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 podcast where we bring you the latest insights shaping patient access, supply chain/logistics, data & tech, and healthcare innovation. I’m your host, and today we’re looking at the potential impact of a government shutdown on the FDA, updates to Medicare Advantage offerings, and new concerns over US maternal and child health outcomes.

With another federal government shutdown now in effect, analysts 

 that the FDA could face significant operational challenges. Key functions such as drug review timelines, inspections, and post-market safety monitoring may be disrupted if funding lapses. Industry stakeholders say prolonged delays could slow innovation and patient access to critical therapies, underscoring the urgency of stable federal support for regulatory operations.

, with expanded benefits designed to improve affordability and care coordination. The plans include enhanced coverage for preventive services, chronic disease management, and supplemental benefits like dental and vision. Aetna says the offerings aim to meet growing demand among seniors for flexible, comprehensive care solutions.

 published by The Commonwealth Fund finds that maternal and child mortality rates in the US remain higher than in most other high-income countries. Researchers attribute the disparities to gaps in access, inequities in care, and systemic issues within the healthcare system. The findings are prompting renewed calls for targeted policy interventions and expanded maternal health programs to address the crisis.

From the risks of regulatory disruption to changes in Medicare coverage and troubling maternal health statistics, these stories highlight the challenges and opportunities shaping US healthcare in 2026.

. For more insights on trends transforming pharmaceutical access and care delivery, visit 

Thanks for listening—until next time, stay well and stay informed.

This episode of Pharma Pulse covers the potential ramifications of a federal government shutdown on FDA operations, Aetna’s newly announced 2026 Medicare Advantage offerings, and new research showing maternal and child mortality rates in the US remain higher than in most high-income nations.

Pharma Pulse: FDA Faces Shutdown Risks, Aetna Unveils 2026 Medicare Advantage Plans, and US Maternal Mortality Remains High

 podcast where we bring you the latest insights shaping patient access, supply chain/logistics, data & tech, and healthcare innovation. I’m your host, and today we’re looking at the importance of telehealth during policy uncertainty, the growing popularity of Medicare Advantage special needs plans, and Halozyme’s latest acquisition.

The American Telemedicine Association is 

 that the US must preserve telehealth access to avoid setbacks in healthcare delivery during the federal government shutdown. Advocates argue that telehealth has become an essential lifeline for patients, particularly in rural and underserved communities. Without clear policies, they say millions could face disruptions in care, highlighting the urgent need for permanent telehealth protections.

 from KFF shows that Medicare Advantage special needs plans, or SNPs, are becoming increasingly popular among seniors. Enrollment has more than doubled over the past five years, reflecting demand for tailored coverage options for patients with chronic conditions or complex health needs. Experts note that while SNPs can improve care coordination, they also require careful oversight to ensure quality and equity across different populations.

Lastly, in business news, Halozyme has signed a 

 to acquire Elektrofi, a biotechnology company specializing in ultra-concentrated drug formulations. The deal is expected to expand Halozyme’s drug delivery capabilities and strengthen its partnerships with major pharma companies. Industry analysts say the acquisition could accelerate development of next-generation therapies and broaden Halozyme’s role in biopharma innovation.

From protecting telehealth access and evolving Medicare coverage to major biopharma acquisitions, these stories illustrate the interplay of policy, patient needs, and industry strategy shaping healthcare today.

This episode of Pharma Pulse covers ATA’s warning that telehealth protections are critical to maintaining care access during a potential federal shutdown, new KFF data showing the rapid rise of Medicare Advantage special needs plans, and Halozyme’s $750 million acquisition of Elektrofi to expand its drug delivery portfolio.

Pharma Pulse: Telehealth Access at Risk During Shutdown, Medicare Advantage SNPs Surge, and Halozyme Buys Elektrofi for $750M

 podcast where we bring you the latest insights shaping patient access, supply chain/logistics, data & tech, and healthcare innovation. I’m your host, and today we’re covering a new government healthcare initiative, rising prescription trends, and a promising breakthrough in gene therapy.

President Donald Trump has announced plans for a 

 designed to connect patients directly to drug information and pricing resources. The platform aims to improve transparency and give Americans easier access to treatment options. While details remain limited, industry observers say the initiative could reshape how patients engage with pharmaceutical products and pricing in the US.

 show that gabapentin is now the fifth most commonly prescribed medication in US community pharmacies. The drug, often used for neuropathic pain and off-label for anxiety and other conditions, has seen a sharp rise in prescriptions over the past decade. Experts caution that while gabapentin fills critical treatment gaps, its growing use raises questions about appropriate prescribing practices and the potential for misuse.

Lastly, in clinical innovation, researchers have reported that a 

 significantly slows the progression of Huntington’s disease. Early trial results show improvements in motor function and quality of life, offering fresh hope for patients facing this devastating neurodegenerative condition. If future studies confirm these findings, the therapy could become the first disease-modifying option for Huntington’s, a milestone long awaited by patients and caregivers.

From digital health policy and prescribing trends to groundbreaking gene therapy, these stories highlight the rapid changes driving today’s pharmaceutical and healthcare landscape.

This episode of Pharma Pulse covers the Trump administration’s plan to launch a government-run healthcare website for patients, new data showing gabapentin has become the fifth most prescribed drug in community pharmacies, and promising trial results from a novel gene therapy that slows the progression of Huntington’s disease.

Pharma Pulse: Trump Plans Direct-to-Patient Website, Gabapentin Prescriptions Surge, and Gene Therapy Slows Huntington’s Progression

 podcast where we bring you the latest insights shaping patient access, supply chain/logistics, data & tech, and healthcare innovation. I’m your host, and today we’re looking at how Medicaid changes may impact care access, new data on a fixed-dose diabetes therapy, and Bristol Myers Squibb’s latest move in direct-to-patient access.

 shows that childhood insurance dynamics strongly predict how Medicaid cuts will affect access to care. Researchers warn that rollbacks in eligibility and coverage could widen existing gaps, especially for children from low-income families. The findings come as several states reconsider their Medicaid budgets, raising concerns about long-term disparities in pediatric health outcomes.

 has been shown to lower rates of heart failure among patients with type 2 diabetes. By simplifying treatment and improving adherence, the therapy not only enhances glycemic control but also reduces cardiovascular risk. Experts say this could mark a significant step forward in integrated care for diabetes patients, who often face elevated risks of heart-related complications.

Lastly, in other news, Bristol Myers Squibb is expanding direct-to-patient access with a 

 for Sotyktu, its TYK2 inhibitor for moderate-to-severe plaque psoriasis. The initiative aims to make it easier for patients to begin and stay on therapy, part of a broader trend of pharma companies developing patient-centric access models that reduce reliance on traditional pharmacy channels.

From Medicaid policy shifts and new treatment advances to evolving access strategies, these stories reflect the diverse forces shaping healthcare and the pharmaceutical industry today.

This episode of Pharma Pulse covers new research showing Medicaid cuts could widen pediatric coverage gaps, clinical trial data on a fixed-dose combination therapy lowering heart failure risk in type 2 diabetes, and Bristol Myers Squibb’s launch of a direct-to-patient program for Sotyktu to improve psoriasis treatment access.

Pharma Pulse: Medicaid Cuts Threaten Childhood Coverage, Fixed-Dose Combo Reduces Heart Failure in Diabetes, and BMS Expands Sotyktu Access

 podcast where we bring you the latest insights shaping patient access, supply chain/logistics, data & tech, and healthcare innovation. I’m your host, and today we’re covering a major shift in US vaccine policy, promising results from a Medicare savings program, and Eli Lilly’s latest manufacturing investment.

The CDC’s vaccine advisory committee has 

 to transition to a broad COVID-19 vaccination recommendation for all adults. This marks a shift away from targeted eligibility criteria, underscoring the agency’s view that COVID-19 vaccination remains a critical tool for long-term public health. Experts say the move should simplify communication and encourage wider uptake, particularly ahead of future seasonal surges.

 shows that the Part D Senior Savings Model has significantly reduced out-of-pocket insulin costs for Medicare beneficiaries, while also improving adherence and diabetes care outcomes. Patients in the program reported paying no more than $35 a month for insulin, leading to better medication consistency and overall health management. Policymakers are watching the model closely as they consider long-term approaches to drug pricing reform.

Lastly, in industry news, Eli Lilly is investing in a 

 in Houston, TX. The site will focus on advanced therapies and support the company’s rapidly growing pipeline, including diabetes and obesity medicines. The expansion highlights Lilly’s ongoing push to strengthen domestic manufacturing capacity and keep pace with rising global demand for its treatments.

From universal vaccine recommendations to reduced insulin costs and major US manufacturing investments, these stories show the dynamic interplay of policy, access, and innovation shaping healthcare today.

This episode of Pharma Pulse covers the CDC’s unanimous vote to broaden COVID-19 vaccine recommendations for all adults, new data showing the Medicare Part D Senior Savings Model lowers insulin costs and improves care, and Eli Lilly’s investment in a new Houston manufacturing facility to support its fast-growing pipeline.

Pharma Pulse: CDC Expands COVID-19 Vaccine Guidance, Medicare Model Cuts Insulin Costs, and Lilly Invests in Houston Facility

 podcast where we bring you the latest insights shaping patient access, supply chain/logistics, data & tech, and healthcare innovation. I’m your host, and today we’re covering new FDA restrictions on GLP-1 compounding, fresh data on RSV immunization in older adults, and challenges pharmacy owners face in a federal drug pricing program.

 its “green list” of bulk drug substances, blocking certain active ingredients from being used in the compounding of GLP-1 therapies. The decision aims to curb the rise of unauthorized compounded semaglutide products, which regulators warn pose potential safety and quality risks. With GLP-1 demand continuing to outpace supply, the ruling reinforces the FDA’s stance on protecting patients by steering prescribers and pharmacies toward approved, regulated products.

 shows that RSV immunization in adults aged 60 and older not only reduces the risk of respiratory illness but also provides cardiorespiratory benefits, such as lowering the risk of exacerbations in patients with chronic heart and lung disease. Experts say the findings strengthen the case for widespread adoption of RSV vaccination in older populations, particularly as the virus contributes to significant seasonal morbidity.

Lastly, community pharmacy owners report they are unable to participate in the Medicaid Drug Price Negotiation Program, citing 

. Many say the system favors larger players, leaving independents at a disadvantage despite their role in providing front-line patient care. Industry advocates are calling for reforms to ensure that small and mid-sized pharmacies can access the program and remain financially sustainable in a tightening reimbursement environment.

From FDA enforcement to vaccination benefits and pricing inequities, these stories highlight the regulatory and market pressures shaping patient care today.

This episode of Pharma Pulse covers the FDA’s decision to restrict bulk ingredients for compounded GLP-1 therapies, new evidence showing RSV vaccines improve cardiorespiratory outcomes in adults over 60, and pharmacy owners’ concerns over barriers to participating in the Medicaid Drug Price Negotiation Program.

Pharma Pulse: FDA Blocks Compounded GLP-1 Ingredients, RSV Vaccination Benefits Seniors, and Pharmacies Struggle With Pricing Program

 podcast where we bring you the latest insights shaping patient access, supply chain/logistics, data & tech, and healthcare innovation. I’m your host, and today we’re covering updates in maternal health guidance, real-world diabetes data, and a new partnership aimed at lowering drug costs and improving access.

The American College of Obstetricians and Gynecologists (ACOG) has 

 its support for COVID-19 vaccination during pregnancy, even as it distances itself from recent CDC guidance. ACOG emphasized that vaccination remains safe and effective for protecting both pregnant individuals and their newborns from severe illness. The statement underscores ongoing efforts to ensure maternal populations remain a focus in vaccine policy, especially as hesitancy persists in some communities.

 shows that the SGLT2 inhibitors dapagliflozin and empagliflozin are safe and effective for patients with type 2 diabetes. The study found no new safety concerns, reinforcing their role in improving both glycemic control and cardiovascular outcomes. With diabetes prevalence continuing to rise globally, the findings strengthen confidence in SGLT2 therapies as a key option in managing long-term complications.

Lastly, in market access news, EVERSANA and Waltz Health are joining forces to 

 designed to tackle drug costs and improve patient access. The system leverages data, analytics, and real-time pricing to help patients and providers identify the most affordable options at the point of care. By combining EVERSANA’s commercialization expertise with Waltz’s technology, the collaboration aims to improve transparency and reduce out-of-pocket burdens for patients navigating an increasingly complex drug pricing landscape.

From maternal health guidance to real-world diabetes safety data and innovative pricing platforms, these stories highlight how science, practice, and technology are working together to improve patient care.

This episode of Pharma Pulse covers ACOG’s renewed support for COVID-19 vaccination during pregnancy, new real-world evidence confirming the safety of dapagliflozin and empagliflozin for type 2 diabetes, and a partnership between EVERSANA and Waltz Health to improve affordability and patient access.

Pharma Pulse: ACOG Reaffirms COVID-19 Vaccine in Pregnancy, SGLT2 Real-World Safety Data, and EVERSANA–Waltz Tackle Drug Costs

 podcast where we bring you the latest insights shaping patient access, supply chain/logistics, data & tech, and healthcare innovation. I’m your host, and today we’re covering a major legal ruling against CVS Caremark, new concerns about HIPAA compliance among small practices, and the role of pharmacists in adverse drug reaction reporting.

 CVS Caremark to pay $290 million in a False Claims Act case tied to Medicare Part D. The whistleblower lawsuit alleged that the company improperly reported drug pricing data, inflating costs to federal programs. The ruling highlights ongoing scrutiny of pharmacy benefit managers and their role in drug pricing transparency, an issue that continues to attract bipartisan attention from lawmakers and regulators.

 finds that while most small medical practices believe they are compliant with HIPAA requirements, the majority actually fall short. The analysis points to gaps in risk assessments, employee training, and safeguards for electronic health records. These shortcomings leave practices vulnerable not only to regulatory penalties but also to data breaches that could compromise patient privacy. Experts stress the need for better education, resources, and auditing to ensure compliance in smaller healthcare settings.

 has found that many pharmacists lack both knowledge and motivation when it comes to reporting adverse drug reactions. Although pharmacists are often the first to identify potential safety issues, barriers like limited training, lack of time, and unclear reporting systems contribute to underreporting. Strengthening education and streamlining reporting tools could help improve pharmacovigilance and patient safety.

From drug pricing accountability to compliance gaps and safety reporting, these stories reflect the challenges and opportunities at the intersection of pharma, healthcare, and regulation.

This episode of Pharma Pulse covers a $290 million False Claims Act ruling against CVS Caremark, a new report showing most small medical practices fall short on HIPAA compliance, and research revealing why pharmacists underreport adverse drug reactions.

Pharma Pulse: CVS Caremark Faces $290M Penalty, Small Practices Miss HIPAA Standards, and Pharmacists Underreport Adverse Drug Reactions

 podcast where we bring you the latest insights shaping patient access, supply chain/logistics, data & tech, and healthcare innovation. I’m your host, and today we’re covering new digital access to GLP-1 therapies, a clinical trial setback for Pfizer, and the pros and cons of patient portals in connecting with physicians.

 with GiftHealth to expand access to GLP-1 weight loss and diabetes medications through LillyDirect, Eli Lilly’s direct-to-patient platform. The partnership combines Goodpath’s personalized care programs with Gifthealth’s pharmacy distribution capabilities, aiming to make it easier for patients to initiate and maintain therapy. With GLP-1 demand soaring, this collaboration could streamline prescribing and improve adherence, while bypassing some traditional access barriers.

 from a Phase III trial of its sickle cell disease treatment. The therapy failed to meet its primary endpoints, dealing a setback to Pfizer’s rare disease pipeline. The company says it will analyze the data further to understand the outcome and determine next steps. The news underscores the high clinical and commercial stakes in sickle cell research, where effective new therapies are urgently needed but remain difficult to achieve.

 highlights the growing role of patient portals in improving access to physicians, enabling patients to message providers, request appointments, and view medical records online. However, increased accessibility can also lead to a surge in message volume, contributing to clinician burnout and longer response times. Health systems are exploring ways to balance convenience for patients with sustainable workloads for providers, including message triaging and integrating AI tools to handle routine inquiries.

From digital partnerships expanding medication access, to clinical trial challenges, to managing the realities of online patient engagement, these stories reflect the fast-evolving intersection of pharma, technology, and healthcare delivery.

You can catch Pharma Pulse directly on 

This episode of Pharma Pulse covers a new collaboration to expand access to GLP-1 therapies via LillyDirect, Pfizer’s Phase III miss in sickle cell disease, and how patient portals are improving access to care while creating new workload challenges for providers.

Pharma Pulse: GLP-1 Access Partnership, Pfizer’s Sickle Cell Setback, and Patient Portal Trade-Offs

 podcast where we bring you the latest insights shaping patient access, supply chain/logistics, data & tech, and healthcare innovation. I’m your host, and today we’re covering three major developments—from new US policy on drug manufacturing to a high-profile pricing change for a leading obesity drug, and new research on vaccine safety.

 directing the creation of a domestic stockpile of active pharmaceutical ingredients, or APIs. The goal is to reduce reliance on foreign sources, strengthen the pharmaceutical supply chain, and ensure readiness for public health emergencies. This policy could have significant implications for manufacturers, potentially accelerating domestic production investments while reshaping global sourcing strategies.

 the UK list price of its GLP-1 drug Mounjaro by 170%. The company attributes the move to aligning prices with the therapy’s value and global market conditions, but the hike has sparked debate over affordability and access—especially as GLP-1 demand surges worldwide. Critics warn that higher prices could limit uptake within the UK’s National Health Service, while proponents say it may reflect the drug’s potential in addressing obesity and diabetes at scale.

 has found no link between aluminum-containing childhood vaccines and adverse health outcomes. Researchers reviewed decades of data and concluded that aluminum adjuvants, used to boost immune response, are safe and do not contribute to chronic illness. The findings are expected to reinforce public health messaging and counter misinformation, particularly as vaccine hesitancy remains a challenge in some communities.

From US manufacturing policy to international drug pricing and reaffirmed vaccine safety, these stories show how regulation, market dynamics, and public health science are intersecting to shape the pharma landscape.

This episode of Pharma Pulse discusses a new executive order to build a domestic API stockpile, Eli Lilly’s 170% price increase for Mounjaro in the UK, and long-term research confirming the safety of aluminum in childhood vaccines.

Pharma Pulse: US API Stockpile Plan, Mounjaro Price Hike in UK, and New Data on Vaccine Safety

Amid intensified competition—and evolving IRA and PBM dynamics—leaders in the access space must now adopt a strategist mindset. 

Hubs as Revenue Protection: Rethinking Patient Access in the Era of Disruption 

Marketed as cost-saving tools, AFPs can also strain safety-net resources.


Alternative Funding Programs Threaten Patient Access

From patent cliffs and government price controls, to self-pay models and staff-model HMOs, a look at the forces that could deflate the bubble—and those factors likely to keep it afloat a while longer.

Popping the Gross-to-Net Bubble, Part VI: The Future of Pharmaceutical Pricing

Amid pressures on pharma to match the lowest international prices, experts warn of “policy laundering” and discriminatory impact.

Inside the MFN Pricing Actions

Capturing insights from executives and industry experts on the biggest challenges shaping pharma today, from drug pricing pressures and access barriers to supply chain shifts, digital adoption, and evolving patient-centered care strategies.

Pharma Commerce's 2025 State of the Industry Survey

Turning Data Into a Strategic Advantage

This video was created based on an article written by Bill Barr, Eric Jen, PharmD, and Wendi LeVigne: 

Monitoring Payer-Level Performance and Planning

You know those reports you get, the ones packed with data? Let's be honest, a lot of the time, they just tell you what already happened, right? Well, in this explainer, we're going to talk about how to flip that script, how to turn that simple scorecard into a real strategic guide that actually helps you shape what happens next for your brand. And this quote right here, it just nails it. We need to stop just pointing out the winners and losers after the game is over.

The whole point is to use that data to drive what your team does next. It's all about playing offense, not just keeping score. So I want you to think about this for a second. Are your reports a scorecard for a game that's already finished, or are they a playbook for the next one? It's a simple question, but, man, we get stuck looking in the rear-view mirror way too often. All right, so let's dig in and really move beyond that old school report card model. We've got to pinpoint the real problem with how most reporting is done.

And here it is, the big failure. Most of our reporting is just a history lesson. It's great at telling you what happened, but it's totally silent on the why, and, more importantly, what on earth you should do about it. You're left with all this information, but no clear path forward, no action plan. Okay, so how do we fix this mess? Well, what I love about the source material for this is that it boils everything down to just two critical questions. You get these right, and you can totally transform that history lesson into a powerful strategic tool.

Here they are, super simple. Question one is all about performance, who's on our side and who's getting in our way? And question two is about the plan. Okay, so what's our move? What are we going to do about it? Any report that's worth its salt has to answer both of these questions every single time.

All right, let's tackle that first question. It makes sense right—before you can build a plan, you’ve got to know where you stand. So how do we really get a clear picture of our performance? The first piece of the puzzle is something called payer contribution. And listen, this is not just about the business you have right now. It's about potential. We're talking about the percentage of all possible prescriptions that a single payer controls. Once you know that, you know exactly how much attention they really deserve. So, how do you actually figure that out? Well, it's a three-step dance. You estimate the total prescriptions in an account, figure out your slice of that pie, and then this is key: You double check it with syndicated data. The whole point is to get a number you can trust so you can point your resources where they'll make the biggest splash.

Now, looking at your market share trend is great, but honestly, it's not enough. You have to connect that trend to actual revenue. Think about it, a tiny 1% drop in share in a massive account—that could be a five-alarm fire for your bottom line, but a huge 10% drop in a tiny account might just be a blip. It's that revenue context that tells you what's really on fire and where you need to focus right now. And this brings us to the last part of gaging performance reimbursement. And let me tell you, a simple label like preferred tier is basically useless. It means nothing without context. The real strategic insight, the gold, comes from asking the questions you see on the right, what are the actual obstacles for the patient? What's their out-of-pocket cost compared to our competitors? That's what tells you if your position is truly favorable or not.

Okay, so we've taken a hard look at our performance. We know where we stand, the good, the bad and the ugly. So now it's time for that second critical question, what's the plan? And to build that plan, we're not just going to wing it. We're going to use a framework called GOST—that stands for goals, objectives, strategies and tactics. It's just a really solid, systematic way to build out plans that are consistent, thoughtful, and, most importantly, hold people accountable.

The first step in planning is goal allocation, and when you boil it all down, for any given payer, you're really only doing one of two things. You're either fighting to gain or maintain your position, or you're trying to drive sales with the position you already have. And deciding how you split your time and money between those two, that is a huge strategic choice, and having a general goal just isn't going to cut it. It has to be a smart objective, you know, specific, measurable, achievable, all that good stuff.

So let's improve. Orr share is fuzzy, but attain a 32% market share by the end of Q—now that's a real target. It's crystal clear. You can measure it, and everyone knows what they're on the hook for. This next part is absolutely crucial. The best strategies aren't just pulled out of thin air. They're not guesses. They are born from a really disciplined analysis of your own internal strengths and weaknesses mapped against the external opportunities and threats you're facing out there in the market. And this table is how you turn that analysis into real action. It literally transmutes a basic SWOT analysis into a strategy generator. So, for example, an SO strategy (strengths opportunities) might mean you use one of your strengths, let's say amazing clinical data, to jump on an opportunity, like a pair who's suddenly really interested in health economics. See how that works? Your analysis directly creates your strategic playbook.

All right, so we've done all this work, we've analyzed our performance, we've built this detailed plan. What's the bottom line? What's the real payoff here? What's the strategic advantage you actually get? Well, the payoff is huge, and it's super clear. First, you get your leadership team focused on the payers that actually move the needle. Second, you drive real accountability across your team, because everyone's working off the same clear, measurable plan, and the end result, you maximize your net revenue and you get the best possible reimbursement for your brand. That's the win. So here's what I want you to do. The next time a performance report lands on your desk, don't just see it as a recap of what already happened. I want you to see it as page one, the first page of your next strategic plan, because your data is telling a story. The only question left is, are you ready to write the next chapter?

This guide shows how to move beyond rear-view reporting and transform data into actionable strategies that drive payer engagement, sharpen planning, and maximize brand performance.

Gross-to-Net Bubble Reshapes Drug Pricing Strategy

This video was created based on Bill Roth's "Popping the Gross-to-Net Bubble" 

Welcome to the explainer. Today, we are talking about the wild and honestly, super complex world of drug pricing, and we're going to tackle what some experts call the gross-to-net bubble. It's a huge shift that's happening right now, and you need to know about it.

So let's just jump right in with a question that gets to the absolute heart of this whole thing. Why is the price you hear about for a drug—you know, it's list price—why is it basically just an illusion? What's the real story behind that number? Well, the answer really boils down to this one critical term, gross-to-net, or GTN for short. The easiest way to think about it is this. It's the massive and usually invisible gap between a drug's official sticker price and the actual cash a drugmaker gets to keep—all those rebates, discounts, and fees live inside that gap, and they bring the real price way, way down.

Okay, so to really get where things are headed, we first have to understand the old way of doing things, the old playbook for pricing drugs. And let me tell you, it's an approach that has a massive hidden trap built right into it. For years, the logic seemed to make perfect sense, right? A new drug gets approved, what's the first thing you do? You go cut deals with the huge commercial insurance managers, the PBMs. Why? Because they control access to millions of patients. You get in good with them. You get massive volume. Simple, but here's the deep flaw in that logic. When you chase volume with those big commercial players, first, you're ignoring a completely different and incredibly powerful set of rules, government pricing regulations, and trust me, those rules can come back to haunt you and cause your actual revenue to just collapse later on, and we're not talking about some small niche problem anymore.

The ground has completely shifted under everyone's feet. The whole landscape of who actually pays for drugs in the US has fundamentally changed the old rules, they just don't work anymore. This is the number that changes absolutely everything—over 55%. That's how many Americans now get their prescriptions covered by government programs like Medicare and Medicaid. That's not just a big number. That's a tipping point. This new reality is nothing short of a seismic shift. Government payers are no longer just a part of the market. They are the market. They're the majority now. So if you ignore their rules, you're literally ignoring the biggest, most powerful player at the table.

So here's the takeaway—you have to flip the entire model on its head, that old commercial first playbook. It's done. The new game is all about building your pricing strategy on a solid foundation from day one. The 

actually uses a perfect analogy for this. It's like building a house you would never, ever try to put up the walls and the roof before you've poured a solid concrete foundation, right? It would be a disaster in this world. The foundation is understanding all of those government or statutory pricing rules. Then you can think about the commercial deals, the walls and the roof and this new statutory first model.

It's a clear three-step process. First, you have to forecast your patient mix, who's going to be using your drug. Second, based on that, you model the absolute lowest price you can have because of government rules. And only then, as the third and final step, do you start layering those commercial deals on top of that solid base. Adopting this model forces you to ask much smarter, long term questions, you start thinking, hmm, if we raise the price, will that trigger inflation penalties, or wait, if we give this one HMO a super deep discount, could that accidentally set a new best price that we then have to give to the government for free? You see, you're no longer just reacting. You're playing chess, not checkers. And look, this is so much bigger than just a new process for the pricing department, this requires a whole new strategic discipline that has to run through the entire company. It's a move away from just reacting tactically to having a real long-term, enterprise-wide strategy.

So what does this actually look like in a company that gets it right? Well, they have what the experts call mature GTN governance. This means they have high-level steering committees looking at the whole portfolio. They use standardized decision models to avoid making costly one-off mistakes. They're constantly planning for downside risk and making sure that everyone from marketing to finance to legal knows who is accountable for what here's the bottom line, gross-to-net is not just some number that an analyst at a back office calculates anymore. It's a C-suite, top-level priority in today's market, having a smart GTN strategy is one of the most critical factors that determines whether a drug brand lives or dies.

Which brings us to this, final, really provocative question. The commercial PBMs, sure, they might have the loudest voices in the room, but the real rules of the game—those are being written by the government now, and the companies that understand this, the ones who play by those rules first, they're the ones who are going to win.

As over half of Americans now receive prescriptions through Medicare or Medicaid, pharma companies must shift from a commercial-first approach to a statutory-first model, making GTN governance a C-suite priority for long-term brand survival.

Potential 250% Pharma Tariffs Could Pressure Margins Without Directly Raising Patient Costs

, Dave Malenfant, a healthcare supply chain expert, discusses the potential impact of a proposed 250% tariff on pharmaceutical imports, emphasizing that the effect depends heavily on where in the supply chain the tariff is applied. If imposed on active pharmaceutical ingredients (APIs), the impact would be minimal, as APIs contribute relatively little to the total cost of a finished drug and adjustments could be made through negotiation. However, if applied to finished pharmaceuticals or key components—such as bottle plugs, closures, molded parts, and glass—the cost implications could be significant, since these materials represent a substantial portion of overall manufacturing costs.

Malenfant notes that the US conducts much of its pharmaceutical research and development domestically but often outsources manufacturing to lower-cost countries, only to re-import the products for sale. He questions this practice, arguing that products sold in the US should be manufactured domestically to strengthen the supply chain and reduce dependency on foreign production. He cites examples of non-US companies, such as the world’s largest generic drugmaker, establishing manufacturing facilities in the United States as a step in the right direction.

The interview also addresses duty drawback, a current process allowing companies to recover duties paid on imported pharmaceuticals, which the proposed tariff regulation would reportedly eliminate. Without duty drawback, the financial burden on manufacturers and distributors would increase.

While higher component costs could drive up product expenses, Malenfant believes that companies are unlikely to pass these increases directly to patients. Instead, they may absorb the costs by reducing margins, particularly since US pharmacompanies already operate with some of the highest profit margins globally. However, the ripple effect would reach insurance companies, prompting complex negotiations between insurers, distributors, and manufacturers to prevent direct cost increases to patients and maintain access to medications.

He also comments on how the tariff could cascade through the pharma supply chain; the

downstream operational challenges that might arise for pharma companies;mitigation strategies industry leaders should already be exploring; and much more.

If a 250% tariff on pharma imports was to be implemented, what would the immediate cost implications look like for manufacturers, distributors, and ultimately, patients?

It depends where the tariff is applied. If you're talking about the active pharmaceutical ingredients, they'll have very minimal impact, as you get into the royalties and all that. When you look at the cost of a pharmaceutical product, a lot of the cost is not in the active ingredient, as much as the components to package it in the processing. If we are buying a finished pharmaceutical and it's got a 250% tariff on it, and the proposed regulation says that there will not be a duty drawback, because right now, on a lot of pharmaceuticals, you have duty drawback, which means you pay duty upfront, and then you can go and apply to the government and draw back.

What that does is it will have a direct impact throughout the entire supply chain, but at the same time, it's telling the US, why aren't we making these pharmaceuticals in the United States? Most of the research and development has been done in the United States, but then we export it out to cheaper countries to make the product, and they import it back in, such as Singapore—I’m not going to talk about India, because India is a unique situation—or other countries, and then we import it back in trying to distribute it within the United States. Good FDA approval and distribute in the United States. I'm not proponent of that. I think if we're going to sell in United States, I firmly believe that we should make it in United States.

An example, Nico, is the largest generic pharmaceutical company in the world is not American, but yet they're now manufacturing in the United States. My view is that, depending on where in the process, is that duty going to apply? Now it says it's going to apply throughout any pharmaceutical, including active pharmaceutical ingredients, components, and manufacturing, but if it's raw materials, active pharmaceutical ingredients will have a very minimal impact on anything, because we can make adjustments in the way we negotiate it.

If it's components like bottle plugs, closures, molded parts, glass, that has a bigger impact, because that is the one of the bigger costs within the main total cost of a pharmaceutical. That will probably increase the cost of the product. Does it mean it's going to be a price increase? I don't believe so. I think the companies will eat it up in their margins, because here in the United States—and I know some of the listening audience will probably not like me saying this—but the US enjoys the largest margins in pharmaceutical drugs in the world.

Having the tariffs, you have to decide, do we eat it in margin, or do we pass it on to the consumer? By the way, it doesn't really get passed on to the consumer, it gets passed on to the insurance companies, and the insurance companies certainly are not going to accept it, so the network is going to be disrupted, and there's going to be a lot of negotiations between the partners, between distributors and insurance companies, to offset it so that there is not a direct impact to the end patient.

In the first part of his Pharma Commerce video interview, Dave Malenfant, a healthcare supply chain expert, explains how steep pharmaceutical import tariffs might affect costs at different points in the supply chain, why component pricing poses a bigger risk than active ingredients, and how insurers, distributors, and manufacturers may negotiate to shield patients from price increases.

How Pharma Can Remain Competitive Amid Rising Healthcare Costs

In the final part of his Pharma Commerce video interview, Philip Sclafani, PwC's pharmaceutical and life sciences lead, discusses operational and pricing strategies pharma executives can adopt to navigate sustained cost inflation, including supply chain optimization, payer collaboration, and value-based approaches to ensure patient access and affordability.

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