ISSUE: The role of HEOR and Market access is growing in importance. We are witnessing many reorganizations across pharma companies with the aim of better integrating access into the overall product strategy. Tatia Woodward and Indranil Bagchi, representing respectively global HEOR and Market Access, will discuss how these functions need to evolve and collaborate to create a holistic strategy that demonstrate the value of innovative products from pipeline until patent expiration. They will share their direct experience in terms of the impact and evolution of their roles, as well as perspectives on what more is needed to elevate the access function within the company. Brian O’Rourke will provide the HTA perspective in terms of evidence required for value demonstration and highlight how institutions like ISPOR can support this evolution.

OVERVIEW: We are witnessing a fundamental transformation of the global HTA landscape. Center for Medicare and Medicaid Services (CMS) is empowered to negotiate drug prices, the EU is creating a singular, comprehensive HTA process, Canada and the UK are updating their frameworks focusing on sustainability and innovation, and collaborations such as the Access Consortium are emerging in various markets. The need to demonstrate the value of new medicines, vaccines, and devices across the entire product lifecycle is becoming more urgent than ever. Real World Evidence (RWE) has emerged as a pillar to demonstrate effectiveness, long term safety, durability, and risk/benefit profile in populations not included in clinical trials, though acceptance of RWE across stakeholder groups remain variable. Value-based pricing is becoming a standard access strategy at launch, for expensive medications that obtain accelerated regulatory approval. The need to reconsider clinical trials program design, often designed just for fast regulatory approval, is forefront to allow collection of data also necessary to inform optimized access and pricing.