With the 2017 FDA approvals and launches of the first gene-modified cell and pure-play gene therapy products to gain licensure in the United States, increasing attention has been paid to the high cost of this emerging class of therapies. Although currently approved therapies are for orphan indications, prices similar to those charged today will be unaffordable for products marketed for larger indications. Using public information, we constructed a cost of goods model for an autologous gene-modified cell therapy product, evaluated the relationship of estimated manufacturing costs to list prices of CAR-T products, and investigated the potential impact of various factors on manufacturing costs. Our findings highlight in particular the importance of maximizing employee productivity, leveraging automation and technology, and accurately forecasting capacity needs to achieve the manufacturing cost improvements that will likely be required to drive broad adoption of autologous gene-modified cell therapies.
Citation: Cell Gene Therapy Insights 2018; 4(11), 1105-1116.