5 market access and pricing pressures shaping pharma strategy

Market access and pricing leaders are operating in a different environment than they were just a few years ago. Policy changes that spent decades in debate are now in play. Evidence expectations from payers have moved beyond regulatory standards. And the intermediary model that shaped commercial drug contracting for a generation is starting to fracture.

Here are five forces every market access and pricing team should be watching closely in 2026.

1. IRA drug prices are now live

In January 2026, negotiated maximum fair prices (MFPs) took effect for 10 high-spend Medicare Part D drugs, with price drops ranging from 38% to 79% for widely used therapies like Eliquis, Jardiance, and Farxiga. A further 15 drugs, including the popular Ozempic and Wegovy, have also been negotiated, with prices taking effect in 2027. The program will expand to high-spend Part B biologics starting in 2028.

First 10 Medicare Part D drugs with negotiated MFPs

Fig. 1 – Negotiated maximum fair prices (MFPs) for the first 10 high-spend Medicare Part D drugs under the Inflation Reduction Act went into effect January 1, 2026. Source: Centers for Medicare and Medicaid Services (CMS).

While the MFP applies specifically to Medicare beneficiaries, it establishes a highly visible benchmark that may influence commercial payer expectations. Even if contracts are not legally tied to the MFP, payers now have a clear reference point for what constitutes a “fair” price.

At the same time, because the government-negotiated price is already lower, manufacturers have less room to offer traditional rebates on those products. In response, pharmacy benefit managers (PBMs) may look to recover value elsewhere, seeking deeper discounts on competing drugs, related therapies, or products not selected for negotiation.

Negotiated prices may also affect other government benchmarks, such as Average Sales Price (ASP), which determines reimbursement for many physician-administered drugs. Because CMS calculates ASP using sales data reported with a two-quarter lag, MFP-induced pricing changes can begin influencing reimbursement levels months after implementation. For manufacturers with commercial or Medicare Advantage contracts linked to ASP, this creates another layer of pricing pressure.

Overall, the IRA’s negotiated pricing program is poised to reshape pricing dynamics across the broader U.S. market, influencing payer behavior, reimbursement formulas, and contracting strategies well beyond Medicare.

What companies are doing now:

• Pressure-test against Medicare benchmarks. Every pricing decision, launch model, and indication sequencing strategy is being evaluated against a world where MFPs set informal reference points across the payer ecosystem. For therapeutic areas adjacent to negotiated drugs, teams are modeling how payers are likely to benchmark net price and access.
• Expect ASP erosion. Manufacturers with commercial or Medicare Advantage contracts tied to ASP are modeling the timing and magnitude of potential erosion. Teams are exploring alternative pricing mechanisms, carve-outs for selected drugs, and proactive communications with payers and providers to maintain continuity of care.
• Model rebate strategy. Commercial plans may push for additional rebates where gaps exist between MFP and net price. Manufacturers face a tradeoff: reducing commercial rebates may protect margins, but risks triggering tighter utilization management or prior authorization. There’s no clean answer, but the range of outcomes needs to be modeled.

2. MFN pricing is introducing new uncertainty

Most favored nation (MFN) pricing concepts, whether in formal policy proposals or voluntary manufacturer commitments, are adding a new layer of complexity to global pricing strategy. MFN frameworks link U.S. drug prices to the lowest prices in comparable international markets, and even the policy conversation alone can influence how manufacturers think about global launch sequencing, international reference pricing exposure, and long-term U.S. price sustainability.

Historically, manufacturers assessed launch decisions largely on the economics of the individual market. Today, those decisions are increasingly evaluated through the lens of potential spillover into U.S. pricing policy and payer negotiations, creating a more interconnected global pricing environment.

As a result, pricing governance structures inside many companies are expanding. Pricing committees that once focused primarily on U.S. contracting or single-market strategy are now reviewing pricing decisions across comparator markets to understand how international prices may affect future U.S. policy exposure or reference-pricing dynamics.

In some cases, this analysis is influencing whether companies launch products in certain markets at all or whether they delay launches until pricing strategies across regions are better aligned.

What companies are doing now:

• Assess pricing through a global comparative lens. Market access leaders are moving toward a globally integrated pricing strategy, rather than treating U.S. and ex-U.S. pricing separately. This includes mapping international reference-pricing pathways, identifying markets with the greatest policy exposure, coordinating launch timing to manage long-term U.S. pricing risk, and evaluating international launch prices, licensing agreements, and commercial discounts, alongside potential effects on future U.S. negotiations or reference-pricing discussions.

3. Payer evidence expectations exceed regulatory standards

Historically, regulatory approval was the primary hurdle for market entry. Today, approval is only the starting point. Payers are demanding stronger evidence on comparative effectiveness, real-world outcomes, durability of response, and total cost of care. In many therapeutic areas, payers are effectively setting evidence thresholds that go beyond what regulators require.

For manufacturers, this means clinical development and market access strategies must work in tandem. Trials designed solely to secure approval may leave critical evidence gaps when it comes time to negotiate coverage.

Increasingly, market access teams are pushing decisions upstream—shaping trial design, endpoint selection, and real-world evidence plans years before launch. Without that alignment, even highly innovative therapies can encounter slow or restricted uptake.

What companies are doing now:

• Embed market access early. Market access teams are getting involved much earlier in clinical development, ensuring evidence planning anticipates payer decision frameworks (not just regulatory approval). This can include designing trials with active comparators, collecting quality-of-life outcomes, and building real-world evidence strategies that start at launch rather than years later.

4. Payers are ramping up utilization management

As drug spending rises, payers are increasingly using utilization management (UM) to control costs. Prior authorization (PA), step therapy, and tighter formulary management are becoming common across therapeutic areas, and even well-established brands are facing scrutiny when high-cost competitors enter the market.

This shift reflects a broader trend: payers are moving from passive coverage decisions to actively shaping therapy pathways. For market access teams, this means that securing formulary placement is no longer the finish line. Manufacturers must anticipate how utilization controls will affect real-world patient access and design contracting strategies that address both clinical value and budget impact.

At the same time, payer infrastructure for UM is becoming more sophisticated. Digital prior authorization systems and enhanced claims data integration allow plans to enforce treatment pathways consistently across large populations. Once these policies are embedded, they can be difficult to change through traditional contracting alone, creating long-term implications for manufacturers’ access strategies.

What companies are doing now:

• Plan for end-to-end access. Manufacturers are shifting from focusing only on formulary access to addressing the entire access journey. That means anticipating step edits, understanding how payers structure clinical pathways, and building evidence and contracting strategies that demonstrate where a therapy should sit in treatment algorithms.

5. PBM reform is challenging the rebate model

The rebate-driven model that has dominated U.S. pharmaceutical contracting for decades is under strain. In early 2026, Congress passed bipartisan PBM reforms as part of the Consolidated Appropriations Act. Under the new rules, PBMs in Medicare Part D must pass through all rebates, fees, and other funds to plan sponsors. Compensation is being delinked from drug list prices, with administrative fees replacing traditional rebate-based incentives.

These changes make clear that rebates will no longer be the primary lever for PBM profit or access decisions. Many PBMs are also voluntarily shifting toward fee-based or administrative models, further challenging traditional rebate economics.

As the rebate system continues to erode, pricing strategies built around large rebates and formulary negotiations may need to pivot toward greater net price transparency, direct-to-provider or direct-to-consumer channels, or value-based contracting models that link payment to outcomes.

What companies are doing now:

• Prepare for a post-rebate environment. This means stress-testing pricing strategies under scenarios where rebate leverage weakens and net price transparency increases. Companies that rely heavily on large rebate structures to secure access will need to rethink how they communicate value and structure contracts in a more transparent pricing landscape.

See the market landscape clearly

Government negotiation is introducing new price anchors. Global pricing debates are affecting U.S. strategy. Payers are raising the bar for evidence. Utilization management is tightening access controls. And the intermediary system that historically mediated pricing negotiations is facing reform.

Taken together, these forces point to a structural shift in the market access environment. The companies that adapt best will be those that treat access and pricing not simply as a contracting exercise, but as a strategic discipline integrated across the commercial function.

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