Advancing cell, gene, and specialty therapies requires enterprise transformation

Cell, gene, and specialty therapies are forcing health systems to rethink how care is delivered, financed, and operationalized across the enterprise. What was once considered a highly specialized clinical capability within pharmacy is now a system-level strategic priority for health systems across oncology, neurology, rare disease, and autoimmune care.

The challenge is no longer whether organizations will participate in advanced therapies—but whether they are operationally prepared to scale them. Leaders throughout the third annual Vizient Cell, Gene, and Specialty Symposium consistently emphasized that long-term success will depend on how effectively health systems align clinical innovation with governance, financial stewardship, operational readiness, and patient access.

The following themes emerged as critical priorities:

Cell, gene, and specialty therapies require enterprise-wide operating models. Advanced therapies have moved from niche clinical capabilities to systemwide strategic operational and financial priorities. Sustainable delivery requires clearly defined ownership, workflows, escalation pathways, communication structures, and site-of-care capabilities across clinical, operational, and financial stakeholders.

Governance must guide therapy adoption and oversight. Traditional pharmacy and therapy (P&T) and high-cost drug review processes are not enough for therapies with novel risks, complex workflows, and significant financial exposure. Organizations need earlier, coordinated review models to assess clinical value, operational readiness, patient eligibility, payer considerations, ethical implications, and financial risk.

Financial readiness starts well before treatment. Financial stewardship begins at pipeline assessment, referral, and pre-approval planning—not billing. Programs must proactively address payer strategy, prior authorization, single case agreements, reimbursement monitoring, denial prevention, and patient-specific financial review.

Operational models must scale beyond one-off launches. As the advanced therapy pipeline continues to expand, health systems can no longer rely on ad hoc processes developed for individual therapy launches. Organizations need repeatable, scalable playbooks that support therapy onboarding, patient intake, lab-pharmacy coordination, service line development, payer escalation, and post-treatment monitoring. Standardized operational models help reduce variability, improve coordination, and position programs to efficiently manage increasing therapy volume and complexity.

Technology, dashboards, and automation are foundational infrastructure. Manual tracking is no longer sustainable as therapy volume and complexity grow. Shared data infrastructure, EMR optimization, dashboards, and workflow automation are needed to improve visibility, reduce handoff risk, support approvals, and align teams across the patient journey. As organizations scale advanced therapies across the enterprise, integrated operational and financial visibility will become increasingly critical to performance and sustainability.

Read more from the Vizient Cell, Gene, and Specialty Symposium for detailed session takeaways and practical action items health systems can use to advance operational readiness, financial stewardship, access, and enterprise alignment for cell, gene, and specialty therapies.