CAR T-cell therapy (listed products) — coverage criteria
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This policy governs medical necessity coverage criteria for specific autologous CAR T-cell therapies for hematologic malignancies for Blue Cross Blue Shield of North Carolina members and outlines required documentation and dosing/administration limits.
For Yescarta (axicabtagene ciloleucel) large B-cell lymphoma indication, removed the requirement that the patient does not have primary CNS lymphoma and removed the associated limitation of use statement.
Added revenue codes 0891 and 0892 associated with policy HCPCS codes and added distribution channel language for gene/cellular therapies.
Added new indication for Breyanzi for relapsed/refractory marginal zone lymphoma (MZL) in adults after at least two prior systemic therapies.
Coverage Criteria for CAR T-cell Therapies
Product-specific medical necessity criteria
Covered when ALL of the following product-specific criteria are met for each listed CAR T product
Product-specific coverage criteria
Covered when ALL of the following product-specific criteria are met (examples extracted for several products):
Primary central nervous system (CNS) lymphoma or active CNS disease is an explicit exclusion for multiple listed CAR T products. Medical record documentation must demonstrate absence of primary CNS lymphoma where specified in the product criteria (for example, tisagenlecleucel and lisocabtagene maraleucel state no primary CNS lymphoma). Requests for products that require absence of CNS disease should include documentation that there are no detectable malignant cells in cerebrospinal fluid and no CNS-3 disease or history of CNS disorders when that exclusion is specified.
For certain products and indications (for example, Tecartus for mantle cell lymphoma), the policy excludes patients with detectable malignant cells in CSF, brain metastases, or a history of CNS lymphoma or CNS disorders; documentation of neurologic status and CNS staging is required to confirm eligibility.
Some product indications exclude patients who have previously received an allogeneic hematopoietic stem cell transplant (HSCT). For example, idecabtagene vicleucel (Abecma) and ciltacabtagene autoleucel (Carvykti) both require that the patient has NOT had a prior allogeneic HSCT as part of the coverage criteria; medical record documentation of prior transplant status is required.
Providers should explicitly document prior transplant history in the authorization submission; requests for patients with prior allogeneic HSCT should be evaluated against the specific product language and will be denied when the product exclusion applies.
Use of the restricted CAR T products is limited to the specific indications, age groups, prior-therapy requirements, lymphodepletion regimens, and dosing ranges outlined for each product. Use outside those product-specific criteria (for example, treating an indication not listed in the product section, treating outside the stated age limits, or administering a regimen/dose not supported by the product criteria) is considered not medically necessary.
Before submission for authorization, confirm that the patient meets the exact product-specific requirements (diagnosis, line(s) of prior systemic therapy, biomarker confirmation if required, planned lymphodepleting chemotherapy, and planned CAR-positive viable T cell dose within the product-specified range). Requests for off-label indications or populations that do not meet these requirements will not meet coverage criteria.
Requests that do not include required documentation for product-specific elements will be considered not medically necessary. Required information includes: patient age as specified by the product, documentation of prior lines of systemic therapy (or prior agents required by indication), prior transplant and prior genetically modified T-cell therapy status, planned lymphodepleting chemotherapy regimen, and documentation of the planned CAR-positive viable T cell dose (including weight-based dosing when applicable).
Common denial triggers include missing or incomplete documentation of diagnosis, prior therapies, prior CAR-T or HSCT status, the specific lymphodepletion regimen, or the planned CAR cell dose. Ensure all required clinical records and planned dosing/lymphodepletion details are submitted with the prior authorization request to avoid documentation-based denials.
| Product / Context | Example Lymphodepleting Regimen (timing) | Notes / Alternative per product |
|---|---|---|
| Tisagenlecleucel (Kymriah) - B-cell precursor ALL | ||
| Fludarabine 30 mg/m2 IV daily x4 AND Cyclophosphamide 500 mg/m2 IV daily x2 (start with first fludarabine dose); within 2 weeks prior to infusion | ||
| Specified in product criteria for pediatric ALL; required for infusion of Kymriah in this indication |
| Regimen | Typical Dose / Schedule | Product-specific variation / use |
|---|---|---|
| Cyclophosphamide + Fludarabine (common) | ||
| Cyclophosphamide 300 mg/m2 IV daily + Fludarabine 30 mg/m2 IV daily x3 (given the 3 days before infusion) | ||
| Widely used as the standard lymphodepleting regimen for lisocabtagene (Breyanzi) and listed as a common regimen across products; timing is the 3 days prior to infusion |
Line-of-Therapy Requirements
second-line_or_later
Most indications require prior disease progression after two or more lines of systemic therapy; product‑specific exceptions and alternative pathways are noted below.
varies
Line‑of‑therapy requirements vary by product and indication; examples below reflect expanded labels and product‑specific criteria.
Biomarker and Re-biopsy Requirements
Coding and Dosing Information
| axicabtagene ciloleucel (Yescarta) | intravenous infusion for administration by a healthcare professional |
| brexucabtagene autoleucel (Tecartus) | intravenous infusion for administration by a healthcare professional |
| ciltacabtagene autoleucel (Carvykti) | intravenous infusion for administration by a healthcare professional |
| idecabtagene vicleucel (Abecma) | intravenous infusion for administration by a healthcare professional |
| lisocabtagene maraleucel (Breyanzi) | intravenous infusion for administration by a healthcare professional |
| obecabtagene autoleucel (Aucatzyl) | intravenous infusion for administration by a healthcare professional |
| tisagenlecleucel (Kymriah) | intravenous infusion for administration by a healthcare professional |
| Q2041 | Axicabtagene ciloleucel, up to 200 million autologous anti-CD19 CAR positive T cells, including leukapheresis and dose preparation procedures, per therapeutic dose |
| Q2042 | Tisagenlecleucel, up to 600 million CAR-positive viable T cells, including leukapheresis and dose preparation procedures, per therapeutic dose |
| Q2053 | Brexucabtagene autoleucel, up to 200 million autologous anti-CD19 CAR positive viable T cells, including leukapheresis and dose preparation procedures, per therapeutic dose |
| Q2054 | Lisocabtagene maraleucel, up to 110 million autologous anti-CD19 CAR positive viable T cells, including leukapheresis and dose preparation procedures, per therapeutic dose |
| Q2055 | Idecabtagene vicleucel, up to 460 million autologous B-cell maturation antigen (BCMA) directed CAR-positive T cells, including leukapheresis and dose preparation procedures, per therapeutic dose |
| Q2056 | Ciltacabtagene autoleucel, up to 100 million autologous B-cell maturation antigen (BCMA) directed CAR-positive viable T cells, including leukapheresis and dose preparation procedures, per therapeutic dose |
| Q2058 | Obecabtagene autoleucel, up to 400 million CD19 CAR-positive viable T cells, including leukapheresis and dose preparation procedures, per therapeutic dose |
| 38225 | Related CPT for CAR-T (apheresis/processing) |
| 38226 | Related CPT for CAR-T (apheresis/processing) |
| 38227 | Related CPT for CAR-T (apheresis/processing) |
| 38228 | Related CPT for CAR-T (apheresis/processing) |
| 0870 | Related CPT/revenue code listing |
| 0871 | Related CPT/revenue code listing |
| 0872 | Related CPT/revenue code listing |
| 0873 | Related CPT/revenue code listing |
| 0874 | Related CPT/revenue code listing |
| 0875 | Related CPT/revenue code listing |
| 0891 | Special Processed Drugs - FDA Approved Cell Therapy (revenue code) |
| 0892 | Special Processed Drugs - FDA Approved Gene Therapy (revenue code) |
Provider Requirements and Actions
Prior Authorization Required
Prior authorization required with submission of clinical documentation demonstrating specific indications. Authorization is required before infusion of any restricted CAR‑T product.
- Prior authorization required for all listed products.
- Authorization limits one treatment course per lifetime (180 days).
Required Documentation — provide medical record evidence
Requests lacking required medical record documentation may be denied. Submit complete records to confirm diagnosis, age, prior lines of systemic therapy, prior transplant status, prior genetically modified T‑cell therapy, tumor biomarker status, and planned dosing/lymphodepletion regimen.
- Documentation must confirm diagnosis and age.
- Documentation must confirm prior lines of systemic therapy and responses.
- Documentation must confirm prior allogeneic HSCT status and prior genetically modified T‑cell therapy.
- Documentation must confirm tumor biomarker(s) (e.g., CD19 expression, lenalidomide refractory status) when required by indication.
- Documentation must include planned lymphodepleting chemotherapy regimen and dates relative to planned infusion.
- Documentation must include planned CAR‑positive viable T‑cell dose (weight‑based dosing when applicable).
Prior Therapy Requirements
Coverage requires trials of specified prior systemic therapies for many indications; medical record documentation of prior therapies and lines of systemic treatment is required and requests may be denied if not provided.
- Evidence of prior therapy lines (e.g., two or more prior lines for multiple myeloma indications, two or more lines or refractory status for lymphomas) [medical record documentation required].
- Specific prior agents required vary by product and indication (e.g., immunomodulatory agent, proteasome inhibitor, and anti‑CD38 antibody for Abecma; prior anthracycline and anti‑CD20 for many lymphomas; BTK and BCL‑2 inhibitors for CLL/SLL).
- For Ph+ ALL, documentation of trials and response/intolerance to TKIs is required.
- Documentation must show whether the patient is ineligible for HSCT when that affects coverage criteria.
Documentation‑dependent Denials — submission pitfalls
Documentation-dependent denials: incomplete or missing supporting records for required prior therapies, prior allogeneic HSCT status, prior genetically modified T‑cell therapy, tumor biomarker results, planned lymphodepletion regimen, or planned CAR T dosing are common denial triggers. Ensure submissions include clear dates, agents, responses, and relevant laboratory/pathology reports.
- Missing documentation of prior lines of systemic therapy or specific required agents.
- No documentation of prior allogeneic HSCT or prior modified T‑cell therapy when required to establish eligibility.
- Absent tumor biomarker reports (e.g., CD19 expression, lenalidomide refractory status).
- No documentation of planned lymphodepleting chemotherapy regimen and timing relative to infusion.
- No documentation of planned CAR‑positive viable T‑cell dose (total or weight‑based as applicable).
Covered Lymphodepleting Regimens
| Product | Preferred Lymphodepletion | Alternative where specified |
|---|---|---|
| Tisagenlecleucel (Kymriah) | ||
| Fludarabine 25–30 mg/m2 IV daily x3–4 + Cyclophosphamide 250–500 mg/m2 IV daily (example: fludarabine 30 mg/m2 x4 + cyclophosphamide 500 mg/m2 x2 for ALL; fludarabine 25 mg/m2 x3 + cyclophosphamide 250 mg/m2 x3 for some lymphoma indications) | ||
| Bendamustine 90 mg/m2 IV daily x2 may be used as alternative for patients unable to receive cyclophosphamide (specified for certain lymphoma indications) |
| Regimen Example | Dose & Schedule | Products / Notes |
|---|---|---|
| Cyclophosphamide 300 mg/m2 IV daily + Fludarabine 30 mg/m2 IV daily x3 | ||
| Cyclophosphamide 300 mg/m2 IV once daily and Fludarabine 30 mg/m2 IV once daily for 3 days prior to infusion | ||
| Listed as the lymphodepleting regimen for lisocabtagene maraleucel (Breyanzi) and cited as a common regimen for multiple CAR T products; product-specific variations (e.g., Kymriah, Yescarta, Obecabtagene) have different dose/schedule examples in the policy |
Definitions and Key Terms
Background
Autologous, genetically modified CAR T-cell therapies are individualized treatments derived from a patient’s own T cells that are engineered to express a chimeric antigen receptor (CAR) targeting disease-specific antigens (for example, CD19 or BCMA). The policy covers a set of restricted autologous CAR T products for relapsed or refractory hematologic malignancies when product-specific clinical criteria are met.
Coverage is product- and indication-specific and generally requires documentation of prior lines of systemic therapy, absence of prior receipt of genetically modified T-cell therapy (unless the product criteria allow otherwise), planned lymphodepleting chemotherapy per product guidance, and a documented planned CAR-positive viable T cell dose within the product-specified dosing limits. Many indications also require tumor biomarker confirmation (for example, CD19 expression for tisagenlecleucel in B-cell precursor ALL) and specify age limits for certain indications.
Revision History and Policy Changes
For Yescarta (axicabtagene ciloleucel) large B-cell lymphoma indication, the requirement excluding patients with primary CNS lymphoma and the associated limitation of use statement were removed per updated FDA labeling; effective April 2026.
Added revenue codes 0891 (Special Processed Drugs - FDA Approved Cell Therapy) and 0892 (Special Processed Drugs - FDA Approved Gene Therapy) and added gene/cellular therapy distribution channel language; policy notification provided 2026-02-01 for effective date 2026-04-01.
Added a new indication for Breyanzi (lisocabtagene maraleucel) for relapsed/refractory marginal zone lymphoma (MZL) in adults after at least two prior systemic therapies, with corresponding dosing table updates.
Added HCPCS code Q2058 for Obecabtagene (Aucatzyl) to the dosing reference effective 2025-07-01 and removed legacy codes C9301, J3490, J3590, and J9999 as of 2025-06-30.
Added HCPCS code C9301 to the dosing reference table for Aucatzyl effective 2025-04-01 and deleted C9399 as of 2025-03-31.
Added Aucatzyl (Obecabtagene autoleucel) to the policy for adult relapsed/refractory B-cell precursor ALL and added new Breyanzi indications for FL and MCL with corresponding dosing updates; Tecartus lymphodepletion regimen for ALL clarified.
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