New table XW2, Anatomical Regions, Transfusion, provides two new codes to describe the intravenous administration of two immunotherapy products as noted below.
|3 Peripheral Vein
4 Central Vein
|4 Brexucabtagene Autoleucel Immunotherapy
7 Lisocabtagene Maraleucel Immunotherapy
Unlike other current chimeric antigen receptor (CAR) T-cell therapy products which are classified in table XW0, Anatomical Regions, Introduction, Brexucabtagene Autoleucel Immunotherapy and Lisocabtagene Maraleucel Immunotherapy are classified under the root operation Transfusion based on the root operation definitions and receipt of public comments. CAR T-cell therapy is comprised of blood/blood products; therefore, the root operation Transfusion is more clinically accurate, because the full definition for the root operation Introduction is “Putting in or on a therapeutic, diagnostic, nutritional, physiological, or prophylactic substance except blood or blood products.
A proposal was discussed at the September 2020 ICD-10 Coordination and Maintenance (C&M) Committee meeting to consider modification of the current codes that are being reported for other CAR T-cell products for consistency in the classification.
Brexucabtagene Autoleucel Immunotherapy
Brexucabtagene autoleucel (formerly known as KTE-X19) is an autologous cellular chimeric antigen receptor (CAR) T-cell therapy that modifies a patient’s cells to treat adults with relapsed/refractory (r/r) mantle cell lymphoma (MCL). The patient’s own T-cells are harvested, activated and genetically modified to produce a chimeric antigen receptor (CAR). The modified T-cells are then expanded and infused back into the patient. Brexucabtagene autoleucel is administered as a single infusion patient-specific immunotherapy.
Lisocabtagene Maraleucel Immunotherapy
Lisocabtagene maraleucel (Liso-cel) is a CD19-directed, autologous chimeric antigen receptor (CAR) T-cell immunotherapy that is comprised of individually formulated CD8 (killer) and CD4 (helper) CAR T-cells for the treatment of adult patients with relapsed or refractory (r/r) large B-cell lymphoma. Lisocabtagene maraleucel component CD4 and CD8 T-cells are purified and cultured separately to maintain compositional control of each cell type. During culture, each cell type is separately modified to have the CAR on the cell surface, expanded and quantified, and frozen in two separate cell suspensions (the CD4 and CD8 cell components). Lisocabtagene maraleucel is administered via infusion at the same target dose of CD4 and CD8 CAR T-cells.