Managing High-Cost, Technology-Dependent Therapies: Systems for Cellular, Gene, and Advanced Biologics—A Narrative Review
Abstract
Background: The advent of advanced therapy medicinal products (ATMPs), including chimeric antigen receptor T-cell (CAR-T) therapies, in vivo gene therapies, and complex biologics, represents a paradigm shift in treating cancer, genetic disorders, and autoimmune diseases. These "living drugs" and sophisticated molecules present unprecedented challenges, requiring a complete re-engineering of traditional healthcare delivery pathways. Aim: This narrative review synthesizes evidence from 2010-2024 on the integrated, multidisciplinary systems required to safely, effectively, and sustainably manage the clinical and operational lifecycle of high-cost, technology-dependent therapies. Methods: A comprehensive search of PubMed, Scopus, Web of Science, and health policy databases was conducted for peer-reviewed literature and gray literature (white papers, health system reports) addressing the operational, financial, and clinical coordination of advanced therapies. Results: The review identifies five critical, interdependent system pillars: (1) a robust pre-treatment patient and product pathway spanning biomarker screening, cell collection, and manufacturing; (2) a specialized pharmacy and logistics infrastructure for storage, handling, and chain of custody; (3) protocolized clinical delivery and toxicity management anchored by specialized nursing; (4) complex financial navigation and reimbursement models; and (5) coordinated scheduling and data management. Failures in any pillar risk…
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