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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, precertification requirements for all
chimeric antigen receptor (CAR) T-cell therapies, including KYMRIAH, are as
follows:
- For AmeriHealth Pennsylvania members, precertification requirements went
into effect as of August 30, 2017.
- For AmeriHealth New Jersey members, precertification requirements will go
into effect as of January 1, 2018.
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 AmeriHealth New Jersey* and
AmeriHealth
Pennsylvania members.
*This list will be updated to include KYMRIAH in the
coming weeks.
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