Forbes December 7, 2024
In the cell and gene therapy space, science continues to outpace commercialization. Take, for example, the first two sickle cell disease gene therapies approved by the Food and Drug Administration, Vertex’s Casgevy (exagamglogene autotemcel) and bluebird bio’s Lyfgenia (lovotibeglogene autotemcel). Both were granted marketing authorization in December 2023. But by August of this year only 20 patients had initiated Casgevy treatment and there were just four patient starts on Lyfgenia, according to Managed Healthcare Executive.
The Biden Administration announced this week that the manufacturers of Lyfgenia and Casgevy have entered into agreements with the Centers for Medicare and Medicaid Services to participate in the Cell and Gene Therapy Access Model, which allows CMS to negotiate outcomes-based agreements on behalf of...
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