The spontaneous regression of certain cancers (eg, renal cell carcinoma, melanoma) supports the idea that a patient's immune system can delay tumor progression and, on rare occasions, can eliminate tumors altogether. These observations have led to research into various immunologic therapies designed to stimulate a patient's own immune system. Adoptive immunotherapy is a method of activating lymphocytes and/or other types of cells for the treatment of cancer and other diseases. Cells are removed from the patient, processed for some period of time, and then infused back into the patient.
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 (Kymriah) intravenous infusion is considered medically necessary for relapseda or refractoryb patients if they meet all of the following criteria:
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 patients 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 (Yescarta) or tisagenlecleucel (Kymriah) intravenous (except as indicateda) infusion is considered medically necessary for relapsed or refractoryb patients if they meet all of the following criteria:
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.
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 patients 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 patients 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 patients 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 patients 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:
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 patients with active infection or inflammatory disorders. It is recommended that severe or life-threatening cytokine release syndrome be treated with tocilizumab. Patients 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:
NOTE: In addition to the above criteria, product specific dosage and/or frequency limits may apply in accordance with the U.S. Food and Drug Administration (FDA)-approved product prescribing information, national compendia, Centers for Medicare and Medicaid Services (CMS) and other peer reviewed resources or evidence-based guidelines. Blue Cross Blue Shield of North Dakota may deny, in full or in part, reimbursement for utilization that does not fall within the applicable dosage and/or frequency limits.