On May 17, 2019, CMS announced a delay in its final national coverage determination for Chimeric Antigen Receptor (CAR) T-cell therapy. Using a patient’s own immune system to attack cancer cells, CAR T-cell therapy has been getting more and more recognition as the potential next step for oncology over the last year.
According to CMS’s announcement, CAR T-cell therapy is a precision cancer treatment wherein each treatment dose is individually manufactured for the patient using their own T-cells, a type of white blood cell known as a lymphocyte. CAR T-cell therapy is a rapidly emerging adoptive cell transfer immunotherapy for select patients with relapsed or refractory cancers. Treatment protocols vary, but may be summarized in five steps:
1. lymphocyte harvesting from the patient with cancer;
2. creation of cancer-targeting lymphocytes in vitro using various immune modulators;
3. selection of lymphocytes with reactivity to cancer antigens using enzyme-linked immuno-assay;
4. depletion of the patient’s remaining lymphocytes using immunosuppressive agents;
5. transfusion of the cancer-targeting lymphocytes back into the patient with cancer-this transfusion represents one treatment.
Frier Levitt Government Affairs (FLGA) has been monitoring developments in this sector since early 2018 and continues to follow the latest news.
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