By Kellie Rademacher, PharmD, Director, Strategy, Inizio Evoke Access
In today’s evolving healthcare landscape, the question for pharmaceutical companies is no longer just “Is the product approved?” but increasingly “Is the product valued?”
As we move through 2025, payers worldwide are sharpening their focus—not only on clinical efficacy, but also on long-term outcomes, real-world impact, and economic value. For manufacturers, this shift signals a critical need to redefine how they approach market access.
The Payer Mindset: From Gatekeepers to Value Evaluators
Across public and private sectors, payers continue to embrace a more holistic definition of value. They’re under considerable pressure to manage rising costs due to policy changes, shifting coverage populations, and economic uncertainty. In turn, this has expanded the access bar for pharma.
Here’s what today’s payers are prioritizing:
Real-World Evidence (RWE)
While randomized controlled trials remain the gold standard for safety and efficacy, they no longer fully satisfy payer needs. Increasingly, payers seek real-world data to validate whether benefits seen in trials translate to day-to-day clinical practice. According to Deloitte, more than 80% of payers now consider RWE essential in their decision-making processes. [1]
Budget Impact and Economic Justification
As more high-cost therapies enter the market—including those for rare diseases and cell and gene therapies—payers are scrutinizing budget impact and cost-effectiveness. Payers are looking for data beyond modeling such as economic data collected during clinical trials. Data on downstream cost offsets and healthcare resource utilization (eg, avoided hospitalizations or reduced disease progression) are becoming a prerequisite. [2]
Alignment with Value Frameworks
Payers are increasingly leaning in on established frameworks such as the National Institute for Health and Care Excellence in the UK, Institute for Clinical and Economic Review, National Comprehensive Cancer Network, and American Society of Clinical Oncology Value Framework to support access decisions. Manufacturers that proactively align evidence packages with these models are better positioned to secure favorable outcomes. [3]
What This Means for Pharma Market Access Teams
So how can pharma evolve to meet these rising expectations?
Start Access Strategy in Phase 2
Evidence strategy and market access planning can no longer wait until phase 3 or approval. Forward-looking organizations are integrating health economics and outcomes research (HEOR), RWE, and pricing insights early - often during phase 2 - to shape studies and communications that address future payer questions.
Collaborate Across Functions
Commercial, medical, regulatory, and development teams must align to build an integrated value story. Early payer engagement - such as advisory boards or scientific advice with healthcare technology assessment (HTA) bodies - can refine evidence-generation plans and reduce access delays. [4]
Broaden the Value Narrative
A compelling access strategy in 2025 doesn’t just focus on clinical benefit. It connects the dots between efficacy, real-world performance, health equity, patient quality of life, and financial sustainability.
Looking Ahead: Leading with Value
The evolving payer landscape is challenging - but it also presents opportunity. Manufacturers that take a proactive, patient-centered, and data-driven approach to market access will be better equipped to deliver both therapeutic and economic value.
In a world where access is earned - not guaranteed - value must be demonstrated early, often, and in real terms that matter to payers and patients alike.
References
[1] Deloitte. Pharmaceutical Market Access: Launch Excellence in a Complex World. Deloitte Insights. 2023. Accessed June 24, 2025. https://www2.deloitte.com/us/en/pages/life-sciences-and-health-care/articles/pharmaceutical-market-access.html
[2] Neumann PJ, Cohen JT, Weinstein MC. Updating cost-effectiveness—the curious resilience of the $50,000-per-QALY threshold. N Engl J Med. 2014;371(9):796-797.
[3] Institute for Clinical and Economic Review (ICER). Value Assessment Framework: 2023–2025 Update. Accessed June 24, 2025. https://icer.org/our-approach/methods-process/value-assessment-framework/
[4] US Food and Drug Administration. Framework for FDA’s Real-World Evidence Program. December 2018. Accessed June 24, 2025. https://www.fda.gov/media/120060/download