The September 29th Deadline Is Slipping: What Pharma Teams Need to Know Now

The bumpy road to drug pricing reform continues as the US Most Favored Nation deadline of September 29th faces delays. Regulatory complexities, competing healthcare priorities like the Strategic API Reserve, and election year politics are all contributing factors that may push implementation into 2024 or beyond.

• MFN model would force Medicare to pay the lowest drug prices available in other economically comparable countries
• Americans currently pay nearly 250% more for medications than citizens in 32 other developed nations
• Pharma manufacturers argue pricing parity could disincentivize R&D and reduce availability of breakthrough treatments
• Regulatory delays announced as the proposal must pass through review and public comment periods
• New Strategic Active Pharmaceutical Ingredients Reserve initiative may be drawing legislative focus away from pricing reform
• 70% of API manufacturing occurs overseas, mainly in India and China
• Election year politics may prefer to defer enforcement while using the MFN narrative for campaign momentum
• International reference pricing likely to become more common in US payer negotiations
• Digital companions and patient support platforms that demonstrate improved outcomes will be crucial for showing value
• Commercial teams should prepare contingency plans rather than waiting for formal announcements

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PostScripts Rx is not intended to constitute medical advice, nor is it intended to influence prescribing decisions or any other medical or clinical decision-making. All medical and clinical judgment and decision-making, prescribing decisions, and all related considerations remain exclusively the responsibility of providers and patients.

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• 0:00 Welcome to Postscripts

Transcript

Speaker 1: 0:00

Hello and welcome to Postscripts, the podcast exploring what happens after the first prescription. We cover the latest innovations in patient access support, digital tools, hcp engagement and pharma marketing that we all hope drive better outcomes for patients. This podcast is for informational purposes only and should not constitute any medical advice for anyone or influence clinical decision-making in any way. Patients should always consult their healthcare professionals. Welcome to the podcast. My name is Brian Carr and I am the Medisafe team, although any opinions expressed here are those of my own and not necessarily those of Medisafe or its partners.

Speaker 1: 0:35

Some progressing news today the bumpy road to drug pricing reform. So what? We're seeing? Some delays in what we're calling the US most favored nation deadline of September 29th. You may recall that was the date that many pharma marketers, patient access leaders, policy watchers are kind of tracking closely, because that's when the administration had originally targeted for enforcement of a most favored nation pricing model that could really force Medicare to pay the lowest price available to comparable markets in developed nations. So that is a fundamental shift in how drug pricing could be regulated here in the US and it really does hold the major implications for everything from the payer negotiations to innovation timelines. But now we're hearing the industry and deciders and policy experts are really questioning whether the administration can even hit that September 29 day, which is about 30 days 30 business days we look at away or if political, supply chain regulatory complexities are already in place. Perhaps lawsuits will force a delay. So today we're diving into what's really going on behind the scenes and what it means for the life sciences and commercial and access teams. So what's at stake here?

Speaker 1: 1:37

The MFN model Most Favored Nation. It was introduced as a pathway for Medicare to pay no more than the lowest drug prices available economically anywhere else in other economically comparable countries. So proponents say it's really necessary to curb those skyrocketing drug costs. By the way, americans pay sometimes nearly 250 percent more than citizens in 32 other developed nations, and that's according to data from the House Ways and Means Committee from 2020. And that's according to data from the House Ways and Means Committee from 2020. So, on the other hand, pharma manufacturers and medical innovation advocates are arguing that such pricing parity could really disincentivize research and development due to the tighter price controls right, lead to reduced availability of breakthrough treatments and it could create logistical and compliance challenges across different Medicare channels. Compliance challenges across different Medicare channels. So for brand and access teams. The impact could really dramatically reshape launch pricing strategies and cadences on which countries launch first some of the payer contracts and long-term forecasting models, some of which will be for launch brands that are coming out and others may already be forecasts that were in place and are embedded for newly launched brands.

Speaker 1: 2:43

You know so what's holding all this up. We are seeing some regulatory delays that were announced yesterday. According to Fierce Pharma, the White House proposal has to pass through some regulatory review and public comment periods, so that's going to still be weeks away from it formally being produced, right and publicized. So officials did cite legal complexity in linking the US pricing to international benchmarks, although, we should note, this is already in place in Europe. So European nations look at the other European nations around them when they determine their prices. But it is noting that each therapy's price is negotiated differently from country to country. This makes an apples to apples comparison difficult could be fraught with exceptions, right.

Speaker 1: 3:22

So, additionally, the administration is really trying to balance this reform alongside some other major health care priorities, such as the Strategic Active Pharmaceutical Ingredients Reserve. So this was interesting that was announced this week, thing that was announced this week. This is the initiative which is aiming to unsure some of those key active pharmaceutical ingredients and bolster the US supply chain. The challenge there is, you know, that could be drawing some legislative focus away from pricing due to the headline risk around shortages in national security. So here's a little bit more on those APIs.

Speaker 1: 3:53

On August 26th, which was, yeah, there was a fact sheet that outlined a new executive order. This wasn't August 26th, which was, yeah, there was a fact sheet that outlined a new executive order. This wasn't August 26th, but it meant to secure the US pharmaceutical chain. But what they called is creating a strategic stockpile of the active pharmaceutical ingredients. What happens is right now, about 70% of those API manufacturing really does occur overseas, mainly in India and China, and that's according to the FDA occur overseas, mainly in India and China, and that's according to the FDA. So when you see, supply constraints could really increase the global drug prices and really complicated any data or pricing models that are supposed to be used in the most favored nation formulas. So that means pricing reform could be difficult to push amidst some of the ongoing shortages or fears of foreign dependence on ingredients that aren't produced here in the US. So from an optics standpoint it may be more feasible for policymakers to show progress through a more resilient supply chain rather than tackling one of those most contentious issues American health care the drug prices.

Speaker 1: 4:49

So another challenge to the meeting that September 29 deadline is the election year calculus. Granted, it's a popular pricing, pricing on drugs is a popular campaign talking point. But really implementing such a sweeping policy, and especially one that can reduce access as well to certain drugs, or slow innovation, could have some political blowback right. So you could imagine some communities or rural areas or some poverty areas might not be getting the drugs or the treatments that otherwise others will be getting because they could be more expensive to get those medications right. So lawmakers on both sides may prefer to defer that enforcement of that and use that whole most favored nation pricing narrative for momentum as they continue in 2026 with their debates and campaign trails, rather than actually make a policy out of it. So we'll see. It could be a volatile election year next year with the midterms.

Speaker 1: 5:40

Anyway, this has implications for pharma commercial teams. So what does it all mean for the access teams, the marketers, innovation leaders? Well, the threat of most favored nation pricing, even if delayed, can't be ignored. It is driving higher scrutiny among payers, providers and teams Really should prepare to be ready with clear value props, cost-effective models and some key adjustments. So integrated pricing models, so that international reference pricing technique is probably going to become more common in payer contract negotiations in the US One of the underwritten things on the EU.

Speaker 1: 6:13

Back to tariffs here. With the EU tariff agreement that was reached in, that was the first time ever the US will actually allow international reference pricing techniques to affect the price of US medications. This is something historically the US had always rejected out of hand, but with that new trade agreement was written in that we would accept pricing techniques used in other countries. So it's real Data quality. You know we could have the need to really validate methodology and comparators of economic models in the formulary submissions. If medications are exactly similar, why wouldn't they be priced the same? But if there's some difference, well okay, if there's a difference, can you quantify that difference enough to justify a higher price that is being paid worldwide?

Speaker 1: 6:54

Now, patient adherence and support these platforms like Medisafe, full disclosure as you know, I work at Medisafe but even platforms that have this digital companions and real world applications, adherence that is demonstrated, that can improve outcomes, show health, economic value. You know, when pharma brands can actually show success in that digital environment, it's going to. They're going to need transparency and partnership with health economics teams and some of these proactive patient engagement solutions that really will reinforce the value of the therapy right and the extra value add if you have got a dedicated digital support platform and team helping with you and your support of that medication. So you can imagine if a scenario where two medications may be equally priced or in the market and what's also going to happen here is transparency on pricing is going to be done at the HCP level. So doctors may be able to choose between two different medications, but they see perhaps more efficacy, more value in one where the patients seem to be more adherent. Why? Because they're using a digital companion, or they have more brand loyalty, because they don't want to switch off it, because they already talked there, whether it's a nurse navigator, or they see plenty of great content that is effective for them in managing their treatment. They don't want to leave a certain brand. So when we, you know, in the marketing terms, we'll talk brand loyalty In the financial office, they'll call that, you know, preserving market share. So what could happen next, although the September. Mfn deadline reportedly is sliding, something we predicted here at the podcast. That doesn't mean teams can just take their foot off the gas.

Speaker 1: 8:19

Several possible scenarios can be in play. I would imagine there's delay, but not abandonment. Policy gets pushed to Q4 early 2026, post-election, even during the election year, and even post-election You're probably going to see some pilot rollouts. The administration might test MFN pricing in limited markets to really gather the impact data. You do see where pharma companies have come to the fore, some of them promising to build $50 billion in injection into the US economy, including building the new production plants in the Virginia area. So you know they may see a scenario where some prices from certain pharma company portfolios are affected differently in a positive way because they are already integrating and making some inroads and producing some things in the US that they had not considered before. You're probably going to see some legislative linking so the MFN provisions at any time could be tied to other larger bills that are being negotiated, especially on supply chain security preparedness. You know, in any scenario commercial and patient access teams should be ready to update their scenario plans and really remain close in dialogue with the market access and public affairs partners and what's happening in the news, things we discuss here every day too, on the podcast. So hey, in conclusion, you know flexibility is going to become a pretty new superpower for our teams and our verticals.

Speaker 1: 9:36

You know, in summary, here you look at the administration's status. It's really right now looking at delays, but the ambition is not going to go away. It's still going to be very active. Can't be in a place where you are going to afford to wait for formal announcements. At least have some contingency plans in place to preserve that market share and brand loyalty, I would argue, through digital solutions that really connect with patients on a real evidence basis and a real world basis. So all right, anyway, thanks for joining us here at Postscripts. If you have found a conversation valuable, please follow or subscribe for more insights. At the intersection of pharma, tech and patient impact, we do interviews. We also do a quick five to 10-minute synopsis every morning or so on things we're following, particularly when it comes to the drug pricing model and the administration's activities around pharma and pharma pricing. All right, folks, have a great day and thanks so much.