Criteria
Coverage is subject to the specific terms of the member's benefit plan.
Federal Employee Program members (FEP) should check with their Retail Pharmacy Program to determine if prior approval is required by calling the Retail Pharmacy Program at 1-800-624-5060 (TTY: 1-800-624-5077). FEP members can also obtain the list through the www.fepblue.org website.
Tisagenlecleucel for B-cell Acute Lymphoblastic Leukemia
Tisagenlecleucel is considered medically necessary for relapsed a or refractory b individuals with B-cell acute lymphoblastic leukemia (ALL) if individuals meet all of the following criteria:
- Confirmed diagnosis of CD19-positive B-cell ALL with morphologic bone marrow tumor involvement (greater than or equal to 5% lymphoblasts); and
- Are up to 25 years old at the time of infusion; and
- Have not received prior treatment with tisagenlecleucel or any other gene therapy or are being considered for treatment with any other gene therapy; and
- Have adequate organ function with no significant deterioration in organ function expected within four (4) weeks after apheresis; and
- Do not have any of the following
- Burkitt lymphoma; or
- Active hepatitis B, C, or any uncontrolled infection; or
- Grade 2 to 4 graft-versus-host disease; or
- Concomitant genetic syndrome associated with bone marrow failure with the exception of Down syndrome; or
- Received allogeneic cellular therapy, such as donor lymphocyte infusion, within six (6) weeks prior to tisagenlecleucel infusion; or
- Active central nervous system ALL (i.e., white blood cell count greater than or equal to 5 cells/μL in cerebrospinal fluid with presence of lymphoblasts).
a Relapsed disease describes 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.
b Refractory (resistant) disease is defined as those individuals who fail to obtain complete response with induction therapy, i.e., failure to eradicate all detectable leukemia cells (less than 5% blasts) from the bone marrow and blood with subsequent restoration of normal hematopoiesis (greater than 25% marrow cellularity and normal peripheral blood counts).
Tisagenlecleucel for Non-Hodgkin Lymphoma
Tisagenlecleucel is considered medically necessary for relapsed or refractory c individuals with aggressive types of non-Hodgkin lymphoma (NHL) if individuals meet all of the following criteria:
- Are adults (age greater than or equal to 18) at the time of infusion; and
- Histologically confirmed diagnosis of diffuse large B-cell lymphoma (DLBCL), not otherwise specified; high-grade B-cell lymphoma or DLBCL arising from follicular lymphoma; and
- Received adequate prior therapy including all of the following:
- Anti-CD20 monoclonal antibody for CD20-positive tumor; and
- Anthracycline-containing chemotherapy regimen; and
- For subjects with transformed follicular lymphoma, prior chemotherapy for follicular lymphoma and subsequently have chemorefractory disease after transformation to DLBCL; and
- Have adequate organ and bone marrow function as determined by the treating oncologist/hematologist; and
- Have not received prior CD19-directed chimeric antigen response (CAR) T-cell therapy treatment or any other gene therapy or are being considered for treatment with any other gene therapy; and
- Do not have primary central nervous system lymphoma.
c Relapsed or refractory disease is defined as progression after two (2) or more lines of systemic therapy (which may or may not include therapy supported by autologous cell transplant).
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 relapsed or refractory c follicular lymphoma if individuals meet all of the following criteria:
- Are adults (age greater than or equal to 18) at the time of infusion; and
- Histologically confirmed diagnosis of follicular lymphoma; and
- Received two (2) or more lines of systemic therapy for treatment of follicular lymphoma; and
- Have adequate organ and bone marrow function as determined by the treating oncologist/hematologist; and
- Have not received prior CD19-directed CAR T-cell therapy treatment or any other gene therapy or are being considered for treatment with any other gene therapy; and
- Do not have primary central nervous system lymphoma.
c Relapsed or refractory disease is defined as progression after two (2) or more lines of systemic therapy (which may or may not include therapy supported by autologous cell transplant).
Axicabtagene Ciloleucelfor Non-Hodgkin Lymphoma
Axicabtagene ciloleucel is considered medically necessary for individuals with histological confirmed large B-cell lymphoma including transformation from follicular lymphoma if individuals meet all of the following criteria:
- Are adults (age greater than or equal to 18) at the time of infusion; and
- Relapsed d or refractory e within 12 months following completion of first-line chemoimmunotherapy that included rituximab and anthracycline; and
- Have adequate organ and bone marrow function as determined by the treating oncologist/hematologist; and
- Have not received prior CD19-directed CAR T-cell therapy treatment or any other gene therapy or are being considered for treatment with any other gene therapy; and
- Do not have primary central nervous system lymphoma
d Relapsed disease defined as complete remission to first-line therapy followed by biopsy-proven disease
e Refractory disease is defined as no complete remission to first-line therapy.
Axicabtagene ciloleucel is considered medically necessary for relapsed or refractory c individuals with aggressive types of NHL if individuals meet all of the following criteria:
- Are adults (age greater than or equal to 18) at the time of infusion; and
- Histologically confirmed diagnosis of DLBCL, not otherwise specified; or primary mediastinal large B-cell lymphoma or high-grade B-cell lymphoma or DLBCL arising from follicular lymphoma; and
- Received adequate prior therapy including all of the following:
- Anti-CD20 monoclonal antibody for CD20-positive tumor; and
- Anthracycline-containing chemotherapy regimen; and
- For subjects with transformed follicular lymphoma, prior chemotherapy for follicular lymphoma and subsequently have chemorefractory disease after transformation to DLBCL; and
- Have adequate organ and bone marrow function as determined by the treating oncologist/hematologist; and
- Have not received prior CD19-directed CAR T-cell therapy treatment or any other gene therapy or are being considered for treatment with any other gene therapy; and
- Do not have primary central nervous system lymphoma.
c Relapsed or refractory disease is defined as progression after two (2) or more lines of systemic therapy (which may or may not include therapy supported by autologous cell transplant).
Axicabtagene Ciloleucel for Follicular Lymphoma
Axicabtagene ciloleucel is considered medically necessary for relapsed or refractory c individuals with follicular lymphoma if individuals meet all of the following criteria:
- Are adults (age greater than or equal to 18) at the time of infusion; and
- Histologically confirmed diagnosis of follicular lymphoma; and
- Received two (2) or more lines of systemic therapy for treatment of follicular lymphoma; and
- Have adequate organ and bone marrow function as determined by the treating oncologist/hematologist; and
- Have not received prior CD19-directed CAR T-cell therapy treatment or any other gene therapy or are being considered for treatment with any other gene therapy; and
- Do not have primary central nervous system lymphoma.
c Relapsed or refractory disease is defined as progression after two (2) or more lines of systemic therapy (which may or may not include therapy supported by autologous cell transplant).
Brexucabtagene Autoleucel for Mantle Cell Lymphoma
Brexucabtagene autoleucel is considered medically necessary for relapsed or refractory mantle cell lymphoma f if individuals meet all of the following criteria:
- Are adults (age greater than or equal to 18) at the time of infusion; and
- Histologically confirmed diagnosis of mantle cell lymphoma; and
- Received adequate prior therapy including anthracycline- or bendamustine-containing chemotherapy, anti-CD20 antibody, and a Bruton tyrosine kinase inhibitor (example ibrutinib or acalabrutinib) ; and
- Have adequate organ and bone marrow function as determined by the treating oncologist/hematologist; and
- Have not received prior CD19-directed CAR T-cell therapy treatment or any other gene therapy or are being considered for treatment with any other gene therapy.
f Relapsed or refractory disease is defined as disease progression after last regimen or failure to achieve a partial remission or complete remission to the last regimen.
Brexucabtagene Autoleucel for B-cell Acute Lymphoblastic Leukemia
Brexucabtagene autoleucel is considered medically necessary for relapsed a or refractory b individuals with B-cell ALL if individuals meet all of the following criteria:
- Confirmed diagnosis of CD19-positive B-cell ALL with morphologic bone marrow tumor involvement (greater than or equal to 5% lymphoblasts); and
- Are 18 years or older at the time of infusion; and
- Have not received prior treatment with brexucabtagene autoleucel or any other gene therapy or are being considered for treatment with any other gene therapy; and
- Have adequate organ function with no significant deterioration in organ function expected within four (4) weeks after apheresis; and
- Do not have any of the following:
- Burkitt lymphoma; or
- Active hepatitis B, C, or any uncontrolled infection; or
- Grade 2 to 4 graft-versus-host disease; or
- Concomitant genetic syndrome associated with bone marrow failure with the exception of Down syndrome; or
- Received allogeneic cellular therapy, such as donor lymphocyte infusion, within six (6) weeks prior to brexucabtagene autoleucel infusion; or
- Active central nervous system ALL (i.e., white blood cell count greater than or equal to 5 cells/μL in cerebrospinal fluid with presence of lymphoblasts).
a Relapsed disease describes 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.
b Refractory (resistant) disease is defined as those individuals who fail to obtain complete response with induction therapy, i.e., failure to eradicate all detectable leukemia cells (less than 5% blasts) from the bone marrow and blood with subsequent restoration of normal hematopoiesis (greater than 25% marrow cellularity and normal peripheral blood counts).
Lisocabtagene Maraleucel for Non-Hodgkin Lymphoma
Lisocabtagene maraleucel is considered medically necessary for individuals with aggressive types of NHL if individuals meet all of the following criteria:
- Are adults (age greater than or equal to 18) at the time of infusion; and
- Histologically confirmed diagnosis of DLBCL, including DLBCL not otherwise specified (including DLBCL arising from indolent lymphoma); high-grade B-cell lymphoma, primary mediastinal large B-cell lymphoma, and follicular lymphoma grade 3B; and
- Meets at least ONE of the following:
- Refractory e to first-line chemoimmunotherapy OR relapse d within 12 months of first-line chemoimmunotherapy; or
- Refractory e to first-line chemoimmunotherapy OR relapse d after first line chemoimmunotherapy AND and are not eligible for hematopoietic stem cell transplantation due to comorbidities or age; or
- Relapse c or refractory c after receiving adequate prior therapy including all of the following:
- Anti-CD20 monoclonal antibody for CD20-positive tumor; and
- Anthracycline-containing chemotherapy regimen; and
- For subjects with transformed follicular lymphoma, prior chemotherapy for follicular lymphoma and subsequently have chemorefractory disease after transformation to DLBCL; and
- Have adequate organ and bone marrow function as determined by the treating oncologist/hematologist; and
- Have not received prior CD19-directed CAR T-cell therapy treatment or any other gene therapy or are being considered for treatment with any other gene therapy; and
- Do not have primary central nervous system lymphoma.
d Relapsed disease defined as complete remission to first-line therapy followed by biopsy-proven disease relapse
e refractory disease is defined as no complete remission to first-line therapy.
c Relapsed or refractory disease is defined as progression after two (2) or more lines of systemic therapy (which may or may not include therapy supported by autologous cell transplant).
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.
