From innovation to implementation: Health‐system pharmacy integration of cell and gene therapies

BACKGROUND: Cell and gene therapies (CGTs) represent a paradigm shift in modern medicine, offering targeted and potentially curative options for complex and rare diseases. Their integration into health-system pharmacy practice requires alignment with the medication-use process to ensure safety, efficacy, and compliance. OBJECTIVE: To propose a practical framework for integrating CGTs into health-system pharmacy workflows, while addressing clinical, operational, and financial considerations. SUMMARY: The framework encompasses four domains: (1) evaluation-strategic assessment of pipeline therapies, including clinical, operational, and financial readiness; (2) clinical integration-formulary review, electronic medical record configuration, clinical pathways, and standard operating procedures development; (3) operational pharmacy integration-establishing infrastructure for receipt, storage, handling, and dispensing, supported by training and process improvement; and (4) financial integration-implementing reimbursement strategies, payment workflows, and budgeting to mitigate financial risk. These recommendations draw on the institutional experience of the authors and emerging standards from professional organizations. CONCLUSION: Proactive planning and interdisciplinary collaboration are essential for successful CGT implementation. Health-system pharmacists are uniquely positioned to lead these efforts, ensuring patient safety, operational efficiency, and financial sustainability as advanced therapeutics reshape the healthcare landscape.