Accessing Cell and Gene Therapies : Insights on Coverage, Reimbursement and Emerging Models

Over the past five years, cell and gene therapies have increasingly moved from the R&D pipeline to the health care setting, putting lifesaving treatments for certain cancers and genetic diseases within patients’ reach. Over ten cell and gene therapies have been approved by the FDA in the past five years and over 500 genebased therapies are in clinical development as of 2023. Based on current pipeline and product success rates, the FDA anticipates approving 10–20 a year by 2025, with spending expected to reach $25 billion annually over the next ten years.

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