Tisagenlecleucel for B-cell Acute Lymphoblastic Leukemia
Tisagenlecleucel is considered medically necessary for individuals with B-cell acute lymphoblastic leukemia if they meet criteria 1 through 7 :
Confirmed diagnosis of CD19-positive B-cell acute lymphoblastic leukemia with morphologic bone marrow tumor involvement (≥5% lymphoblasts).
Meet any one of the following:
Relapsed disease defined as the reappearance of leukemia cells in the bone marrow or peripheral blood after the attainment of a complete remission with chemotherapy and/or allogeneic cell transplant.
Refractory disease defined as failure to obtain complete response with induction therapy (ie, failure to eradicate all detectable leukemia cells [< 5% blasts] from the bone cellularity and normal peripheral blood counts). When Philadelphia chromosome-positive: failure of 2 tyrosine kinase inhibitors. Are up to 25 years of age at the time of infusion Have not received prior CD19-directed chimeric antigen receptor T-cell treatment, any other cell therapy, or any gene therapy or are being considered for treatment with any other cell therapy or any gene therapy. Have adequate organ function with no significant deterioration in organ function expected within 4 weeks after apheresis. Do not have any of the following: Burkitt lymphoma. Active hepatitis B, C, or any uncontrolled infection. Grade 2 to 4 graft-versus-host disease. Concomitant genetic syndrome associated with bone marrow failure with the exception of Down syndrome. Received allogeneic cellular therapy, such as donor lymphocyte infusion, within 6 weeks prior to tisagenlecleucel infusion. Active central nervous system acute lymphoblastic leukemia (ie, white blood cell count ≥5 cells/μL in cerebrospinal fluid with presence of lymphoblasts). Tisagenlecleucel for Non-Hodgkin Lymphoma Tisagenlecleucel is considered medically necessary for individuals with large B-cell lymphoma if they meet criteria 1 through 7 : Histologically confirmed diagnosis of diffuse large B-cell lymphoma not otherwise specified, high grade B-cell lymphoma, or diffuse large B-cell lymphoma arising from follicular lymphoma. Relapsed or refractory disease defined as progression after ≥2 lines of systemic therapy including anti-CD20 monoclonal antibody for CD20-positive tumor and anthracycline-containing chemotherapy. When the individual has histological transformation of follicular lymphoma or nodal marginal zone lymphoma to diffuse large B-cell lymphoma: prior chemotherapy for follicular lymphoma and ≥2 chemo-immunotherapy regimens for the transformed disease. At least 18 years of age at the time of infusion. Have adequate organ and bone marrow function as determined by the treating oncologist/hematologist. Have not received prior CD19-directed chimeric antigen receptor T-cell therapy treatment, any other cell therapy, or any gene therapy or are being considered for treatment with any other cell therapy or any gene therapy. Do not have primary central nervous system lymphoma. Tisagenlecleucel is considered investigational for the treatment of relapsed or refractory primary mediastinal large B-cell lymphoma. Tisagenlecleucel for Follicular Lymphoma Tisagenlecleucel is considered medically necessary for individuals with follicular lymphoma if they meet criteria 1 through 6: Histologically confirmed diagnosis of follicular lymphoma. Relapsed or refractory disease as defined as progression after ≥2 lines of systemic therapy for follicular lymphoma. At least 18 years of age at the time of infusion. Have adequate organ and bone marrow function as determined by the treating oncologist/hematologist. Have not received prior CD19-directed chimeric antigen receptor T-cell therapy treatment, any other cell therapy, or any gene therapy or are being considered for treatment with any other cell therapy or any gene therapy. Do not have primary central nervous system lymphoma. Axicabtagene Ciloleucel for Non-Hodgkin Lymphoma Axicabtagene ciloleucel is considered medically necessary for individuals with large B-cell lymphoma if they meet criteria 1 through 5: Meet any one of the following: Histologically confirmed diagnosis of large B-cell lymphoma that is considered relapsed or primary refractory within 12 months following completion of first-line chemo-immunotherapy that included an anti-CD20 monoclonal antibody and anthracycline-containing regimen. Histologically confirmed diagnosis of diffuse large B-cell lymphoma not otherwise specified, primary mediastinal large B-cell lymphoma, high grade B-cell lymphoma, or diffuse B-cell lymphoma arising from follicular lymphoma, and all of the following: Relapsed or refractory disease defined as progression after ≥2 lines of systemic therapy including anti-CD20 monoclonal antibody for CD20-positive tumor and anthracycline-containing chemotherapy. When the individual has histological transformation of follicular lymphoma or nodal marginal zone lymphoma to diffuse large B-cell lymphoma: prior chemotherapy for follicular lymphoma and ≥2 chemo-immunotherapy regimens for the transformed disease. At least 18 years of age at the time of infusion. Have adequate organ and bone marrow function as determined by the treating oncologist/hematologist. Have not received prior CD19-directed chimeric antigen receptor T-cell therapy treatment, any other cell therapy, or any gene therapy or are being considered for treatment with any other cell therapy or any gene therapy. Do not have primary central nervous system lymphoma. Axicabtagene Ciloleucel for Follicular Lymphoma Axicabtagene ciloleucel is considered medically necessary for individuals with follicular lymphoma if they meet criteria 1 through 6: Histologically confirmed diagnosis of follicular lymphoma. Relapsed or refractory disease defined as progression after ≥2 lines of systemic therapy for follicular lymphoma. At least 18 years of age at the time of infusion. Have adequate organ and bone marrow function as determined by the treating oncologist/hematologist. Have not received prior CD19-directed chimeric antigen receptor T-cell therapy treatment, any other cell therapy, or any gene therapy or are being considered for treatment with any other cell therapy or any gene therapy. Do not have primary central nervous system lymphoma. Brexucabtagene Autoleucel for B-cell Acute Lymphoblastic Leukemia Brexucabtagene autoleucel is considered medically necessary for individuals with B-cell acute lymphoblastic leukemia if they meet criteria 1 through 7 : Confirmed diagnosis of CD19-positive B-cell acute lymphoblastic leukemia with morphologic bone marrow tumor involvement (≥5% lymphoblasts). Meet any one of the following: Relapsed disease defined as the reappearance of leukemia cells in the bone marrow or peripheral blood after the attainment of a complete remission with chemotherapy and/or allogeneic cell transplant. Refractory disease defined as failure to obtain complete response with induction therapy (ie, failure to eradicate all detectable leukemia cells [<5% blasts] from the bone marrow and blood with subsequent restoration of normal hematopoiesis [>25% marrow cellularity and normal peripheral blood counts]).
When Philadelphia chromosome-positive: failure of tyrosine kinase inhibitors.
At least 18 years of age at the time of infusion.
Have not received prior CD19-directed chimeric antigen receptor T-cell treatment, any other cell therapy, or any gene therapy or are being considered for treatment with any other cell therapy or any gene therapy.
Have adequate organ function with no significant deterioration in organ function expected within 4 weeks after apheresis.
Do not have any of the following:
Burkitt lymphoma.
Active hepatitis B, C, or any uncontrolled infection.
Grade 2 to 4 graft-versus-host disease.
Concomitant genetic syndrome associated with bone marrow failure with the exception of Down syndrome.
Received allogeneic cellular therapy, such as donor lymphocyte infusion, within 6 weeks prior to brexucabtagene autoleucel infusion.
Active central nervous system acute lymphoblastic leukemia (ie, white blood cell count ≥5 cells/μL in cerebrospinal fluid with presence of lymphoblasts).
Brexucabtagene Autoleucel for Mantle Cell Lymphoma
Brexucabtagene autoleucel is considered medically necessary for individuals with mantle cell lymphoma if they meet criteria 1 through 5:
Histologically confirmed diagnosis of relapsed or refractory mantle cell lymphoma.
Received adequate prior therapy including anthracycline- or bendamustine-containing chemotherapy, anti-CD20 monoclonal antibody, and a Bruton tyrosine kinase inhibitor (ie, acalabrutinib, ibrutinib, zanubrutinib).
At least 18 years of age at the time of infusion.
Have adequate organ and bone marrow function as determined by the treating oncologist/hematologist.
Have not received prior CD19-directed chimeric antigen receptor T-cell therapy treatment, any other cell therapy, or any other gene therapy or are being considered for treatment with any other cell therapy or any gene therapy.
Lisocabtagene Maraleucel for Non-Hodgkin Lymphoma
Lisocabtagene maraleucel is considered medically necessary for individuals with large B-cell lymphoma if they meet criteria 1 through 6:
Histologically confirmed diagnosis of large B-cell lymphoma, including diffuse large B-cell lymphoma not otherwise specified (including diffuse large B-cell lymphoma arising from indolent lymphoma), high-grade B-cell lymphoma, primary mediastinal large B-cell lymphoma, and follicular lymphoma grade 3B.
Meets at least one of the following:
Primary refractory or relapsed disease within 12 months of first-line chemo-immunotherapy that included an anti-CD20 monoclonal antibody and anthracycline-containing regimen.
Primary refractory or relapsed disease within 12 months of first-line chemo-immunotherapy that included an anti-CD20 monoclonal antibody and anthracycline-containing regimen and are not eligible for hematopoietic stem cell transplantation due to comorbidities or age.
Relapsed or refractory disease as defined as progression after ≥2 lines of systemic therapy including anti-CD20 monoclonal antibody for CD20-positive tumor and anthracycline-containing chemotherapy.
When the individual has histological transformation of follicular lymphoma or marginal zone lymphoma to diffuse large B-cell lymphoma: prior chemotherapy for follicular lymphoma or marginal zone lymphoma and ≥2 chemo-immunotherapy regimens for the transformed disease.
At least 18 years of age at the time of infusion.
Have adequate organ and bone marrow function as determined by the treating oncologist/hematologist.
Have not received prior CD19-directed chimeric antigen receptor T-cell therapy treatment, any other cell therapy, or any gene therapy or are being considered for treatment with any other cell therapy or any gene therapy.
Do not have primary central nervous system lymphoma.
Tisagenlecleucel, axicabtagene ciloleucel, brexucabtagene autoleucel, and lisocabtagene maraleucel are considered investigational when the above criteria are not met.
Tisagenlecleucel, axicabtagene ciloleucel, brexucabtagene autoleucel, and lisocabtagene maraleucel are considered investigational for all other indications.
