New PBM rules will put market access strategies to the test

With 2026 bringing state-driven PBM reforms, drugmakers and insurers must rethink pricing, contracting, and access strategy.

The pharmacy benefit management (PBM) industry is at a crossroads. With nearly 80% of the U.S. market controlled by just three players—Express Scripts (The Cigna Group), OptumRx (UnitedHealth Group), and CVS Caremark (CVS Health)—concerns over drug affordability and patient access are mounting. This market dominance has made PBMs a primary target for lawmakers, employers, patient advocates, and independent pharmacies, all pushing for greater transparency and lower pricing.

A patchwork of state PBM reforms is taking shape

So far in 2025, more than half a dozen states have introduced or enacted legislation targeting PBMs, with measures ranging from rebate transparency and tighter licensing requirements to spread pricing bans. According to the FTC, the three largest PBMs brought in $1.4 billion from spread pricing between 2017 and 2021, underscoring the stakes of these legislative moves.

While specific laws vary from state to state, they share a common goal: rebalance power within the pharmaceutical supply chain. Among the more aggressive reforms:

• Arkansas passed a law that bans PBMs from owning pharmacies, aiming to break up the vertically integrated business model that critics argue creates conflicts of interest.
• Alabama is requiring PBMs to reimburse community pharmacies at Medicaid rates, banning spread pricing, and prohibiting patient steering.
• Iowa is limiting patient steering and under-reimbursement, curbing specialty drug labeling, and setting a standard dispensing fee.

Expect these reforms to shift how drugs are priced, dispensed, and reimbursed at the state level, creating a more complex environment that could force companies to rethink market access strategies. Some of these laws may even serve as blueprints, fueling broader reform efforts in 2026, with far-reaching implications for providers, insurers, and investors alike.

Legal challenges may delay but not deter state efforts to rein in PBMs

While state-level reforms gain momentum, PBMs are challenging them in court, threatening to stall or dilute these efforts. For example, CVS Health and Cigna, which owns Express Scripts, have filed lawsuits to block Arkansas from enforcing its new law that bans PBMs from owning pharmacies. Similarly, Iowa’s efforts to prohibit patient steering and enforce higher pharmacy reimbursements are partially blocked by court injunctions citing federal preemption and constitutional issues.

Legal outcomes remain uncertain, but even temporary injunctions can delay implementation and blur the regulatory landscape for stakeholders trying to plan ahead. Still, the volume and momentum of state-level action suggest that while enforcement may stall, the push for reform is unlikely to fade, especially as bipartisan interest in PBM oversight grows in Congress.

Market disruptors gain traction amid industry scrutiny

Adding to the regulatory pressure, market forces are shaking up the traditional PBM business model, with disruptors reimagining the value proposition.

• Mark Cuban’s Cost Plus Drug Company and Amazon Pharmacy are pioneering transparent, cost-plus pricing models that eliminate hidden fees and promise predictable drug costs.
• Coalitions of smaller PBMs, organized around transparency initiatives, are also gaining bipartisan support by advocating for simpler, fairer pricing structures.
• Direct-to-consumer, cash-pay options are gaining popularity among patients, some of whom are choosing to bypass insurance altogether in favor of lower out-of-pocket prices and simpler purchasing experiences.

These models appeal not only to patients, but directly to employers and other payors frustrated with the complexity and opacity of established PBMs.

PBMs roll out cost-plus models to counter disruptors

To counter the growing disruption from more transparent, consumer-friendly alternatives, industry giants have begun rolling out new pricing models:

• Express Scripts launched ClearCareRx, offering a 100% pass-through model where plan sponsors pay actual pharmacy costs plus a fixed fee, with rebates returned in full.
• OptumRx followed with Cost Made Clear initiatives, including Cost Clarity and Cost Advantage, and rolled out the Trend Guarantee model, combining fixed per-member costs with value-based guarantees.
• CVS Caremark launched CostVantage and TrueCost models, adopting similar cost-plus pricing structures.

These programs aim to preserve relationships with large employers and plan sponsors, but questions remain around their implementation. Critics point to administrative fees and non-passed-through rebates that may still obscure the full cost picture, limiting the true transparency these programs promise. Whether they deliver sustainable cost savings for payors and patients is still an open question.

Rethinking market access in a changing landscape

The combined pressure from state-level reforms and emerging disruptors is prompting a broad reassessment of market access strategies across the pharmaceutical supply chain.

• Drug manufacturers will need to adapt to a landscape where traditional pathways, such as rebate-driven formulary placement, are challenged or constrained. As transparency requirements grow, the leverage of high-rebate contracts may diminish, pushing manufacturers to better align list prices with net costs and rethink contracting approaches.
• Health plans and employers will continue to reevaluate their relationships with traditional PBMs, exploring alternatives like transparent disruptors or in-house pharmacy benefit solutions to gain more control over cost and transparency.
• PBMs themselves are strengthening direct partnerships with manufacturers to secure greater formulary control, while simultaneously introducing new pricing models and transparency messaging to preserve market share.
• Patients are increasingly turning to cash-pay options, adding another layer of complexity. Manufacturers and payors will need to adjust how they support patient access as more consumers step outside traditional benefit pathways.

In this environment, formulary strategies and contracting approaches, as well as patient access programs, will need to become more agile and in line with the changing expectations of regulators, payors, and patients alike. Ultimately, the balance between managing costs and ensuring patient access will be tested as the market evolves.

What to watch in the year ahead

With new regulations coming into force through 2026, decisions made now will have lasting implications for how therapies reach patients and how stakeholders compete in an evolving market. Here’s what to watch in 2026:

• Legal flashpoints: Keep an eye on federal court rulings around PBM state laws. A decision affirming states’ rights to regulate PBMs could upend vertical integration.
• Federal momentum: Will Congress act on bipartisan PBM reform bills stalled in 2025? Even partial movement could signal seismic change.
• Emerging winners: Transparent PBMs, provider-aligned models, and disruptors that solve real-world access or pricing issues will likely continue to gain share.
• Formulary shakeups: As net pricing power erodes, formulary access could shift from rebate depth to real-world value, outcomes, or patient experience.

Data as a strategic advantage in the PBM shake-up

Public pressure, disruptive market entrants, and a wave of state-level policy changes are converging to challenge the traditional PBM model and reshape drug pricing and access dynamics. As these new rules take hold and market dynamics shift, the organizations with the clearest view of the ecosystem will be best positioned to compete.

Definitive Healthcare’s data and analytics provide the critical visibility organizations need to make informed decisions, from understanding prescribing patterns and drug utilization trends to uncovering affiliations and finding the key opinion leaders who influence treatment decisions across markets.

Sign up for a demo.