The Challenge
A biopharma company developing a first-in-class immunology therapy was preparing for its pivotal Phase III program.

While the clinical data were promising, market access planning hadn’t begun.

Key issues emerged:

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• Endpoints were not fully aligned with payer-relevant outcomes
   

• Comparator selection didn’t reflect real-world treatment practices
   

• No HEOR or RWE strategy was defined for post-launch support
   

Waiting until after regulatory submission to address these would have delayed HTA readiness and weakened the value narrative.

 

Our Approach
We established a cross-functional market access framework early in development, bringing together clinical, HEOR, regulatory, and commercial teams to align around a unified access strategy.

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🔹 Access-Driven Clinical Design
Refined trial endpoints and comparators to ensure future HTA relevance.

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🔹 HEOR and Evidence Integration
Mapped early cost-effectiveness modeling and burden-of-illness evidence to payer priorities.

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🔹 Value Proposition Blueprint
Developed the foundational payer value story to guide GVD and local HTA dossier planning.

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🔹 Evidence Roadmap
Outlined pre- and post-launch evidence generation activities, including RWE and PRO collection.

 

The Results

✔️ HTA-Ready Submission: Evidence aligned with payer expectations from day one.

✔️ Accelerated Reimbursement: Positive recommendation achieved three months ahead of forecast.

✔️ Unified Messaging: Global, regional, and affiliate teams adopted one consistent value narrative.

✔️ Strategic Foundation: The early framework became a template for future pipeline products.

 

The Insight
Embedding market access early transforms development from reactive to strategic.

👉 Lesson Learned: When cross-functional teams align on access goals before the data read out, every study, model, and message becomes part of a single, coherent story — one that payers believe in.