Medical Affairs and Scientific Communications Forum

Clinical meaningfulness is broadly established as a critical, patient-centric tenant of treatment value, but the definition, assessment, and valuation of meaningfulness in chronic progressive diseases remain heavily debated across stakeholders. Traditional frameworks may not adequately capture unique aspects of these conditions—such as the meaningfulness of slowed deterioration, stability, and life extension—which introduces challenges when characterizing therapeutic value to clinicians, regulators, payers, and, ultimately, patients. In this session, we discuss a case study where regulatory, payer, clinician, health economics, and communications perspectives were integrated to rethink clinical meaningfulness in chronic progressive diseases. This timely session illustrates a practical and strategic communications-centered approach used to describe stakeholder priorities and pitfalls, summarize key similarities and differences between stakeholder perspectives, and translate those perspectives into a cohesive narrative promoting innovative methods that reflect real world patient priorities.