Evidence‑to‑Action: Translating HEOR and Policy Shifts into Real‑World Impact

Insights from ISPOR

The healthcare ecosystem in 2026 is at an inflection point where evidence generation alone is no longer sufficient—stakeholders must translate evidence into operational, financial, and policy‑relevant action. Insights from ISPOR 2026 underscore the growing centrality of real‑world evidence (RWE), decision‑grade HEOR, and AI‑enabled analytics, while concurrent policy shifts—including the Inflation Reduction Act (IRA), Medicare drug price negotiation, Medicaid and 340B scrutiny, and broader federal retrenchment—are forcing both health systems and pharmaceutical manufacturers to act on evidence faster and with greater precision. Together, these forces are redefining how value is demonstrated, negotiated, and sustained.

ISPOR 2026: Evidence Moves from Supportive to Decisive

ISPOR 2026 reinforced that HEOR and RWE are no longer adjuncts to access or policy decisions—they are central inputs. Conference themes emphasized that payers, policymakers, and providers increasingly rely on real‑world outcomes, utilization patterns, and comparative effectiveness to guide coverage, pricing, and care delivery decisions.[1,2] Evidence is now a determinant, not a supplement.

Key takeaways included:

• RWE has become “decision‑grade.” Regulators and CMS now expect evidence that is methodologically rigorous, reproducible, and transportable across settings—not tailored analyses built for a single market or audience[2]

• Global evidence convergence. U.S. policy (e.g., IRA, MFN pricing discussions) is influencing global market access expectations, increasing pressure for evidence packages that hold up across multiple HTA and payer frameworks[3]

• AI governance over AI novelty. While AI featured prominently, ISPOR discussions emphasized governance, auditability, and transparency over experimentation, signaling that evidence must be trusted to be actionable[2]

Implication: Evidence strategies must be designed with end‑use in mind—policy defense, provider adoption, and financial decision‑making—not just publication or submission

Policy Environment: Accelerating the Need for Evidence‑to‑Action

The IRA’s implementation of Medicare drug price negotiation in 2026 marks one of the most consequential shifts in pharmaceutical economics in decades. Negotiated Maximum Fair Prices (MFPs), inflationary rebates, and Part D redesign are compressing margins while increasing scrutiny of real‑world value.[4,5]

• For health systems, lower patient out‑of‑pocket costs may improve adherence, but margin pressure, formulary restrictions, and administrative complexity are increasing
• For pharmaceutical companies, the evidence must now justify not only clinical benefit, but budget impact, utilization efficiency, and downstream system value under constrained pricing environments

Additionally, Medicaid, 340B, and transparency pressures are growing as 340B continues to face heightened scrutiny, litigation, and calls for transparency, with policy uncertainty creating operational risk for covered entities and manufacturers alike.[6,7] Recent trends include:

• Manufacturer demands for more granular data to prevent duplicate discounts
• Increased HRSA audit activity and reporting expectations
• Ongoing debate over rebate‑based models and contract pharmacy access

Implication: Evidence that clearly links 340B savings and access strategies to patient outcomes and system sustainability will be increasingly important to defend program integrity and partnership trust.

Broader federal and state policy shifts remain as well. The One Big Beautiful Bill Act (OBBBA), Medicaid eligibility changes, reduced federal healthcare spending, and increased state‑level variability are adding fragmentation and financial strain across the system.[8,9] Health systems are operating in more fiscally constrained environments, with greater responsibility for demonstrating value and accountability. At same time, pharma is navigating sustained pricing pressure and heightened expectations for evidence that supports access, not just innovation.

What “Evidence‑to‑Action” Means in Practice

Across ISPOR insights and policy realities, a clear pattern emerges – evidence must be designed to drive decisions. Effective evidence‑to‑action strategies need to integrate RWE, HEOR, and operational data to show real‑world impact. Evidence must translate findings into tools health systems can use—dashboards, population insights, site‑of‑care analyses and support joint decision‑making between pharma, providers, and payers rather than unilateral value claims. This aligns with the growing expectation that pharma partners help health systems navigate policy complexity, optimize care delivery under financial constraints, demonstrate outcomes across the Quintuple Aim.

In conclusion ISPOR 2026 made clear that the future belongs to organizations that can operationalize evidence, not just generate it. As policy reforms reshape pricing, access, and accountability, both health systems and pharmaceutical manufacturers must move from evidence‑as‑proof to evidence‑as‑action—using decision‑grade RWE to guide strategy, partnerships, and care transformation. Those who succeed will be the ones who connect data to decisions, and insight to impact, in an increasingly constrained and transparent healthcare environment.

Leveraging health systems to generate evidence that demonstrates value and drives adoption.
Petauri Kinect helps develop strong, repeatable evidence to inform policy decisions, drive provider use, and demonstrate financial impact. We help navigate complexity, prove value, and sustain access in a challenging pricing environment.

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References

1. https://advisory.avalerehealth.com/insights/key-health-policy-actions-to-watch-for-the-rest-of-2025

2. https://www.definitivehc.com/blog/healthcare-policies-reshaping-care-business

3. https://www.forvismazars.us/forsights/2026/03/340b-program-major-developments-through-early-2026

4. https://www.linkedin.com/posts/keithknutzen_ispor-ispor2026-heor-activity-7465858414771097601-hdx0/

5. https://www.linkedin.com/pulse/reflections-from-ispor-2026-evolving-heor-market-cx9he/

6. https://www.ajmc.com/view/the-ira-s-unintended-consequences-for-drug-pricing-and-coverage

7. https://healthlawblog.dickinson-wright.com/2026/03/6-key-federal-health-law-changes-in-2025-and-their-2026-impact/

9. https://www.340bhealth.org/