CurrentEmblemHealthPolicy MG.MM.PH.419

Aucatzyl (obecabtagene autoleucel) — CAR T‑cell therapy coverage criteria

Medical coverage criteria and administration requirements for a single-dose Aucatzyl (obecabtagene autoleucel) treatment for adults with relapsed or refractory B‑cell precursor acute lymphoblastic leukemia (ALL). Applies to EmblemHealth-administered benefits.

Policy Summary

PayerEmblemHealth

PolicyAucatzyl (obecabtagene autoleucel) — CAR T‑cell therapy coverage criteria

Policy CodePolicy MG.MM.PH.419

Change TypeNo material changes

Effective DateJan 30, 2025

Next Review DateJan 30, 2025

Key ActionObtain prior authorization with submission of clinical documentation demonstrating the member meets all policy criteria.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

1maximum doses (per lifetime)

410 x 10^6total CAR‑T dose

Days 1 & 10split dose schedule

20%marrow blast threshold

≥18minimum age

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Coverage and Medical Necessity Criteria

Initial Therapy — Approve a single dose

Approve a single dose if the patient meets ALL of the following (A through M):

Initial Approval Criteria: A. Prescribed by or in consultation with an oncologist; B. Patient is at least 18 years of age; C. Patient has a diagnosis of relapsed or refractory disease; D. For Ph‑positive disease: previous therapy has included a tyrosine kinase inhibitor (e.g., bosutinib, dasatinib, imatinib, nilotinib, or ponatinib); E. For Ph‑negative disease: relapsed or refractory disease (no TKI requirement); F. No clinically significant active infection or inflammatory disorder; G. No live vaccines within 6 weeks prior to the start of lymphodepleting chemotherapy and no live vaccines during Aucatzyl treatment until immune recovery; H. Screened for hepatitis B virus (HBV), hepatitis C virus (HCV), and HIV per clinical guidelines prior to leukapheresis; I. Infection prophylaxis per local guidelines; J. No prior CAR‑T therapy; K. Has not received other anti‑CD19 therapy OR if previously received anti‑CD19 therapy, re‑biopsy demonstrates CD19‑positive disease; L. Used as single‑agent therapy (except lymphodepleting or bridging chemotherapy); M. Patient will be monitored for signs and symptoms of cytokine release syndrome (CRS) for at least 14 days after treatment and counselled to seek immediate care for CRS or neurologic events, and will remain within proximity of the infusion center for at least 4 weeks following infusion.

All criteria A–M required

Dosing Requirements

Approve dosing when ALL of the following are met:

Dosing: A. Administer a total dose of 410 x 10^6 CAR‑T cells by intravenous infusion; B. The total dose is split and administered on Days 1 and 10 (±2 days).410 x 10^6 total; split schedule Days 1 & 10

Dosing stratified by bone marrow blast percentage per dosing table

Dosing by marrow blasts: If bone marrow blasts >20% then Day 1 = 10 x 10^6 CAR‑T cells and Day 10 = 400 x 10^6 CAR‑T cells; If bone marrow blasts ≤20% then Day 1 = 100 x 10^6 CAR‑T cells and Day 10 = 310 x 10^6 CAR‑T cells.20% blasts

Specific per‑policy dosing table

Bone marrow blasts	Day 1 dose	Day 10 dose (±2 days)	Total dose	Coverage
> 20%
10 x 10^6 CAR‑T cells
400 x 10^6 CAR‑T cells
410 x 10^6 CAR‑T cells
Covered with criteria
≤ 20%
100 x 10^6 CAR‑T cells
310 x 10^6 CAR‑T cells
410 x 10^6 CAR‑T cells
Covered with criteria

Patients with a clinically significant active infection or inflammatory disorder are excluded from Aucatzyl (obecabtagene autoleucel) therapy until the infection or inflammatory condition has resolved. This is a required criterion for initial approval and must be documented in the clinical submission before authorization can be granted.

Patients who have received live vaccines within 6 weeks prior to the start of lymphodepleting chemotherapy are not eligible for Aucatzyl until the 6‑week interval has passed. Additionally, patients must not receive live vaccines during Aucatzyl treatment and until immune recovery; vaccination history and timing must be documented in the authorization request.

Coverage is limited to a single lifetime administration of Aucatzyl. Coverage cannot be renewed and a maximum of one dose per lifetime will apply; requests for additional doses or renewals will not be approved.

Dosing, Administration, and Regimen Details

Regimen	Dose schedule	Dose splitting details	Notes	Coverage
Obecabtagene autoleucel (Aucatzyl), single‑agent CAR T‑cell therapy
Total 410 x 10^6 CAR‑T cells administered IV
Split-dose infusion on Days 1 and 10 (±2 days); dosing tiered by bone marrow blast percentage (see dosing table)
Single lifetime dose; used as single‑agent therapy except lymphodepleting or bridging chemo; patient monitoring for CRS and neurologic events required
Covered with criteria

inv-09: Bone marrow blasts percentage — dosing threshold (>20% vs ≤20%)

Threshold> 20% vs ≤ 20% bone marrow blasts (used to stratify dosing tiers)

If >20% blastsDay 1 = 10 x 10^6 CAR‑T cells; Day 10 = 400 x 10^6 CAR‑T cells

If ≤20% blastsDay 1 = 100 x 10^6 CAR‑T cells; Day 10 = 310 x 10^6 CAR‑T cells

Applicable Codes and Billing Identifiers

Applicable Procedure CodesHCPCSCovered

J9999	Not otherwise classified, antineoplastic drugs
C9399	Unclassified drugs or biologicals

Applicable NDCs / Product presentationsNDC

83047-0410-xx	Aucatzyl 410 × 10^6 CD19 CAR-positive viable T cells (three to five infusion bags)
83047-0010-xx	10 × 10^6 CD19 CAR-positive viable T cells in one 50mL infusion bag (Blue)
83047-0100-xx	100 × 10^6 CD19 CAR-positive viable T cells in one 50mL infusion bag (Orange)
83047-0100-xx	100 × 10^6 CD19 CAR-positive viable T cells in one 250mL infusion bag (Orange)
83047-0300-xx	300 × 10^6 CD19 CAR-positive viable T cells in one 250mL infusion bag (Red)

Applicable ICD-10 DiagnosesICD-10Covered

C91.00	Acute Lymphoblastic Leukemia Not Having Achieved Remission
C91.02	Acute Lymphoblastic Leukemia, In Relapse

Prior Authorization, Documentation, and Billing Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required. The treating physician or primary care provider must submit clinical documentation demonstrating the member meets ALL policy criteria (diagnosis, prior therapies, lab/testing results, screening, and monitoring plans) to EmblemHealth for preauthorization and/or post‑payment review. Failure to provide required documentation will prevent proper review and may result in denial.

Prior authorization required with submission of clinical documentation showing patient meets policy criteria
Applicable procedure codes: J9999 (Not otherwise classified, antineoplastic drugs); C9399 (Unclassified drugs or biologicals)

Documentation Required

Documentation Required to Establish Medical Necessity

The treating clinician must submit complete clinical evidence supporting medical necessity, including but not limited to: diagnosis documentation, prior lines of therapy, relevant laboratory and infectious disease screening (HBV, HCV, HIV), documentation of absence of active infection, vaccination history relative to live vaccines, monitoring plans for cytokine release syndrome (CRS) and neurologic events, and any re‑biopsy results showing CD19 status when prior anti‑CD19 therapy was given. EmblemHealth will use this information to determine medical necessity; the absence of these materials may result in denial.

Evidence must show member meets ALL policy criteria (see clinical criteria)
Include HBV, HCV, HIV screening results and vaccination history
Include monitoring and proximity plans for post‑infusion care (CRS monitoring for ≥14 days and staying near infusion center for ≥4 weeks)

Documentation Required

Prior Therapy Documentation Required

Document prior therapies clearly. For Ph‑positive disease, provide prior tyrosine kinase inhibitor (TKI) therapy history (examples: bosutinib, dasatinib, imatinib, nilotinib, ponatinib). For patients with prior anti‑CD19 therapy, provide re‑biopsy results confirming CD19 positive disease. Also document that the patient has not received prior CAR‑T therapy when applicable.

Document prior lines of therapy, including specific TKIs for Ph‑positive disease
If prior anti‑CD19 therapy occurred, submit re‑biopsy confirming CD19 positivity
Document no prior CAR‑T therapy when applicable

Biomarker and Cytogenetic Requirements

inv-17: CD19 — biomarker requirement (CD19-directed therapy)

BiomarkerCD19 positivity required when patient previously received anti‑CD19 therapy (re‑biopsy must demonstrate CD19 positive disease)

ContextCD19-directed therapy is the target of Aucatzyl (obecabtagene autoleucel), and prior anti‑CD19 exposure must be documented

Example prior anti‑CD19 agentBlinatumomab (example listed in policy)

inv-18: Philadelphia chromosome (Ph) — cytogenetic consideration

Cytogenetic considerationPhiladelphia chromosome (Ph) status must be documented; Ph‑positive patients must have received prior tyrosine kinase inhibitor (TKI) therapy

Examples of TKIsExamples include bosutinib, dasatinib, imatinib, nilotinib, or ponatinib (policy examples)

Ph‑negative pathwayPatients with Ph‑negative disease follow standard prior therapy documentation requirements (no TKI requirement)

Drug and Therapy Definitions

inv-15: Obecabtagene autoleucel — definition and indication

DefinitionCD19‑directed genetically modified autologous T‑cell immunotherapy indicated for relapsed or refractory B‑cell precursor acute lymphoblastic leukemia (ALL) in adults

Product nameObecabtagene autoleucel (Aucatzyl)

Administration componentsInvolves leukapheresis, lymphodepleting chemotherapy, and split‑dose IV infusion with monitoring for cytokine release syndrome and neurologic events

Obecabtagene autoleucel (Aucatzyl) is a CD19-directed autologous CAR T‑cell immunotherapy indicated for adults with relapsed or refractory B‑cell precursor acute lymphoblastic leukemia (ALL). Treatment involves leukapheresis to collect T cells, lymphodepleting chemotherapy followed by a split‑dose intravenous infusion totaling 410 x 10^6 CAR‑T cells administered on Days 1 and 10 (±2 days), with dosing tiers determined by bone marrow blast percentage. Patients require pre‑treatment screening for infectious agents and close monitoring for cytokine release syndrome and neurologic events after infusion.

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