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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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