Optum provides contractual protection for payers covering cellular therapies, including all chimeric antigen receptor T-cell (CAR T) therapies and select gene therapies.

Ex vivo cell and gene therapy refers to treatments that involve extracting a patient’s cells, genetically modifying them ex vivo (outside of the body) and returning them back to the patient’s body to help treat certain diseases. The FDA approval of CAR T-cell therapy in 2017 has brought significant advances in the treatment and cure of certain hematologic cancers. Beyond CAR T, other ex vivo cell and gene therapies have recently come to market to target solid tumors and treat genetic conditions.

Novel therapies, like CAR T-cell therapy, are being driven by rapid advances in biotechnological research, but they can be incredibly costly. Currently, ex vivo cell and gene therapies are one-time treatments targeted for a relatively small number of patients,^* but invoice prices in the United States range from $427K–$727K or ex vivo cell therapy, and between $2.2M–4.25M for ex vivo gene therapy.

When navigating how to approach cell and gene therapy for members, payers should consider the following:

• Do you have access to clinical indications for ex vivo cell and gene therapies?
• How will the therapy be reimbursed under the existing provider contracts?
• Is a prior authorization process in place that will flag the service as a cell or gene therapy case?
• How will payers analyze the total cost of care for patients treated with ex vivo cell and gene therapies?

*Optum. Internal claims and pricing information. Oct. 2024.