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How recent executive orders—both under the Biden and Trump administrations—have reshaped the drug pricing landscape, and the legal challenges or uncertainties they present for pharmaceutical companies

What life sciences companies should be doing now to proactively prepare for further executive action on drug pricing and market access

The key differences in how executive policies versus legislative actions affect the pharma industry’s pricing and commercialization strategies

The legal and strategic risks executive policy shifts pose to investors and biopharma leaders who may be planning product launches or portfolio expansion over the next few years

Alice Valder Curran outlines the steps manufacturers should take to better prepare for upcoming executive actions on drug pricing and market access.

How Recent Executive Orders Impact the Drug Pricing Landscape

 interview, Vibhu Tewary, project director, IQVIA Institute for Human Data Science, discusses:

Highlights of the company’s report surrounding the “Long-term Market Sustainability for Infused Biosimilars in the US: Foundational Analytics on Emerging Risks to Sustainability”

The process that constructing and piecing together a report of this magnitude entails, along with where the idea itself came from

The ongoing challenges surrounding ASP-based reimbursement

A closed-door, multi-stakeholder virtual roundtable (based on his original report) that was previously held

Vibhu Tewary offers insight on this market segment, including a behind-the-scenes of what goes into designing a report. 

The Path Forward for Infused Biosimilars in the US

 interview, Mark Bouck, chairman and CEO of PharmAlliance, a pharmaceutical and life sciences services platform, dives into:

How PharmAlliance’s acquisition of Complete Health Economics Outcomes Research Solutions (CHEORS) helps expand global reach

The platform’s biggest goal to when it comes to CHEORS and market access services

How CHEORS helps navigate cost-effectiveness and market access hurdles

Acquisitions in the space that are currently in the works

Mark Bouck discusses PharmAlliance’s latest acquisitions, while reiterating its goals surrounding health economics and outcomes research.

Navigating Market Access Hurdles

 interview, Brandon Newman, Xevant’s CEO and founder, explores:

The implications of the Inflation Reduction Act’s price negotiation provisions, and how these could result in ripple effects across the healthcare system

The role that pharmacy benefit managers (PBMs) and other intermediaries' play when it comes to determining drug costs, and how spread pricing is involved

How Xevant helps improve drug cost transparency efforts

Strategies for affordability Newman would offer the pharma industry that can be implemented immediately

Brandon Newman joins The Pharmaceutical Commerce Podcast to discuss the evolving role of PBMs, including the importance of drug price transparency. 

A Further Examination of Pharmacy Benefit Managers

A qualitative study explores how MA plan leaders, kidney care managers, and dialysis providers perceive the benefits, risks, and marketing practices surrounding MA enrollment for patients with end-stage kidney disease.

How Industry Stakeholders View Medicare Advantage Expansion for Patients with Kidney Disease

As drug development increasingly targets multiple indications, pharma companies must make strategic branding decisions—balancing regulatory requirements, market dynamics, and patient safety—to choose between single-brand or multi-brand approaches.

Multi-Indication Drug Branding in Today’s Pharmaceutical Industry

State Medicaid leaders create a plan to ensure safety, affordability, and equitable access for children and families living with rare diseases.

Medicaid’s Role in the CGT Sector

Analysis compares care quality and efficiency within physician groups that treat Medicare Advantage patients under at-risk contracts, versus fee-for-service.

Does Risk-Based Payment Drive Better Care in Medicare Advantage?

When automatically moved from a zero-dollar silver plan to one that requires a premium due to plan turnover, do lower-income health insurance marketplace enrollees lose or switch coverage?

The Hidden Costs of Zero-Premium Plan Turnover

Deepening Access Gaps

, Marschall Runge, MD, PhD, dean of the University of Michigan Medical School and author of 

, addresses the potential impacts of a federal cap on Medicaid provider taxes and how such a policy could affect hospital systems. particularly in states like Michigan that have uniquely implemented Medicaid expansion.

Runge emphasized that hospitals already operate on extremely thin margins when it comes to Medicare and Medicaid reimbursement. Any policy that restricts revenue opportunities from these programs threatens their financial sustainability. He noted that, contrary to popular belief, hospitals often struggle just to break even under current public payer rates, and additional funding through provider taxes has historically helped improve access to care.

His primary concern centers on patient access. Runge pointed out that healthcare access is already limited due to workforce shortages—especially in primary care—and that wait times are growing. Reducing hospital revenue by capping provider taxes could exacerbate these issues, particularly in underserved areas.

He warned that a federal cap would create new challenges, not only financially but operationally, by potentially limiting patient access across the entire care continuum, from primary to specialty services. He stressed that focusing solely on budgetary savings without considering the downstream impact on health outcomes and system strain is shortsighted. In his view, the proposed cap would have minimal benefit to the federal budget but could lead to long-term harm to patient care and public health infrastructure.

Runge urged policymakers to think beyond dollars and cents and consider how such decisions affect real-world health outcomes, workforce strain, and already fragile access points within the healthcare system.

He also comments on how this proposal might affect access to care for Medicaid patients, particularly in expansion states; alternatives or modifications he would propose to ensure both fiscal responsibility and the sustainability of hospital funding; the role academic medical centers should play in shaping Medicaid policy moving forward; and much more.

How does a federal cap on Medicaid provider taxes potentially impact hospital systems?

They will definitely feel it, and I can speak specifically about our health system. Michigan has had its own unique approach to Medicare-Medicaid expansion, and that has been good overall. It has increased our access, meaning the ability of patients to get here, and we do everything from primary care through extremely specialized care.

One thing that people just don't quite understand about Medicare and Medicaid is that it's very difficult for a hospital to break even, much less have a profit, so when there're approaches to increasing revenue from those programs, those always improve access, and we have lots of data about that, as do hospitals across the country.

My biggest concern has to do with access. I think patient access to healthcare is compromised already for many different reasons. It's compromised because we don't have enough physicians, we don't have enough other healthcare providers. I think that anything that further compromises it will be bad for healthcare and bad for health, so if you think about it, concerning wait times, let's just take an easy one, primary care.

They're long wait times here and everywhere else. It's hard to find a new primary care physician. That then carries over into every part of health. If what we care about—and what I care about—is health, the more we keep people out of healthcare, the better. We have to improve their health, and so we need to be addressing these things. I think thinking about this strictly from a dollars and cents standpoint, I think really has very little impact on the federal budget anyway. I think it'll create new challenges for healthcare.

In the first part of his Pharma Commerce video interview, Marschall Runge, MD, PhD, dean of the University of Michigan Medical School and author of The Great Healthcare Disruption, explains how a federal cap on Medicaid provider taxes could potentially impact hospital systems.

Supply Chain Planning in the Current CGT Climate

, Mark Sawicki, PhD, Cryoport Systems’ president and CEO, discusses the evolving state of global cell and gene therapy commercialization. Sawicki highlighted significant progress in key operational areas, noting that companies are now better prepared for commercial launches than in the past. Early challenges in manufacturing readiness have been largely resolved, with organizations now demonstrating clear strategies, scalable capacity, and well-vetted supply chains. Regulatory hurdles have also been substantially addressed, and most companies are effectively engaging primary launch sites, especially major academic medical centers, ensuring they are trained and ready for product deployment.

However, several persistent challenges remain. Reimbursement, particularly in Europe, continues to be a major hurdle—even for mature companies with marketed therapies. Another notable issue is physician education, especially outside of large teaching hospitals. Many community-based physicians lack a deep understanding of cell and gene therapies, creating a barrier to broader adoption.

Sawicki also pointed to community care engagementas an area needing attention. While major centers are prepared, regional and community sites are lagging in terms of readiness and support. According to available market data, current therapies are reaching only about 20% of the addressable patient population in the United States and Europe, with even lower uptake globally.

Finally, standardization of processes, particularly across clinical sites and within supply chain systems, remains an issue. Inconsistent procedures and infrastructure gaps at these levels hinder the ability of sites to fully support these complex therapies. Addressing these shortcomings will be critical to expanding access and realizing the full potential of cell and gene therapy worldwide.

Sawicki also comments on how supply chain expectations have shifted amid tighter funding, FDA leadership changes and evolving CMC standards; the critical role of cryopreservation, real-time logistics data and AI-enabled fulfillment in protecting product integrity and patient outcomes; what pharma leaders can borrow from CGT’s operational playbook to improve resilience across therapeutic areas; and much more.

How have recent shifts in FDA leadership, funding constraints, and evolving CMC standards impacted supply chain planning for CGT products?

It's really a wait and see. A lot of folks are just taking it slowly to understand any impact. The previous administration was very supportive of cell and gene. The current administration has expressed support, but we obviously have to see that play out, and so I think a lot of folks in the industry are kind of in a wait and see modality right now around that.

From a financing standpoint, there was over $15 billion raised last year in 2024 for cell and gene, which was 30% growth over 2023, which is very positive. There's a potential of 10 EU and 17 US filings, and five to six new therapy approvals this year, representing a record number of approvals last year. That piece continues to be extremely aggressive, and as more of these therapies get into the market, the awareness improves, the visibility improves, the infrastructure improves, the standardization improves, which really ties back into the supply chain planning, and standards—all of those elements, really.

As this becomes more mainstream, there's a lot more impetus to address those issues, and we see a lot of that right now, lots of folks are earnestly looking at standardization, in particular, around supply chain, regulatory, and patient management, which should all have very positive impacts over time.

In the second part of his Pharma Commerce video interview, Mark Sawicki, PhD, Cryoport Systems’ president and CEO, explains how recent shifts in FDA leadership, funding constraints, and evolving CMC standards have each played a role in this process.

Fixing the Pharma Pricing Puzzle

, LeAnn Boyd, PharmD, Liviniti’s founder and CEO, discusses the deeper, systemic issues behind rising healthcare and drug costs that are not fully addressed by the MFN (Most-Favored Nation) executive order. She acknowledges that the healthcare landscape has seen incredible advancements in therapies that significantly improve patient outcomes and well-being. As more people utilize pharmacy benefits—rising from 50% to around 70% in recent years—overall drug spending has naturally increased. While greater access to treatments is positive, Boyd emphasizes that this doesn't fully explain the sharp rise in costs.

She views the MFN executive order as a useful initial step—a spark that brings attention to the issue, especially considering that the US pays significantly more for medications than other countries. However, Boyd expresses concern that the order lacks the depth needed to address all the systemic contributors to high drug prices.

A key issue, she argues, lies in the misaligned incentives within the drug pricing ecosystem. Many stakeholders, such as pharmacy benefit managers (PBMs) and other intermediaries, have compensation structures that are tied to the list price of medications. This creates a perverse incentive to favor higher-priced drugs, as higher costs directly translate into greater profits for these players. As long as stakeholders are financially rewarded based on drug prices rather than patient value or outcomes, upward pressure on prices will persist. Boyd concludes that unless these incentive structures are realigned to reflect value-based compensation, rather than price-driven earnings, any reform—like the MFN rule—will fall short of creating lasting change in the healthcare cost landscape.

Boyd also comments on how PBMs will be significantly impacted by the EO; why PBMs that operate on 

lat admin fee model rather than rebates create more transparency and value for both payers and patients; what meaningful drug pricing reform looks like in her view; and much more.

What would meaningful drug pricing reform look like to you?

 Number one, it has to be comprehensive. This is a very complex pricing system that we live in, and as I mentioned, there's a lot of different stakeholders along the way. You have to address drug pricing, from the group purchasing organizations (GPOs), which control a lot of the manufacturer rebating arrangements, the GPO arrangement with the individual PBMs that they're supporting, and the PBMs that have dispensing pharmacies, whether that's specialty mail retail pharmacies, as well as care.

You have to make sure that this reform is comprehensive enough that eliminates any shifting of the economics from up, down, left, right, backwards, forwards, and just truly play it straight. The cost of the drug is the cost of the therapy, and it's passed through down to the people that are paying for the drug, which is the plan that's supporting them, and the member themselves that's contributing not only co-pays, but also premium dollars into these plans. To me, it's real-time pricing information, so everybody can be informed: consumers at the time that they're getting a therapy prescribed to them, so they can make the right decisions for them, individually in connection with their doctor. Right now, regarding that pricing information, a patient does not leave the doctor's office, nor does the doctor typically know what it's going to cost that patient until they get to the pharmacy counter, and then everyone's working in a very reactive retrospective process that creates disruption, frustration, and friction for that individual patient.

How do we help patients at the point of prescribing in a more informed manner to make these decisions? You have to have real-time, transparent pricing information, and those same stakeholders that benefit from linking their revenue to the drug cost also benefit from keeping that information pretty much under wraps, and it makes it hard to get to that true cost of therapy at the point of prescribing.

In the final part of her Pharma Commerce video interview, LeAnn Boyd, Liviniti’s founder and CEO, describes what meaningful drug pricing reform looks like to her. 

Establishing Additional Transparency

Boyd also comments on how PBMs will be significantly impacted by the EO; why PBMs that operate on flat admin fee model rather than rebates create more transparency and value for both payers and patients; what meaningful drug pricing reform looks like in her view; and much more.

For PBMs that operate on a flat admin fee model rather than rebates, why does that approach create more transparency and value for both payers and patients?

 We've been operating that model since day one. We're 14, 15, years into this model. Whereas a clinical pharmacist, it was always about how do we help support a patient, and how do we also help support that employer that's funding typically 90% of all their medication cost, how do we help the patient and the employer get on the right medication, the most cost effective, clinically effective therapy? When you eliminate the reliance or the reward of high-cost therapies, revenue linked to drug pricing spread and rebates, you remove that misalignment.

Now, a PBM can very simply think, what is in the best interest of this patient, what is the best interest of this plan, and help them with lots of transparent information. What is the true net cost price of this drug? Where are different places they can access this and work collaboratively, not only with the patient but also their prescriber to make sure that when they're making decisions about therapy, everyone understands the cost and the factors involved with that. That flat admin fee model just eliminates any misalignment to encourage use of therapies for anything other than what is in the best interest of this patient and the clinical outcomes that they're trying to achieve.

There’s no reason to hold back on data. There's no reason to not be able to share where the lowest cost providers are in the marketplace, and it really helps patients and plans make wise decisions on how we find these therapies.

In the third part of her Pharma Commerce video interview, LeAnn Boyd, Liviniti’s founder and CEO, explains how a flat admin fee model can potentially create more value for both payers and patients.

Moving Beyond the Rebate-Driven Model

lat admin fee model rather than rebates createmore transparency and value for both payers and patients; what meaningful drug pricing reform looks like in her view; and much more.

The EO targets rebate-driven PBM models. How do you see this impacting major players in the space, and what ripple effects might that have on the industry?

Naturally, you go straight to that it will impact the revenue for these larger PBMs, and regarding two major sources, one is spread pricing, and that's typically a percentage of the drug cost. If the drug cost is lower, that spread is going to become lower, although I guess a large PBM could maximize that further to make up some differences there.

The second is, as we've been speaking about, the rebate-driven portion of their models, which is still a very substantial portion and how they operate. To me, how you get to a lower price—like in an international type pricing scenario—is you have to eliminate some cost in the drug. The go-to place is the rebates. If you start cutting out that portion of drug cost that exists today, that removes that source for these large PBMs.

I do think they will have to think through how they make that up, or how do they move with that change in the revenue model now, as they're all connected through different vertical integrations. Do they make that up with the medical carrier side, do they make that up in their dispensing portions of their business? I do think the revenue that's linked to the cost of the drugs for them will be materially impacted if this EO does lower the cost equivalent to those international prices.

In the second part of her Pharma Commerce video interview, LeAnn Boyd, Liviniti’s founder and CEO, discusses how this MFN executive order can affect players in the space that operate under a rebate-driven PBM model. 

Analysis of the MFN Executive Order 

Boyd also comments on how PBMs will be significantly impacted by the EO; why PBMs that operate on flat admin fee model rather than rebates createmore transparency and value for both payers and patients;

what meaningful drug pricing reform looks like in her view; and much more.

As both a pharmacist and CEO, what do you believe are the most critical root causes of rising healthcare and drug costs that this MFN executive order doesn’t address?

Just to set the stage on the rising drug costs, there are some great, wonderful therapies that can do amazing things, and help patients treat diseases, find better healthcare, better well-being overall. I do think in one sense, the utilization of those is great, and we're going to see those costs continue to rise as people become more and more utilizers of those therapies.

Just a few years ago, we would look at our block of business, and only about 50% of people utilized their pharmacy benefits. Now, it's closer to 70%, so you're seeing more people being treated and utilizing therapies. With that being said though, the price and the cost are continuing to rise, so it is nice to see something like the executive order come out and hopefully be that spark to really dive into and address why the price still is an issue, especially when our prices are much higher than other comparative countries. I do think that it's a spark, and it's an attempt to push things in the right direction, but I don't know if it's comprehensive enough that you're truly going to address all players in the system that are contributing to the cost.

Fundamentally, I believe it's how many of those stakeholders in the whole pricing of medications, their compensation is linked very, very closely to the price of the drug. There's this misalignment that says you get paid more, you earn more if you have higher cost therapies in the mix, versus if you have people lying and getting paid fair rate for the value that they're bringing. I think that's a fundamental issue that we're still missing, [the fact that] the different stakeholders continue to drive compensation based on the cost of medication, and until that's fixed, you're always going to have people promoting or you're going to see drug prices continue to climb.

In the first part of her Pharma Commerce video interview, LeAnn Boyd, Liviniti’s founder and CEO, outlines the most critical root causes of rising healthcare and drug costs that the MFN executive order doesn’t address.

Using Data to Influence Drug Pricing Policy 

, Maggie McCullough, PolicyMap’s CEO, highlights how geospatial mapping can play a critical role in identifying and addressing pharmacy deserts—areas where access to pharmacies is limited or nonexistent. With an estimated 17.7% of the US population affected, the issue is increasingly urgent, particularly as major chains like Rite Aid close locations. Using Philadelphia as a case study, McCullough explains that 13% of the city’s pharmacy locations were Rite Aid stores, and their closure could significantly impact local access to medications and health services.

Geospatial tools like PolicyMap allow stakeholders to visualize not just where pharmacies are closing or opening, but also the broader context of the communities they serve. This includes assessing whether alternative pharmacy options exist nearby and evaluating how easily residents can access them. Physical distance is only part of the picture—transportation availability, such as car ownership or access to public transit, is also crucial.

McCullough further emphasizes that pharmacy access now extends into the digital realm. Telepharmacy is a growing solution, but it requires reliable internet access and digital devices—resources not all households have. Understanding these additional barriers is essential for designing effective interventions.

By layering geographic, transportation, and socio-economic data, mapping platforms can help policymakers, health systems, and community organizations proactively identify at-risk areas before they become pharmacy deserts. This data-driven approach enables more targeted responses that account for the real-life conditions affecting healthcare access, including digital equity.

McCullough also comments on what PolicyMap’s data reveals about the relationship between pharmacy access and broader health disparities in underserved communities; how mobile and digital solutions can be deployed effectively to close the gap in areas identified as pharmacy deserts; how data-driven insights support PBMs and healthcare leaders in negotiating fairer drug pricing; and much more.

In regions with limited pharmacy access, how can data-driven insights support PBMs and healthcare leaders in negotiating fairer drug prices?

 In the pharmacy deserts, we know that these populations tend to have lower incomes, and as a result, even if they can get to the pharmacy, they may not have the money to pay for the drugs that they need to help with their conditions. This is where reducing drug pricing becomes so important. Certainly, what we've seen is that when people can best make the case for how a certain intervention—like reducing drug prices in particular deserts—not all deserts that might work, but particular deserts—and say, if we can reduce drug pricing in these areas, we're going to see better health outcomes, reduced hospitalization rates, and lower healthcare costs for the system as a whole. The ability to clearly make that argument with factual data becomes very, very important, so that it's not just an opinion. It’s about using that data, making that argument, and then thinking about the intervention, right?

What I've heard—I haven't seen any of this yet—but heard about people saying in these zones, potentially negotiating lower prices for all drugs. I've also heard about ideas of negotiating lower prices for the drugs that are addressing the chronic conditions that are most prevalent in that community, so it's a combination of the claims data and the on-the-ground, community-level data that can help make those decisions.

The one thing that I have seen that I think is really important because of all of the pharmacy pricing at some point is that there's a federal component to it. When making these maps to make the case, you want to highlight which neighborhoods are most in need. You can pinpoint them, but then make the map at a congressional district level, so you can go to congresspeople, and they can see very clearly where their constituents are suffering and how some of these interventions are going to benefit particular pockets in their community. I think bringing it home in a very clear and simple way to congresspeople is important, and I think that's one of the most powerful contributions of geospatial work to this effort.

In the final part of her Pharma Commerce video interview, Maggie McCullough, PolicyMap’s CEO, illustrates how data-driven insights can support PBMs and healthcare leaders in negotiating fairer drug prices?

GLP-1 Drugs Reshape Reimbursement and Coverage Models

, a session leader from “U.S. Pharmaceutical Transitions: What’s Next?” shared key insights on the current and future state of the market. The conversation highlighted the rapid growth of specialty pharmaceuticals—now comprising over half of the total market—and examined critical industry developments ranging from biosimilar uptake and GLP-1 drug disruption to persistent challenges like retail pharmacy closures and drug shortages. With an eye toward long-term trends and underexplored risks, the discussion underscored how therapeutic priorities and commercial strategies are evolving in a complex and increasingly constrained healthcare landscape.

PC: GLP-1s are dominating so much of the conversation. Based on your analysis, what ripple effects are you expecting GLP-1s to have across other therapeutic areas?

I focus on the reimbursement impact of GLP-1s, particularly how retail pharmacies are losing money on every prescription they dispense. As a result, there’s growing momentum to restrict dispensing—shifting from 90-day supplies to just 30-day fills. We're also seeing a migration toward direct-to-consumer platforms like LillyDirect and NovoCare, where patients can access these medications at more predictable prices.

On the payer side, some companies are starting to exclude coverage altogether due to the high cost. Clinically, GLP-1s show potential beyond diabetes and obesity—there's promise in areas like sleep apnea and cardiovascular conditions. The bigger, long-term question is: if patients become significantly healthier through these medications, will they still need treatments for heart disease, high cholesterol, and related conditions? That shift, though, will likely take five or more years to materialize.

 The “U.S. Pharmaceutical Transitions: What’s Next?” sessionoffered a timely look at current market dynamics, with a focus on growth areas, emerging challenges, and broader industry shifts. Specialty pharmaceuticals now make up 52% of the total market, with strong momentum in immunology, oncology, and HIV treatments. Notably, the introduction of a private-label biosimilar to Humira is making a measurable impact.

Discussion also touched on macro-level issues such as drug shortages, retail pharmacy closures, and new product launches. Tariff uncertainties and economic pressures are contributing to instability, particularly in retail pharmacy, where closures are occurring at a rate of approximately four per day. Pharmacies are struggling with staffing shortages and expanded responsibilities, such as administering immunizations, with no near-term policy solutions in sight.

The session also explored the expanding footprint of GLP-1 drugs, which have disrupted both therapeutic and commercial landscapes. Retail pharmacies often lose money dispensing them, prompting a shift to 30-day fills and increasing reliance on manufacturer-direct programs like LillyDirect and novoCare. Although GLP-1s are being explored for additional indications such as sleep apnea and cardiovascular conditions, broader coverage remains limited, especially under Medicare and Medicaid.

In terms of long-term trends, panelists noted the increasing focus on rare diseases, orphan drugs, and cell and gene therapies—high-cost treatments for smaller patient populations. While biosimilars are gaining ground in biologics, development is lagging; out of 128 eligible biologic molecules, only 12 have active biosimilar programs.

An underappreciated trend is the role of pharmaceutical rebates in subsidizing health insurance premiums. A decline in rebates could lead to higher premiums, potentially reshaping payer dynamics. As the market evolves, industry leaders must navigate pricing pressure, access challenges, and shifting therapeutic priorities.

Doug Long, VP, industry relations, IQVIA, discusses how soaring demand for GLP-1 therapies is driving reimbursement challenges, shifting distribution models, and expanding the drugs’ potential into new therapeutic areas.

Latest Conference Coverage

Asembia 2025: GLP-1 Drugs Reshape Reimbursement and Coverage Models

Tracking Long-Term Outcomes Key to Advanced Therapy Value

, Fran Gregory, VP, emerging therapies, Cardinal Health, shared key insights into the evolving landscape of cell and gene therapies. Speaking about the current state of the market, the anticipated growth of the pipeline, and the critical steps needed to ensure long-term sustainability, Gregory highlighted both the transformative potential of these therapies and the systemic challenges that must be addressed. Her perspective offered a comprehensive look at where the field stands today—and where it's heading next.

PC: How are we seeing patient outcomes evolve with the rollout of these advanced therapies, and what still needs improvement?

That was a central theme of our session. We know these treatments are significantly improving patient outcomes—lives are being saved. But we now need to back that up with robust health economic modeling and clear, data-driven evidence. It's time to move into a space where we're showing, through statistical models, how these therapies provide long-term value to patients.

Anna Purdum, who was also on my panel, discussed health economic modeling and the role ICER plays in evaluating these therapies. ICER’s work helps demonstrate the value these treatments bring to patients. What really needs more focus now is long-term outcomes tracking—making sure patients are followed over time so we can truly understand the durability and sustained impact of these therapies. That data can then feed into health economic analyses, which we can take to payers to help shape sustainable payment models that support long-term access and financial viability.

 The session began with an overview of the cell and gene therapy (CGT) landscape—where the industry stands today and what the future may hold. The discussion included a pipeline review, highlighted key products, and identified both current successes and future areas of focus. Since the first CGT approval eight years ago, there has been significant progress. The conversation emphasized the need to continue advancing the field to ensure its momentum is sustained.

The CGT pipeline is rapidly evolving and holds tremendous promise, with projections estimating over 100,000 patients may benefit by 2030. However, this comes with a projected $75–80 billion cost to the healthcare system, prompting the need for sustainable payment models. Currently, around half of the pipeline targets oncology and hematology, but the field is expanding to include neurology, ophthalmology, rheumatology, and immunology, signaling broader therapeutic impact.

Patient outcomes from CGTs are transformative, yet there’s a growing need for long-term data to quantify their durability and cost-effectiveness. The discussion underscored the importance of robust health economic modeling and outcomes tracking to demonstrate value and guide reimbursement strategies. Insights from groups like ICER already point to the value of CGTs, but more evidence is required to solidify these claims.

Innovative payment models are crucial for long-term sustainability. The most promising models include outcomes-based contracts, where reimbursement aligns with patient response, and annuity payments, which spread costs over time. Models based on performance guarantees are less popular due to their all-or-nothing structure.

Looking ahead, the boldest move the industry can make is to collaboratively develop systems that ensure patient access while addressing affordability. Achieving this balance will require cooperation across stakeholders—payers, manufacturers, providers, and intermediaries—to ensure CGTs deliver on their full potential.

Fran Gregory, VP, emerging therapies, Cardinal Health, emphasizes the need for long-term outcomes tracking and robust health economic modeling to demonstrate the sustained value of advanced therapies and support future payment strategies.

Asembia 2025: Tracking Long-Term Outcomes Key to Advanced Therapy Value

Why AI Could Be the Key to Solving Access Challenges in Healthcare

, Chip Parkinson, the new CEO of Gift Health, shared his perspective on stepping into the role and the evolving challenges and opportunities across the healthcare landscape. Drawing on a diverse background that spans manufacturers, payers, and employer consulting, Parkinson discussed how his new position places him in closer contact with patients and prescribers than ever before. He also reflected on the state of specialty pharmacy, the potential of AI to improve access and affordability, and the importance of seeking diverse viewpoints in a rapidly shifting industry.

PC: Patient access and affordability continue to be huge focuses—did you see any new solutions or partnerships at Asembia that excite you in that area?

 Absolutely. This is a rapidly evolving space, especially with the emergence of AI and large language models. For the first time, we have the ability to analyze vast datasets—pharmacy and medical claims, refill data, first fills—and gain a true understanding of what patients are experiencing.

Chip Parkinson, CEO, GiftHealth, explains how AI-powered data integration is bringing new hope to patients by revealing hidden access barriers, streamlining treatment pathways, and challenging outdated utilization management practices.

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