EXECUTIVE SUMMARY

‍Outcomes-based contracting is transitioning in 2026 from a conceptual value play to an operational necessity as payers grapple with constrained budgets and demand evidence tied to real-world performance. Manufacturers that can deliver credible, rapid real-world evidence and align financial risk with outcomes will gain a competitive edge in access negotiations.

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Outcomes-based contracting has been a hot topic for years, but in 2026 it is entering a more pragmatic phase. As payer budgets tighten and scrutiny intensifies, the conversation will likely shift from “innovative contracting” to “risk management.” Payers are less interested in novelty and more interested in whether manufacturers can not only credibly demonstrate real-world performance, but also do so quickly enough to inform access decisions.

“We’re seeing exponential changes in both [real-world data and real-world evidence] … external control arms becoming more mainstream,” - Sujay Jadhav, CEO of Verana Health (Link)

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WHY THE OLD MODEL STRUGGLED TO DELIVER

‍Many outcomes-based agreements in recent history failed not because the concept was flawed, but because execution was fundamentally unrealistic. Endpoints were too complex, and timelines stretched beyond commercial relevance. Payers have become understandably skeptical, viewing outcomes-based contracting as administratively complex and slow to deliver actionable insights.

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WHAT'S CHANGED?

Outcomes-based contracting 2.0 is simpler, faster, and more grounded in operational reality. The focus is on a small number of payer-relevant outcomes; persistence, avoidable utilization, and disease-specific events that can be measured using existing data sources. The goal is not perfect evidence, but credible signals that a therapy performs as-promised in real-world settings.

This evolution has important implications for launch planning. RWE-readiness is no longer an ambiguous “nice to have” for post-launch optimization; it is increasingly a prerequisite for access discussions. Manufacturers that can articulate what outcomes they will track, how quickly data will emerge, and how performance will be operationalized in contracts will have a clear advantage in negotiations.

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‍4  ACTIONS TO TAKE NOW:

1. Define payer-aligned, measurable endpoints early:‍

Focus on a narrow set of clinically meaningful and operationally trackable outcomes (e.g., persistence, hospitalizations) that payers recognize as drivers of value.

2. Invest in fit-for-purpose RWE infrastructure:‍

Build or partner to access claims and clinical data streams that allow for timely performance measurement and adjudication.

3. Develop rapid adjudication processes:‍

Align contract timing with payer budget cycles by designing mechanisms to detect early signals of performance without waiting multiple years.

4. Collaborate with stakeholders up front: Engage payers, providers, and data partners during contract design to ensure feasibility, shared expectations, and clarity on evidence needs.

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ALKEMI'S PERSPECTIVE

The next generation of access strategy will reward manufacturers who treat real-world evidence as a commercial capability, not just an ancillary research function. Outcomes-based contracting will not replace traditional pricing and rebates, but it will increasingly complement them as payers look for manufacturer accountability and predictability.

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Max Klietmann is VP of Market Access Services at Alkemi, where he helps life sciences teams build payer-ready access strategies for launch and beyond.