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

Access USA 2025: Uncovering Patient Access Complexities

The conference’s first panel offers insight on the current state of awareness among beneficiaries of the Part D cap and Medicare Prescription Payment Plan via the PAN Foundation’s latest research.

Access USA 2025: Spreading Awareness of Medicare Part D Reforms 

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

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

From matrix programs to anti-abandonment strategies, predictions for a new era.


Breaking Point: How 2025 Will Reshape Patient Support Services

The latest AARP report concludes that plan members who hit this amount are expected to see savings, even when premiums are considered. 

Analysis: Medicare Part D Enrollees Who Reach the $2,000 OOP Spending Cap to Save an Average of $2,474 Nationally 

Access USA converges in Philadelphia to explore new—and needed—solutions to boost patient outcomes.

Conference Connect: Progressing Patient Assistance 

Kevin Hagan, CEO, Pan Foundation, discusses central concerns for patient assistance programs as changes to Medicare and the Inflation Reduction Act take effect. 

PAP 2025: Navigating Inflation Reduction Act Reforms Amid Uncertainty for 2025

A Day 3 presentation dives into the impact of copay accumulators, maximizers, and AFPs on driving cost savings. 

Hubs East 2025: The Patient Access Landscape

The presentation suggests ways to educate patients on the options available to them, with the hope of ultimately improving health outcomes. 

PAP 2025: Boosting Patient Empowerment

The session provides an overview of the uninsured population, and also tackles challenges faced by patients when it comes to accessing PAPs.

PAP 2025: Understanding the Uninsured Landscape

Why Patient Empowerment is Key  

 executive director at the Otsuka Patient Assistance Foundation, discusses two key sessions: "Establishing and Transitioning to a Foundation" and "Empowering Patients to Take Control of Their Healthcare." The first session focuses on the important aspects of transitioning to a foundation, emphasizing the risks associated with regulations and the need for robust patient support programs. The second session highlights the importance of guiding patients through their healthcare journey by removing barriers and enhancing their health literacy, helping them make informed health choices.

Thorpe outlines three critical factors when creating an independent patient assistance program (PAP) foundation: risk tolerance, conflict of interest, and funding stability. These factors are essential to ensure the successful operation and long-term sustainability of the foundation. She also stresses the importance of maintaining clear separation between the foundation and its core business operations, focusing on good stewardship and well-defined guidelines.

Thorpe emphasizes the significance of patient empowerment, noting that most patients struggle with understanding healthcare terms and concepts, with many having low health literacy. Empowering patients by improving their understanding of healthcare options is vital to help them make better health decisions.

Regarding digital innovation, Thorpe explains that while digital tools are crucial for patient engagement and literacy, they must be simple and engaging. Given the overwhelming digital landscape patients face, it’s important to create experiences that are easy to navigate and actively keep patients engaged, as prolonged use can be challenging. Simplifying digital interactions helps avoid patient fatigue and ensures long-term engagement.

How can foundations ensure that they maintain strong patient support while operating separately from their core businesses?

 In general, foundations should really have separation, and that separation is really focused in on two factors. Number one, good stewardship, and building cohesive guardrails and guidelines that offset those parameters for both the manufacturer as well as the foundation.

 Empowering patients is really important because patients do not understand healthcare in general. Nine out of 10 patients do not understand simple healthcare terms. Thirty-three percent of our population reads at a third-grade level, so health literacy is very important when building patient assistance programs, because we really want the patient to embrace their health journey and make good health choices. Without that education and that knowledge, they are at a disadvantage, and we want to broaden their awareness and their understanding so that they can engage in their health journey.

What role does digital innovation play in enhancing patient engagement and healthcare literacy?

 Digital technology is, of course, extremely important across all entities. We're really engaged with the digital innovation. With regard to foundations in patient support, understanding the patient journey is key. Digital innovation may or may not work for the patients that we serve. When you do have digital innovation, keep it engaging with what the patient is doing, what the patient is experiencing in their health journey, and then keep it simple. We want simplicity when we're talking to our patients. They are so engaged with all these digital components, that it's almost overwhelming, and so we want it engaging and simple. Keep it active. One of the biggest things is the boredom that happens—patients engage for a little bit, but not for a long term. And so, how do you keep it engaging, and how do you keep patients active in utilizing the digital tools?

In the final part of her video interview with Pharma Commerce Editor Nicholas Saraceno, Rachel Thorpe, executive director at the Otsuka Patient Assistance Foundation, emphasizes the importance of the separation of core business and foundation, the value of patient empowerment, and the impact of digital innovation. 

Latest Conference Coverage

PAP 2025: Why Patient Empowerment is Key  

Creating an Independent Patient Assistance Foundation 

What factors should be considered when creating an independent PAP foundation?

So with regard to how to transition a foundation, or if you're thinking about transitioning to an external foundation, there are three factors that you have to think through. One is risk tolerance—what the manufacturer’s risk tolerance is, what the future foundation’s risk tolerance is.

Secondly is conflict of interest. What are the some of the conflict of interests that are associated with the manufacturer and the foundation? And then, what is your funding stability? What is your long-term plan to sustain these programs indefinitely, or within the terms of the patient or product population?

In the second part of her video interview with Pharma Commerce Editor Nicholas Saraceno, Rachel Thorpe, executive director at the Otsuka Patient Assistance Foundation, lays out the ways to begin transitioning a foundation. 

PAP 2025: Creating an Independent Patient Assistance Foundation 

Establishing and Transitioning to a Foundation 

You headlined the “Establishing and Transitioning to a Foundation” session, with a presentation on “Empowering Patients to Take Control of Their Healthcare” forthcoming. Could you provide a brief synopsis of both sessions?

So with regard to “Transitioning to a Foundation,” it really is more about what are some of the stewardships that you need when transitioning over, and what the risks are associated with the regulatory, and how you can build these programs to support patients. With regard to “Empowering Patients in Their Healthcare,” it's really about nurturing that patient journey, reducing barriers that they may face, and improving their literacy of their healthcare to help them understand what health choices they have.

In the first part of her video interview with Pharma Commerce Editor Nicholas Saraceno, Rachel Thorpe, executive director at the Otsuka Patient Assistance Foundation, describes the various conference sessions that she participated in. 

PAP 2025: Establishing and Transitioning to a Foundation 

Peer-To-Patient Support

PC: What are some common barriers patients face when starting specialty medications, and how can peer-to-patient outreach help?

Our program is a peer-to-patient platform, which I believe is critical. It addresses emotional barriers such as fear, misinformation, mistrust, anxiety, feeling overwhelmed, not knowing who to turn to, uncertainty about the process, and concerns about what comes next. By connecting patients with peers, it provides them with someone who listens and understands their experience.

From there, patients can be guided in the right direction without a clinical, white-coat discussion. Our peers are not clinicians; they are considered peer-to-patient supporters. This program helps improve adherence by addressing the emotional barriers patients face.

A few years ago, the AMA released a study showing that five of the top eight reasons for non-adherence were emotionally driven. Our platform directly tackles these challenges, providing patients with the support they need.

The Good Start program by Pleio is designed to assist specialty pharmacies in improving patient engagement and adherence by providing comprehensive, patient-centric support. Specialty medications often involve complex onboarding processes, leaving patients feeling overwhelmed. Good Start addresses this by offering a structured, wraparound approach that guides patients from the moment they receive their medication. The program ensures patients understand the specialty pharmacy process, introduces them to their care teams, and creates a supportive environment that reduces anxiety.

A key feature of Good Start is its peer-to-patient outreach model, which addresses emotional barriers such as fear, mistrust, and anxiety—factors that significantly contribute to medication non-adherence. Non-clinical peers engage with patients in a more relatable manner, providing reassurance and helping them navigate the treatment process without the intimidation of clinical discussions. This approach aligns with findings from the AMA, which highlight that emotional barriers are a major cause of non-adherence.

Patient engagement in specialty pharmacy is evolving alongside technological advancements. While digital tools provide valuable resources, they can also be overwhelming. Patients expect more personalized support, including human check-ins that reinforce adherence. Pleio’s program has demonstrated success in improving key adherence metrics, including a 5% increase in proportion of days covered (PDC), an 80% rise in average scripts per patient, and a 60% boost in medication volume.

Jen Butler, chief commercial officer, Pleio, discusses the effectiveness of peer-to-patient outreach when starting specialty medications. 

Hubs East 2025: The Role of Emotional Support in Improving Patient Adherence

Patient Assistance Challenges for Nonprofits

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: What are the biggest challenges charitable organizations face in sustaining funding and ensuring donations reach the patients who need them most?

I think there are two major challenges for a nonprofit organization like Hope Charities. First, there’s always a gap between available resources and the growing need. Every day, we do everything we can to ask for donations, hoping to expand our ability to serve more people.

One major challenge is ensuring the financial sustainability of these programs. Another is educating patients about available assistance in a timely manner. The learning curve in health care is steep, and when it comes to financial aid, it can be even steeper. Our responsibility is twofold: we must educate patients as much as possible while also navigating the reality that funding is often limited. Many programs hesitate to expand outreach because they’re already underfunded, but better funding is exactly what’s needed to serve more people.

I often compare this challenge to riding a bicycle—there are two wheels, and maintaining balance requires shifting pressure between them at different times. For us, it’s about finding the right balance between patient education and donor engagement. Both are equally critical, and improving in both areas is essential for long-term success.

 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 challenge of nonprofits securing sustainable funding while ensuring patients are aware of available assistance. 

PAP 2025: The Ongoing Challenge for Nonprofit Patient Assistance Programs

Out-of-Pocket Costs Rare Disease

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.

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

How HCPs and Patients Influence the CGT Approval Process

, Jenna Dale, direct of client relations at Cencora, shares how pharmaceutical manufacturers are able to handle supply chain disruptions. She explains that while these issues may arise due to political or environmental factors, they aren't new challenges for the industry. Manufacturers have faced similar hurdles before and are accustomed to managing risks that affect production. The key to overcoming these challenges, according to Dale, is having a robust continuity plan in place. Such plans help ensure that manufacturing remains uninterrupted, even when external factors like tariffs create obstacles. By identifying potential risks and preparing for them, manufacturers can continue the development and commercialization of therapies despite external pressures.

Dale also comments on key challenges preventing the United States from meeting the FDA’s forecast of 10 to 20 cell and gene therapy (CGT) approvals per year by 2025, the need for continued investment by the FDA in reviewers and staff to support clinical reviews, and much more.

The involvement of HCPs and patient organizations is critical in understanding meaningful clinical outcomes. What role do these groups play in shaping the approval process, particularly for rare patient populations with significant unmet needs?

So I'll start from the provider perspective. I think, especially in rare disease, but really, this is applicable across cell and gene for different types of therapies than maybe what the agency may be used to seeing in terms of devices or traditional pharmaceuticals. That said, from a healthcare professional (HCP) perspective, allowing the opportunity to give their expert insights and clinical experience, not only to the agency, but to all the stakeholder communities, so that we know that we're developing therapies that ultimately are going to achieve some type of clinical significance, some type of clinical outcome that is meaningful from the provider's perspective, and of course, most importantly, from the patient's perspective.

To focus on where the HCP is coming from, being able to give their insight into how we can develop these therapies to achieve a meaningful clinical outcome, is really important. That helps us design trials and implement the trials operationally, more meaningfully as well, and then they can help really interpret and contextualize the data. Making this something that's clinically meaningful to the right audiences is really critical, and then the providers can also help advocate and educate the patients.

A lot of patients have a lot of questions about cell and gene therapies, and so being able to trust your provider and get more information through those medical channels is critically important for patients, not only thinking about participating in a trial, but ultimately enrolling in a clinical trial, or families, caregivers, parents, if it's a pediatric indication. Having that advocate and educational champion through the HCP lens is really important. And then, similarly, on the patient side of things, patients are the strongest voice in this entire community.

I think every manufacturer's goal is to develop a therapy that is going to help a patient, which involves listening to what matters to the patient. Do we have patient-centric clinical outcomes in our clinical trials? Are we developing this with the patient in mind that not only recruit patients into the clinical trials, but retains patients into the clinical trials if they have a better understanding up front of what that's going to take in terms of an investigational protocol? And then the patients can go be such a strong voice, both in terms of policy, but also in terms of the FDA’s review. If they have listening sessions or advisory committees where they want to hear directly from patient communities, engaging with the patient community and understanding from their perspective, really just opens the eyes of all of the different stakeholders involved, whose ultimate goal it is to help treat those patient populations more effectively.

In the final part of her video interview with Pharma Commerce Editor Nicholas Saraceno, Jenna Dale, director of client relations at Cencora, describes why these pharma supply chain stakeholders are vital in understanding meaningful clinical outcomes. 

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