CurrentCignaPolicy IP0734

Oncology (Injectable - CAR-T) - Aucatzyl

Defines prior authorization, clinical criteria, dosing, and coding for medical-benefit coverage of Aucatzyl (obecabtagene autoleucel) for treatment of relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL) in adults under Cigna-administered plans.

Policy Summary

PayerCigna

PolicyOncology (Injectable - CAR-T) - Aucatzyl

Policy CodePolicy IP0734

Change TypeNew policy; HCPCS coding updated; annual revision

Effective Date

Next Review Date

Key ActionPrior Authorization is required for medical benefit coverage of Aucatzyl; approval duration is 6 months to allow preparation and administration of one dose.

SourceLink

POLICY UPDATE CHANGES

New policy created (Summary of Changes = New policy).

Updated HCPCS coding: removed C9399, J3490, J3590 and added C9301 (effective until 6/30/2025) and Q2058 (effective 7/1/2025).

Annual Revision recorded with no criteria changes.

1Covered Indication (ALL adult relapsed/refractory B-cell precursor)

1Dose regimen approved (single dose split Days 1 & 10)

6Approval duration (months)

2HCPCS product codes listed

Coverage Summary

Covered with criteria: Aucatzyl (obecabtagene autoleucel) is covered with prior authorization for the FDA‑approved indication of relapsed or refractory B‑cell precursor acute lymphoblastic leukemia (ALL) in adults when the policy clinical criteria are met. Approval is for a single therapeutic dose (administered per the dosing schedule) and the prior authorization approval duration is 6 months to allow preparation and administration of one dose. The policy requires specialist prescribing or consultation (oncologist) and references NCCN guidance. The product carries boxed warnings for cytokine release syndrome, neurologic toxicity including ICANS, and secondary hematologic malignancies.

Key Thresholds and Quick Facts

Age>= 18 years

Total dose410 x 10^6 CAR-T cells

Dosing scheduleDose split and administered on Days 1 and 10 (± 2 days)

Approval duration6 months

HCPCS product codesC9301 (effective until 6/30/2025); Q2058 (effective 7/1/2025)

Initial Therapy Criteria (FDA‑approved indication)

FDA-Approved Indication (Acute Lymphoblastic Leukemia)

Approve a single dose if the patient meets ALL of the following (A, B, C, D, E, and F):

Age: Patient is >= 18 years of age>= 18 years
Disease: Patient has B-cell precursor disease
Disease Status: Patient has relapsed or refractory disease
Lymphodepletion:

Continuation Therapy & Exclusions

Not Medically Necessary

Aucatzyl for any other use is considered not medically necessary.

Not Medically Necessary: Any indication other than relapsed or refractory B-cell precursor ALL in adults as specified above

There are no separate continuation therapy criteria — coverage is limited to a single approved therapeutic dose (approval duration 6 months to permit preparation/administration). Coverage is specifically denied if the patient has previously received CAR‑T therapy; prior authorization is required and requests for additional or repeat dosing beyond the single approved product dose are not supported by the policy.

Applicable Codes

Considered Medically Necessary - CPT (CAR-T related procedures)CPTCovered

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
38226	Chimeric antigen receptor T-cell (CAR-T) therapy; preparation of blood-derived T lymphocytes for transportation (e.g., cryopreservation, storage)
38227	Chimeric antigen receptor T-cell (CAR-T) therapy; receipt and preparation of CAR-T cells for administration
38228	Chimeric antigen receptor T-cell (CAR-T) therapy; CAR-T cell administration, autologous

Considered Medically Necessary - HCPCS (product codes)HCPCSCovered

C9301	Obecabtagene autoleucel, up to 410 million CD19 CAR-positive viable T cells, including leukapheresis and dose preparation procedures, per therapeutic dose (Effective until 6/30/2025)
Q2058	Obecabtagene autoleucel, up to 400 million CD19 CAR-positive viable T cells, including leukapheresis and dose preparation procedures, per therapeutic dose (Effective Date 7/1/2025)

Provider Actions & Billing Rules

Prior Authorization

Prior authorization required

Prior Authorization is required for medical benefit coverage of Aucatzyl; approval is required for those who meet the policy Criteria and Dosing. The approval duration is 6 months to allow preparation and administration of one dose.

Approval duration: 6 months

Documentation Required

Specialist prescribing/consultation requirement

Aucatzyl must be prescribed by or in consultation with a physician who specializes in the condition being treated (oncologist). Medical directors may exercise clinical judgment on coverage requests.

Clinical Evidence & Guidance

Evidence summary: NCCN (ALL v2.2025) recommends Aucatzyl as a Preferred Regimen (category 2A) for Philadelphia chromosome–negative B‑cell ALL and as an Other Recommended Regimen (category 2A) for Philadelphia chromosome–positive B‑cell ALL following TKI therapy. The prescribing information is listed as Aucatzyl intravenous infusion prescribing information, Autolus; August 2025. The product labeling includes a boxed warning for cytokine release syndrome, neurologic toxicity including ICANS, and secondary hematologic malignancies.

Background

Product description and mechanism: Aucatzyl is a CD19‑directed genetically modified autologous T cell immunotherapy indicated for relapsed or refractory B‑cell precursor ALL in adults. The recommended total dose is 410 x 10^6 CAR‑T cells, split and administered on Days 1 and 10 (± 2 days) per the dosing table. The product carries boxed warnings for cytokine release syndrome, neurologic toxicity including ICANS, and secondary hematologic malignancies.

Definitions

CAR-T (definition)Chimeric antigen receptor T-cell therapy

ICANS (definition)Immune Effector Cell-Associated Neurotoxicity Syndrome

Revision History

4/15/2025New policy creation

New policy created (Summary of Changes = New policy).

4/15/2025Coding update

Updated HCPCS coding: removed C9399, J3490, J3590 and added C9301 (effective until 6/30/2025) and Q2058 (effective 7/1/2025).

2/1/2026Annual RevisionLatest

Annual Revision recorded with no criteria changes.