Can Prelaunch Collaboration With Payers Address Uncertainty in Value Assessments Amid Growing Regulatory and Access Gaps?

ISSUE: Recent years have seen significant changes in the regulatory landscape, with the FDA and EMA becoming more open to innovative clinical trial designs in oncology and rare diseases. These advancements have facilitated earlier patient access to treatments. However, such shifts are not always embraced by payers. The uncertainty surrounding the value of these medicines, regarding population impact, comparative effectiveness, and long-term outcomes, often remains unclear at launch. Furthermore, the high price tags associated with these treatments pose additional challenges for payers, complicating reimbursement decisions and delaying access.Can closer collaboration between pharmaceutical companies and payers help bridge the gap between regulatory advancements and access challenges by reducing uncertainty regarding short-term budgets and long-term outcomes? This issue is not just about trust; it also involves barriers related to accounting systems, data transparency, privacy concerns, revenue uncertainty, and a reluctance to share risk. OVERVIEW:This panel will explore potential solutions for developing a comprehensive strategy to demonstrate the value of medicines at launch while ensuring pricing reflects their true value for all stakeholders. Moderated by Cristina Masseria, the discussion will gather perspectives from various stakeholders. Brian Solo and Brian O’Rourke will address the barriers and opportunities for value demonstration in the USA and globally, examining the evolving relationship between payers and pharmaceutical companies. Are payers resisting current pricing strategies, and which barriers may be more easily overcome? Can cross-country collaboration in data generation, horizon scanning, and negotiations provide a path forward? Diane Munch will share the pharmaceutical company’s perspective, discussing pricing and evidence generation strategies, as well as potential solutions for deeper collaboration with national, regional, and local stakeholders throughout a product’s lifecycle.