EXECUTIVE SUMMARY

Evidence strategy has become a critical driver of market access and commercial success. Regulatory approval is no longer enough. Payers and HTA bodies want earlier and stronger proof of real-world value, comparative performance, economic impact, and long-term relevance to the healthcare system.

Companies that start evidence planning during clinical development and align teams early will be in a stronger position to win access and support successful launches.

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Approval isn't  the finish line

A growing number of breakthrough therapies are reaching regulatory approval yet still struggling to reach patients.  The issue is that the evidence needed for market access is no longer the same as the evidence needed for approval. In 2026, the biggest shift in market access is not a single policy change or pricing reform. It is a structural shift: evidence strategy has become central to commercial success.

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The old launch sequence is breaking down

For years, most launch strategies followed a familiar sequence: prove safety and efficacy, secure regulatory approval, and then build the value story for payers. That sequence is now breaking down. Today, payers and HTA bodies are asking tougher questions much earlier. The U.S. Inflation Reduction Act has increased scrutiny on long-term value and price sustainability. In Europe, agencies such as NICE in the UK and Germany’s IQWiG are challenging manufacturers more often on comparative effectiveness and economic evidence. Even highly innovative therapies are facing delayed access when the evidence package does not clearly show value compared with standard of care.

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Real-world evidence is essential

One major shift is the growing importance of real-world evidence in reimbursement and access decisions. Randomized trials still establish efficacy, but they rarely answer the questions payers care about most: how a therapy performs across broader patient populations, whether it reduces downstream costs, and how durable the outcomes are. In oncology, for example, launches increasingly rely on real-world registries to show comparative effectiveness and survival benefits beyond trial populations.

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Value is now defined broadly

At the same time, value expectations are expanding beyond clinical endpoints. Payers and HTA bodies are evaluating therapies across several dimensions, including economic impact, quality of life, health equity, and system sustainability. This can be seen in the growing use of value-based contracts and warranty models in the U.S., including outcomes-based agreements for gene therapies and specialty drugs where payment is tied to patient outcomes over time. These arrangements require manufacturers to plan data collection, patient tracking, and analytics infrastructure years before launch. Evidence strategy is no longer just about proving a drug works. It is about proving that it delivers value to the healthcare system.

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Analytics and AI are reshaping evidence generation

Another important change is the role of advanced analytics and AI in evidence generation. Healthcare datasets, including EHRs, claims data, and patient registries, are expanding rapidly. Leading manufacturers are using machine learning to identify responder populations, predict real-world treatment patterns, and model economic outcomes. Several pharma companies now use AI-driven observational analyses to estimate comparative effectiveness against standard therapies when head-to-head trials are not feasible. These insights are increasingly shaping payer negotiations, pricing strategy, and market access planning.

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Alkemi’s perspective

The takeaway is clear: market access strategy must start during clinical development, not after approval. The organizations that succeed in 2026 are aligning clinical, medical, HEOR, and commercial teams around a unified evidence roadmap from the earliest phases of development. They are designing trials with payer endpoints in mind, planning real-world evidence programs before launch, and anticipating how policy changes, from the IRA to evolving HTA frameworks, will shape access. Innovation alone is no longer enough. The companies that win in today’s environment will be the ones that treat evidence as a strategic asset, built early, integrated across functions, and designed to answer the questions payers will ask tomorrow, not just the questions regulators ask today.

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