Senior Vice President, Market Development, at ConnectiveRx.

Chris Dowd, ConnectiveRx

2024 was a pivotal year for the patient support landscape, as the space underwent a substantial shift shaped by market dynamics, regulatory changes, and the evolving needs of patients.

After a quarter marked by intense discussions at industry conferences and candid conversations with pharmaceutical leaders grappling with unprecedented change, one thing is clear: 2025 will fundamentally transform how drugs are covered, paid for, and filled in America.

Here are five predictions for how the landscape will shift in the year ahead:

By mid-2025, we'll witness the most significant healthcare policy battle since the Affordable Care Act. The Republican-controlled Senate, pursuing Trump administration priorities, is likely to substantially challenge key Inflation Reduction Act (IRA) provisions, particularly around drug price negotiations. While the slim Senate and House majorities could make it difficult to institute a full repeal of the IRA, parts of it are vulnerable.

As North Star Opinion Research Vice President Jon McHenry noted in a recent panel discussion, Republicans will likely use unspent IRA funds to help offset the continuation of Trump-era tax cuts expiring in late 2025. However, the $2,000 out-of-pocket cap for Medicare beneficiaries will likely survive, creating an interesting dynamic where manufacturers must navigate a hybrid policy landscape.

To stay ahead of the IRA roller coaster in the coming year, stakeholders in the patient support ecosystem—from providers to hub and patient services teams—need to work overtime to understand the evolving nuances of what’s changing and communicate it effectively. A PDR survey of US healthcare providers (HCPs) reveals that 38% of providers “know nothing” about the pharmaceutical provisions in the IRA, while an additional 55% only know “a little.” This highlights myriad opportunities for pharma manufacturers to also provide welcome education to HCPs about changes in access to their branded drugs.

The death of the dominance and attention on “traditional” copay programs, the surge in prevalence of accumulator adjustment and maximizer programs, and the continued usage of alternative funding programs will force a complete reimagining of manufacturer support. By Q3 2025, we'll see the emergence of matrix support programs that combine product access, procedure coverage, treatment-journey assistance, and patient success programs in entirely new ways.

Buy-and-bill programs already account for half of specialty product assistance. With the gross-to-net (GTN) pressure on brands to do more with less, including the evolution of copay affordability programs over the last five years, these matrix support programs will only continue to grow in necessity. High-end specialty medications are a prime example: In the same way biologics took the market by storm over the last seven to 10 years despite initial skepticism, cell and gene therapy pipelines and approvals are continuing to escalate—and programs supporting their adoption and adherence will be key.

As the market shifts from traditional copay programs to more sophisticated matrix programs, pharma brands need to seek out best-in-class support options to serve patients. They should consider establishing working groups in their organizations to meet with their field reimbursement managers as well as marketing and managed care teams to stay on top of what patients and providers are expecting (and demanding) in order to build programs that raise the bar.

Pharmacy benefit managers (PBMs) currently “don’t have any friends in Washington,” as McHenry noted in the recent panel. Pressure on PBMs by both federal and state governments in the form of anti-PBM legislation is unprecedented, and, considering RFK Jr.’s reformist views and the power he could wield, their influence will likely wane in the coming year.

With that in mind, the bipartisan "Patient Before Monopolies Act" will pass in 2025, fundamentally restructuring the PBM industry. As Sens. Elizabeth Warren and Josh Hawley's unlikely alliance pushes the legislation forward, we'll see initial steps to dismantle vertical integration between insurers, PBMs, and pharmacies. This will create immediate market disruption but ultimately lead to more transparent drug pricing models by year's end.

Staying on top of these developments is paramount. Whether through internal or external resources, manufacturers should remain in ongoing contact with state government relations teams to understand how legislation is evolving and how they can react.

4. The rise of ‘anti-abandonment’ programs

Even with a mature patient services model, fewer than half of specialty patients make it through payer controls to fill their prescriptions at 90 days, according to the IQVIA Institute.

With new-to-brand abandonment rates hitting 35% to 40% and the industry losing billions in potential revenue, 2025 will see manufacturers pivot away from traditional adherence programs, toward sophisticated early-intervention models. These programs will leverage predictive analytics to identify at-risk patients before they abandon therapy, combining financial support, behavioral interventions, and digital engagement in novel ways. This shift is particularly crucial as the industry grapples with expanding formulary exclusion lists from major PBMs such as CVS Caremark, Express Scripts, and OptumRx.

Leveraging patient data and AI-driven targeting models can help brands build effective anti-abandonment programs. By scoring key demographic information such as age, drug class, prior experiences, and previous adherence (or lack thereof), early-intervention algorithms can help determine the likelihood of abandonment. From there, brand teams can build tailored programs to improve adherence.

In 2025, GLP-1 agonists will face unprecedented restrictions and rejection rates from payers due to cost, demand, and indication alignment (e.g., trends that include moves by Kaiser, Independence Blue Cross, and Blue Cross Blue Shield of Michigan). While Medicare may expand coverage under the new administration, commercial payers will simultaneously implement a new generation of sophisticated access barriers that go far beyond traditional prior authorization—requiring documented participation in behavioral health programs, mandatory step therapy through lower-cost alternatives, and possibly even time-limited authorizations tied to demonstrable outcomes. And to further complicate the long-term GLP-1 reimbursement landscape, the US Department of Health and Human Services has announced that Ozempic, Rybelsus, and Wegovy will be included in the 2025 round of Medicare drug price negotiations, with adjusted prices becoming effective in 2027. Taken together, these multiple challenges will push pharmaceutical manufacturers to repeatedly reimagine GLP-1 access and support.

Learning from oncology's experience with advanced patient support programs that integrate financial, clinical, and behavioral support, we will see companies move away from traditional copay assistance toward more holistic “lifestyle support hubs” that combine financial assistance with digital coaching, behavioral modification tracking, and outcomes documentation. Traditional support models that “help with copays and prior authorization” will be enhanced by end-to-end patient success programs that help patients navigate increasingly complex payer requirements while supporting long-term therapy success. According to Kevin Herwig, health policy manager at the HIV + Hepatitis Policy Institute, we've already seen this evolution in HIV treatment support programs, where successful adherence increasingly depends on providing comprehensive social, behavioral, and financial support—GLP-1s will accelerate this trend dramatically across all chronic conditions.

The multiple disruptions looming this year will create a clear divide between brands that embrace these changes and those that maintain traditional commercial approaches. For brand leaders, the time to prepare is now, while there's still opportunity to gain first-mover advantage in their therapeutic areas. The future belongs to the bold.

Chris Dowd, Senior Vice President, Market Development, at ConnectiveRx, is a new guest columnist for Pharmaceutical Commerce, covering the patient support space. With a nearly 30-year career spanning leadership roles across Big Pharma, healthcare startups, and patient support, Dowd is a preeminent industry voice in patient access and adherence.

Articles

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


Breaking Point: How 2025 Will Reshape Patient Support Services

The drug pricing reforms introduced by the Inflation Reduction Act of 2022 (IRA) are expected to significantly impact pharmaceutical companies’ revenues and profitability. The IRA requires the US Department of Health and Human Services to negotiate drug prices, introduces penalties for drug price increases greater than inflation, and makes manufacturers responsible for 20% of catastrophic care costs for Part D patients whose spending exceeds the $2,000 out-of-pocket (OOP) cap.

The USC Schaeffer Center for Health Policy and Economics reports that “taken together, these provisions have been estimated to lead to an approximately 31% decrease in US pharmaceutical revenues through 2039 and result in 135 fewer new drug approvals.” Similarly, an analysis from 5POINT10 predicts a more than 20% hit to the operating income of global biopharma (even more in the US).

Despite the challenges created by the IRA, brand leaders must keep their focus on the day-to-day work of helping patients access—and pay for—their medications. So, what does the IRA mean for patient access leaders, pharma brand managers, and patient service owners? I recently moderated a panel on the topic with three industry experts whose insights I’m sharing here.

According to Sarah Butler, chief commercial officer at ADVI Health, four key areas will be affected, and manufacturers will need to adjust their strategies going forward.

Pre-IRA, the market incentivized biopharma companies to launch a drug first in a smaller population, such as rare disease, because they could continue to earn revenue on the drug while conducting ongoing R&D to expand to additional indications. Now, companies have to make difficult decisions to choose which indication is launched first because once the molecule is on the market, the clock starts ticking to be selected for IRA negotiation.

Because manufacturers need to consider how to delay getting on the list as much as possible, looking at volume projections is more important than ever. Even with a medium- or lower-priced drug, if the volume is high, the drug can appear on the IRA negotiation list sooner than you might think. Market dynamics and the competitive environment also play a crucial role. For example, GLP-1s launched this year in weight loss and have completely impacted the order of drugs on the IRA negotiation list. Paying attention to those market dynamics while preparing for launch is critical.

Manufacturers are likely to launch new drugs in Europe or Asia first in order to develop the drug, conduct additional studies, and prepare to file for the indication that will have the greatest impact in the US. Restricting drug access in the US to potentially groundbreaking drugs is likely to cause a backlash among patient advocacy groups and other healthcare stakeholders.

In addition to changes in launch strategy that are likely to happen as a result of the IRA, brands are likely to face hard decisions around adjustments to copay assistance programs, hub eligibility criteria, the amount of free product they’re able to offer and where they go overall with the brand in order to continue providing support to patients who need it.

Data points to a potential reduction of as much as 40% in the number of FDA-approved drugs over the next 10 years—up to 139 therapies—as a result of the IRA. Some manufacturers may consolidate resources around fewer products and lower investments, while others could pursue assets they might not otherwise approve, and some may discontinue trials. Alexion, for example, has gone on the record and publicly discussed delaying some investments in R&D.

Manufacturers are also beginning to change their organizational structures and adjust engagement strategies to respond to IRA negotiation and create more alignment with their global pricing colleagues. Teams focused on government are getting larger.

Once the negotiated prices are announced in September before taking effect in 2025, the spillover effect on the commercial market will be significant, particularly with Part D, where pricing designs will likely become even more complex. It is important for manufacturers to know their places on the list and use projections to avoid any surprises in terms of submitting evidence packages to the Centers for Medicare & Medicaid Services.

When new laws directly impact patients, it is critical to educate them about how these regulations will affect their medication journey.

“It’s all about getting the information out to the patient, explaining it to them in ways they can understand it, and meeting them where they are—and not just the patient, but of course, caregivers as well,” said Richard Fahrer, oncology marketing director, patient solutions, at Pfizer.

Copay smoothing is one area Part D patients are likely to need help understanding. Designed to put a $2,000 OOP cap on medications and spread patient costs evenly over the course of the year to make monthly costs more predictable, guidance on this is evolving and still being released.

“For patients to be able to take advantage of the program, they need to understand how it works, how to enroll, and how to smooth out that copay,” noted Fahrer. “They’re also going to need to make sure they make their payments on time, because if they opt-in to copay smoothing and then miss payments, they risk being dropped from the program and expected to pay a lump sum.” Interestingly, in a post-webinar conversation with an attendee, Fahrer learned that at least one independent patient assistance charity is suggesting that patients who expect to gain charitable support should not sign up for smoothing as it could disrupt the charity’s qualification and approval processes.

Making that information available to both patients and caregivers, in multiple languages wherever possible, and also educating prescribing physicians, practice managers, reimbursement specialists, and other patient advocates—as well as internally within the pharma manufacturer—is also critical.

In addition, hub services vendors have an opportunity to act as an intermediary to enroll patients in the copay smoothing program “because that’s going to be a little bit tricky in 2025,” explains Butler. Since patients aren’t able to enroll at the pharmacy counter and need to do so via paper, phone, or online application, the process needs to be as easy as possible.

Payers are poised to buckle down and do all they can to shrink their risk around the IRA impact. According to Don Sawyer, senior vice president of market access at Stemline Therapeutics, “The negotiations are going to get much more extreme and they’re going to leverage everything they possibly can do.

In the absence of information, payers “are going to backstop themselves, and who’s going to be there to backstop them is who has always been there to backstop them, the manufacturers,” added Sawyer. Payers are also likely to raise premiums, potentially reduce the number of Part D options, and use a more restrictive benefit design with existing plans.

In anticipation of the IRA and expected reduction in hub, patient assistance programs, and affordability program budgets, manufacturers should be looking to streamline their patient support operations. Leveraging artificial intelligence, electronic benefit verifications, more sophisticated benefits support, and blended staffing models all can help brands do more with less without shortchanging patients. 

Chris Dowd is Senior Vice President, Market Development, at ConnectiveRx.

What does the legislation mean for patient access leaders, pharma brand       managers, and patient service owners? Industry experts weigh in.


The IRA’s Impact on Patient Hub, Access, and Affordability Programs

As life slowly moves back toward what we think of as normal, Covid-19 continues to test and transform our healthcare system. As a result, the patient support space is evolving in several important ways.

Patients are slowly moving back—back into doctors’ offices, back into hospitals, and, therefore, back into the patient support hub and through their patient journeys again—enough so that we’re now cautiously applying a post-pandemic lens.

It is incredible to consider that nearly one billion diagnosis visits did not happen in 2020, equating to just 19% of expected visits for the year, and some specialties—including dermatology, urology, and neurology—struggled more than others to bounce back.

Simply put, if patients don’t make it to the doctor’s office, they often don’t get diagnosed—and they can’t start on a course of treatment to help them get better. While telehealth doctor visits saw an uptick during the pandemic, the vast majority of patients, 70%, chose a nearby doctor for their virtual appointments, signaling they may at some point want to return to in-person care.

In fact, 50-60% of people who made virtual appointments with specialty providers (podiatrists; OB-GYNs; orthopedic surgeons; and ear, nose and throat specialists) booked a follow-up in-person appointment with the same practice.

 This points to telehealth continuing to be a complement for in-person care rather than an alternative.

As mentioned above, there’s no question that the pandemic has fueled a growing patient acceptance of and comfort with remote care. According to 

, while growth in digital health adoption had stalled pre-pandemic, healthcare consumers have shown an interest in virtual care, with 62% indicating they would choose virtual for health and wellness advisories and 57% open to remote monitoring of ongoing health issues through at-home devices.

In addition, as increasing numbers of healthcare consumers are open to receiving virtual healthcare services from their traditional providers (54%), they are also willing to receive virtual care from technology or social media companies such as Google and Microsoft (27%); retail brands such as Best Buy, Walmart, and Amazon (25%); and medical startups (21%).

Meanwhile, as the Delta variant stresses the country’s healthcare system, an uptick in the use of telehealth as a replacement for in-person care has been reflected not just nationally but in specific regions as they are impacted, with growth data corresponding to the timing of these regional virus flare-ups.

When it comes to paying healthcare provider (HCPs) for their teleheath services, payers are not yet in agreement about how to best go about it and providers are voicing their frustration. Some payers argue that HCPs should be compensated on par with their in-person fees, while others rationalize that because they can see more patients remotely and don’t have a full office staff to support, they should receive lower pay. Despite these growing pains, adoption continues to accelerate because all parties agree that telehealth is a powerful tool that ultimately benefits patients. Realizing its full potential means more than simply enabling remote clinical services. Telehealth has the power to reimagine how patients are understood, engaged and supported in their lifelong health and wellness journeys.

As a result of the pandemic and the associated isolation, patients are also moving to different sites of care. Pharmacists and pharmacies are now doing more than ever because people couldn’t get to the doctor’s office for more than a year. And patients have become used to this new route, seeing their pharmacy and pharmacists almost as surrogate doctors.

 poll of healthcare leaders revealed that nearly half of doctors, 49%, are working more hours, on average, this year than in 2020.

 With doctors busier than ever as we move through Covid recovery, patients continue to rely on pharmacies. Additionally, as more state and federal laws allow for more healthcare services to be delivered by pharmacists, demand and willingness of the patient care can be met at the pharmacy counter.

When looking at the ability of patients to get tested and immunized against the virus, community pharmacists have proven their ability to reach patients who were unable to visit their physician’s office. They have played a critical role in helping to ensure patients understand the importance of therapy and potential side effects they may experience, and to help ensure the best possible outcomes are achieved.

Recent data confirms pharmacists’ increasing role as a crucial link in patient continuation of therapy. In a ConnectiveRx analysis of patient compliance with a medication from Brand X, there was a nearly 24% improvement in compliance among patients under medication therapy management (MTM), based on the proportion of days covered. In addition, MTM generated a 37% increase in refill persistency per patient.

With an increased reliance on our devices, patients have become willing—and increasingly even expect—to access, share and receive personal health information through the internet, apps and bots, and the pandemic has only accelerated this shift. Whereas pre-pandemic, patients may have shown a hesitancy to enroll in services such as a copay cards, patient support (hub) services or patient portals, the combination of this consumerization and the impact of the pandemic has led a record number of patients to abandon their fear of sharing their personal health information online. From simple program enrollment to complex remote monitoring, patients continue to carry their consumer behavior into their healthcare journeys and are willing to share what it takes in order to get the care they need.

This growing willingness among patients to divulge personal information to HCPs, hospitals and apps ultimately can transform the patient experience and healthcare overall because the reports that are generated from this data have the potential to change the game.

Pharma companies are continuing to look for new ways to meet HCPs because rep visits were nearly decimated during Covid and are only slowly creeping back. According to a recent survey of over 1,000 HCPs by the Physicians Desk Reference,

 more than half of respondents, 55%, are not permitting rep visits, either because of institutional policy or personal choice.

In-person detailing is now approximately only 52% of the norm/pre-pandemic levels. Reps were saturated in offices, and some offices did not allow reps to visit. While the pandemic meant no rep visits, offices are now slowly letting them back—but only at 52-60% capacity, higher for some specialists.

Another way to look at it is share of voice: Brands have lost 50% share of voice in offices, so pharma continues to buy into new share-of-voice tools as they seek novel ways to get their brand messaging across to providers and patients. These tools that help brands reach pharmacists and that help pharmacists reach and educate patients have never been more valuable.

One example is in electronic health record (EHR) messaging, which has evolved from simply an advertising channel into a critical touch point between both pharmaceutical companies and prescribers and prescribers and their patients, enabling deeper patient education and support. Pharma brands are increasing their budgets in this area going into 2022, while also increasingly spending on digital and virtual e-detailing and share-of-voice tools, including text and telehealth services. According to a recent ConnectiveRx survey

of pharma manufacturers, respondents are most likely to report budget increases for digital marketing outreach (59%) and patient engagement (57%), followed closely by virtual e-detailing (52%) and prescriber engagement (48%).

Making the enrollment channel faster and easier for patients to access potentially life-saving therapies is just one of many successful strategies for increasing the likelihood that patients receive their first dose and remain on their course of treatment.

With continuing changes in patient and physician behavior, pharmaceutical companies will continue to adjust to these new realities and seek innovative partners to help.

Chris Dowd is Senior Vice President, Market and Product Development at ConnectiveRx.

1. IQVIA, “Monitoring the Impact of COVID-19 on the Pharmaceutical Market, Week Ending May 28,” June 11, 2021

4. “COVID-19 Impact on Prescribing and Rx Affordability” Physician Desk Reference survey of 1,050 healthcare providers, October 2021

5. “Patient Communication & the COVID-19 Pandemic” CBI and Informa Engage online survey for ConnectiveRx, September 8-20, 2021

The biggest areas of adjustment in patient support brought on by changes in consumer and physician behavior