IRA, MFN Pressure, and Coverage Volatility Are Reshaping Specialty Drug Access

Key Takeaways

• IRA implementation is influencing payer behavior now, particularly in Medicare Advantage and Part D, not just in future pricing cycles.
• Utilization management is intensifying as plans respond to greater financial exposure for high-cost therapies.
• High-cost specialty drugs are under the greatest pressure, especially in oncology, immunology, neurology, and other catastrophic-spend categories.
• MFN-style pricing pressure is expanding, with models such as GLOBE and GUARD raising concerns about international reference pricing and cross-border pricing risk.
• Coverage churn and affordability instability are increasing, creating new challenges for forecasting, treatment continuity, and access.
• Commercial spillover remains a concern, as Medicare pricing benchmarks may increasingly influence broader payer negotiations.
• Launch strategy is becoming more complex, with manufacturers needing to account for pricing pressure, sequencing decisions, and earlier access friction from day one.

At Asembia 2026, Dee Chaudhary, Principal, Commercial Strategy Consulting Life Sciences and Healthcare, Clarivate, outlined how the Inflation Reduction Act (IRA), renewed Most Favored Nation (MFN)-style pricing pressure, and broader coverage volatility are reshaping payer behavior and creating new challenges for manufacturers of high-cost specialty therapies in a session titled "Swallowed by Reform: IRA, OBBB, MFN Pricing, and the Future of High-Cost Specialty Drugs."

Throughout the session, Chaudhary emphasized that drug pricing policy is no longer unfolding gradually or in isolation. Instead, multiple policy and market forces are moving at once, with direct implications for pricing strategy, launch planning, utilization management, and patient access.

For payer stakeholders, the message was clear: policy changes are increasingly translating into real-time coverage decisions, tighter management of specialty spend, and more restrictive benefit design.

IRA Moves From Policy Design to Market Reality

A central theme of the session was that the IRA is no longer simply a policy framework—it is now affecting market behavior in measurable ways.

Chaudhary said negotiated pricing cycles are now operational and recurring annually, with payer expectations, PBM contracting behavior, and launch pricing assumptions shifting accordingly. In her view, this marks a transition from “policy theory” to “real-world math” for manufacturers and market access teams.

She pointed to several downstream effects already visible in the market, including:

• More restrictive Medicare Advantage plan designs
• Higher coinsurance
• Greater use of prior authorization and step edits
• Site-of-care restrictions
• Increased pressure on products associated with high specialty spend

According to Chaudhary, plans are responding to a new environment in which they are carrying greater liability and are therefore showing less tolerance for unmanaged specialty costs.

Payers Tighten Controls on High-Cost Specialty Products

Chaudhary repeatedly returned to one theme: payers are escalating utilization management faster and more broadly than many stakeholders initially expected.

Drawing on Clarivate’s plan-level and formulary data, she said the company has observed intensifying payer action across Medicare Advantage and Part D offerings, with tighter restrictions becoming a new baseline rather than an exception.

Among the trends she highlighted:

• Biosimilar-first strategies
• Tighter prior authorization requirements
• Step edits
• Site-of-care controls
• Formulary tiering changes
• Greater friction in access for specialty products

She also suggested that the impact is not confined to drugs directly affected by negotiation. In her view, non-negotiated competitors are also being pushed toward pricing and access parity, creating broader pressure across therapeutic classes.

For payers, the discussion underscored how benefit redesign and utilization tools are becoming core responses to rising specialty liability.

Medicare Benefit Changes Are Driving More Restrictive Designs

Chaudhary said recent Medicare changes are affecting both plan design and patient experience. She described a shift away from legacy Medicare Advantage and Part D offerings toward benefit structures that better manage risk, including narrower access and greater cost-sharing.

She also highlighted what she characterized as a “sleeper issue”: enhanced true out-of-pocket counting and earlier entry into catastrophic coverage. Once members reach that phase, she noted, plans assume significantly greater liability, increasing their incentive to manage high-cost therapies more aggressively.

The result, she said, is earlier and more durable pressure on specialty drugs, with less assumption of a clean early access window.

MFN Models Add New Cross-Border Pricing Risk

Beyond the IRA, Chaudhary discussed renewed international reference pricing pressure and the emergence of MFN-linked models, including GUARD for Part D and GLOBE for Part B and Medicaid.

She said these models are advancing in parallel and could compress the US pricing premium by linking ex-US pricing decisions more directly to US pricing risk. That dynamic, she argued, introduces new corridor risk for manufacturers and could influence how companies think about launch pricing across markets.

Chaudhary framed this as a growing strategic issue, particularly for products with global launch sequencing decisions or sensitivity to reference pricing spillover.

The discussion pointed to a future in which international pricing mechanics may influence reimbursement negotiations and market access assumptions more directly.

Coverage Churn and Affordability Volatility Could Disrupt Access

Another major theme was instability in coverage and affordability. Chaudhary described a more volatile environment in both Medicaid and commercial coverage, with verification rules, eligibility changes, and affordability pressures contributing to patient churn.

She argued that this instability can disrupt continuity of care, reduce adherence, and complicate forecasting for both manufacturers and other stakeholders. She also suggested that volatility may be especially pronounced among vulnerable populations and those already at the edge of coverage stability.

That could translate into:

• More interrupted treatment journeys
• Greater variability in enrollment and utilization Increased abandonment
• More aggressive cost-management responses

Chaudhary also indicated that states may respond to these pressures by expanding tools such as prescription drug affordability boards and Medicaid value-based pharmacy contracting.

Launch Strategy Must Account for Earlier Friction

Chaudhary said the evolving policy environment is changing not only access strategy but also launch strategy.

In particular, she argued that manufacturers can no longer assume a six- to 12-month runway before major access pressure emerges. Instead, products—especially high-cost specialty therapies—may launch directly into tighter payer scrutiny, earlier utilization management escalation, and greater pricing sensitivity.

She also discussed the strategic implications of orphan drug sequencing, noting that the timing and order of approvals may now carry greater consequences for future negotiation exposure and asset value.

Her broader point was that pricing, access, forecasting, and patient support functions can no longer operate in silos. In a more volatile environment, those decisions increasingly need to be coordinated from the outset.

Medicare Solvency Pressure Could Intensify Pricing Scrutiny

In the latter part of the session, Chaudhary highlighted Medicare hospital insurance solvency as an underappreciated issue that could contribute to future pricing and reimbursement pressure.

She argued that if solvency concerns accelerate, policymakers may look more aggressively for high-yield savings mechanisms, with drug pricing remaining a visible and accessible target. In that context, she suggested there could be growing appetite for deeper benchmarking, expanded negotiation pressure, and tighter reimbursement across Part B and Part D.

She also cautioned that when Medicare tightens, commercial markets often follow, with PBMs potentially anchoring more heavily to Medicare-derived benchmarks.

For payers, that scenario could reinforce a broader trend toward tighter specialty management and lower tolerance for high-cost exposure.

Reference

Chaudhary, D. Swallowed by reform: IRA, OBBB, MFN pricing, and the future of high-cost specialty drugs. Asembia. 2026. Las Vegas, NV.