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

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.

To propose a practical framework for integrating CGTs into health-system pharmacy workflows, while addressing clinical, operational, and financial considerations.

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.

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.