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 intravenous infusion is considered medically necessary for relapseda or refractoryb individuals if they meet all of the following criteria:
- Confirmed diagnosis of CD19-positive B-cell acute lymphoblastic leukemia with morphologic bone marrow tumor involvement (≥5% lymphoblasts)
- Are up to 25 years old at the time of infusion
- Have not received prior treatment with tisagenlecleucel or any other gene therapy or are being considered for treatment with any other 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 with the exception of Down syndrome
- Received allogeneic cellular therapy, such as donor lymphocyte infusion, within 6 weeks prior to tisagenlecleucel infusion
- Individual has active central nervous system 3 acute lymphoblastic leukemia (i.e., white blood cell count ≥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, 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).
Axicabtagene ciloleucel or tisagenlecleucel intravenous (except as indicateda) infusion is considered medically necessary for relapsed or refractoryb individuals if they meet all of the following criteria:
- Are adults (age ≥18) at the time of infusion
- Histologically confirmed diagnosis of diffuse large B-cell lymphoma, not otherwise specified; or primary mediastinal large B-cell lymphomaa or high-grade B-cell lymphoma or diffuse large B-cell lymphoma arising from follicular lymphoma
- Received adequate prior therapy including all of the following
- Anti-CD20 monoclonal antibody for CD20-positive tumor
- Anthracycline-containing chemotherapy regimen
- For subjects with transformed follicular lymphoma, prior chemotherapy for follicular lymphoma and subsequently have chemorefractory disease after transformation to diffuse large B-cell lymphoma
- Have adequate organ and bone marrow function as determined by the treating oncologist/hematologist
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.
a Tisagenlecleucel intravenous infusion is considered investigational for the treatment of relapsed or refractory primary mediastinal large B-cell lymphoma
b Relapsed or refractory disease is defined as progression after 2 or more lines of systemic therapy (which may or may not include therapy supported by autologous cell transplant)
Other applications of adoptive immunotherapy are considered investigational
Policy Guidelines
Autologous lymphocytes used as part of adoptive immunotherapy may be harvested in a pheresis procedure or may be isolated from resected tumor tissue.
The recommended dosage of tisagenlecleucel for individuals with B-cell acute lymphoblastic leukemia who are 50 kg or less is 0.2 to 5.0×106 chimeric antigen receptor-positive viable T cells per kilogram of body weight intravenously; for individuals above 50 kg, dose is 0.1 to 2.5×108 total chimeric antigen receptor-positive viable T cells (non-weight-based) intravenously.
The recommended target dose of tisagenlecleucel for individuals with large B-cell lymphoma is 0.6 to 6.0 ×108 chimeric antigen receptor-positive viable T cells intravenously.
The recommended target dose of axicabtagene ciloleucel for individuals with large B-cell lymphoma is 2×106 CAR-positive viable T cells per kg body weight, with a maximum of 2×108 chimeric antigen receptor- positive viable T cells intravenously.
Central nervous system (CNS) disease for B-cell acute lymphoblastic leukemia is defined by the following groups:
- CNS 1: Absence of blasts on cerebrospinal fluid cytospin preparation, regardless of the white blood cell (WBC) count
- CNS 2: WBC count of less than 5/mL and blasts on cytospin findings
- CNS 3: WBC count of 5/mL or more and blasts on cytospin findings and/or clinical signs of CNS leukemia (eg, facial nerve palsy, brain/eye involvement, hypothalamic syndrome)
Tisagenlecleucel and axicabtagene ciloleucel have black box warnings because of the risks of cytokine release syndrome and neurologic toxicities that include fatal or life-threatening reactions. They should not be administered to individuals with active infection or inflammatory disorders. It is recommended that severe or life-threatening cytokine release syndrome be treated with tocilizumab. Individuals should be monitored for neurologic events after treatment.
Tisagenlecleucel (Kymriah) and axicabtagene ciloleucel (Yescarta) are available only through a restricted program under a risk evaluation and mitigation strategy (REMS) called the Kymriah REMS and Yescarta REMS, respectively. The requirement for the REMS components are as follows:
- Health care facilities that dispense and administer tisagenlecleucel or axicabtagene ciloleucel must be enrolled and comply with the REMS requirements.
- Certified health care facilities must have onsite, immediate access to tocilizumab, and ensure that a minimum of 2 doses of tocilizumab are available for each individual for administration within 2 hours after tisagenlecleucel or axicabtagene ciloleucel infusion, if needed for treatment of cytokine release syndrome.
- Certified health care facilities must ensure that health care providers who prescribe, dispense, or administer tisagenlecleucel or axicabtagene ciloleucel are trained to manage cytokine release syndrome and neurologic toxicities.
Procedure Codes
