Strengthening Global Market Access Readiness Through Early Payer & HTA Planning
Introduction: A global biopharma company preparing to advance towards asset commercialisation approached Thelansis with a clear priority that they wanted to enter multiple markets with confidence that their clinical evidence, pricing expectations, and value communication would withstand payer scrutiny. The therapy showed strong early promise, but the success in Phase 3 does not automatically translate into smooth reimbursement pathways, especially in regions where HTA bodies demand tight alignment between clinical value, real-world relevance, and economic justification. Over the past decade, Thelansis has supported companies in similar transitions by helping them understand how payers think, what evidence resonates, and where access bottlenecks typically arise. Problem Statement: The client faced three immediate challenges: Uncertainty around payer expectations across the U.S., EU5, Japan, and selected emerging markets, particularly in unmet need, differentiation,...