CurrentCareSourcePolicy N/A

PHARMACY POLICY STATEMENT Arkansas PASSE

Defines medical-benefit coverage and prior authorization criteria for Aucatzyl (obecabtagene autoleucel) for adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL) under CareSource Arkansas PASSE pharmacy policy.

Policy Summary

PayerCareSource

PolicyPHARMACY POLICY STATEMENT Arkansas PASSE

Policy CodePolicy N/A

Change TypeNew policy

Effective DateJul 1, 2025

Next Review Date

Key ActionObtain prior authorization for Aucatzyl (obecabtagene autoleucel) prior to infusion per CareSource policy.

SourceLink

POLICY UPDATE CHANGES

New policy for Aucatzyl created

1Covered Indications (ALL)

0Reauthorizations allowed

1Prior Authorization required

Coverage Summary

Coverage stance: covered_with_criteria. Scope: Defines medical-benefit coverage and prior authorization criteria for Aucatzyl (obecabtagene autoleucel) for adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL) under the CareSource Arkansas PASSE policy. FDA approval: Approved by the FDA in 2024 for adults with relapsed or refractory B-cell precursor ALL. Benefit type: Medical benefit; prior authorization is required.

Initial Authorization - Acute Lymphoblastic Leukemia (ALL)

Covered when ALL of the following are met:

ALL of the following

Age: Member is at least 18 years of age>= 18 years
Prescriber: Medication must be prescribed by a hematologist/oncologist
Diagnosis: Member has a diagnosis of B-cell acute lymphoblastic leukemia (B-cell ALL)
Documentation of one of the following
- Ph-: Relapsed or refractory Philadelphia chromosome negative (Ph-) disease
- Ph+: Relapsed or refractory Philadelphia chromosome positive (Ph+) disease following therapy that has included tyrosine kinase inhibitors (TKIs)
Biomarker: Documentation of CD19 tumor expression
Bone marrow lymphoblasts: Bone marrow with > 5% lymphoblasts by morphologic assessment> 5% by morphologic assessment
ECOG: Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 10 or 1
Infection screening: Member has been or will be screened for hepatitis B virus (HBV), hepatitis C virus (HCV), and human immunodeficiency virus (HIV)
Prior CAR-T exclusion: Member has NOT had prior CAR-T therapy
Prior CAR-T therapy is an exclusion for approval
Dosage / quantity limit: Dosage/Quantity limit: 410 X 10^6 CD19 CAR-positive viable T cells as a split dose IV infusion on day 1 and day 10 (+/- 2 days)
Dose expressed in policy verbatim

Provider Actions & Authorization Requirements

Prior Authorization

Prior Authorization Required

Obtain prior authorization for Aucatzyl (obecabtagene autoleucel) prior to infusion per policy.

Documentation Required

Clinical documentation required

Document the following in the medical record for initial authorization: age (>= 18 years); prescribing provider specialty (hematologist/oncologist); diagnosis of B-cell acute lymphoblastic leukemia (B-cell ALL); Philadelphia chromosome (Ph) status and prior therapies (including tyrosine kinase inhibitors for Ph+ disease); evidence of CD19 tumor expression; bone marrow percent lymphoblasts (> 5% by morphologic assessment); Eastern Cooperative Oncology Group (ECOG) performance status (0 or 1); and screening for hepatitis B virus (HBV), hepatitis C virus (HCV), and human immunodeficiency virus (HIV).

Age: >= 18 years
Prescribing provider specialty: hematologist/oncologist
Diagnosis: B-cell ALL
Ph status and prior therapies (including TKIs for Ph+)
CD19 tumor expression
Bone marrow > 5% lymphoblasts by morphologic assessment
ECOG performance status 0 or 1
Screening for HBV, HCV, and HIV

Denial Risk

Prior CAR-T therapy exclusion

Claims will not meet medical necessity and authorization is excluded if the member has had prior CAR-T therapy.

Billing Rule

Dosage / quantity limit

Authorize dosing per policy: 410 X 10^6 CD19 CAR-positive viable T cells as a split dose IV infusion on day 1 and day 10 (± 2 days). Quantity limit corresponds to the single authorized dose as stated in the policy.

Dose: 410 X 10^6 CD19 CAR-positive viable T cells
Schedule: split dose IV infusion on day 1 and day 10 (± 2 days)

Background & Definitions

Aucatzyl (obecabtagene autoleucel) is a CD19-directed autologous CAR-T cell therapy. The FDA approved Aucatzyl in 2024 for the treatment of adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL). Per this policy, Aucatzyl does not have a REMS program.

Aucatzyl: Brand name for obecabtagene autoleucel, a CD19-directed autologous CAR-T cell therapy.

ECOG: Eastern Cooperative Oncology Group performance status.

Clinical thresholds

Age>= 18 years

Bone marrow lymphoblasts> 5% by morphologic assessment

ECOG performance status0 or 1

Policy Summary

PayerCareSource

PolicyPHARMACY POLICY STATEMENT Arkansas PASSE

Policy CodePolicy N/A

Change TypeNew policy

Effective DateJul 1, 2025

Next Review Date

Key ActionObtain prior authorization for Aucatzyl (obecabtagene autoleucel) prior to infusion per CareSource policy.

SourceLink

On This Page

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PHARMACY POLICY STATEMENT Arkansas PASSE

Coverage Summary

Continuation / Reauthorization Criteria

Provider Actions & Authorization Requirements

Applicable Codes & Benefit

Clinical Evidence & References

Background & Definitions

Revision History

Medical benefit	Aucatzyl (obecabtagene autoleucel) is covered under the medical benefit
Prior Authorization Required	Prior authorization required per policy