This article explores the overlooked yet critical role of early strategic planning for payer reimbursement in drug development. It highlights how misalignment between regulatory and payer evidence requirements—especially around long-term and comparative data—can delay access to innovative therapies.
To address these challenges, the authors advocate for broader use of advanced modeling methods, specifically Model-Based Meta-Analysis (MBMA) and Quantitative Systems Pharmacology (QSP). These tools can:
Predict long-term outcomes early (as soon as Phase 1 or 2)
Identify evidence gaps
Inform the Target Product Profile (TPP)
Strengthen health technology assessment (HTA) submissions
While MBMA and QSP are well-established in clinical development, their adoption in health economics and outcomes research (HEOR) remains limited due to organizational silos and a lack of awareness.
The article also emphasizes the value of these methods in diagnostics and devices, supporting development of a “Target Reimbursement Profile” aligned with payer expectations.
Greater integration of MBMA and QSP into early HEOR strategy can enhance evidence quality, improve payer engagement, and accelerate patient access to new therapies. Collaboration across R&D, regulatory, and market access functions is key to unlocking this potential.
Author(s): Ananth Kadambi, Nicholas C. Anderson, Sandra A.G. Visser, Matthew L. Zierhut
Year: February 25, 2025
Explore how MBMA and QSP can strengthen your early market access strategy.
Learn more about Model-Based Meta-Analysis (MBMA) and Quantitative Systems Pharmacology (QSP) and how they can help bridge regulatory and payer requirements to accelerate access to innovative therapies.
