Evolving Landscape Of Payer Coverage For Cell And Gene Therapies (CGTs): Trends And Insights

Cell and gene therapies (CGTs) have reached a critical turning point in the U.S. healthcare system, with 22 FDA approvals occurring between 2022 and 2025 alone. As these transformative treatments enter the market, biopharmaceutical manufacturers face a complex access environment defined by high upfront costs and rigorous payer scrutiny. This white paper examines how formulary decision-makers evaluate these assets, emphasizing that clinical efficacy and durability remain the primary drivers of coverage.

While payers are expediting reviews for therapies approved under accelerated pathways, significant gaps persist in the communication of comparative effectiveness and long-term safety data. Understanding these evolving expectations is essential for developing a sustainable value narrative that ensures patient access to curative medicine.