenous product, 436 00:30:13,483 --> 00:30:17,533 often with the addition of the active ingredient hyaluronidase. 437 00:30:17,616 --> 00:30:22,846 CMS has proposed that while fixed dose combination products are generally treated 438 00:30:22,930 --> 00:30:25,864 as separate drugs and not negotiated together, 439 00:30:25,947 --> 00:30:30,062 where hyaluronidase or another active ingredient has been added, 440 00:30:30,146 --> 00:30:35,179 and the only effect of that addition is to change the route of administration, 441 00:30:35,262 --> 00:30:36,640 say from IV to sub-Q, 442 00:30:38,760 --> 00:30:43,060 I think CMS is likely to finalize that proposal, and I think CMS is likely to 443 00:30:43,170 --> 00:30:49,207 to be legally challenged on that proposal. And I think a court could consider... 444 00:30:49,290 --> 00:30:54,078 arguably... a more narrow challenge to certain drug price negotiation policies, 445 00:30:54,161 --> 00:30:58,424 even if it's unlikely that the entire law is found unconstitutional at this point. 446 00:30:58,508 --> 00:31:00,968 Got it. Yeah, that was a great answer, actually, 447 00:31:01,052 --> 00:31:04,944 because I've spoken to a few payers that have been knocking this one around 448 00:31:05,027 --> 00:31:09,237 and without necessarily a solution on it. The other thing I mentioned was Part B. 449 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 450 00:31:13,614 --> 00:31:17,506 buy and build economics rather than the traditional Part D kind of pharmacy 451 00:31:17,589 --> 00:31:18,490 benefit. I can... 452 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 453 00:31:24,009 --> 00:31:27,798 the system who have got all sorts of issues with this, 454 00:31:27,881 --> 00:31:33,320 and maybe small providers, GPOs, other people now being drawn into this whole 455 00:31:33,403 --> 00:31:37,551 freakonomic, if you like, of these drug price negotiations. 456 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 457 00:31:43,443 --> 00:31:45,810 and injectables and going to ASP? 458 00:31:48,630 --> 00:31:52,912 of organizations either going underwater or struggling with that kind 459 00:31:52,995 --> 00:31:57,550 of reimbursement. Yeah, and I'll say, you know, one of the potentially – 460 00:31:57,750 --> 00:32:02,790 more promising challenges to the drug price negotiation was one actually – 461 00:32:03,060 --> 00:32:08,856 brought by the infusion centers. Right. So, but I, you know, my, 462 00:32:08,939 --> 00:32:10,960 I continue to believe, 463 00:32:11,160 --> 00:32:17,099 that this issue has gained less. I think most providers continue to be not fully 464 00:32:17,182 --> 00:32:21,408 aware of, of what is coming for this third buy pay, right? 465 00:32:21,491 --> 00:32:25,560 The fact that there are going to be highly high-volume, 466 00:32:25,710 --> 00:32:28,628 Part B drugs where they earn significant margin today, 467 00:32:28,711 --> 00:32:32,907 where they will be where they will that margin will be significantly reduced. 468 00:32:32,991 --> 00:32:37,270 And I think there's growing awareness that it's slower than you might expect. 469 00:32:37,680 --> 00:32:41,883 We're still waiting on, even though we're just around the corner, 470 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 471 00:32:47,439 --> 00:32:52,780 or make providers whole on Part B drugs under the Drug Price Negotiation Program. 472 00:32:52,920 --> 00:32:56,299 Really fascinating that they've been able to push this that long. 473 00:32:56,382 --> 00:32:59,389 It actually wasn't included in the proposed rule for IPA3, 474 00:32:59,472 --> 00:33:03,840 even though IPA3 will be the first year that Part B products are being negotiated. 475 00:33:04,470 --> 00:33:09,452 And it may be that until the prices are effective January 1, 2028, 476 00:33:09,536 --> 00:33:15,515 that really or leading up to that, that we don't see major provider activation. 477 00:33:15,599 --> 00:33:16,750 But I do think. 478 00:33:16,860 --> 00:33:20,788 There are a lot of really unique considerations as we move from negotiating 479 00:33:20,871 --> 00:33:24,187 just pharmacy dispense products to physician dispense products. 480 00:33:24,270 --> 00:33:27,488 I think it's likely there is going to be, right? 481 00:33:27,571 --> 00:33:33,058 So when a provider prescribes a pharmacy dispense product that's been negotiated, 482 00:33:33,142 --> 00:33:38,850 I don't think we believe necessarily that there's really any significant difference 483 00:33:38,970 --> 00:33:40,010 impact 484 00:33:40,200 --> 00:33:43,783 to prescribing behavior. Maybe there has been some impact of formulary behavior, 485 00:33:43,866 --> 00:33:46,207 although frankly I don't think we've seen that. 486 00:33:46,290 --> 00:33:50,525 It's going to be different when we have the prescriber buying and billing 487 00:33:50,608 --> 00:33:55,376 the product and being reimbursed at MFP. So I think one major change here to watch 488 00:33:55,459 --> 00:34:00,109 for is, are we going to see a real change in prescribing behavior and physicians 489 00:34:00,192 --> 00:34:03,960 retreating away from that? prescribing drugs with MFPs. 490 00:34:04,110 --> 00:34:08,467 And do you remember, Ross, when, I mean, often in the negotiations, 491 00:34:08,551 --> 00:34:12,245 this kind of idea of a system affects, right? That, look, 492 00:34:12,329 --> 00:34:15,510 if you negotiate a really low MFP that's so low. 493 00:34:15,690 --> 00:34:19,510 then you're actually going to have formularies move away. 494 00:34:19,620 --> 00:34:23,827 and almost penalize the mfp product you just spend nine months negotiating 495 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 496 00:34:28,722 --> 00:34:32,987 spoke to health plans and payers and formularies it was quite clear that if 497 00:34:33,071 --> 00:34:37,683 they started penalizing mfp products they would lose their medicare business like 498 00:34:37,767 --> 00:34:42,379 in fact i remember some of our payers i said that cms have actually rejected bids 499 00:34:42,463 --> 00:34:44,260 for the first time now based on 500 00:34:44,760 --> 00:34:48,848 plans, trying to move. And so they're doing other things like moving from 501 00:34:48,931 --> 00:34:53,591 a copay to co-insurance model and raising premiums and kind of hiding MFPs and some 502 00:34:53,674 --> 00:34:55,560 of that. If when it comes to the. 503 00:34:56,940 --> 00:35:01,768 intravenous like what are you saying is physicians may penalize mfp intravenous 504 00:35:01,851 --> 00:35:06,637 drugs right i mean if there's two you know if there are two competing products 505 00:35:06,720 --> 00:35:10,669 The clinician views them as clinically comparable and one has an MFP, 506 00:35:10,752 --> 00:35:15,344 you know, arguably I could see strong incentives for the prescriber to move away 507 00:35:15,428 --> 00:35:20,220 from prescribing the one that has a lower reimbursement differential, right? Yeah. 508 00:35:20,310 --> 00:35:24,607 Where the net between the buy-in bill is lower. 509 00:35:24,690 --> 00:35:27,899 It might be the survival of the organization. If it's small, 510 00:35:27,982 --> 00:35:28,970 it might be out... 511 00:35:29,190 --> 00:35:32,657 you know, in some of it might be not a large teaching academic unit. 512 00:35:32,740 --> 00:35:35,090 It may be like a small out in the rural area. 513 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 514 00:35:40,164 --> 00:35:44,404 the lifespans and future of MFN. I know we've covered some of this already. 515 00:35:44,487 --> 00:35:49,073 One of the popular questions we've had, and people have been feeding me questions 516 00:35:49,156 --> 00:35:52,473 already, going, oh, you're going to have policy and payers. 517 00:35:52,557 --> 00:35:56,393 The intersection of MFP and MFN has cropped up a few times. In fact, 518 00:35:56,476 --> 00:35:59,563 some of our payers didn't even know the answer to this. 519 00:35:59,647 --> 00:36:02,990 If a product has been through the negotiation with an MFP, 520 00:36:03,300 --> 00:36:05,680 whether it's Part D or Part B. 521 00:36:06,180 --> 00:36:10,689 and then it's suddenly subject to MFN, Guard Globe. Is there a carve-out? 522 00:36:10,773 --> 00:36:13,709 Is there a statutory carve-out which says, look, 523 00:36:13,793 --> 00:36:18,805 the fact you've been through MFP means you're actually safe from Guard and Globe, 524 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. 525 00:36:23,167 --> 00:36:28,179 My understanding is that products that have been negotiated can still be included 526 00:36:28,263 --> 00:36:32,206 in models like, for example, Generous or Guard and Globe. Right. 527 00:36:32,289 --> 00:36:34,680 So it doesn't protect them in any way? 528 00:36:36,180 --> 00:36:40,932 are protected from is having that MFM price incorporated into the drug price 529 00:36:41,016 --> 00:36:45,004 negotiation or a renegotiation. Right. So what you're saying is, 530 00:36:45,088 --> 00:36:48,380 say you have an MFP. that's been negotiated. 531 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. 532 00:36:52,865 --> 00:36:56,873 That's correct. Your MFP price is protected from that part of the equation. 533 00:36:56,956 --> 00:37:01,320 Yeah. Yes, that's right. Got it. Okay. That makes sense. That makes sense. And – 534 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 535 00:37:07,114 --> 00:37:10,777 planning their longer term U.S. and ex-U.S. launch strategies? 536 00:37:10,860 --> 00:37:14,100 What are you telling them or how are you advising them? 537 00:37:14,183 --> 00:37:17,061 And they can't always necessarily watch and wait. 538 00:37:17,144 --> 00:37:21,834 What is what is where is the direction? And I get there's a heterogeneous model 539 00:37:21,917 --> 00:37:25,240 depending on the drugs, depending on the disease areas. 540 00:37:32,160 --> 00:37:35,724 Kind of map broadly how that might play out when you're supporting or what 541 00:37:35,808 --> 00:37:37,058 companies might be doing. 542 00:37:37,170 --> 00:37:41,331 Yeah, well, I mean, I guess I think the most fundamental piece is we're building 543 00:37:41,414 --> 00:37:44,143 it into the models and the market access plan, right? 544 00:37:44,226 --> 00:37:47,963 I'm just to give an example. I'm working with a client right now putting 545 00:37:48,046 --> 00:37:53,130 together... sort of a memo on they're launching their first product in the U.S., 546 00:37:53,220 --> 00:37:57,780 later this fall, and they sort of asked for a soup to nuts, right, from a – 547 00:37:57,900 --> 00:38:02,426 federal payer perspective, what do we need to do from a Medicare coverage, 548 00:38:02,510 --> 00:38:03,880 coding, reimbursement, 549 00:38:04,020 --> 00:38:07,549 Life cycle management, all of these pieces. And, you know, 550 00:38:07,632 --> 00:38:12,531 two years ago, discussions of MFN and the Guard and Globe and and and even three 551 00:38:12,614 --> 00:38:17,637 or four years ago, drug price negotiation would not have been a part of that plan. 552 00:38:17,720 --> 00:38:22,640 They have to now. Right. So now, you know, companies need to be thinking about. 553 00:38:22,890 --> 00:38:27,650 launch indications, launch sequencing very differently than they did 554 00:38:27,960 --> 00:38:31,389 a few years ago. Companies need to be thinking about market sequencing, 555 00:38:31,473 --> 00:38:34,852 right, where they're launching different than they did, right? I mean, 556 00:38:34,936 --> 00:38:38,832 one helpful thing, frankly, is you know, at least right now is, you know, 557 00:38:38,915 --> 00:38:41,690 now that these models have come to light, you know, 558 00:38:41,880 --> 00:38:46,265 And we understand, for example, the market basket of countries and, you know, 559 00:38:46,348 --> 00:38:50,700 how CMS will select the price from those market baskets of other countries. 560 00:38:50,790 --> 00:38:55,837 companies are able to start designing or building around these constraints, 561 00:38:55,920 --> 00:38:59,513 Although I think one big limiting factor is it's a little, you know, 562 00:38:59,597 --> 00:39:02,163 I don't think we're in a stable period. You know, 563 00:39:02,246 --> 00:39:05,407 we don't know if Globe and Guard are here to stay. You know, 564 00:39:05,490 --> 00:39:09,138 we don't know if Generous is here to stay. We don't know if Congress, 565 00:39:09,221 --> 00:39:11,733 the next Congress, may wish to legislate on MFN. 566 00:39:11,817 --> 00:39:14,497 And so I will say it's a really difficult time to. 567 00:39:14,580 --> 00:39:17,209 to be a manufacturer and plan for these things, right? 568 00:39:17,292 --> 00:39:20,223 Because it's very hard to plan around uncertainty. You know, 569 00:39:20,306 --> 00:39:22,584 the last thing you want to do is not, you know, 570 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 571 00:39:26,735 --> 00:39:31,472 launched in Germany. and made your product available to patients and saved lives or, 572 00:39:31,555 --> 00:39:34,979 you know, reduced harm and you would have been fine. Right. 573 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. 574 00:39:39,581 --> 00:39:43,220 Which is this just, total lack of uncertainty as to where, 575 00:39:43,380 --> 00:39:46,520 all of this is going. But I guess my key point is 576 00:39:46,770 --> 00:39:50,970 No organization should be going through planning, 577 00:39:51,300 --> 00:39:55,400 of a product and not taking into account these important factors. 578 00:39:55,620 --> 00:39:59,927 Yeah, totally. And one of the legal things that's come through, which could be very 579 00:40:00,010 --> 00:40:04,590 is. Some markets, like Spain recently, is looking to put through legislation which 580 00:40:04,673 --> 00:40:05,507 says, 581 00:40:05,770 --> 00:40:09,485 These confidential discounts legally and contractually are confidential. 582 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 583 00:40:13,893 --> 00:40:17,292 to give a discount, you can't just go and tell the U.S. president. 584 00:40:17,375 --> 00:40:21,406 It's meant to be a two way protection because some of the countries are seeing 585 00:40:21,489 --> 00:40:25,151 that they're not going to get launches there because the view is, well, 586 00:40:25,235 --> 00:40:27,450 the confidential price isn't confidential. 587 00:40:35,770 --> 00:40:39,010 to tell other countries what discounts they've been giving. 588 00:40:39,093 --> 00:40:43,346 So if markets suddenly start doubling down on this confidentiality illegally, 589 00:40:43,430 --> 00:40:46,951 if you go to Spain, come and give us 30% discount, that's great, 590 00:40:47,034 --> 00:40:50,105 'cause we want access. We're never gonna pay a US price, 591 00:40:50,188 --> 00:40:53,597 it's never gonna happen, but this is a contractual obligation, 592 00:40:53,680 --> 00:40:55,367 you can't go and share it now. 593 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 594 00:41:00,159 --> 00:41:01,470 of block an MFN route. 595 00:41:01,630 --> 00:41:06,350 How does that look now if you then want to go and do a voluntary reporting, 596 00:41:06,880 --> 00:41:11,191 If you signed a deal which says you can't share our contract. I mean, 597 00:41:11,274 --> 00:41:14,758 my understanding is that most of the agreements to date, 598 00:41:14,841 --> 00:41:18,280 the sort of NFN agreements, you know, contain clauses, 599 00:41:18,490 --> 00:41:25,230 that recognize that a manufacturer may in certain instances, you know, be... 600 00:41:25,420 --> 00:41:30,733 compelled, from reporting, right? In other words, can't report and create exemptions 601 00:41:30,816 --> 00:41:34,716 for that. which seems to suggest the Spain model could be a really good model. 602 00:41:35,020 --> 00:41:39,700 But I also had this suspicion that, that, um... 603 00:41:39,820 --> 00:41:42,887 U.S. federal policymakers, commerce... 604 00:41:42,970 --> 00:41:48,004 are going to be really unhappy with that move, right? And that long-term, 605 00:41:48,088 --> 00:41:49,630 that's probably not... 606 00:41:50,020 --> 00:41:55,420 a sustainable model, right? If every country just makes these prices not... 607 00:41:55,510 --> 00:41:59,565 Disclosable There's going to be something that comes next I just can't imagine 608 00:41:59,648 --> 00:42:02,854 that's how this all nets out Totally, totally So Ross, I mean, 609 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 610 00:42:07,128 --> 00:42:11,182 episode Because I think yours is going to be the longest Because we've covered 611 00:42:11,266 --> 00:42:14,558 the most content. You have been totally awesome, Ross. 612 00:42:14,641 --> 00:42:17,940 Anything exciting for you now over the next sort of – 613 00:42:18,023 --> 00:42:22,726 we're halfway through the year now. What does the next six months look like 614 00:42:22,809 --> 00:42:25,661 for you? Are you coming over to Europe at all? 615 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, 616 00:42:30,785 --> 00:42:34,148 got our little flat booked and made a veil. Wonderful. 617 00:42:34,231 --> 00:42:37,593 And we'll have to eat some spicy Indian food together. 618 00:42:37,677 --> 00:42:41,250 I'm going to take you out and test your waters, I think. 619 00:42:41,770 --> 00:42:45,243 Yes, I love that. Yeah, and I guess I would just say, I mean, 620 00:42:45,326 --> 00:42:47,207 it is that I don't anticipate the 621 00:42:47,290 --> 00:42:51,836 pace of change slowing. I do think it's really important to watch the outcome 622 00:42:51,919 --> 00:42:56,646 of the midterm elections because I think Democrats and Republicans have slightly 623 00:42:56,729 --> 00:43:00,160 different perspectives on MFNs. 624 00:43:00,280 --> 00:43:05,877 And then I think one of the really, but divided government is a high likelihood 625 00:43:05,960 --> 00:43:08,470 that, in 2027,000, 626 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 627 00:43:16,630 --> 00:43:20,306 towards some sort of broader drug pricing reform that incorporates mfn ross i think 628 00:43:20,389 --> 00:43:23,657 you're going to probably be the most popular episode we'll definitely have 629 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 630 00:43:27,544 --> 00:43:30,948 to working with you again i look forward to presenting with you again and i'm 631 00:43:31,032 --> 00:43:34,571 definitely looking forward to seeing you in london soon same my friend we'll see 632 00:43:34,655 --> 00:43:38,205 each other soon okay take care thanks for having me thank you thank you 633 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 634 00:43:52,277 --> 00:43:53,310 podcasts i need 635 00:43:53,410 --> 00:43:57,444 Yeah, Ross is amazing. In fact, thanks to all of our guests across this season 636 00:43:57,527 --> 00:44:01,403 for being so generous with their time, their unique insights, perspectives, 637 00:44:01,486 --> 00:44:04,970 and really shaping, I think, maybe a different direction, I sense. 638 00:44:05,410 --> 00:44:10,563 our payer exchange going? Because really, we've gone from interviewing different 639 00:44:10,646 --> 00:44:15,472 payers across different seasons to maybe this deep dive, this US deep dive, 640 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 641 00:44:20,923 --> 00:44:23,410 in the US and then the global economy. 642 00:44:23,860 --> 00:44:27,517 implications of that. Now, when we started planning this season, 643 00:44:27,600 --> 00:44:32,309 the objective was simple. Understand how changes in US pharmaceutical policy might 644 00:44:32,393 --> 00:44:34,822 influence the future of market access. Now, 645 00:44:34,906 --> 00:44:37,277 having listened to all four conversations, 646 00:44:37,360 --> 00:44:40,608 I think the discussion has become much broader than that. 647 00:44:40,691 --> 00:44:42,617 We've heard from a regional plan. 648 00:44:42,700 --> 00:44:47,761 specialty pharmacy, self-insured employers and policy expert from the legal 649 00:44:47,844 --> 00:44:53,453 perspective for manufacturers. So some of the biggest changes the industry has seen 650 00:44:53,537 --> 00:44:55,320 in decades, each looked at 651 00:44:55,570 --> 00:44:59,345 The same challenge through a different lens with some common themes, 652 00:44:59,428 --> 00:45:00,790 but we kept coming back, 653 00:45:00,910 --> 00:45:04,647 to some key issues. How do we support innovation while keeping healthcare 654 00:45:04,730 --> 00:45:07,734 affordable? How do we demonstrate value beyond price alone? 655 00:45:07,817 --> 00:45:11,554 And how do organizations make good decisions when they're not going to be 656 00:45:11,637 --> 00:45:14,943 able to do it? while the policy landscape is still evolving? 657 00:45:15,026 --> 00:45:17,366 Those questions aren't confined to the US. 658 00:45:17,450 --> 00:45:20,655 They increasingly influence pharmaceutical manufacturers, 659 00:45:20,738 --> 00:45:23,450 payers and healthcare systems around the world. 660 00:45:24,010 --> 00:45:27,406 So where next for the payer exchange? Well, let me tell you, 661 00:45:27,490 --> 00:45:32,104 season four is already in pre-production. We're planning our return to Europe for 662 00:45:32,187 --> 00:45:36,396 an entire season focused on one healthcare market that's changing rapidly. 663 00:45:36,479 --> 00:45:40,571 And I'm delighted to say we'll be welcoming back one of our most popular 664 00:45:40,655 --> 00:45:44,515 guests from our very first season. Until then, thanks for listening. 665 00:45:44,598 --> 00:45:46,570 Thanks for joining me on the payer 666 00:45:49,060 --> 00:45:53,082 If you would like to participate, maybe you're a current or former payer, 667 00:45:53,165 --> 00:45:57,412 maybe you're involved with policy, maybe you've heard and you want to be part 668 00:45:57,496 --> 00:46:01,912 of the conversation. Please contact me on LinkedIn or on Vipora.com and I'd love 669 00:46:01,995 --> 00:46:05,848 to engage with you. Until then, it's bye from me. Thank you very much. 670 00:46:05,932 --> 00:46:07,900 Omar Ali, Head of Payers at Vipora. 671 00:46:19,060 --> 00:46:26,060 Thank you. 672 00:46:32,230 --> 00:46:36,775 Every conversation in this season explores a different perspective on the challenges 673 00:46:36,858 --> 00:46:39,696 shaping pharmaceutical market access today. Together, 674 00:46:39,779 --> 00:46:43,663 they reflect the kind of discussions we're having every day with payers, 675 00:46:43,746 --> 00:46:47,134 policy experts and life science organizations around the world. 676 00:46:47,218 --> 00:46:50,055 You know, at Vipora, we're all about access strategy. 677 00:46:50,138 --> 00:46:54,408 We help pharmaceutical companies bridge the gap between the value of innovation 678 00:46:54,491 --> 00:46:56,750 and the realities of health care funding. 679 00:47:02,230 --> 00:47:05,241 we support better decisions, stronger partnerships, 680 00:47:05,325 --> 00:47:09,246 and ultimately better patient access to your innovative medicines. 681 00:47:09,330 --> 00:47:13,616 If today's conversation has inspired questions about your own challenges 682 00:47:13,699 --> 00:47:17,621 in market access, pricing, value-based and innovative contracting, 683 00:47:17,704 --> 00:47:20,837 or you'd just simply like to continue the discussion, 684 00:47:20,920 --> 00:47:25,570 we'd be delighted to hear from you. Visit Vipora.com to connect with our team, 685 00:47:25,653 --> 00:47:28,301 discover more episodes of the Payer Exchange, 686 00:47:28,384 --> 00:47:30,690 and more specialist on-demand content. 687 00:47:32,230 --> 00:47:33,063 you