(46) Integrating Cell and Gene Therapies into Managed Care: An Analysis of U.S. Payer Insights

Background: : Cell and gene therapies (CGTs) hold immense promise but present unique challenges for managed care.

Objective: : To explore payer perspectives, coverage barriers, reimbursement models, and operational strategies for CGT access and integration.

Methods: : From February to March 2025, we conducted a qualitative study using double-blinded interviews with key CGT decision-makers across the U.S. payer landscape. Interviews were 45-60 minutes, semi-structured, and included quantitative Likert-scale ratings and open-ended qualitative feedback. Discussion topics included CGT access and adoption, formulary and approval process, value and reimbursement, provider networks, and outlook on CGTs’ future. Data were anonymized and analyzed to identify key trends, variations, and consensus areas among payers.

Results: : 20 payers participated in the study, including 7 national health plans, 7 regional health plans, 2 national managed Medicaid, 2 national managed Medicare, and 1 regional and 1 national integrated delivery network. Eleven payers held leadership roles within Pharmacy services, 7 had medical officer or director positions, and 2 held other leadership positions. Interviewed payer organizations represented approximately 280 million covered lives. Payers generally expressed a favorable view of CGT clinical value, with 90% agreeing they are safe and 80% agreeing they are efficacious. Despite this overall confidence, 95% of payers generally agreed that the U.S. healthcare system is not adequately prepared for broad CGT adoption. The two most cited challenges for CGT reimbursement are high costs and long-term uncertainty. To mitigate financial risk, payers ranked stop loss as the preferred strategy, followed by risk pools and outcomes-based agreements. However, barriers to implementing innovative payment models persist, with the most frequently cited being member portability risk and difficulty of long-term patient tracking. Coverage policies vary widely by payer type. Payers most commonly relied on clinical trial inclusion/exclusion criteria, as well as the FDA label for coverage decisions. Utilization management is stringent, typically aligning with clinical trial criteria over FDA labels for prior authorization requirements.

Conclusions: : Payers recognized the transformative potential of CGTs, but highlighted challenges, including long-term outcomes, high costs, and member portability. Addressing these barriers will require collaboration among payers, providers, manufacturers, and policymakers to ensure effective CGT integration into managed care.

Sponsorship:: Analyses and abstract development sponsored by McKesson.