As pharmaceutical manufacturers prepare for the first cycle of Maximum Fair Prices (MFPs) to take effect on January 1, 2026—and with negotiations for IPAY 2027 already underway—the Inflation Reduction Act (IRA) is reshaping the industry’s economic model. Early experiences with the Drug Price Negotiation Program (DPNP) show the legislation impacts not only pricing, but also evidence strategy, governance, and clinical development. The core challenge: how can manufacturers continue delivering high-impact innovation to patients when new pricing constraints narrow the path for breakthrough therapies that require long-term, high-risk investment? 

While the tension between shareholder value and patient/payer value has long existed, today’s environment demands faster policy adaptation and cross-functional coordination. The IRA has made alignment across evidence, access, and strategy not just a competitive advantage, but a requirement for long-term success. As highlighted in Pharmaceutical Executive, organizations taking an enterprise-wide approach are best positioned to meet these evolving demands and avoid fragmented, compliance-only responses. 

At Kenway Consulting, we view the IRA Drug Price Negotiation Program as a systems-level challenge. We guide our clients to establish new ways of working, integrated operating models, clearer governance, and cross-functional coordination—elements that cannot be improvised once a product is selected.  

Leading organizations are shifting their focus—treating IRA not as a narrow policy requirement, but as a catalyst for improving innovation and value alignment across the enterprise. 
 
Four Enterprise Shifts Enabling IRA-Ready Operating Models 

1. Embed Value Strategy from Day One 

Kenway helps clients reframe early-stage development to incorporate value strategy from the outset. Resilient organizations are evolving how they: 

• Integrate value criteria into pipeline decisions at the therapeutic area level 

• Anticipate comparative effectiveness needs earlier in trial design 

• Elevate real-world and patient-centered outcomes alongside clinical endpoints 

This is not about reinventing clinical excellence. It's about expanding the definition of success to reflect how therapies will be evaluated under IRA dynamics. According to a recent BCG analysis, this kind of early value planning—across access, evidence, and clinical strategy—is becoming foundational in portfolio management decisions. 

Operational Implications: Incorporating value into early-phase governance requires updating clinical milestone criteria, linking HEOR more tightly to trial design, and embedding access assumptions into scenario planning. 

What Success Looks Like: R&D teams proactively identify comparative evidence gaps early enough to address them. Therapeutic area strategies reflect both scientific and value dimensions, and clinical programs are designed to answer key value questions without compromising scientific integrity. 

2. Align Governance Around Innovation and Value 

Kenway guides organizations in redesigning governance models that weigh scientific potential alongside pricing risk. Cross-functional frameworks help teams: 

• Align on tradeoffs between scientific promise and pricing exposure 

• Embed value milestones alongside traditional clinical gates 

• Make portfolio decisions based on an integrated view of access and evidence readiness 

An analysis by IQVIA highlights how the IRA is accelerating shifts in pricing and lifecycle economics, driving the need for more integrated governance models to manage exposure and value realization across assets. 

Operational Implications: This requires redesigning governance forums to include access, HEOR, and legal input earlier, and adjusting decision-rights frameworks to reflect shared accountability for value. 

What Success Looks Like: Senior leadership makes pipeline and investment decisions with full visibility into both scientific potential and value implications. Stage-gate reviews include robust assessment of comparative positioning, and resource allocation reflects both innovation goals and risk tolerance. 

3. Drive Cross-Functional Ownership 

Kenway partners with clients to strengthen coordination across historically siloed teams. We help organizations: 

• Establish dedicated forums to align R&D, Medical, Access, and Commercial leaders 

• Create joint accountability for development and evidence strategy 

• Align team objectives around shared value demonstration goals 

Cultural Challenge: Cross-functional ownership is more than coordination. It requires a shift in mindset from handoff to co-ownership—and that shift often runs up against resource constraints, overloaded teams, and misaligned incentives. Many organizations are asking leaders to do more with less, making sustained integration difficult without dedicated bandwidth and prioritization. 

 What Success Looks Like: Evidence generation priorities are jointly owned by R&D and commercial stakeholders. Value messaging is consistent from scientific publications through payer and policy engagement, and teams share common objectives that span traditional functional boundaries. 

4. Reimagine Evidence Generation as a Strategic Asset 

Evidence strategies are increasingly moving upstream—requiring better planning, clearer governance, and alignment across R&D, Access, and Commercial teams. We help organizations: 

• Develop proactive evidence roadmaps by Phase 2 

• Invest in real-world evidence (RWE) capabilities to support both access and regulatory outcomes 

• Coordinate messaging across scientific and economic value communications 

The FDA has increasingly recognized the role of real-world evidence in regulatory decision-making, signaling its strategic value in both development and access contexts. 

Strategic Payoff: This strengthens not only CMS negotiation positioning but also long-term differentiation with payers, providers, and policymakers—addressing the broader value challenge beyond IRA compliance. 

What Success Looks Like: Evidence strategies anticipate and address potential therapeutic alternatives before they emerge. Real-world data complements traditional clinical endpoints. Value narratives are consistent across all external engagements—from regulatory filings to payer negotiations. 

Leading Through Strategic Integration 

Regulatory disruption often serves as a catalyst for organizational innovation. In the pharmaceutical context, the IRA is accelerating the shift toward enterprise-wide operating models that integrate innovation, value, and access from the ground up. 

 Kenway helps organizations: 

• Centralize governance structures to unify innovation and access priorities 

• Embed evidence planning within therapeutic area leadership teams 

• Launch capability-building efforts focused on comparative value, access alignment, and negotiation readiness 

These models don’t replace scientific leadership—they enhance it. By grounding operating models in governance, planning, and execution frameworks that support both clinical and economic outcomes, companies enable innovation to reach patients with resilience and speed. 

Kenway's Perspective 

At Kenway Consulting, we partner with pharmaceutical leaders to translate IRA strategy into sustained advantage. We collaborate closely with client teams to design governance structures and operating models that reduce complexity and enable confident, cross-functional decision-making. 

Our work focuses on a persistent challenge: guiding R&D, Medical Affairs, and Commercial functions to move in alignment rather than in isolation, as pricing and policy challenges intensify. 

Looking to accelerate your organization’s IRA readiness? Connect with our Healthcare Practice Lead to get started.