Cell and gene therapies in managed care: US payer insights on coverage and financial risk

AIMS: Cell and gene therapies (CGTs) are increasingly transforming the treatment of serious and life-threatening conditions, offering durable and, in some cases, potentially curative benefit. However, high upfront costs paired with the expectation for long-term value realization create misalignment with conventional managed care and reimbursement models. Although innovative payment and risk-sharing strategies have been proposed, adoption remains limited. Understanding how payers are navigating these challenges is increasingly critical as CGTs continue to transition into established standards of care. METHODS: third-party vendors to minimize bias. Data collection included Likert-scale ratings and open-ended inquiries regarding access, formulary processes, and reimbursement frameworks. RESULTS: Twenty payer decision-makers were interviewed. While 17 viewed CGTs as among the most important medical innovations of our time, 18 agreed that the US healthcare system is not adequately prepared for broad CGT adoption. Top barriers to reimbursement include high upfront costs and long-term durability uncertainty. Preferred mitigation strategies include reinsurance/stop-loss and risk pools. Member portability and data tracking remain primary barriers to innovative payment models. LIMITATIONS: Sample size may not represent all US payers. Qualitative study findings identify trends and consensus only. CONCLUSIONS: Payers acknowledge the significant clinical promise of CGTs, but high upfront costs and long-term durability uncertainty continue to complicate coverage strategies and limit broader adoption. Ongoing evaluation of reimbursement frameworks, financing strategies, and emerging long-term evidence may help characterize how coverage and payment models evolve as the CGT landscape expands.