Rethinking Access Frameworks for the Next Generation of Multi-Indications/I&I Therapies

ISSUE: The Inflammation & Immunology (I&I) therapeutic area is a rapidly evolving landscape. Driven by innovation and advances in the understanding of immune responses, development efforts are leading to a broad range of new treatments. These include biologics such as monoclonal and bispecific antibodies targeting interleukins, orally administered small molecules that inhibit key proteins like Janus Kinases, and next-generation cytokine modulators. These innovative therapies will allow for more precise targeting, improved clinical outcomes and, ultimately, better patient health. However, they also raise complex questions for both pharmaceutical companies and payers in defining appropriate access conditions. These include for example the management of multi-indication assets, combination therapies, the recognition of novel benefits (e.g., remission), the validation of new endpoints, the segmentation of target populations, and the emergence of new treatment lines. Finding the right balance to ensure that the most promising innovations reach the appropriate patients will require a thorough understanding of the evolving I&I landscape, along with the constraints and priorities of all stakeholders. OVERVIEW: The session will open with an introductory overview by Stéphane Bazoche or Jessica Weddle (first 15 minutes). While much has been written about scientific and commercial trends in I&I, the impact of innovation on market access remains underexplored—despite the significant challenges it raises for both industry and payers. This panel will examine the evolving value framework for I&I therapies, highlighting the key dimensions of value demonstration that will require attention in the years ahead to ensure appropriate and sustainable patient access. Topics will include the implications of clinical differentiation, the assessment of novel outcomes, and the policy and HTA shifts needed to keep pace with scientific progress. The session will be particularly relevant to Market Access and HEOR professionals, especially those engaged in the I&I space, who seek to better anticipate and navigate the access environment for next-generation therapies.