Last Review Date: 12/03/2024

Date of Origin: 12/03/2024

Dates Reviewed: 12/2024

1. Length of Authorization

Coverage will be provided for one treatment course (1 split dose infusion of Aucatzyl) and may not be renewed.

2. Dosing Limits

A. Max Units (per dose and over time) [HCPCS Unit]:

• 1 split dose infusion totaling 410 million CAR-positive viable T-cells

3. Initial Approval Criteria ^1,4-7

Coverage is provided in the following conditions:

• Patient does not have a clinically significant active infection or inflammatory disorder; AND
• Patient has not received live vaccines within 6 weeks prior to the start of lymphodepleting chemotherapy, and will not receive live vaccines during Obecabtagene autoleucel treatment and until immune recovery following treatment; AND
• 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
• Prophylaxis for infection will be followed according to local guidelines; AND
• Patient has not received prior CAR-T therapy; AND
• Patient has not received other anti-CD19 therapy (e.g., blinatumomab,) OR patient previously received other anti-CD19 therapy and re-biopsy indicates CD-19 positive disease; AND
• Used as single agent therapy (not applicable to lymphodepleting or bridging chemotherapy while awaiting manufacture); AND

Acute B-Cell Precursor Lymphoblastic Leukemia (ALL) † Ф ^1-10

• Patient is at least 18 years of age; AND
• Patient has a diagnosis of relapsed; AND
  • Patient has Philadelphia chromosome (Ph)-positive disease; AND
    • Previous therapy has included tyrosine kinase inhibitors (TKIs) (e.g., bosutinib, dasatinib, imatinib, nilotinib, or ponatinib); OR
  • Patient has Philadelphia chromosome (Ph)-negative disease

† FDA Approved Indication(s); ‡ Compendia Recommended Indication(s); Ф Orphan Drug

4. Renewal Criteria

Coverage cannot be renewed.

5. Dosage/Administration ¹

6. Billing Code/Availability Information

HCPCS Code:

• J9999 - Not otherwise classified, antineoplastic drugs

NDC(s):

• Aucatzyl 410 × 10⁶ CD19 CAR-positive viable T cells is supplied in three to five infusion bags: 83047-0410-xx
  • 10 × 10⁶ CD19 CAR-positive viable T cells in one 50mL infusion bag (Blue) - 83047-0010-xx
  • 100 × 10⁶ CD19 CAR-positive viable T cells in one 50mL infusion bag (Orange) - 83047-0100-xx
  • 100 × 10⁶ CD19 CAR-positive viable T cells in one 250mL infusion bag (Orange) - 83047-0100-xx
  • 300 × 10⁶ CD19 CAR-positive viable T cells in one 250mL infusion bag (Red) - 83047-0300-xx

7. References

1. ClinicalTrials.gov. NCT04404660. An Open-Label, Multi-Centre, Phase Ib/II Study Evaluating the Safety and Efficacy of AUTO1, a CAR T Cell Treatment Targeting CD19, in Adult Patients With Relapsed or Refractory B Cell Acute Lymphoblastic Leukaemia. https://clinicaltrials.gov/study/NCT04404660?intr=NCT04404660&rank=1#participation-criteria  .
2. Jabbour E, Tholouli E, Sandhu KS, et al., Obecabtagene autoleucel (obe-cel, AUTO1) in adults with relapsed/refractory B-cell acute lymphoblastic leukemia (R/R B-ALL): Overall survival (OS), event-free survival (EFS) and the potential impact of chimeric antigen receptor (CAR)-T cell persistency and consolidative stem cell transplantation (SCT) in the open-label, single-arm FELIX phase Ib/II study.. JCO 42, 6504-6504(2024). DOI:10.1200/JCO.2024.42.16_suppl.6504.
3. Mejstrikova E, Hrusak O, Borowitz MJ, et al. CD19-negative relapse of pediatric B-cell precursor acute lymphoblastic leukemia following blinatumomab treatment. Blood Cancer J. 20177; 659. DOI 10.1038/s41408-017-0023-x
4. Ruella M, Maus MV. Catch me if you can: Leukemia Escape after CD19-Directed T Cell Immunotherapies. Computational and Structural Biotechnology Journal 14 (2016) 357–362.
5. Braig F, Brandt A, Goebeler M, et al. Resistance to anti-CD19/CD3 BiTE in acute lymphoblastic leukemia may be mediated by disrupted CD19 membrane trafficking. Blood; 129:1, 2017 Jan.
6. Majzner RG, Mackall CL. Tumor Antigen Escape from CAR T-cell Therapy. Cancer Discov 2018;8:1219-1226.
7. Maude SL, Frey N, Shaw PA, et al. Chimeric antigen receptor T cells for sustained remissions in leukemia. N Engl J Med. 2014;371(16):1507-1517.
8. Fitzgerald JC, Weiss SL, Maude SL, et al. Cytokine release syndrome after chimeric antigen receptor T cell therapy for acute lymphoblastic leukemia. Crit Care Med. 2017;45(2):e124-e131.
9. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Acute Lymphoblastic Leukemia Version 2.2024. National Comprehensive Cancer Network, 2024. NATIONAL COMPREHENSIVE CANCER NETWORK®, NCCN®, and NCCN GUIDELINES® are trademarks owned by the National Comprehensive Cancer Network, Inc. To view the most recent and complete version of the Guidelines, go online to NCCN.org. Accessed November 2024.
10. Lee DW et al (2019), ASTCT Consensus Grading for Cytokine Release Syndrome and Neurologic Toxicity Associated with Immune Effector Cells. Biol Blood Marrow Transplant. 2019 Apr; 25(4):625-638.

Appendix 1 – Covered Diagnosis Codes

Appendix 2 – Centers for Medicare and Medicaid Services (CMS)

The preceding information is intended for non-Medicare coverage determinations. Medicare coverage for outpatient (Part B) drugs is outlined in the Medicare Benefit Policy Manual (Pub. 100-2), Chapter 15, §50 Drugs and Biologicals. In addition, National Coverage Determinations (NCDs) and/or Local Coverage Determinations (LCDs) may exist and compliance with these policies is required where applicable. Local Coverage Articles (LCAs) may also exist for claims payment purposes or to clarify benefit eligibility under Part B for drugs which may be self-administered. The following link may be used to search for NCD, LCD, or LCA documents: https://www.cms.gov/medicare-coverage-database/search.aspx. Additional indications, including any preceding information, may be applied at the discretion of the health plan.

Medicare Part B Covered Diagnosis Codes (applicable to existing NCD/LCD/LCA): N/A