Cell and gene therapy trials strain nearly every assumption built into traditional budgeting and coverage analysis models. This session pairs general coverage analysis principles with the specific challenges of CAR-T and similar high-cost therapies, including apheresis, manufacturing, bridging therapy, inpatient admission, and toxicity management. We will examine how to distinguish routine costs from research-only items when the standard of care itself is in flux, and how to budget for complications that may or may not occur. The discussion covers both the analytic decisions and the negotiation strategy needed to make the numbers work. Attendees will leave better prepared for the next high-cost protocol that lands on their desk.