CurrentCareSourcePolicy N/A

Aucatzyl (obecabtagene autoleucel) CAR‑T therapy — Medical benefit prior authorization and coverage criteria

Medical benefit prior authorization and coverage criteria for Aucatzyl (obecabtagene autoleucel) for treatment of relapsed or refractory B-cell precursor acute lymphoblastic leukemia in adults under CareSource Medicare Advantage lines of business.

Policy Summary

PayerCareSource

PolicyAucatzyl (obecabtagene autoleucel) CAR‑T therapy — Medical benefit prior authorization and coverage criteria

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Next Review DateN/A

Key ActionObtain prior authorization and document that the patient meets the listed eligibility and dosing criteria; approval duration is 6 months.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

410total recommended CAR‑T cell dose

Split Day1/Day10administration schedule

6 moauthorization period

Boxedsafety concerns

All Statesgeographic applicability

Policy Summary

PayerCareSource

PolicyAucatzyl (obecabtagene autoleucel) CAR‑T therapy — Medical benefit prior authorization and coverage criteria

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Next Review DateN/A

Key ActionObtain prior authorization and document that the patient meets the listed eligibility and dosing criteria; approval duration is 6 months.

SourceLink

On This Page

Initial Therapy

Coverage of Aucatzyl is recommended in those who meet the following criteria:

Initial approval for Acute Lymphoblastic Leukemia: Approve a single dose if the patient meets ALL of the following (A, B, C, D, and E):

Eligibility: A) Patient has B-cell precursor disease; B) Patient is >= 18 years of age; C) Patient received or plans to receive lymphodepleting chemotherapy prior to infusion; D) Patient has not been previously treated with CAR-T therapy; (IC-COMP applies).

Examples of prior CAR-T therapies listed in policy: Aucatzyl, Tecartus, Breyanzi, Kymriah, Yescarta, Abecma.

Dosing: Administer a total dose of 410 x 10^6 CAR-T cells by intravenous infusion; the dose is split and administered on Day 1 and Day 10 (+2 days).

Split dosing depends on bone marrow blast percentage (>20% vs <20%) as described in dosing guidance.

Coverage of Aucatzyl is not recommended for circumstances not listed in the Recommended Authorization Criteria. Criteria will be updated as new published data become available.

Preferred and Alternative Regimens

Regimen	Indication / Line of therapy	Coverage status	Notes
Aucatzyl (obecabtagene autoleucel) CAR‑T therapy	Relapsed or refractory Philadelphia chromosome–negative B‑cell acute lymphoblastic leukemia (ALL)	Covered	Preferred regimen per NCCN (category 2A). Single dose administration; total dose 410 x 10^6 CAR‑positive viable T cells given as split dose on Day 1 and Day 10 (+2 days); dosing split depends on bone marrow blast percentage. Prior authorization recommended; patient must be ≥18 years, have B‑cell precursor disease, receive or plan lymphodepleting chemotherapy, and must not have prior CAR‑T therapy. Approval duration: 6 months.
Aucatzyl (obecabtagene autoleucel) CAR‑T therapy	Philadelphia chromosome–positive B‑cell ALL following tyrosine kinase inhibitor (TKI) therapy	Covered	Listed by NCCN as an Other Recommended Regimen (category 2A) for Ph‑positive disease after TKI treatment. Same dosing and authorization requirements as for Ph‑negative disease. Monitor for boxed warnings including CRS and neurotoxicity.

Coding, Dose, and Documentation Notes

Referenced coding guidancemixed

No codes listed

Bone marrow blasts

Threshold> 20% versus < 20% determines split dosing; bone marrow blast percentage is measured within 7 days before lymphodepleting chemotherapy.

> 20% split dosingWhen bone marrow blasts > 20%: Day 1 = 10 x 10^6 CAR‑T cells; Day 10 (+2 days) = 400 x 10^6 CAR‑T cells.

< 20% split dosingWhen bone marrow blasts < 20%: Day 1 = 100 x 10^6 CAR‑T cells; Day 10 (+2 days) = 310 x 10^6 CAR‑T cells.

Total recommended doseTotal dose = 410 x 10^6 CAR‑T cells administered as the split schedule above.

Prior Authorization and Documentation Requirements

Prior Authorization

Prior Authorization Recommended

Prior authorization is recommended for medical benefit coverage of Aucatzyl. Approval is recommended for patients who meet the policy's Recommended Authorization Criteria. The approval duration is 6 months to allow adequate time to prepare and administer a single dose of therapy.

Approval duration: 6 months
Prior authorization: recommended

Denial Risk

Previous CAR‑T Exclusion

Patient must not have been previously treated with CAR‑T therapy to be eligible for approval. Examples of CAR‑T products include Aucatzyl, Tecartus (brexucabtagene autoleucel), Breyanzi (lisocabtagene maraleucel), Kymriah (tisagenlecleucel), Yescarta (axicabtagene ciloleucel), and Abecma (idecabtagene vicleucel).

Previous CAR‑T exposure = exclusion

Documentation Required

Coding and Documentation Note

This policy incorporates Medicare coverage guidance (NCDs/LCDs) and may reference HCPCS and ICD‑10 codes in companion articles. Presence of a specific code alone is not sufficient to approve coverage, and absence of a code does not necessarily exclude coverage. See Sources of Information and companion articles for coding lists used for reference.

Policy references Medicare NCD/LCD guidance and companion articles
HCPCS and ICD‑10 code lists are for reference only

Denial Risk

General Denial Risk

Coverage is not recommended for circumstances not listed in the Recommended Authorization Criteria. Criteria will be updated as new published data become available.

Denial likely if request does not meet Recommended Authorization Criteria

Product and Clinical Background

Aucatzyl (obecabtagene autoleucel) is a CD19-directed CAR‑T cell therapy indicated for treatment of relapsed or refractory B‑cell precursor acute lymphoblastic leukemia (ALL) in adults. The total recommended CAR‑T cell dose is 410 x 10^6 CD19 CAR‑positive viable T cells administered by intravenous infusion, delivered as a split dose on Day 1 and Day 10 (+2 days); the dosing split is determined by bone marrow blast percentage (>20% versus <20%). The therapy carries significant risks, including cytokine release syndrome, immune effector cell‑associated neurotoxicity, and potential secondary hematologic malignancies; prior authorization is recommended and approval is contingent on meeting the policy's listed criteria, including that the patient has not previously received CAR‑T therapy and will receive lymphodepleting chemotherapy prior to infusion.

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Aucatzyl (obecabtagene autoleucel) CAR‑T therapy — Medical benefit prior authorization and coverage criteria

Recommended Authorization Criteria

Preferred and Alternative Regimens

Coding, Dose, and Documentation Notes

Prior Authorization and Documentation Requirements

Positioning and Salvage Use

Product and Clinical Background

Key Definitions