BIO’s 15th annual Patient Advocacy Changemakers event spotlighted access barriers that can determine whether breakthrough therapies actually reach patients. Panels discussed how utilization management tools—particularly step therapy—can trap patients after insurers deny coverage for prescribed drugs, and highlighted the need for engagement strategies focused on coverage evidence and payer decision pathways. The takeaway for the biotech sector was direct: manufacturing and regulatory wins do not translate to real-world impact without coverage pathways, utilization approvals, and practical evidence strategies that payers accept.