Why Matching the Affordability Model to the Therapy Is What Will Endure

In a session at Asembia’s AXS26 Summit, David Skomo, chief operating officer, and Sarah Thomas, head of growth and commercialization, both at HealthDyne, offered to attendees a structured framework for thinking through which affordability models actually work, under which conditions, and for which patient populations. Additionally, they provided a candid accounting of where the models in widest circulation today fall short.¹

The session arrives at a moment when the affordability landscape has rarely been more fragmented or more consequential. Pharmacy benefit manager (PBM) reform is accelerating. The TrumpRx government pricing website is reportedly generating 1 million visits per week. Direct-to-patient programs are proliferating. And manufacturers are under mounting pressure from legislators, employers, and patients alike to demonstrate that their access strategies deliver more than optics. The core question Skomo and Thomas posed is the one that cuts through all of it: how many patients actually get on therapy and stay on it?

The Framework: Affordability Pressure Meets Therapy Complexity

Skomo anchored the session’s analytical core in a 2-axis framework that maps affordability pressure, defined as out-of-pocket exposure and patient price sensitivity, against therapy complexity, meaning the degree of clinical support, monitoring, and logistics a given treatment requires. The intersection of those 2 dimensions, he argued, is where the right channel model lives.

The takeaway he was most insistent on was that a direct-to-patient model is a powerful signal, not a universal solution. It performs best when out-of-pocket exposure is high, patients are price sensitive, and clinical complexity is relatively low. That is precisely why the model has flourished in generics, maintenance medications, and chronic categories where coverage is limited or excluded. As complexity increases—specialty drugs, orphan therapies, high-touch biologics—the value calculus shifts decisively back toward specialized, managed channels.

“The point isn’t to debate whether direct to patient is a good idea or a bad one,” said Skomo. “The point is recognizing that success depends on matching the model to the therapy and not to the headlines that we see today.”

He illustrated the danger of conflating signal with outcome through the TrumpRx case study. One million visits per week to a government drug pricing website is a meaningful data point, but only about one thing: the intensity of demand for affordability. What the traffic does not reveal is how many patients convert, how many navigate the clinical, financial, and logistical barriers successfully, and how many sustain therapy long enough to produce the outcomes that justified prescribing in the first place.

“If there's one thing that we should take away from this first section of the presentation is this: demand for affordability has never been higher, but demand alone does not equal durable access, traffic, searches, downloads,” emphasized Skomo. “Those are the signals. They tell us where the pressure exists. They don't tell us whether the model actually works.”

What Each Channel Actually Delivers

Thomas provided an assessment of 4 access model categories: direct-to-patient, digital pharmacy, traditional coverage, and specialized channel models. Her framing was not which model wins, but what each one actually does—and where manufacturers tend to overestimate what it can carry.

On the direct-to-patient side, Thomas identified the model’s genuine value proposition: it removes the PBM as gatekeeper, returns pricing transparency to the patient, and enables a more direct manufacturer-to-patient relationship that can drive conversion and build durable brand trust. She was equally direct about its limitations.

“If you have a medication that is $50,000 a month, your average consumer, even on a net cost basis, likely can't afford to maintain and sustain access on a cash basis over time,” said Thomas. “You need to understand that right now, in the given infrastructure, until there's additional mandated legislation, those dollars are not deductibles. They're not integrated into the benefit, and that is the primary behavior that patients are used to navigating today.”

Digital pharmacy models, including platforms like GoodRx, Cost Plus Drugs, and their telehealth-integrated successors, have demonstrated genuine efficacy in the generic and lifestyle therapy categories. Thomas acknowledged their efficiency and their ability to rapidly expand patient reach, particularly when layered with physician-led telehealth access for conditions where prescriber awareness has historically been a bottleneck. But she drew a clear line at specialty: the margin dynamics of digital pharmacy platforms are built for broad generic baskets, not for high-cost, high-complexity specialty products.

Traditional coverage is not going away, noted Thomas. It remains the primary mechanism through which employers and plan sponsors manage pharmaceutical cost exposure. But she reframed it in terms that cut against manufacturers who rely on it as a patient-centric tool: traditional coverage is fundamentally a risk-mitigation mechanism for payers, not an access-optimization mechanism for patients.

For specialized channel models—limited distribution, physician-administered biologics, high-touch therapies with active monitoring requirements—Thomas was equally candid. The model is essential: without it, many of the most clinically important therapies simply would not reach patients at all. But she identified a systemic failure within it: most existing specialized channel programs are built on legacy infrastructure.

“Many of these are legacy solutions,” said Thomas. “They have kind of archaic, call-based, heavy, time-intensive care models. And patients today need better tools. They need to be able to take some of those learnings from direct to patient and have access to similar clinical tools, but in a more digital format.”

The Trust Deficit—and Why Transparency Is the Path Through It

One of the session’s most pointed segments addressed a structural problem that Thomas framed in terms manufacturers rarely discuss publicly: the pharmaceutical industry’s trust deficit with patients. Despite the billions invested in research and development that produces cures and meaningful clinical advances, those investments are not generating the patient trust they deserve because the models and infrastructure through which drugs reach patients have operated against patient transparency and choice for decades.

“Pharma has been one of the most—if not the most—heated industries for patients in the broader media news,” said Thomas. “And it doesn’t make sense. You’re putting research and development dollars, billions of dollars, into making sure that patients around the world have access to the next best product. That deserves some recognition. And those investments are largely not being met with trust because of the traditional models and infrastructure.”

The direct-to-patient channel, she argued, offers manufacturers a rare opportunity to close this gap: not through marketing spend, but through the structural act of putting transparency, choice, and net cost visibility directly in the patient’s hands. That shift, when it works, creates something the traditional rebate-and-formulary model cannot produce, which is genuine brand trust, built on a transactional experience that felt fair to the patient.

This dynamic has particular implications in the context of products approaching loss of exclusivity, a scenario Thomas highlighted as an underappreciated strategic use case for direct-to-patient.

“You start to create an opportunity to maintain that relationship and that value you’ve created with the patient on a more durable basis—if the price is right and the access is easy to navigate,” said Thomas.

The Emerging Employer Channel: From Direct-to-Patient to Direct-to-Employer

The session’s most forward-looking segment addressed a development that Thomas positioned as one of the most significant emerging opportunities in the access landscape: the evolution of direct-to-patient models into direct-to-employer channels. Employers, she argued, are increasingly watching the direct-to-patient space and asking whether it could serve as a procurement mechanism, particularly for therapy categories where the value delivered by the traditional PBM channel has become difficult to demonstrate.

She noted that direct-to-employer programs have already launched, with the glucagon-like peptide-1 (GLP-1) category as the initial proving ground. These represent a logical starting point given that the majority of employers still exclude GLP-1 coverage entirely, creating a natural population of price-sensitive, intent-motivated patients with no viable traditional channel alternative. The longer-term implication, however, extends well beyond GLP-1s.

This trajectory aligns with broader market dynamics. According to a January 2026 analysis from Morgan Lewis, alternative prescription drug access models—including direct-to-employer and direct-to-consumer approaches—are gaining traction as employers reassess PBM-based pricing structures, with these emerging models creating parallel channels that challenge long-standing assumptions about how drugs are purchased and delivered.² The same analysis noted that for plan sponsors, direct-to-consumer models create a parallel access channel that operates outside the plan design, financial structure, and oversight. This could alter employee expectations around access, transparency, and affordability in ways that the Employee Retirement Income Security Act fiduciaries will increasingly need to address proactively.

Which Model Endures? The Portfolio Evaluation Manufacturers Need to Conduct

The winning affordability strategy is not a model; it is a methodology.¹ Specifically, it is the discipline of evaluating each product in a manufacturer’s portfolio against the therapy complexity and affordability pressure axes, determining what channel configuration actually serves that therapy’s patient population, and deploying a layered combination of models rather than defaulting to whichever approach is generating the most conference coverage in a given year.

Thomas was explicit about the scenarios where direct-to-patient is the wrong primary lever: very high-cost therapies requiring ongoing clinical coordination, limited distribution products with active safety monitoring requirements, and any product where the patient population cannot sustain cash pricing at any realistic net cost point. For those therapies, the question is not how to build a direct channel, but how to modernize the specialized channel infrastructure that already serves them—incorporating the digital tools, consumer-driven transparency, and reduced administrative friction that direct-to-patient models have demonstrated are achievable.

For the broader portfolio, the session opens up a set of questions:

• Where is affordability pressure highest for this patient population?
• How complex is the clinical management of this therapy?
• Is PBM formulary placement secure or vulnerable?
• Is this product approaching loss of exclusivity?
• Is the employer market for this category emerging or already active?

The answers to those questions, Thomas and Skomo argued, point toward a channel configuration that is genuinely fit for purpose, not one designed around what is generating traffic, what has worked in another therapeutic area, or what the regulatory environment is currently spotlighting.

“When everything aligns and you are able to put together the right product, the right price point and financial dynamics and the right patient journey and access points, that's where we really see affordability come to life,” said Thomas.

The throughline across the entire session was a reframing of what “affordability strategy” actually means. Demand for affordability has never been higher, but demand alone does not equal durable access. The manufacturers that will navigate the next several years most successfully are not those deploying the most visible channel innovation. They are those who have done the work of matching model to molecule and building patient journeys that do not stop at discovery, but extend all the way through starts, persistence, and outcomes.

References

1. Skomo D, Thomas S. The affordability race: which models will endure? Presented at: AXS26; April 27-30, 2026; Las Vegas, NV.

2. Straight to the source: what direct drug models mean for employer plan sponsors in 2026. Morgan Lewis. January 13, 2026. Accessed April 29, 2026. https://www.morganlewis.com/pubs/2026/01/straight-to-the-source-what-direct-drug-models-mean-for-employer-plan-sponsors-in-2026