Inside The Payer Perspective On Cell And Gene Therapy Coverage

Cell and gene therapies represent a $76 billion market opportunity by 2030, but access remains complicated by high costs and evolving reimbursement structures. Recent research with 19 US payer organizations reveals that nearly three-quarters now engage with manufacturers before FDA approval—a fundamental shift in how coverage decisions unfold. The data shows pharmacy directors wield as much influence as medical directors in formulary decisions, despite CGTs typically falling under medical benefits. Payers make faster coverage determinations for accelerated approval pathways, driven by high unmet need rather than comprehensive clinical data.

However, the greatest gap remains long-term outcomes evidence and cost-effectiveness analyses. As approximately 20 new CGTs prepare to launch, manufacturers face pressure to move beyond one-off payment solutions toward scalable reimbursement models that clearly link surrogate endpoints to survival, morbidity, and healthcare resource utilization.