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    OpenPayerPolicy UpdatesHematology/OncologyBaylor Scott & White CAR-T coverage update | OpenP…
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    CurrentBaylor Scott & White Health PlanPolicy 315

    Obecabtagene autoleucel (Aucatzyl) CAR-T therapy coverage criteria

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    Medical necessity and coverage criteria for the use of obecabtagene autoleucel (Aucatzyl) in adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL) for Baylor Scott & White Health Plan members.

    Policy Summary
    PayerBaylor Scott & White Health Plan
    PolicyObecabtagene autoleucel (Aucatzyl) CAR-T therapy coverage criteria
    Policy CodePolicy 315
    Change TypeAdded exclusion
    Effective DateMay 1, 2026
    Last ReviewApr 23, 2026
    Next Review DateApr 23, 2027
    Key ActionSubmit prior authorization with documentation that the member meets all policy criteria, including age ≥18, CD19+ disease, ECOG 0-1, and authorized treatment center attestation.
    SourceLink
    POLICY UPDATE CHANGES

    Added exclusion of prior therapy with CAR-T cell immunotherapy.

    ≥18

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    minimum patient age for coverage
    ECOG 0-1performance status required
    CD19+tumor biomarker required
    One lifetimesplit-dose therapy allowed per lifetime
    42%efficacy (CR rate)

    Coverage Criteria for Obecabtagene autoleucel (Aucatzyl)

    Initial Therapy Criteria

    Covered when ALL of the following are met

    Age: Member is ≥ 18 years old
    Diagnosis and disease state: Diagnosis of relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL) documented in the medical record AND meets one of the following: (a) Ph-negative disease: primary refractory after two induction cycles; first relapse after remission ≤ 12 months; relapsed/refractory after ≥ 2 systemic therapies; or relapsed/refractory ≥ 3 months after allogeneic HSCT; OR (b) Ph-positive disease: failed two lines of any TKI OR failed one line of second-generation TKI (e.g., bosutinib, dasatinib, nilotinib) OR intolerant to TKI therapy OR has a contraindication to TKI therapy
    Biomarker: Documentation of CD19 tumor expressionCD19 positive

    If prior blinatumomab, repeat biopsy must indicate CD19-positive disease

    Specialist: Diagnosed by a hematologist or oncologist
    Site of care: Provider attests that treatment will occur at an authorized treatment center
    Monotherapy and dosing: Obecabtagene autoleucel will be used as monotherapy with dose and frequency consistent with FDA labeling or NCCN guidelinesTotal recommended dose 410 x 10^6 CD19 CAR-positive viable T cells administered as split-dose infusion (Day 1 and Day 10 ± 2 days)
    Lymphodepletion and apheresis: Member has or will receive lymphodepleting chemotherapy (e.g., fludarabine and cyclophosphamide) before infusion and is eligible for apheresis
    Performance status: ECOG performance status 0 or 1ECOG 0-1
    Medication and timing exclusions: Member is NOT taking disallowed medications within specified timeframes (examples include: corticosteroids >10 mg prednisone equivalent within 7 days of leukapheresis or within 72 hours prior to infusion; immunosuppressives within 2 weeks; donor lymphocyte infusion within 2 weeks; drugs for GVHD within 2 weeks; antineoplastic chemotherapy within 1 week prior to leukapheresis or preconditioning; TKIs within 72 hours prior to preconditioning; alemtuzumab within 6 months; clofarabine or cladribine within 3 months; live vaccine within 4 weeks; intrathecal antineoplastic chemotherapy within 2 weeks)

    See policy for complete list and timing details

    The policy excludes members with the following disease-specific or prior-treatment conditions: prior treatment with tafasitamab or loncastuximab; Burkitt's leukemia/lymphoma; chronic myelogenous leukemia in lymphoid blast crisis; history or presence of clinically relevant central nervous system pathology (for example, epilepsy, paresis, aphasia, stroke, severe brain injuries, dementia, Parkinson's syndrome, uncontrolled mental illness, or psychosis); presence of CNS-3 disease or CNS-2 disease with neurologic changes; active or uncontrolled infection requiring systemic antimicrobials; active or latent Hepatitis B, active Hepatitis C, HIV, HTLV-1/2, or positive syphilis test; active significant acute graft-versus-host disease (overall Grade 2, Seattle criteria); moderate/severe chronic GVHD requiring systemic steroids or immunosuppressants; prior grade ≥3 neurotoxicity following blinatumomab; receipt of allogeneic hematopoietic stem cell transplantation within 3 months of planned CAR‑T; pregnancy; and prior CAR‑T cell immunotherapy.

    The policy also lists multiple medication- and timing-related exclusions that may preclude eligibility, including recent antineoplastic chemotherapy within 1 week prior to leukapheresis or preconditioning, tyrosine kinase inhibitors within 72 hours prior to preconditioning, alemtuzumab within 6 months, clofarabine or cladribine within 3 months, receipt of a live vaccine within 4 weeks prior to leukapheresis, and intrathecal antineoplastic chemotherapy within 2 weeks prior to preconditioning. These exclusions must be evaluated against the member’s clinical record when considering approval.

    Obecabtagene autoleucel dosing is administered as a split course. Baylor Scott & White Health Plan allows one split-dosed course per lifetime as medically necessary. Any requests for additional split-dosed courses (repeat courses) are considered experimental and investigational and therefore not medically necessary because effectiveness of repeat courses has not been established.

    Use of obecabtagene autoleucel for indications other than relapsed or refractory CD19-positive B-cell precursor acute lymphoblastic leukemia (ALL) is considered experimental and investigational and therefore not medically necessary because the effectiveness of the therapy for other indications has not been established.

    Regimens and Dosing

    RegimenTotal dose / ScheduleLymphodepletionCoverage status
    Obecabtagene autoleucel (Aucatzyl) for relapsed or refractory CD19-positive B‑cell precursor ALL meeting policy eligibility criteria
    410 x 10^6 CD19 CAR‑positive viable T cells administered as split‑dose infusion on Day 1 and Day 10 (±2 days)
    Preceded by fludarabine and cyclophosphamide lymphodepleting chemotherapy
    Covered with criteria
    RegimenDetailsRationaleCoverage status
    Additional courses of split‑dosed obecabtagene autoleucel beyond one lifetime course
    Any repeat split‑dosed course after the single allowed lifetime course
    Effectiveness of repeat courses has not been established; policy considers repeat courses experimental/investigational
    Not medically necessary (experimental/investigational)

    Billing and Coding

    Covered CPT CodesCPTCovered
    38228Chimeric antigen receptor T-cell (CAR-T) therapy; CAR-T cell administration, autologous.
    HCPCS / J-codesHCPCS
    C9339Unclassified drugs or biologicals (hospital outpatient use).
    J9999Not otherwise classified, antineoplastic drugs.
    ICD-10 CodesICD-10
    C91.00Acute lymphoblastic leukemia not having achieved remission
    C91.02Acute lymphoblastic leukemia, in relapse
    inv-08: Total recommended CAR-T dose — dosing summary badge/key facts
    Total recommended dose410 x 10^6 CD19 CAR-positive viable T cells
    Administration scheduleSplit-dose infusion: Day 1 and Day 10 (±2 days)
    Lymphodepletion requirementAdminister after fludarabine and cyclophosphamide lymphodepleting chemotherapy
    Dose based on assessmentTiming of Day 10 dose guided by bone marrow blast assessment

    Provider Actions and Documentation Requirements

    Prior Authorization

    Prior Authorization Required

    Prior authorization is required. Submit documentation showing the member meets all policy criteria. Failure to provide required eligibility and clinical documentation may result in denial.

    • Submit complete medical records supporting diagnosis, prior treatments, and CD19 tumor expression
    • Include documentation of treatment at an authorized CAR‑T treatment center
    • Provide ECOG performance status and evidence of eligibility for apheresis
    Documentation Required

    TKI Failure / Intolerance Requirement for Ph-positive ALL

    For members with Philadelphia chromosome (Ph)-positive B-cell precursor ALL, documentation must demonstrate failure or intolerance to TKI therapy as specified in the policy before consideration for obecabtagene autoleucel (Aucatzyl).

    • Document the specific TKIs used (e.g., imatinib, dasatinib, nilotinib, bosutinib, ponatinib) and dates of therapy

    Line of Therapy / Indication Context

    Biomarker Requirements

    inv-17: CD19 — Positive tumor expression required for eligibility
    Biomarker requirementPositive tumor expression of CD19 required for eligibility
    Documentation sourceCD19 tumor expression must be documented in the medical record/biopsy
    Post-blinatumomab requirementIf prior blinatumomab, repeat biopsy must indicate CD19-positive disease

    Definitions

    inv-14: Split-dose course definition — one course administered as two infusions (Day 1 and Day 10 ±2 days); policy allows one lifetime split-dose course
    DefinitionA single course in which the total recommended dose is administered as two infusions (Day 1 and Day 10 ±2 days)
    Lifetime allowancePolicy allows one split-dose course per lifetime; additional courses considered experimental/investigational
    Lymphodepletion contextSplit-dose course is given after fludarabine and cyclophosphamide lymphodepletion
    inv-15: CD19-positive disease — requirement that tumor expression of CD19 be documented on biopsy
    Documentation requirementTumor expression of CD19 must be documented on biopsy for eligibility
    Implication after prior therapyIf prior blinatumomab, a repeat biopsy confirming CD19 positivity is required

    Background

    CAR T-cell therapy involves collecting a patient’s autologous lymphocytes, genetically modifying T cells to express a chimeric antigen receptor targeting tumor antigens (for this product, CD19), and reinfusing the modified cells after lymphodepleting chemotherapy. The FDA approved obecabtagene autoleucel (Aucatzyl) for adults with relapsed or refractory CD19-positive B-cell precursor ALL based on clinical trial evidence. The policy aligns coverage with that indication and the FDA/NCCN‑consistent dosing approach, which specifies a total recommended dose of 410 x 10^6 CD19 CAR‑positive viable T cells administered as a split-dose infusion on Day 1 and Day 10 (±2 days) following lymphodepletion with agents such as fludarabine and cyclophosphamide.

    Revision History

    2026-04-23policy_revisionLatest

    Updated policy to add prior treatment with CAR-T cell immunotherapy as an exclusion.

    2025-03-10policy_creation

    Policy created (new policy effective 2025-03-10).

    2026-05-01effective_date

    Policy effective date set to 2026-05-01 following the April 23, 2026 revision.

    Policy Summary
    PayerBaylor Scott & White Health Plan
    PolicyObecabtagene autoleucel (Aucatzyl) CAR-T therapy coverage criteria
    Policy CodePolicy 315
    Change TypeAdded exclusion
    Effective DateMay 1, 2026
    Last ReviewApr 23, 2026
    Next Review DateApr 23, 2027
    Key ActionSubmit prior authorization with documentation that the member meets all policy criteria, including age ≥18, CD19+ disease, ECOG 0-1, and authorized treatment center attestation.
    SourceLink
    On This Page
    Coverage Criteria for Obecabtagene autoleucel (Aucatzyl)Regimens and DosingBilling and CodingProvider Actions and Documentation RequirementsLine of Therapy / Indication ContextBiomarker RequirementsDefinitionsBackgroundRevision History
  1. For "failed" TKIs provide objective evidence of treatment failure (e.g., lack of response, progression, relapse) from clinical notes, imaging, or laboratory results
  2. If intolerance is claimed, include documentation of adverse events or toxicity attributable to the TKI that led to discontinuation
  3. If a contraindication is claimed, include the clinical rationale and supporting records
    4. Documentation Required

    Required Clinical Documentation

    Required clinical documentation must be supplied to support medical necessity determinations.

    • Diagnosis confirmation and treating hematologist/oncologist notes
    • Pathology or flow cytometry reporting CD19 tumor expression
    • Records of prior systemic therapies (lines of therapy) and dates
    • Prior HSCT dates if applicable and timing relative to relapse
    • Documentation of planned lymphodepleting chemotherapy and dosing consistent with FDA labeling or NCCN guidance
    Denial Risk

    Prior Authorization and Eligibility Documentation

    Prior authorization and eligibility documentation must be complete. Failure to document required eligibility criteria (including TKI failure/intolerance when applicable) may result in denial.

    • Ensure documentation of TKI failure/intolerance for Ph-positive ALL is included with the authorization request
    • Include evidence of absence of exclusionary conditions (e.g., prior tafasitamab or loncastuximab, active infections, uncontrolled CNS disease, significant graft-versus-host disease)
    • Confirm dosing plan reflects single split-dosed course per lifetime unless otherwise authorized
    Role in coverage decisionCD19-positive disease is a required biomarker for approval of obecabtagene autoleucel