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Josh Marsh, Vice President and General Manager of Cardinal Health Sonexus™ Access and Patient Support, outlines the recent shift in the patient services industry towards a hybrid hub model for in-house management and outsourced support. 

Hybrid Hub Models for the Patient Journey

It's time to include hubs in the patient treatment journey

Shedding the Secondary Label

Use of an eBV system can save months of re-verification work and >$100,000 in operational costs

Planning for the surge: Taking a proactive approach to benefits re-verification season

Video interview with Omar Hafez about IPAY 2028 and what it means for the industry

From Uncertainty to Opportunity: Navigating IPAY 2028

Omar Hafez, SVP of Market Access at Avalere Health, discusses the upcoming changes tied to the Initial Price Applicability Year (IPAY) 2028—the first year Medicare will include medical benefit drugs in its price negotiations. There are significant implications for therapeutic areas like oncology, immunology, and neurology, and this new pricing model could affect provider reimbursement and patient access. Hafez offers strategic insights for pharmaceutical manufacturers on how to prepare, including understanding the importance of real-world evidence and global pricing strategies.

How the 2028 Medicare drug price negotiations will reshape market access, provider reimbursement, and patient care

Revolutionizing Pharma Patient Assistance Programs, KnippeRx Leads the Future of Patient Care

In today’s healthcare landscape, groundbreaking treatments such as cell and gene therapies, mRNA vaccines, and GLP-1 drugs are transforming patient care. At the same time, essential medications remain vital for treating a wide range of conditions. Ensuring these treatments reach patients safely and efficiently is crucial—and can be accomplished by modernizing, future-proofing, and securing the healthcare supply chain.

We envision the supply chain of the future as an interconnected network of both physical and digital assets, not merely a series of transactions. Modernizing our supply chain is key for enhancing efficiency, visibility, and infrastructure. In recent years, we have embraced digital enablement to optimize our operations by integrating artificial intelligence and machine learning across our healthcare ecosystem. This has allowed us to optimize logistics, including transportation routes and delivery schedules, thereby reducing costs and improving efficiency; in our newest distribution center, we’ve automated 90% of the fulfillment processes. The goal is to ensure that our supply chain remains efficient and adaptable to future challenges.

In the ever-changing pharmaceutical landscape, the advancement of medical treatments, including drugs for rare diseases and specialty therapies, offers great promise and hope. It’s vital that our supply chain provide these crucial therapies safely and efficiently.

Specialty therapies often require specific conditions, such as temperature control and light protection, necessitating robust infrastructure and meticulous management. Additionally, many new medicines have shorter shelf lives, requiring precise inventory management to prevent stockouts and expirations, so in order to meet this growing demand, we encourage stakeholders to consider expanding cold chain storage, infrastructure, and quality controls. Overall, our efforts have resulted in nearly double-digit growth in cold chain lines year-over-year.

The commitment to those we serve drives us to uphold stringent safety and security standards, maintaining a rigorous chain of custody from manufacturer to patient. The Drug Supply Chain Security Act (DSCSA) is designed to protect US consumers by securing the supply chain against counterfeit, contaminated, or harmful drugs through electronic traceability mandates. Over the past decade, we have actively engaged in industry readiness for DSCSA serialization compliance, and we continue to advance our preparedness as we near the May 27 compliance deadline for wholesale distributors.

The industry has developed and implemented various track-and-trace technologies to comply with the DSCSA and to enhance the security and integrity of the pharmaceutical supply chain. These technologies include serialization, which assigns unique identifiers to prescription drug packages, and real-time tracking, allowing continuous monitoring of product location and status. 

Together, these innovations provide comprehensive visibility and control, safeguarding against counterfeit drugs and maintaining product integrity.

Ammie McAsey is SVP of Customer Distribution Experience at McKesson.

Ensuring that essential treatments reach patients safely and efficiently is an increasing imperative in today's pharma landscape.

Strategies to Modernize, Future-Proof, and Secure the Healthcare Supply Chain

Day 1 of Informa’s Access USA conference from Philadelphia—featuring Patient Assistance & Access Programs (PAP) and Hub and Specialty Models East—was kicked off by Tommy Bramley, Cencora’s SVP of global consulting services.

Titled “State of the Industry—The Evolving Landscape of Healthcare Coverage and Access in 2025,”

 the goal of the Access USA general session was to explore the dynamics impacting healthcare coverage and access this year, with an emphasis on industry-defining issues.

Bramley led off the session with the thought-provoking question of what most concerns attendees in terms of maximizing patient outcomes. The audience felt that the following:

After establishing where stakeholders’ priorities lie, he alluded to three main challenges that lie ahead concerning uncertainty: US federal and state policy priorities; unintended consequences of the Inflation Reduction Act (IRA); and payer economics.

When it comes to pharmaceuticals, the current Trump administration’s priorities are still being developed. Little has been released from Project 2025 regarding pharmaceutical changes Bramley noted, but IRA negotiations for 2027 are continuing. Pharmacy benefit manager (PBM) legislation is also under discussion by Congress.

There are various initiatives that could possibly affect PAPs. Regarding Medicaid, there is an interest in reduced Medicaid spending by $2.3 trillion over 10 years, with the chance to lower Medicaid expansion funding. These—along with other factors—could decrease enrollment and place pressure on PAPs.

Back during the Biden administration, coverage was proposed for anti-obesity meds under Part D and Medicaid. If this were to be finalized, Medicare Part D and Medicaid beneficiaries would have GLP-1s covered, but the projected costs to both federal and state governments would be $15 billion. Just for additional perspective, obesity costs the United States $480 billion in direct costs, and $1.24 trillion in indirect costs.

“This starts to point out the challenges with our healthcare system and willingness to pay, versus ability to pay, and certainly our ability to deal with chronic diseases. So yes, we want to address these direct costs,” Bramley stated.

In order to address those indirect costs, there are currently 11 state prescription drug affordability boards that exist to control cost at local or state level.

Patients have expressed relief related to the $2000 out-of-pocket (OOP) cap, and come 2026, it’s believed that during the initial coverage phase, plans will cover 65% of coverage, followed by the patient at 25%, followed by either the manufacturer or government covering the remaining 10% over the plan year. In the catastrophic phase, the plan would cover 60%, manufacturer 20%, and either the government covering negotiated or applicable drugs at 40% or 20%.

Meanwhile, the IRA introduces the Medicare Prescription Plan (M3P), which allows one to spread OOP prescription drug costs over the course of a year as opposed to paying them all at once at the pharmacy. It’s currently a work in progress—being in its first year, there is no ability to enroll at point of sale at this moment. In the long-term however, Bramley explained that it could help improve Rx drug affordability, while increasing patient adherence. The intention is to achieve price smoothing, which involves stabilizing prices and reducing price fluctuations, often by averaging prices over time or across different periods.

Patients are also worried concerning changes to current Part D plans, such as premium increases or other restrictions. As it stands now, the future of standalone prescription drug plans is uncertain.

There are also concerns about access to next year’s negotiated products—although plans are required to cover negotiated drugs, there aren’t mandates regarding coverage methods.

Last year, the Big 3 PBMs reportedly excluded 1,453 unique Rx medicines from their formularies, representing a 1,233 rise from 2014. And from 2014-2025, the number of meds that were excluded by one or more PBMs rose by an average of 38% per year.

The problem lies with affordability. Even when a prescription is filled, 90% of Rxs cost under $20, but 1% cost more than $125. For about one-third of brand-name commercial prescriptions across the top 10 therapy areas and for 63% of obesity Rxs, patients use copay cards.

For the aforementioned 1% of higher costs, this is where copay accumulators, copay maximizers, and alternative funding programs come into play, which will be explored more in-depth throughout the conference.

1. Bramley T. State of the Industry—The Evolving Landscape of Healthcare Coverage and Access in 2025. March 18, 2025. Access USA (general session). Philadelphia.

The conference’s opening session highlights the sector’s current landscape of healthcare coverage and access. 

Latest Conference Coverage

Access USA 2025: This Year’s State of the Industry

Out-of-Pocket Costs Rare Disease

Charitable donations have long been a vital lifeline for patients struggling to afford life-saving medications, particularly those with chronic and rare diseases. Over the past few decades, various assistance programs—including nonprofit safety nets, third-party organizations, and manufacturer-sponsored free drug initiatives—have emerged to bridge the gap between medical advancements and patient affordability. However, despite these efforts, high out-of-pocket costs still prevent many individuals from accessing essential treatments. In an interview with 

, Jonathan James, CEO of Hope Charities, shares insights on reducing barriers to care and improving patient access.

PC: Can you provide insights into the real-world out-of-pocket costs patients face, particularly in high-cost therapeutic areas?

’ll share a personal story. I was born with hemophilia, and managing hemophilia is costly, especially when considering life expectancy. As long as I can maintain access to my medications, my life expectancy is relatively in line with the general population. The big problem is that if I lose access to this medication at any point, it becomes a massive hurdle.

Many people with bleeding disorders today spend around $1 million annually. That cost has increased over time, but not exponentially—rather, it has risen incrementally year over year. There’s a strong focus on rare disease groups like hemophilia because they require high-cost medications. One of the biggest challenges we face is that keeping supplemental insurance is often more difficult than even developing the medication needed to treat the condition itself.

Thanks to medical advancements, people with hemophilia are now living longer and healthier lives. In the past, many were unable to work and were completely dependent on disability benefits, often confined to wheelchairs. Today, we have a thriving community of individuals who can live fully productive lives, attend college, and enter highly skilled professions. However, if they lose access to their medication, everything changes.

The challenge is that these individuals are now at risk of becoming vulnerable again—potentially returning to wheelchairs and being unable to work. This raises an important question: Is it better for someone to be a productive, taxpaying citizen who supports their family and contributes to the economy, or should they be forced into a situation where they are entirely dependent on social services?

We believe productivity is the better path, and out of that belief comes our drive, passion, and determination to do everything we can. This includes helping cover out-of-pocket expenses to ensure continued access to care.

Charitable donations have played a crucial role in helping patients access life-saving medications, particularly those with chronic and rare diseases who face significant financial barriers. Over the past 25-30 years, various assistance programs—including nonprofit safety nets, third-party organizations, and manufacturer-sponsored free drug programs—have emerged to support patients struggling with the rising costs of healthcare. However, despite these efforts, many individuals still face challenges in affording their treatments, with high out-of-pocket costs often preventing them from receiving necessary care.

For conditions like hemophilia, where annual treatment costs can exceed $1 million, losing access to medication can mean a drastic decline in quality of life, forcing patients to rely on disability or face severe health complications. While charitable programs provide critical relief, they also struggle with sustainability due to funding shortages and limited public awareness. Many organizations must balance the need to educate patients about available assistance while ensuring they have enough resources to support those in need.

Healthcare policies such as the Inflation Reduction Act and Medicaid redeterminations have also influenced access to care, sometimes alleviating costs for certain populations while creating new challenges for others. While high-cost medications often receive the most scrutiny, hospitalization and inpatient care account for a much larger portion of healthcare spending. Expanding financial assistance for prescription medications could help reduce hospital admissions and lower overall healthcare costs.

Looking forward, there is a need for more sustainable models of charitable giving and financial aid to ensure that patients can consistently access the treatments they need. Policy reforms, expanded subsidies, and a greater focus on preventative care may help create a more equitable healthcare system while reducing the financial strain on both patients and assistance programs.

Jonathan James, CEO, Hope Charities, discusses the critical importance of maintaining access to life-saving medications for patients with rare diseases to lead productive lives. 

PAP 2025: The Impact of Out-of-Pocket Costs on Patients with Rare Diseases

Informa’s Access USA conference leveraged its KOL base with a roundtable on “Unravelling the Complexities of Patient Access and Affordability.”

 Featuring Ian Ocilka, ConnectiveRx’s chief strategy officer as moderator, he was accompanied by Nancy Bell, vice president and head of market access at Celcuity; Shannon Ashmon, lead, patient services–oncology, US market access at Eisai, US; and Larry Bressler, Disc Medicine’s vice president of marketing.

With the help of real-world strategies and emerging trends, the goal of the roundtable was to dive deep into how patient access needs are being assessed, along with the value of affordability when it comes to impacting healthcare decisions from a leadership perspective.

The development of market access tools and strategies

Ocilka kicked things off by raising the question of how market access tools and strategies have changed over the past five years, along with what panelists believe to be the most important emerging trends in market access in 2025, beginning with perspective.

“I think no one would be surprised to hear that vertical and horizontal integration and consolidation across the continuum are some of the most prevalent things in our industry today,” Bell said. “You look at that as well as the federal policies are coming out, whether it be pertaining to 340B or PBMs, and I think those are some of the biggest things that are impacting manufacturers today— and I think the biggest change I've seen—is how we look at the business.

“A lot of times, patient services was patient services. Payers were payers, and never the two shall meet or discuss. Now, if you're making decisions without understanding what each part of the business is doing, then you're going to have some significant impact on the brand, and potentially, sustainability. When I look at strategies, when I look at the different tools that are at our disposal—whether it's predictive analytics or real-world evidence—those are the things I have to think about. How is the business changing? And if this one domino gets pushed down, is it going to set an entire cascade? And how do I manage that to best help the brand perform and protect its integrity?”

The speedy development of tech has also been essential, as it has allowed for getting more patients on therapy.

“I think back five years ago, we were in the midst of a global pandemic, and if there was a silver lining around COVID, it’s the rapid adoption of new technologies,” Ashmon pointed out. “We all remember those HCP portals to get patients enrolled in therapy, but now, what I'm really excited about is predictive AI, so we can identify patients who might need financial support earlier in that treatment journey, and when we think about adherence, identifying how patients would prefer to be contacted to ensure adherence, whether it's text every other day, phone calls—those are some of the things that we've seen over the last five years come to pass. I would say a micro trend that we're noticing is the engagement with our market access colleagues and our government affairs team and pharma. We even have a policy expert embedded in our patient services program.”

How drug provisions in the IRA are impacting market and patient access

When it comes to the Inflation Reduction Act (IRA)’s effects on outpatient pharmacies and PAP programs—along with hub and copay programs—industry is ranging in terms of initial sentiments.

“It’s yet to be determined. We think it's going to be a great thing for patients as it relates to our PAP program, but it's still early,” said Ashmon. It's March. I haven't seen any clean data from our team to support whether patients are enrolling in an M3P [Medicare Prescription Payment Plan], but what we have heard, Nancy, anecdotally from medical pharmacies, integrated pharmacies, is that they're pleased with hearing that foundation support is going much further with the redesign to Medicare Part D, so that's exciting to hear.”

In Bell’s opinion, IRA only scratches the surface in terms of concerns.

“This stuff keeps me up at night, and I think it's easy to point a finger at the IRA because it was just so monumental. But it's not the only thing. We have to worry about the continued expansion of 340B in the state's overruling previous judgments when it comes to managing the distribution, the tariffs that just were put in place on importing from ex-US countries. There is so much pressure coming down that I think our ability to hear it, take it in, understand it, and then apply it—[pushes us] to raise the bar in ourselves. In order to be successful, those types of things are not going to go in.

“To Shannon's point, we put everything on the side. We're like, this is what we think is going to happen. This is what everyone's telling us, but we just don't know yet, because a lot of it is really just going into effect this year. We still need true data to make accurate assumptions versus hypotheses. If I could give a piece of advice on this, sometimes it's so easy to put things on a slide and say, no, there's smoothing. Even if patients have to pay the $2000, it's going to be fine. Smoothing is a lot harder than people realize. Let’s be realistic about it, and let's make sure that the people in our in our companies, understand that, yes, there're options, but it doesn't mean it’s guaranteed, and let's really put that effort into making sure we do try to get things across the finish line, and we do really support them.”

Improving patient support programs in response to personnel

Bressler, who operates in the marketing sector but also has experience leading market access in the rare disease space, pointed to the value of the economic side of the equation. What factors impact one’s program?

“First of all, understanding the cost of drivers for your gross-to-net, understanding your rebates, your chargebacks, the patient support program, every aspect of your program [is key]. If you don't understand the costs and everything that's cutting into your profitability, it’s kind of hard to maximize your programs, to make sure that you're actually achieving the optimal profitability that you can. That's my first piece of advice. Also, understanding your segment mix, your payer mix, that is a huge component of your first event. Understanding what percentage of your population is coming from 340B and coming from commercial payers.

“Ensuring that the patients who are in your programs are not leaking out [is also important] … What components do you need to put into your program to ensure that the revenue’s coming in, that you're supporting them, that you have things that are keeping people on therapy, as well as matching up with the cost piece that's actually pulling away some of your revenue? It's looking at it as a top-line and then a bottom-line sort of approach, and looking at all the different drivers that can impact the profitability of the drugs.”

When pulling key thoughts from this presentation, Bell urged the audience to keep in mind that these insights are all from a leadership perspective; the ideas should be adjusted to suit one’s particular situation.

“I hope you can come out of this session understanding how leadership is looking at it and what they're thinking about, which might help you,” she said. “Adapt your approach, because the way as a leader looks at it today is not the same as we looked at it five or 10 years ago. I think really understanding that is important.”

1. Ocilka I, Bell N, Neff S, Ashmon S. Leaders Council Insight—Unravelling the Complexities of Patient Access and Affordability. March 18, 2025. Access USA (general session). Philadelphia.

A roundtable explores how patient access needs are being measured, while also discussing the value of affordability in decision-making. 

Josh Marsh, Cardinal Health Sonexus Access and Patient Support

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