Overview: This policy addresses coverage for multiple FDA‑approved autologous CAR‑T products including axicabtagene ciloleucel (Yescarta), brexucabtagene autoleucel (Tecartus), ciltacabtagene autoleucel (Carvykti), idecabtagene vicleucel (Abecma), lisocabtagene maraleucel (Breyanzi), obecabtagene autoleucel (Aucatzyl), and tisagenlecleucel (Kymriah) (listed products).

Coverage stance and limits: Coverage is conditional (covered with product‑specific medical necessity criteria). Coverage is limited to one treatment course per lifetime (duration 180 days) and to one unit per therapeutic dose per product as specified in the policy.

Required documentation and expectations: Providers must submit medical record documentation supporting the selected product’s indication, patient age, prior therapies, required disease testing (eg CD19 expression when specified), planned lymphodepleting chemotherapy regimen and timing, and documentation of the planned CAR‑positive viable T cell dose (must not exceed product‑specific maximums).

Dosing and lymphodepletion: Product‑specific dosing ranges and required lymphodepleting chemotherapy regimens are specified by product (examples summarized in thresholds). Planned dosing must adhere to the product maximums and any weight‑based calculations where applicable; lymphodepleting agents and timing must follow the exact regimen required for the product.

Distribution and billing note: For certain CAR/gene cellular therapies distribution from a specialty pharmacy provider and specific revenue code mapping may be required; providers should contact Blue Cross NC to coordinate and use the specified Q20xx HCPCS codes and updated revenue codes (eg 0891, 0892) as applicable.

FDA‑approved indications (selected examples): Yescarta (axicabtagene ciloleucel) is indicated for adults with relapsed or refractory large B‑cell lymphoma (including DLBCL NOS, primary mediastinal LBCL, high‑grade B‑cell lymphoma, DLBCL arising from follicular lymphoma) and relapsed or refractory follicular lymphoma after two or more lines of systemic therapy; limitations exclude primary CNS lymphoma.

Tecartus (brexucabtagene autoleucel) is approved for adults with relapsed or refractory mantle cell lymphoma (MCL) and for relapsed or refractory B‑cell precursor acute lymphoblastic leukemia (ALL) in adults; Carvykti (ciltacabtagene autoleucel) and Abecma (idecabtagene vicleucel) are approved for relapsed/refractory multiple myeloma per their labeled prior‑therapy requirements; Breyanzi (lisocabtagene maraleucel), Aucatzyl (obecabtagene autoleucel), and Kymriah (tisagenlecleucel) have product‑specific hematologic malignancy indications as detailed in the policy.

Product‑specific dosing examples and HCPCS: Yescarta dosing is based on CAR‑positive viable T cells with a target 2 x 10^6 cells/kg and a maximum of 2 x 10^8 (HCPCS Q2041). Tecartus dosing differs by indication (eg MCL target 2 x 10^6 cells/kg, max 2 x 10^8; adult ALL max 1 x 10^8), Breyanzi dosing is specified as cell‑count ranges (eg 90–110 x 10^6 for many indications; HCPCS Q2054), Abecma and Carvykti doses and Aucatzyl total/split dosing are specified in the product tables (see HCPCS Q2055, Q2056, Q2058, Q2042).

Lymphodepleting chemotherapy regimens: Each product requires a specified pre‑infusion lymphodepleting regimen and timing (examples: Yescarta — cyclophosphamide 500 mg/m2 + fludarabine 30 mg/m2 on days −5, −4, −3; Kymriah for ALL — fludarabine 30 mg/m2 x4 + cyclophosphamide 500 mg/m2 x2 within two weeks prior to infusion; Breyanzi, Abecma, Carvykti, and others specify cyclophosphamide and fludarabine regimens or alternate bendamustine where indicated).

Conditional coverage criteria summary: Coverage is contingent on meeting all product‑specific medical necessity criteria including documented diagnosis, patient age limits, no prior genetically modified T‑cell therapy where required, required prior lines/classes of therapy, absence of specified CNS disease or prior allogeneic HSCT when applicable, receipt/plan for the specified lymphodepleting regimen, and documentation of the planned CAR‑positive viable T cell dose not to exceed product maximum.

Refer to product sections for full, exact dosing ranges, lymphodepletion agents/doses and timing, and indication‑specific prior therapy requirements (policy references FDA package inserts for each product).

Definitions:

CAR‑positive viable T cells — chimeric antigen receptor‑expressing viable T cells as specified per product dosing (policy and HCPCS descriptions reference cell counts/targets and product maximums).

Lymphodepleting chemotherapy — pre‑infusion chemotherapy regimens (for example fludarabine plus cyclophosphamide, or bendamustine when indicated) required to be administered within the specified timing prior to CAR‑T infusion as noted for each product.