ModifiedAnthemPolicy CC-0272

Medical Drug Clinical Criteria - Aucatzyl (obecabtagene autoleucel)

Clinical criteria for medical-benefit coverage and prior authorization of Aucatzyl (obecabtagene autoleucel), a one-time CAR T-cell therapy for adult relapsed or refractory B-cell acute lymphoblastic leukemia (B-ALL). Includes eligibility, exclusions, required lab/organ function, and coding references.

Policy Summary

PayerAnthem

PolicyMedical Drug Clinical Criteria - Aucatzyl (obecabtagene autoleucel)

Policy CodePolicy CC-0272

Change TypeAnnual update and coding revisions

Effective DateDec 22, 2025

Next Review Date

Key ActionSubmit prior authorization documentation demonstrating age ≥18, B-ALL diagnosis with CD19 expression and ≥5% bone marrow blasts, relapsed/refractory status, Ph+ or Ph- TKI history as required, organ function labs and cardiac testing, ECOG 0-1, no prior CAR T therapy, and plan for single administration.

SourceLink

POLICY UPDATE CHANGES

Annual Update: Add criteria to specify use in both B-ALL Philadelphia positive or Philadelphia negative populations and provide examples for lab values defined as adequate hepatic, renal, and cardiovascular function.

Removed HCPCS C9301 effective 6/30/25 and added Q2058 effective 7/1/25.

Added CPT 38225-38228 and ICD-10 Procedure XW0338A and XW0438A; added ICD-10-CM C91.00 and C91.02.

New agent PA review for Aucatzyl (obecabtagene autoleucel) on 11/22/2024; initial coding included HCPCS NOC C9399 and J9999.

1One-time administration

18+Minimum age (years)

Coverage Summary

Aucatzyl (obecabtagene autoleucel) is a one-time, CD19-directed CAR T-cell therapy for adults with relapsed or refractory B-cell acute lymphoblastic leukemia (B-ALL) with medical-benefit coverage stance covered_with_criteria and requires prior authorization.

Key thresholds and quick facts

One-time administration1

Minimum age18+

Bone marrow blasts at screening>= 5% blasts

Primary HCPCS for drugQ2058

Initial Therapy Criteria (Medical Necessity)

Prior Authorization

Prior authorization required with clinical criteria

Requests must document patient age 18 years or older; diagnosis of B‑cell acute lymphoblastic leukemia (B‑ALL); confirmed CD19 tumor expression; bone marrow morphological disease with >= 5% blasts at screening; relapsed or refractory disease; Philadelphia chromosome (Ph+) versus Ph‑ status with documentation of required tyrosine kinase inhibitor (TKI) history for Ph+ cases (inadequate response or intolerance to at least two TKIs, or failed one line or second‑generation TKI, or TKI contraindicated) when applicable; adequate organ function laboratory results (ALT/AST, total bilirubin, creatinine clearance) and cardiac assessment (LVEF) per thresholds; ECOG performance status 0–1; no prior treatment with CAR T or other genetically modified T‑cell therapy; and plan for one‑time, single administration of Aucatzyl. Include applicable procedure/drug codes Q2058 and CPT 38225–38228 on the submission.

Patient age >= 18
Diagnosis: B‑cell acute lymphoblastic leukemia (B‑ALL)
Confirmed CD19 expression
Bone marrow blasts >= 5% at screening
Relapsed or refractory disease
Ph+ vs Ph‑ status with required TKI history for Ph+ cases
Organ function labs: ALT/AST, total bilirubin, creatinine clearance
Cardiac assessment: LVEF documented
ECOG performance status 0–1
No prior CAR T or other genetically modified T‑cell therapy
Planned as a one‑time, single administration
Include codes: Q2058; CPT 38225, 38226, 38227, 38228

Exclusions / Not Approved

Denial Risk

Denial risk for excluded conditions

Claims may be denied when the request meets any of the excluded conditions listed in the policy. Providers should verify absence of exclusion triggers before submitting for coverage.

Repeat administration of Aucatzyl
Use in combination with other chemotherapy agents
Concomitant prescription with other CAR T‑cell or genetically modified T‑cell therapies
Active graft‑versus‑host disease (GVHD)
Presence of CNS‑3 disease or CNS‑2 disease with neurological changes
History or presence of CNS disorders (seizure disorder, cerebrovascular ischemia/hemorrhage, dementia, cerebellar disease, autoimmune CNS involvement)
Diagnoses: Burkitt's lymphoma/leukemia; CML lymphoid in blast crisis
Active or latent hepatitis B, active hepatitis C, HIV positive, or other active/uncontrolled infection
Prior history of CAR T or other genetically modified T‑cell therapy

Provider Actions & Documentation Requirements

Documentation Required

Organ function and performance documentation

Providers must supply relevant laboratory and cardiac test results to demonstrate the patient meets organ function and performance thresholds required for approval. Specifically, submit recent ALT/AST and total bilirubin, a creatinine clearance calculation, and cardiac assessment (ECHO or MUGA when indicated) documenting left ventricular ejection fraction (LVEF). Also document the patient's ECOG performance status.

ALT/AST (<= 2.5 x ULN)
Total bilirubin (<= 1.5 x ULN; except Gilbert's syndrome)
Creatinine clearance (>= 50 cc/minute)
LVEF (>= 45% or >= institution lower limit of normal) documented by ECHO or MUGA when indicated
ECOG performance status (0–1)

Prior authorization submissions must document that Aucatzyl is planned as a single, one-time intravenous administration and include required clinical information (age ≥18, B-ALL diagnosis, CD19 expression, bone marrow blasts ≥5%, relapsed/refractory status, organ function labs, ECOG 0-1, absence of prior CAR T therapy). For Philadelphia chromosome–positive (Ph+) cases, document prior tyrosine kinase inhibitor (TKI) history per criteria. Include applicable procedure/drug codes such as Q2058 and CAR-T CPT codes 38225–38228 on PA requests as appropriate.

Applicable Codes

Covered/Applicable CPT codes (informational)CPT

38225	Chimeric antigen receptor T-cell (CAR-T) therapy; harvesting of blood-derived T lymphocytes for development of genetically modified autologous CAR-T cells, per day [when specified for Aucatzyl (obecabtagene autoleucel)]
38226	Chimeric antigen receptor T-cell (CAR-T) therapy; preparation of blood-derived T lymphocytes for transportation (e.g., cryopreservation, storage) [when specified for Aucatzyl (obecabtagene autoleucel)]
38227	Chimeric antigen receptor T-cell (CAR-T) therapy; receipt and preparation of CAR-T cells for administration [when specified for Aucatzyl (obecabtagene autoleucel)]
38228	Chimeric antigen receptor T-cell (CAR-T) therapy; CAR-T cell administration, autologous [when specified for Aucatzyl (obecabtagene autoleucel)]

Covered/Applicable HCPCSHCPCS

Q2058

Obecabtagene autoleucel, 10 up to 400 million CD19 CAR-positive viable T cells, including leukapheresis and dose preparation procedures, per infusion [Aucatzyl]

ICD-10-PCS / Procedure codes (informational)ICD-10

XW0338A	Introduction of Obecabtagene Autoleucel into Peripheral Vein, Percutaneous Approach, New Technology Group 10 [Aucatzyl]
XW0438A	Introduction of Obecabtagene Autoleucel into Central Vein, Percutaneous Approach, New Technology Group 10 [Aucatzyl]

ICD-10-CM Diagnosis codes (informational)ICD-10

C83.50-C83.59	Lymphoblastic (diffuse) lymphoma
C91.00	Acute lymphoblastic leukemia not having achieved remission
C91.02	Acute lymphoblastic leukemia, in relapse

Clinical Evidence

Safety observed in the phase 2 FELIX trial (median two prior lines of therapy) included cytokine release syndrome (CRS) occurring in 63% any grade with 3% grade ≥3, and immune effector cell-associated neurotoxicity syndrome (ICANS) occurring in 23% any grade with 8% grade ≥3. Aucatzyl carries boxed warnings for CRS, ICANS, and T-cell malignancies observed with similar BCMA- and CD19-directed genetically modified T-cell therapies.

Definitions

Autologous cells: Harvested from the individual's own cells.

Allogeneic cells: Harvested from a histocompatible donor.

ECOG performance status: A scale to assess disease impact on daily living abilities; 0 = fully active through 5 = dead.

Revision History

2024-11-22creation

Initial policy creation and coding: New agent prior authorization review for Aucatzyl (obecabtagene autoleucel) on 11/22/2024; initial coding included HCPCS NOC C9399 and J9999. (material)

2025-03-04coding_added

Coding additions: Added CPT 38225-38228, ICD-10-PCS procedure codes XW0338A and XW0438A, and ICD-10-CM diagnosis codes C91.00 and C91.02. (material)

2025-05-28coding_change

Coding change: Removed HCPCS C9301 effective 2025-06-30 and added Q2058 effective 2025-07-01. (material)