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Take the Direct Route to Commercialization in Canada

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. 

Access USA 2025: Uncovering Patient Access Complexities

Informa’s Access USA conference from Philadelphia continued with its first panel discussion of the conference. Amy Niles, chief mission officer of the PAN Foundation—a national charitable foundation and healthcare advocacy group—was joined by Bill Allen, a patient and family advisory council member with PAN Foundation; Susan Neff, aging services supervisor and SHIP/MIPPA with the Pennsylvania Department of Aging; and Dan Sherman, founder and president of the NaVectis Group, and a financial navigator for Lacks Cancer Care.

Titled “Moving the Needle on Awareness of the Medicare Part D Reforms,”

 its name does a wonderful job of foreshadowing potential coverage points. The premise of the session dates back to fall of last year, when the PAN Foundation conducted a national poll expressing that 87% of Medicare beneficiaries had not seen, read, or heard any sort of information concerning about the Medicare Part D reforms that took effect Jan. 1, 2025. Since that time, this year, PAN decided to once again release a poll with Medicare beneficiaries as a way to measure the value of educational outreach, so this session provided a deeper dive into these efforts.

Specifically, PAN Foundation wanted to understand the awareness and knowledge levels of Medicare beneficiaries both before and after CMS conducted its outreach in advance of the Medicare Part D cap—which ensures that individuals with Medicare Part D plans will not pay more than $2,000 in out-of-pocket costs for covered prescription drugs within a year—and the Medicare Prescription Payment Plan (M3P).

There were two waves of research, including:

 Research conducted in June 2024 with 1,006 adults on Medicare/Medicare Advantage

 Research conducted in January 2025 with 1,001 adults on Medicare/Medicare Advantage

After analyzing both waves, these only represent a sliver of the findings, but the awareness of both reforms increased by 27% from June 2924 to January 2025, while awareness among all the surveyed groups (people with chronic conditions, people with disabilities, those eligible for the Low-Income Subsidy, white Medicare beneficiaries, and Medicare beneficiaries of color) also rose. Further, 66% of Medicare beneficiaries want to learn more about these reforms.

Beneficiaries are no more or less likely to believe the Part D reform or the M3P would be personally helpful to them.

Regarding Part D findings, over 1 in 3 Medicare beneficiaries (35%) reported unaided awareness of the cap, an increase from 1 in 10 (11%) in Wave 1. When aided (having a description of what the reform entails), nearly 7 in 10 (69%) realized they’ve heard of it, an increase from 40% in Wave 1, while 37% are at least somewhat familiar, up from 14% in Wave 1.

“I think the Part D cap is particularly helpful for the individuals with rare diseases, chronic diseases,” said Niles. “They're used to spending thousands and thousands of dollars out of pocket, and now, that has come down to $2,000. It's going to be very beneficial for that individual. Tommy [Bramley] also talked about the peace of mind that it gives people. That is true. You never know when you may be diagnosed with a chronic disease or a rare disease, and having that peace of mind is very helpful.”

In terms of 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, there continues to be a lack of understanding—2 in 5 beneficiaries still don’t under the plan well. And arguably even more shocking—1% of the people polled by PAN have opted into the payment plan to date.

When asked about his experience with opting into M3P and as an individual Niles that could benefit from the Part D cap, benefit, Allen—who’s been living with prostate cancer since 2004—described his experiences from a patient perspective.

“Well, the first thing that you encounter is that being retired and then having to have access to medications is very expensive for my disease. The most typical thing was you get inundated with a lot of papers at the beginning of the October enrollment period,” he explained. You're getting your annual notice of change from Medicare. You're getting information from agencies to pick a supplemental or advantage plan—there're a lot of steps. There's a lot of salesmanship going on at this time when you're trying to make a decision.

“… I'm on Medicare with an insurer supplement. My wife is on Medicare with another insurer. I got a letter in the mail. She got a conversation from a physician's assistant in the doctor's office. She felt like, 'I don't know what this means.' I got a five-page letter, and I'm trying to read through and make a decision, do I opt in or opt out. We never thought to communicate together because we thought this only applies to my plan. And when I asked her about it, she said, ‘I had no idea what it meant.’ … So that's a lack of communication just in a household. Can you imagine what the communication is in mass?

Niles then posed the question to the panel: if you had the opportunity to speak to Congress or to speak with CMS, today or tomorrow, what recommendations and changes would you like to see, either with the Medicare reforms or the Medicare Part D design in general?

“We wish that they could change the name from Medicare Prescription Payment Plan to ‘Option’ instead of ‘Plan’ because the word plan also is used for stand-alones for Medicare Advantage and Medigap. … And I wholly agree with what Tommy presented earlier about the stand-alone plans,” Neff commented. “We hope that CMS can bolster them because there are still people who want to have Medigap with a stand-alone. They don't want to go to Medicare Advantage, we're seeing. We only have 14 left, and we see the prices of those plans—with their premiums being very, very high, so we hope that CMS takes some action to bolster those stand-alone plans.”

As for Sherman, it all comes down to education.

“Let's just be honest here, insurance companies are not excited about this program … There is no meat behind the requirement for the Part D enrollee to actually reimburse the insurance company,” he pointed out. “The only thing that can happen is that they'll kick them out of the prescription payment plan. I think I read somewhere that they're predicting at least a 30% loss in this, that they're not going to get reimbursed … I know providers might not like to hear what I'm going to say, but I would like that there actually is a requirement that providers need to provide education about this, at a certain threshold. It can't be for every single prescription, but for me, to be as proactive as possible is what's going to be the most beneficial.”

1. Niles A, Allen B, Neff S, Sherman D. Moving the Needle on Awareness of the Medicare Part D Reforms. March 18, 2025. Access USA (general session). Philadelphia.

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 

Tackling Gaps in Manufacturing, Funding, and Expertise

, Jenna Dale, director 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 approvals (CGT) per year by 2025, the need for continued investment by the FDA in reviewers and staff to support clinical reviews, and much more.

What are the key challenges currently preventing the United States from meeting the FDA’s 

 of 10 to 20 CGT approvals per year by 2025, and how can these be addressed?

So really, I think partially the complexity of development and manufacturing of these therapies— there's incredible complexity to understanding how to not only manufacture and scale according to different patient populations that need to be targeted, so navigating some of those challenges from the development and manufacturers perspective, but then also understanding what the regulatory hurdles may be. How do we effectively understand the outcomes that we're trying to study in the clinical trial setting that ultimately will help us achieve a regulatory filing approval and eventual launch?

Navigating some of those regulatory hurdles through communication with the agency is really key as well. I mentioned the clinical trial challenges—I think having that dialog between the manufacturers and the agencies, from pre-clinical development through clinical development, and ultimately gearing toward that regulatory filing, makes a big difference in trying to expedite that pathway to market, and really understanding what the criteria are going to be, so that we can proactively try to mitigate those challenges and risks.

There's also COVID. COVID did a number on the entire sector. We really saw a decrease in financing and funding available. We know that these therapies are incredibly complex and require a high cost of investment to develop and ultimately achieve a commercial launch. Navigating funding hurdles as well has been a challenge, and I think really slowed some of the progress to an extent. And then finally, I think the workforce and expertise shortages come into play here. As a sector, the cell and gene sector is still relatively in its infancy stages, and so finding folks that have had an opportunity to work through the development and commercialization, both on the manufacturing side and from the regulatory agencies perspective as well, just to understand these therapies, and ultimately, how to develop and commercialize them. I think all of those things have really factored into why we haven't yet achieved the goal, but the exciting part is, I see a lot of progress being made in each of these areas that hopefully will start to see us catch up to that goal a little bit more quickly here in the near future.

In the second part of her video interview with Pharma Commerce Editor Nicholas Saraceno, Jenna Dale, director of client relations at Cencora, explains the challenges associated with meeting the FDA’s 2025 CGT forecasted approval goal. 

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