Panel outlines structure needed to scale cell and gene therapy programs

A decade into chimeric antigen receptor (CAR) T-cell therapy, payer variability remains one of the most persistent and underestimated barriers to building a sustainable cell and gene therapy (CGT) program, according to experts who took part in a recent panel discussion co-hosted by Managed Healthcare Executive^®, Pharmacy Times^®, and The American Journal of Managed Care^®. Prior authorization approval does not guarantee payment, reimbursement models differ widely across payers, and community centers face structural barriers that academic medical centers largely do not.

The panel included Zahra Mahmoudjafari, PharmD, MBA, BCOP, FHOPA, director of pharmacy in advanced therapeutics at the University of Kansas City Health Center; Jenny Craven, PharmD, BCPS, senior clinical pharmacist and pharmacy lead for emerging therapies at UC Davis Health; Elias Pittos, PharmD, BCOP, CSP, medical director of cell, gene, and advanced therapies at McKesson; and Mark Duckworth, senior director of cellular and gene therapy operations at Children's Hospital of Philadelphia.

For health system and payer executives, the panel's core message was that CGT readiness is a governance problem before it's a clinical one. Success depends on identifying institutional champions across every stakeholder lane — pharmacy, managed care, financial clearance, legal, and clinical teams — and organizing them under a centralized steering structure with clear decision rights. Ethicists and contracting teams, the panel noted, are the groups most often left out of that structure early on, to the program's later detriment.

That governance challenge compounds as the CGT pipeline grows. With therapy volume expanding, some institutions may need a distinct standard operating procedure for nearly every product — a scaling problem the panel flagged as a systemic threat to program sustainability, not just an operational inconvenience. Panelists argued that procedures need dedicated pharmacist leads and single accountable owners to survive staff turnover, rather than living as static documents.

In this discussion, the panel walks through what that means in practice for executives building or scaling a program now: where governance structures break down, why coverage and payment are two different questions, and why community centers need a different playbook than academic centers.

Looking ahead, the panel expects allogeneic and in vivo therapies to ease delivery logistics and expand access at community sites but cautioned that rising volume and evolving reimbursement models may force a fundamental rethink of the buy-and-bill paradigm itself.