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Postscripts Rx
Conversations Beyond the Prescription. Where pharma, HCPs, life science and digital health solutions meets patients—after the script is written. Conversations on digital health, engagement, and real-world impacts that are re-writing the future of patient engagement.
Postscripts Rx
Counting Down: 47 Days Until Pharma's Pricing Reckoning
The clock is ticking for pharmaceutical companies as the September 29 deadline for most favored nation pricing plans looms just 47 days away. This sweeping policy shift represents one of the most significant pricing reforms in recent history, with profound implications for everyone from brand marketers to patient access teams.
Five major developments are converging to reshape the pharmaceutical landscape. First, government price negotiations are accelerating, targeting high-cost drugs without generic competition much earlier than originally projected. The Congressional Budget Office estimates these negotiations could save Medicare over $100 billion in the next decade. Second, the July 27 US-EU drug pricing deal introduces shared reference pricing models that could fundamentally alter global launch sequences and reimbursement ceilings. Third, new domestic manufacturing incentives offer substantial benefits for companies shifting production to the United States, including tax credits and expedited regulatory reviews, though potential tariff increases on imported medications could create new affordability challenges.
The fourth development involves comprehensive PBM reform that mandates transparent rebate reporting and price disclosure at the point of care. This increased transparency creates opportunities for patient service teams to better understand cost barriers in real-time and develop targeted interventions. Finally, recent adjustments following a Supreme Court ruling on Medicare Part B reimbursement could lead hospitals serving low-income populations to remove expensive therapies from their formularies, creating unpredictable access obstacles for specialty treatments.
As these changes converge, the healthcare system stands at a critical crossroads of affordability, innovation, and access. Forward-thinking pharmaceutical teams that integrate pricing, access, digital, and commercial strategies will be best positioned to navigate this new terrain. Digital health solutions that monitor treatment irregularities, enable proactive patient support, and leverage predictive analytics will become increasingly valuable tools for identifying and addressing barriers before they lead to treatment abandonment. How will your organization respond to these unprecedented changes? Subscribe to Post-Rifle for ongoing insights at the intersection of pharma, technology, and patient impact.
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.
Welcome to Post-Rifle, the podcast exploring what happened after the first prescription. We cover the latest innovations in patient access support, digital tools, hcpa management and pharma marketing that we hope drive better outcomes for patients. This podcast is for informational purposes only and does not constitute any medical advice or should influence any clinical decision-making. Patients should always consult their healthcare professionals. Welcome to the podcast. My name is Brian Carr from the Medisave team, although my opinions expressed here are my own and not necessarily those of Medisave or its partners. What we're talking about today, very quickly, is what pharma needs to know before the September 29 deadline set by the US administration for pharma companies to deliver most favorite nation pricing plans for the American consumer. That's about 47 days away and it's 31 or so if you're counting business days. So this is a sweeping policy shift that could expect to impact pricing in ways that we really haven't seen before, and it's all prompted by the recent legislative, legal trade developments and this date really kind of signifies how long it's been mandated pricing reforms with potentially pretty broad implications for pharma brand marketers, patient access teams, h&ps, manufacturers and even innovation departments. And today, very quickly, we're going to break down five major developments that we see are shaping the landscape ahead of this change and examine some of the emerging data, some high-level implications and really a central next step. Keep an eye on what's going on here If you're in pharma, commercialization, patient services or in addiction. This is a quick strategic briefing based on what we know so far. One government price negotiations are kicking off in its accelerated timeline with potentially big impact. You know there's been long debates on federal negotiations on drug pricing and they're really officially set to begin with 10 drugs impacted as early as September 29. This kind of accelerated some of the original timelines projected for 2026 or later, signaling the start of longer-term price controls under this expanded Medicare drug negotiation authority. Here's what we know as of today. In August, a couple days ago, cnn reported that the first wave of this is going to target high-cost drugs that do not have generic competition, so high-value portfolio products could be impacted for many brands. The Congressional Budget Office has estimated, by the way, that the federal government could save over $100 billion in Medicare-related drug costs over the next decade through these negotiations alone. So for pharma marketers and access teams, the signals it really just only needs to revisit pricing strategies perhaps, and patient co-pay, pathway messaging for certain effective therapies, digital solutions that can enhance market share, protect market share and connectivity with patients, particularly in the primary care and chronic disease categories.
Speaker 1:What's also happening, the second thing that you really all keep an eye out for, is the US EU drug pricing deal. That was actually it happened on July 27th as part of the new trade agreement between the US and the EU, but what really didn't get reported as much on is the pricing situation for medication. So it included the introduction of what they call shared reference pricing models, which is a somewhat fancy way of saying you get to. What Europe does already is take the paraphrasing here, really, but they take the averages of prices throughout European countries as an indicator of what certain countries should pay for their pricing on medication. So the US, as prior to July 27th, did not do that and take that into consideration, but the new pricing deal that was announced as part of the tariffs says the US will take that into consideration starting after July 27th. So what this shared reference pricing could do is basically enforce what is already happening in Europe, but basically, prices are negotiated based on what other countries are paying, and that's exactly what the US administration has said they want as well.
Speaker 1:So you know, we do see. You know regulatory harmonization could be generally good for pipeline launches, but it could also mean this now the? U, the U? S is going to allow international reference pricing to enter that conversation on how much they should be reimbursing for for Medicare, and you know it's something we previously have resisted, the previous administration have resisted in the US, right. What they could do is drive down reimbursement ceilings and therefore influence the launch trajectory of maybe new therapies, even globally, right. What you may have is new therapies may launch in the US first. They may launch even more increasingly in other countries first. So pharma teams that are probably already considering how this could affect global launch sequencing, planning and even engagement with payers and a lot of their forecasting models some of them are already baked and out there, you know, launch brands or they're in their second or third year. They may need to revisit some of those models, especially given the volatile currency dynamics that are happening in between international markets right now.
Speaker 1:The third impact to keep an eye on is the domestic manufacturing incentives. They really could alter supply chain strategy. So you may have seen earlier this month new legislation that is being pushed offers tax incentives and what kind of didn't get covered as much as expedited FDA and EPA reviews for pharma companies that want to shift production overseas into the US. So there were three major incentives it's up to a 25% federal tax credit on domestic production costs they're doing shorter validation timelines for new US-based production facilities, really expediting it and a priority FDA review for supply security risk therapies if everything's US-produced right. So its position is a cost-saving and risk mitigation strategy.
Speaker 1:Patient support and access leaders will need to understand how potential shifts in the manufacturing location could disrupt availability, especially during transition. For example, there's also a reporting this week that tariffs on international medications coming into the US could be increased as much as 250 percent, particularly for meds that are even generics right. So that cost could actually enter the equation and, as we all know, cost is one of the factors of non-adherence with medications. So it could be a factor that the patient access and support teams are going to want to keep in mind. You know digital solutions like Medisafe's companion that we're all familiar with, obviously can help monitor the irregularities and that could, you know, be triggered by regional or fulfillment-based issues. You know when you can trigger, find out what about them before they escalate. Contact a patient In your support programs. Hey, we notice you haven't taken the meds. Well, you may actually say, well, I'm kind of rationing them. I know I can't afford the new price increase If I take fewer meds. I can, you know, space them out over the month. You know we've all heard that, so that could be something that is an impact there.
Speaker 1:Fourth, you know you got to think PBM reform could be finally funded. You may see a lot more direct access to midstream data and it's one of the least visible but most powerful developments based on a funding bill that passed in late 2024. Cnn had pointed out that congressional approval now pays for the reform, will now pay for the pharmacy benefit managers, particularly requiring transparent rebate reporting, final price disclosure to prescribers and patients at point of care. Limitations on vertical integration between the PBMs and payers, and it could open new opportunities for patient service teams to prescribers and patients at point of care. Limitations on vertical integration between the PBMs and payers. And it could open new opportunities for patient service teams to really better understand these cost barriers in real time and especially with transparency, and really tailor interventions dynamically, especially when they're laid with the support tools predictive analytics, especially from data platforms like Medistate, for example, you know, do predictive trends, sometimes using AI, where we could see, you know, what patients may be at risk of falling off treatment or based on other trends we've seen in their behavior right. So it's really going to enhance the need to have remote reporting and real-time data real-world data as well that can really inform pharma decision makers and support teams and not only enhance brand loyalty but also protect brand market share if pricing becomes one of the major considerations.
Speaker 1:Lastly, here, keep an eye on the Supreme Court decision, the Medicare Part B reimbursement. There was a 2022 ruling that initially limited how healthy human services could reimburse hospitals for outpatient drugs. What's happened is recently follow-up adjustments were announced that are feeling concerned that hospital systems might face further disparities in their Medicare Part B reimbursement. So what does this really mean? Some hospitals that are serving low-income populations, especially in the 340B program, may drop some expensive therapies or formularies. You know, if the reimbursement is uncertain, this means patient access obstacles could increase unpredictably for specialty therapies. You know pharma brand leaders, especially in oncology or rare diseases, should probably look forward to looking, look ahead to plan and identify support on those effective patients with strong navigator tools, hub support. You know wraparound services as well. You know it includes tools like Medisafe and others. With dynamic notification field tracking, they can really help ensure patients stay connected and, if barriers come up, they can talk to their support teams about them right away and they won't need to drop off as much.
Speaker 1:So a couple of strategic takeaways for the industry stakeholders here. You know, as we were watching this countdown, the pharma industry is. You know many of them are preparing to integrate a policy awareness into commercialization strategy and execution. Key actions for brand marketing, for example, could use the moment to revamp payer strategies, messaging framework and value for both patients and HCPs, such as pricing shifts, fluctuating co-pays, unexpected supply chain changes that could come about with whether it's tariffs on medications coming in from overseas or new production facilities being launched in the US.
Speaker 1:Innovation teams lots of eyes are going to be on how they evaluate new US manufacturing incentives and integrate with digital traceability and operational scale-up plans and ROI how digital can be brought in by innovation teams and really help return on investment at a time when prices may be squeezed right. Hcp engagement teams it's really going to be incumbent on them to educate prescribers in real time and maybe at some of the PBM changes that are coming and the visibility to coverage using data-driven field comms and updates. Right, you know the digital health integrators. Neil's going to be looking at enhanced ecosystem integrations with tools, with Medisafe. You already saw and we talked about it in a different podcast on the transparency of health records plans that the US government is talking about enforcing. That would really bridge adherence gaps, visualize ref refill trends and really track engagement and surrounding cost concerns digitally and transparently.
Speaker 1:All right, with many of these changes that are converging, the healthcare system really is at a tipping point. Some consider that because, when it comes to affordability, innovation, access whether it's going to be a global pricing alignment, domestic production or even PBM reforms each lever really can affect the patient journey and therefore commercial and clinical success. And the proactive teams, those who are working cross-functionally with pricing access, digital commercial, are really positioned to adapt and also thrive in the new terrain and using digital platform tools like Medisafe and others are here to support patients throughout the complexity. They can combine the personalization, real-world data and intelligence guidance. It's going to be an interesting couple of weeks here as we approach the deadline and see what happens with the September 29 date. I really do.
Speaker 1:Thank you two for joining us on Postgres. If you found this conversation valuable, follow, subscribe for more insights. At the Unisection of Pharma Technology and Patient Impact, we typically do a daily podcast that's five to 10 minutes most, just to keep you updated on what we're hearing. Until the next time, keep looking forward, and the real work begins after that script is written. Thanks, folks.
