Designing for Access: Early Integrated Evidence Generation Planning in the Era of Expanded Value Frameworks

Moderator: Mark Yates, MBChB (MD), PhD

Speaker(s): Pedro Saramago Goncalves, MSc, PhD, Sebastian Heidenreich, PhD, & Martin Parkinson, MRPharmS

This webinar will demonstrate how an integrated evidence strategy strategically combines perspectives from health economics and market access with patient-centered research and RWE to shape impactful decisions across the product lifecycle.

The team will address complexities of planning evidence generation for HTA bodies and payers, examining differing needs, especially in terms of comparators and endpoints, applicability of evidence, and how they approach and manage uncertainties, providing practical examples and solutions. The primary focus will be on European HTA frameworks, while highlighting implications for global evidence strategies. Participants will learn how early strategy can help decision makers:

• Understand the breadth and depth of evidence needs and identify gaps across the lifecycle continuum; locate, develop, and synthesize “hard to reach” data essential to planning.
• Define patient-relevant endpoints, align comparators and evidence and build economic models that anticipate regulatory, HTA, and payer scrutiny across global markets.
• Elevate the value of clinical data beyond traditional outcomes through collection of patient experience data in clinical trials.
• Develop real-world evidence strategies — including the use of a comprehensive Real-World Data Optimization framework and direct-to-patient and provider approaches to demonstrate unmet need, reduce uncertainty, and accelerate decision making.