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New precertification requirement for CAR T-cell therapy

September 22, 2017

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On August 30, 2017, the U.S. Food and Drug Administration (FDA) issued a historic action by approving the first gene therapy to be available in the United States. KYMRIAHTM (tisagenlecleucel) is approved to treat children and young adults with B-cell acute lymphoblastic leukemia (ALL) who do not respond to standard treatment or have suffered relapses.

To coincide with the FDA approval, as of August 30, 2017, precertification requirements went into effect for all chimeric antigen receptor (CAR) T-cell therapies, including KYMRIAH, for all Independence commercial and Medicare Advantage members.

KYMRIAH is a genetically modified autologous T-cell immunotherapy that is customized by using an individual patient?s own T-cells for treatment. The patient?s T-cells are collected and sent to a manufacturing center, where they are genetically modified to include a new gene that contains a specific protein (a chimeric antigen receptor) that directs the T-cells to target and kill leukemia cells that have a specific antigen on the surface. Once the cells are modified, they are infused back into the patient to kill the cancer cells.

A second CAR T-cell therapy (axicabtagene ciloleucel) is also under development for adults with advanced lymphomas, utilizing this method with a different agent.

We are in the process of developing a medical policy for KYMRIAH. In the interim, requests for KYMRIAH will be evaluated in accordance with the manufacturer?s prescribing information, FDA labeling, and available peer-reviewed literature.

A comprehensive list of all drugs and services that require precertification is available online for Independence commercial and Medicare Advantage* members.

*This list will be updated to include KYMRIAH in the coming weeks.

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