Background

Aucatzyl (obecabtagene autoleucel) is a CD19-directed genetically modified autologous T-cell immunotherapy for relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL) in adults.

Policy (Criteria)

Aucatzyl (obecabtagene autoleucel) is considered MEDICALLY NECESSARY for Acute Lymphoblastic Leukemia when the following criteria are met:

1. Prescribed by or in consultation with an oncologist AND
2. Patient is at least 18 years of age; AND
3. Patient has a diagnosis of relapsed or refractory disease; AND

1. Patient has Philadelphia chromosome (Ph)-positive disease; AND
   1. Previous therapy has included tyrosine kinase inhibitors (TKIs) OR
2. Note: Examples include bosutinib, dasatinib, imatinib, nilotinib, or ponatinib)
3. Patient has Philadelphia chromosome (Ph)-negative disease AND

4. Patient does not have a clinically significant active infection or inflammatory disorder; AND
5. Patient has not received live vaccines within 6 weeks prior to the start of lymphodepleting chemotherapy, and will not receive live vaccines during Aucatzyl treatment and until immune recovery following treatment; AND
6. Patient has been screened for hepatitis B virus (HBV), hepatitis C virus (HCV), and human immunodeficiency virus (HIV) in accordance with clinical guidelines prior to collection of cells (leukapheresis); AND
7. Prophylaxis for infection will be followed according to local guidelines; AND
8. Patient has not received prior CAR-T therapy; AND
9. Patient has not received other anti-CD19 therapy (example: blinatumomab) OR
10. Patient previously received other anti-CD19 therapy and re-biopsy indicates CD-19 positive disease; AND
11. Used as single agent therapy (not applicable to lymphodepleting or bridging chemotherapy while awaiting manufacture) AND
12. Patient will be monitored for signs and symptoms of Cytokine Release Syndrome (CRS) for at least 14 days after treatment with Aucatzyl and will be counselled to seek immediate medical attention should signs and symptoms of CRS or a neurological event occur at any time; AND
13. Patient will stay within proximity of the Aucatzyl infusion center for at least 4 weeks following infusion.

Continuation of Aucatzyl (obecabtagene autoleucel) is considered NOT MEDICALLY NECESSARY there is a maximum of one dose per lifetime.

Dosing Limits

Aucatzyl is 410 x 106 CAR T-cells administered by intravenous (IV) infusion. The total dose is split with part of the dose administered on Day 1 and the remainder of the dose given on Day 10 (± 2 days).

Length of Authorization

Coverage will be provided for 1 dose and may not be renewed. The dose is split, based on the percentage of blasts in the bone marrow within 7 days of starting lymphodepleting chemotherapy, and administered on Days 1 and 10 (± 2 days).

References

1. Aucatzyl intravenous infusion [prescribing information]. Gaithersburg, MD: Autolus; January 2025
2. “Coding and Billing Guide - Autolus Assist.” Coding and Billing Guide, Autolus, Inc., June 2025, www.autolusassist.com/downloads/product-coding-and-billing-guide.pdf.

Coding Section

Procedure and diagnosis codes on Medical Policy documents are included only as a general reference tool for each Policy. They may not be all-inclusive.

This medical policy was developed through consideration of peer-reviewed medical literature generally recognized by the relevant medical community, U.S. FDA approval status, nationally accepted standards of medical practice and accepted standards of medical practice in this community, technology assessment program (TEC) and other non-affiliated technology evaluation centers, reference to federal regulations, other plan medical policies, and accredited national guidelines.

"Current Procedural Terminology © American Medical Association. All Rights Reserved" 

History From 2025 Forward