Brexucabtagene autoleucel (Tecartus) coverage
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Defines medical necessity and prior authorization criteria for a single administration of brexucabtagene autoleucel (Tecartus) for adult patients with relapsed/refractory mantle cell lymphoma (MCL) or B-cell precursor acute lymphoblastic leukemia (ALL) across Delaware First Health lines of business.
No material clinical or coverage changes in this revision.
Coverage Criteria
Initial Therapy - Mantle Cell Lymphoma
Covered when ALL of the following are met:
Approval duration: 3 months (single initial treatment dose only). Up to 4 doses of tocilizumab (Actemra) may be requested, each up to 800 mg.
Initial Therapy - Acute Lymphoblastic Leukemia
Covered when ALL of the following are met:
Approval duration: 3 months (single initial treatment dose only). Up to 4 doses of tocilizumab (Actemra) may be requested, each up to 800 mg.
Other Indications / Label Changes
Other uses not specified above:
See cited policies (e.g., CP.CPA.190, HIM.PA.33, CP.PMN.255, CP.CPA.09, HIM.PA.154, CP.PMN.53) for process details.
Coverage criteria (excerpt)
Covered when FDA-authorized indications are met and REMS requirements are followed; trial-based eligibility considerations inform clinical appropriateness
Boxed warnings require monitoring and management plans for cytokine release syndrome (CRS) and neurologic toxicities.
Prior allogeneic stem cell transplant or prior CAR T‑cell therapy were exclusionary in trials and should be documented if present.
Confirm planned dose does not exceed indication‑specific maximums and follow current prescribing information and product labeling.
Coverage will not be authorized for non‑FDA approved indications that are not addressed in this policy unless the provider supplies sufficient documentation of efficacy and safety per applicable off‑label use policies (e.g., CP.CPA.09, HIM.PA.154, CP.PMN.53). For mantle cell lymphoma (MCL), patients with a history of or current central nervous system (CNS) disease or CNS disorders detected by MRI (including but not limited to detectable cerebrospinal fluid malignant cells, brain metastases, CNS lymphoma, seizure disorder, cerebrovascular ischemia/hemorrhage, dementia, cerebellar disease, cerebral edema, posterior reversible encephalopathy syndrome, or autoimmune disease with CNS involvement) or a history of allogeneic stem cell transplantation are excluded from coverage under the standard criteria.
Patients with evidence of CNS involvement were excluded from the pivotal trials and represent conditions that must be assessed before approval. Specifically, coverage considerations include the presence of detectable cerebrospinal fluid malignant cells, brain metastases, or a history of CNS lymphoma. For acute lymphoblastic leukemia (ALL), the policy also excludes patients with CNS‑3 disease—defined as detectable cerebrospinal blast cells in CSF with ≥ 5 WBCs per mm3—and other CNS disorders such as seizure disorder, cerebrovascular ischemia/hemorrhage, dementia, cerebellar disease, cerebral edema, posterior reversible encephalopathy syndrome, or autoimmune disease with CNS involvement.
Tecartus is indicated to be administered a single time; therefore, continued therapy will not be authorized. Approval for an initial administration does not permit repeat dosing for continuation purposes.
Per boxed warning language, do not administer Tecartus to patients with active infection or inflammatory disorders because of the risk of severe cytokine release syndrome. Administration in the setting of active infection or uncontrolled inflammatory disease is contraindicated until the condition is resolved and appropriate monitoring and management plans are in place.
Coding and Clinical Thresholds
| CP.PHAR.472 | Policy reference number (internal policy identifier) |
| Q2053 | Brexucabtagene autoleucel, up to 200 million autologous anti-cd19 car positive viable t cells, including leukapheresis and dose preparation procedures, per therapeutic dose |
Provider Actions, Prior Authorization & Documentation
Prior authorization required; PDAC review and clinical criteria must be documented
Prior authorization is required for all requests; each request will undergo Precision Drug Action Committee (PDAC) Utilization Management Review. Provide documentation that the member meets the indication-specific approval criteria including diagnosis, recent ALC, prior systemic therapies, CNS status, history of allogeneic stem cell transplant, and prior CAR T-cell therapy history.
- PDAC Utilization Management Review required for all requests
- Document diagnosis and indication-specific criteria (MCL or ALL)
- Document recent ALC (within last 30 days) and prior systemic therapy history
- Document CNS status (MRI results) and history of allo-SCT or prior CAR T)
Submit prior authorization with clinical justification and REMS confirmation; bill using HCPCS Q2053
Prior authorization must include clinical justification that the patient meets approval criteria and confirmation that Tecartus will be used under the REMS program. When billing, reference HCPCS code Q2053 for brexucabtagene autoleucel per the policy coding guidance.
- Include clinical justification with prior authorization submission
- Confirm REMS program participation/enrollment
- Use HCPCS Q2053 for billing informationally per policy
Step therapy not applicable (single‑use CAR T); document prior systemic regimens
Step therapy sequencing is not applicable for Tecartus because it is a single‑use, single‑administration CAR T-cell therapy; however, the policy lists therapeutic alternatives and prior systemic regimens to document prior treatments before approval.
- Tecartus is a single administration product — continued therapy not authorized
- Provide documentation of prior systemic regimens (therapeutic alternatives table in appendices)
No explicit step‑therapy steps; eligibility tied to PDAC and guideline alignment
There are no explicit step‑therapy sequences in this excerpt; policy history and revisions tie eligibility language to external PDAC review and guideline alignment rather than to mandated stepwise prior treatments.
- Policy updates redirect prior authorization reviews to PDAC; no explicit multi-step therapy sequencing required in policy text
Submit office notes, labs, imaging and other clinical information to support approval criteria (PDAC review)
Providers must submit supporting documentation such as office chart notes, laboratory results, imaging, and other clinical information showing the member meets all approval criteria; all requests are reviewed by PDAC.
- Office notes documenting indication and specialty physician involvement (oncologist/hematologist)
- Laboratory results (including recent ALC)
- Imaging reports (brain MRI) and prior therapy records
Provide clinical documentation demonstrating eligibility (including ALC ≥ 100 cells/μL)
Documentation should demonstrate trial-consistent eligibility where applicable, including a recent absolute lymphocyte count (ALC ≥ 100 cells/μL), prior therapy history, and planned dosing within policy limits.
- Recent (within 30 days) ALC ≥ 100 cells/μL (ZUMA-2 eligibility reflected)
- Record of prior systemic regimens and dates
- Planned target dose (e.g., 2 × 10^6 CAR+ viable T cells/kg) and confirmation dose will not exceed maximums
Document REMS enrollment and REMS program requirements are being followed
Document that Tecartus use will follow the Yescarta and Tecartus REMS Program requirements and that the treating center is REMS-compliant.
- Confirm REMS enrollment and adherence to REMS monitoring/mitigation strategies
- Provide documentation that administration setting meets REMS requirements
Requests for non‑FDA indications or patients with excluded CNS disease may not be authorized
Coverage will not be authorized for uses that are non‑FDA approved and not supported per off‑label policies; requests with CNS disease exclusions or other trial‑based exclusions should be denied unless adequately justified.
- Non‑FDA approved indications require off‑label policy evidence to be considered
- Presence of excluded CNS disease or history (per indication) risks denial
Patients with CNS involvement (detectable CSF malignant cells, CNS‑2/3 disease, history of CNS lymphoma) are exclusionary
Patients with CNS involvement as defined in the trials (detectable cerebrospinal fluid malignant cells, CNS-2/CNS-3 disease, or history of CNS lymphoma) were excluded from pivotal trials and represent exclusionary conditions for approval.
- CNS‑3: detectable cerebrospinal blast cells in CSF with ≥ 5 WBCs/mm3
- CNS‑2: detectable CSF blast cells with <5 WBCs/mm3 (with neurological changes excluded in ZUMA-3)
- History of CNS lymphoma, brain metastases, or other CNS disorders excluded
Active infection or inflammatory disorders at administration are contraindicated and may trigger denial
Do not administer Tecartus to patients with active infection or inflammatory disorders per boxed warning; active infection or uncontrolled inflammatory conditions at the time of administration could lead to denial or deferral until resolved.
- Boxed warning: do not administer to patients with active infection or inflammatory disorders
- Treatment should be deferred until infections/inflammatory disorders are controlled
Initial Therapy Criteria and Dosing
Initial Therapy — Initial therapy criteria by indication (single dose only)
Initial therapy criteria by indication (single dose only).
Single initial therapeutic dose only; subsequent doses not covered.
Single initial therapeutic dose only; subsequent doses not covered.
Initial dosing — Initial dosing and product information
Initial dosing and product information
Product provided as a single‑dose frozen suspension in an infusion bag labeled for the specific recipient.
Ensure planned dosing does not exceed these maximums and document rationale if dosing approach differs from flat vs kg‑based guidance.
Continuation Therapy
Continuation Therapy — Continuation therapy rules
Continuation therapy rules
Approval duration: Not applicable (single‑dose therapy).
Quantity Limits and Associated Drugs
Site of Care Requirements
Administer only at REMS‑compliant sites with CRS/neurologic monitoring capability
Administration must occur in a setting that is enrolled in the Tecartus REMS and capable of monitoring for and managing cytokine release syndrome (CRS) and neurologic toxicities per REMS and boxed‑warning requirements.
- Facility must meet REMS requirements for monitoring and mitigation of CRS and neurologic events
- Site must be able to treat severe CRS (e.g., tocilizumab access) and provide neurologic monitoring
Follow REMS requirements and monitor/manage CRS and neurologic toxicities during administration
Ensure administration follows REMS program requirements including appropriate monitoring and management plans for cytokine release syndrome and neurologic toxicities as specified in the REMS and boxed warnings.
- Follow REMS monitoring/mitigation strategies and boxed‑warning management (e.g., tocilizumab for severe CRS)
- Document monitoring and management plans as part of authorization and REMS compliance
Background
Tecartus (brexucabtagene autoleucel) is an autologous CD19‑directed CAR T‑cell therapy approved for adult patients with relapsed or refractory mantle cell lymphoma (MCL) and for adult relapsed or refractory B‑cell precursor acute lymphoblastic leukemia (ALL). The product is distributed under the Yescarta and Tecartus REMS Program
Definitions
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