If you’re a leader following recent political events and their impact on the US market access environment, then you’ve probably had a tumultuous 2025. Tracking a host of new policy initiatives, studying evolving market dynamics, and looking ahead to gauge the strategic implications has not been easy. It gets even more challenging when doing all that in the context of complicated therapeutic areas like oncology.

In times of significant disruption—and the current period certainly qualifies—creating an appropriate strategy requires a proactive, analytical approach to evaluate the potential impacts, discern the implications, and draw useful insights. Recently, we attended the 2025 summit of the AVBCC (Association for Value Based Cancer Care), a forum with representation from across the oncology landscape including patients, payers, advocates, manufacturers, regulators, healthcare providers, and more.  The official theme of this year’s conference was “When leaders lead, markets follow.” We thought the theme was extremely appropriate, given current events. To be an effective leader, one will need to effectively navigate the major disruptions that are taking place in US oncology market access.

In this paper, we describe several major areas of disruption that are affecting market access. However, we also take it a few steps further to:

  • Offer our perspectives on how those areas are likely to evolve during 2026
  • Discuss questions that biopharma companies should consider as they move into the new year
  • Identify additional factors to monitor

Major Areas of Disruption

Most Favored Nation Pricing

The current administration’s focus on aligning U.S. drug prices with those in other developed countries, known as the Most Favored Nation (MFN) drug pricing policy, is upending traditional approaches to US market access strategy.  As of mid-day on October 27, 2025, there have been three public MFN deals: Pfizer, AstraZeneca, and EMD Serono. The details on each of these deals are still to be seen, but public statements from these manufacturers and the White House indicate that their agreements focus on MFN pricing in Medicaid, direct to patient sales through TrumpRx.gov, and more global pricing equality on future drug launches.  While it is expected that more of the 17 manufacturers the White House initially targeted will announce similar negotiated agreements, it is not clear how many can be expected.  It is also unclear whether these currently negotiated agreements, along with securing others, will impact the implementation of the GUARD & GLOBE CMMI Models.

Pharmaceutical leaders anticipate that several more deals will be announced in the coming weeks, as more companies seek to negotiate their own unique terms (e.g., gaining a priority review voucher) and gain protection against threats made by the administration (such as tariffs, FTC investigations, and FDA review delays).

Questions for Biopharma Companies to Consider:

  1. Which companies will make deals next? How many deals are needed to shift the focus away from the enactment of the GLOBE/GUARD CMMI models?

  2. For small- to mid-size biotech companies - Is the administration interested in making deals with manufacturers outside the list of 17 or is it best to wait it out and see if GLOBE/GUARD are enacted or if deals with the large manufacturers are sufficient to appease the administration?

  3. As the only form of MFN that would be retrospective, what is our organization’s current exposure to Medicaid? Given current Medicaid Best Price discounts, how much more would MFN enactment reduce Medicaid prices?

  4. How will the current direct to consumer pricing impact our current and future portfolio of brands? Will it change our launch pricing strategies?

  5. How will collaboration on global launch impact current ways of working and partnership across global market access teams?

  6. How impactful would the threats be from the administration if enacted? Is our manufacturing at risk of steep Section 232 tariffs? Do we have pending acquisitions subject to FTC investigation? Do we have new products where delays in FDA approval would significantly impact forecasts?

  7. How critical is our ex-US revenue given our disease focus? Are we at risk given current licensing dynamics? (e.g., if US rights are owned, but the company has out licensed commercialization for Europe)

Inflation Reduction Act and Maximum Fair Price Negotiations

Maximum Fair Price (MFP) negotiations that resulted from the Inflation Reduction Act (IRA) have a clear revenue impact for pharmaceutical companies. However, the threat to community providers is less discussed and often overlooked.

Medicare Part B drugs are soon to be selected for Initial Price Applicability Year (IPAY) 2028. Once MFP is negotiated, the proposed rule specifies that CMS will publish MFP only. CMS would no longer publish the Average Sales Price (ASP), which is commonly used across payer types to determine provider reimbursement for administering drugs currently.

This matters a lot for community providers, especially community oncology clinics. Provider reimbursement for professional services is severely underfunded, leaving clinics to rely on drug reimbursement for an outsized portion of their revenue. Once MFP is negotiated, reimbursement may be meaningfully lower for Medicare patients, and may spill over to commercial plans as well.  The popular assumption is that the Trump Administration will seek steeper reductions after criticizing the Biden administration for not negotiating well enough in the first round of IRA negotiations.

Barbara McAneny, MD, immediate past president of the American Medical Association, put it bluntly, “If this is not fixed, community clinics will not be able to sustain themselves and will need to sell out to hospitals. Hospitals that do not receive special discounts (via programs like 340B) will determine that these are not profitable segments and will remove oncology as a service line, resulting in reduced access to oncology care.”

If Dr. McAneny’s concerns are borne out, it could have implications for biopharma companies. Oncology drugs are increasingly physician-administered injectables. Reduced access from clinic closures would translate directly to lower patient adherence and reduced utilization.

Questions for Biopharma Companies to Consider:

  1. Are our products or competitors at risk of MFP negotiations? If so, what direct/indirect pricing pressures may we experience? What strategies and tactics may we consider implementing to blunt the impact?

  2. If our products are HCP-administered, what proactive steps can we take to support providers and ensure reimbursement stability in advance of IPAY 2028 when ASP phases out for MFP-negotiated products?

  3. If community oncology clinics decline meaningfully in 2028 and beyond, are we prepared to shift treatment administration to alternative settings? What will this impact be to overall GTN?

Increasing Desire to Bypass Middlemen

Pharmaceutical manufacturers and healthcare providers have long aired grievances related to why middlemen, such as pharmacy benefit managers (PBMs) and payer group purchasing organizations (GPOs), are extracting so much value from the ecosystem.

Common concerns from manufacturers include:

  • Steep Rebates Required to Gain Access: In competitive markets, steep rebates are required to gain formulary access, leading to instances of middlemen capturing more value than manufacturers.
  • Opaque Business Practices: Since business practices are not transparent, the percentage of rebate revenue that gets pocketed vs. passed on to patients or benefit sponsors is unclear.
  • Threats to Agreeing to Alternative Channels: PBMs reportedly threaten to block drugs on formulary if manufacturers choose to sell directly through models such as Cost Plus Drugs.
  • Vertical Integration: Vertically integrated PBMs are seen as favoring affiliated businesses and steering patients away from non-affiliated pharmacies, disrupting traditional free market dynamics.

Providers, clinics, and health systems often express these concerns:

  • Spread Pricing and Audit Difficulty: PBMs are viewed as playing “games” around reimbursement, engaging in spread pricing (charging the plan sponsor/employer more than they reimburse the pharmacy), which providers often do not have the resources to audit.
  • Administrative Burden (Prior Authorizations): PBMs impose utilization management practices such as prior authorizations (PAs), which delay care and waste physician/staff time since an estimated 95% of PAs in oncology eventually get approved.

While policy may fix specific business practices, it is unlikely to fix everything related to so-called “middleman” organizations. Instead, utilizing alternative channels to bypass traditional middlemen has gained popularity. These channels include participating in TrumpRx’s Direct-to-Consumer (DTC) initiative, contracting directly between manufacturers and health systems, and encouraging human resources departments within large employers to pressure test the costs associated with traditional PBMs ensuring patients get access to the lowest cost care.

However, it remains an uphill battle, given that the big 3 PBMs continue to dominate market share. With this power, the big 3 PBMs can threaten to block access to drugs, which makes it risky for a biopharma company to be an early mover.  In June, CMS administrator Dr. Mehmet Oz called on the the PBMs to abandon the current rebate model or risk elimination from the federal government.  Just this week, Cigna announced that it will be phasing out prescription drug rebates and instead offering discounts directly to consumers in 2027. This trend will likely continue and it will have a far-reaching impact on current and future pricing and contracting negotiations.

Questions for Biopharma Companies to Consider:

  1. Will the move away from rebate models with the PBMs shift the focus more to fees? What else could PBMs ask for from pharma manufacturers?

  2. What is the current and forecasted Gross-to-Net of our products? How may the elimination of rebates change overall exposure while preserving patient access?

  3. What products make sense to have available through DTC channels? (e.g., low risk of drug-drug interactions, easy to self-administer, low disease severity, low adverse events)

  4. Do we have the resources to write and iterate on more direct contracts? Or does partnering with a GPO save meaningful resources?

  5. If we seek a partnership with a Transparent PBM or a Cost-Plus model, would we risk being blocked by one of the Big 3 PBMs? Do we have an appetite for that risk?

Areas to Monitor

With all the uncertainty in the oncology landscape today, monitoring and identifying signals of where the market is heading is critical. Within the areas we have discussed, here are the key factors to watch:

Most Favored Nation Pricing
  • MFN Deals (Number of deals and contents of deal)

  • GLOBE/GUARD details if published
IRA and MFP Negotiations
  • Final 2026 Physician Fee Schedule Rule (Will ASP truly not be published for MFP-negotiated drugs like the proposed rule suggests?)
Increasing Desire to Bypass Middlemen
  • PBM Legislation

  • Growth of Alternates to Big 3 PBMs

  • Shifts in Big 3 PBM Business Practices

Looking Forward

If you’re a biopharma leader with questions about how the evolving landscape is impacting your unique commercialization or market access strategy, then please Contact Us via our website.  We will be glad to schedule an initial conversation so we can get to know you and your business needs better!