Medical Drug Criteria (MDC)

MDC Num:       P1.002.015
MDC Name:     Aucatzyl (Obecabtagene autoleucel)
MDC ID:          [P1.002.015] [ Ac / L / M+ / P+]

Last Review:       September 22, 2025
Next Review:      September 20, 2026
 

Related MDC:NONE

AUCATZYL (Obecabtagene autoleucel)

Summary

Aucatzyl is an autologous anti-CD19 CAR-T therapy indicated for adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (B-ALL). Recommended total dose: 410 × 10⁶ CAR⁺ T cells, given in 2 split infusions (Day 1 and Day 10 ±2 days) after lymphodepleting chemotherapy. Boxed warnings for CRS (cytokine release syndrome), ICANS (immune effector cell-associated neurotoxicity), and secondary hematologic malignancies. No formal contraindications in the Prescribing Information.

Policy Statements

Covered indication: Adults with relapsed/refractory B-ALL per FDA label and FELIX trial data.
 
One-time course of therapy, administered as two split infusions in REM-certified centers with full emergency support.
 
Prior authorization required, with complete clinical documentation (see “Required medical information”).

Policy Guidelines

Typical medical necessity criteria

1. Age ≥18 years.
 
 
2. Relapsed/refractory B-ALL defined as:
 
Primary refractory disease.
 
First relapse ≤12 months.
 
Relapsed/refractory after allogeneic transplant.
 
≥2 relapses after standard chemo.
 
In Ph+ ALL: failure of ≥2 TKIs unless contraindicated/intolerant.
 
 
 
3. Prior lymphodepleting chemotherapy (fludarabine/cyclophosphamide).
 
 
4. Aucatzyl used as monotherapy post-LD.
 
 
5. Adequate organ and marrow function.
 
 
6. No uncontrolled systemic infection at start of therapy.
 
 
7. If previously treated with blinatumomab, disease must be CD19-positive.
 
 
8. No prior anti-CD19 CAR-T therapy.
 
 
9. One treatment course only (two split doses, Day 1 and Day 10).

DOSAGE/ADMINISTRATION

Total recommended dose: 410 × 10⁶ CAR⁺ T cells (provided in 3–5 bags, 10M/100M/300M, color-coded).
 
Infusion schedule: split doses on Day 1 and Day 10 (±2 days). Infusion plan depends on bone marrow blast %, assessed within 7 days before LD chemo.
 
Premedication: acetaminophen; tocilizumab must be on site before infusion. Do not use leukodepleting filters.
 
Lymphodepletion: fludarabine + cyclophosphamide per PI.

REQUIRED MEDICAL INFORMATION

Documented diagnosis of B-cell precursor ALL.
 
Treatment history (lines of therapy, transplant status, relapse/refractory status).
 
Bone marrow evaluation (≤7 days before LD) with blast % to guide dosing.
 
Performance status and organ function adequate for LD and CAR-T infusion.
 
CD19 expression confirmed if patient previously received blinatumomab.
 

EXCLUSION CRITERIA

Age <18 years.
 
Uncontrolled systemic infection or active inflammatory conditions at infusion.
 
Prior anti-CD19 CAR-T therapy.
 
Inability to complete lymphodepletion or tolerate emergency toxicity management.

BENEFIT APPLICATION 

Prior authorization required; approval typically limited to 3 months to complete the 2-infusion course

OTHER CRITERIA

Practice Guidelines and Position Statements

NCCN (ALL, adult): incorporated Aucatzyl/obe-cel as a recommended therapy for relapsed/refractory adult ALL after FDA approval (Dec 2024).

Medicare National Coverage

NCD 110.24: Autologous CAR-T is covered for cancer when used for an FDA-approved or medically accepted compendium indication, at qualifying centers. Billing rules follow CMS coding updates, local MAC guidance, and DRG/APC assignments.

References

1. FDA Prescribing Information – Aucatzyl (Rev. 11/2024).
2. FDA Drug Approval (11/08/2024).
3. Florida Blue Medical Coverage Guideline (CAR-T, 2025).
4. CMS NCD 110.24.
5. CMS coding updates (Q2058/C9301).
6. Autolus Assist Billing & Coding Guide (2025).
7. NCCN Guidelines (Adult ALL, 2024–2025).

Codes

Applicable Modifiers

Policy History