Pharmaceutical manufacturers face a critical question: How do you preserve high-impact innovation when new pricing constraints narrow the path for breakthrough therapies requiring long-term, high-risk investment?
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.
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.
Organizations that act proactively can turn regulatory pressure into strategic advantage.
At Kenway Consulting, we've guided healthcare and life sciences organizations through complex regulatory and operational transformations. We view the IRA Drug Price Negotiation Program as a systems-level challenge that requires 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.
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:
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:
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:
The 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.
How Kenway Helps: We work with clients to establish governance frameworks that make cross-functional collaboration sustainable, not aspirational. This includes designing decision-rights structures, aligning incentives, and creating forums that enable co-ownership without adding unsustainable workload.
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:
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. Organizations that build evidence capabilities now position themselves for sustained competitive advantage as the regulatory landscape continues to evolve.
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.
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:
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.
The IRA Drug Price Negotiation Program represents more than a regulatory hurdle—it’s a catalyst for building more resilient, integrated operating models. Pharmaceutical leaders who act now can transform pricing constraints into opportunities for strategic differentiation.
At Kenway Consulting, we partner with pharmaceutical manufacturers 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 guiding R&D, Medical Affairs, and Commercial functions to move in alignment rather than in isolation, helping organizations preserve innovation while navigating intensifying pricing and policy challenges. Connect with our Healthcare & Life Sciences Practice Lead to discover how Kenway can help your organization build IRA-ready capabilities that drive both compliance and competitive advantage.