CurrentCignaPolicy IP0734

Aucatzyl

Defines prior authorization, coverage criteria, dosing, and coding for Aucatzyl (obecabtagene autoleucel) for treatment of relapsed or refractory B‑cell precursor acute lymphoblastic leukemia in adults under Cigna-administered health plans.

Policy Summary

PayerCigna

PolicyAucatzyl

Policy CodePolicy IP0734

Change TypeNew policy with coding updates

Effective DateApr 15, 2025

Next Review Date

Key ActionSubmit prior authorization documenting age, relapsed/refractory B‑cell precursor ALL diagnosis, plan for lymphodepleting chemotherapy, no prior CAR‑T therapy, and that Aucatzyl is prescribed by or in consultation with an oncologist.

SourceLink

POLICY UPDATE CHANGES

New policy created for Aucatzyl with HCPCS coding updates.

Prior authorization requirement and approval duration set to 6 months.

410 x 10^6total recommended CAR‑T cells per therapeutic dose

2administration days

6 monthsapproval duration (single dose)

C9301 → Q2058HCPCS coding transition

Trek Health ingests and normalizes Transparency in Coverage data and payer policy updates to give provider organizations a clear view of how commercial reimbursement behaves across markets, payers, and services. Our platform transforms raw payer disclosures into structured intelligence that supports contract evaluation, payer negotiations, and service line strategy. By combining market benchmarks with ongoing policy visibility, Trek helps teams identify variability, risk, and opportunity in commercial reimbursement. The result is faster insight, stronger negotiating positions, and more informed financial decisions.

Coverage Criteria for Aucatzyl (obecabtagene autoleucel)

FDA‑Approved Indication

Approve a single dose if ALL of the following are met:

FDA‑approved indication criteria: A) Patient is ≥ 18 years of age; AND B) Patient has B‑cell precursor disease; AND C) Patient has relapsed or refractory disease; AND D) Patient received or plans to receive lymphodepleting chemotherapy prior to infusion of Aucatzyl; AND E) Patient has not been previously treated with CAR‑T therapy; AND F) Aucatzyl is prescribed by or in consultation with an oncologist.

Examples of CAR‑T therapies listed in policy; receipt of sample product does not satisfy criteria.

Dosing

Dosing criteria that must be met for approval:

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

Dose split is determined by bone marrow blast percentage: see split details in operational note.

Aucatzyl (obecabtagene autoleucel) is covered only when the patient meets the FDA‑approved indication and specified criteria. Aucatzyl for any use other than the listed FDA‑approved indication is considered not medically necessary.

Use of Aucatzyl for any indication other than relapsed or refractory B‑cell precursor acute lymphoblastic leukemia (ALL) in adults is not medically necessary and will not be approved under this policy.

Initial Therapy — Approval and Dosing Schedule

Initial Therapy

Initial dose approval and schedule — ALL criteria must be met:

Initial therapy criteria: Meet FDA‑approved indication criteria (age ≥18, B‑cell precursor ALL, relapsed/refractory, plan/receipt of lymphodepleting chemotherapy, no prior CAR‑T therapy, prescribed/consult by an oncologist); AND dosing of total 410 x 10^6 CAR‑T cells split across Days 1 and 10 (±2 days) per bone marrow blast percentage.

Single therapeutic dose approval; receipt of sample product does not satisfy criteria.

Dosing split (operational): If bone marrow blasts > 20%: Day 1 = 10 x 10^6 CAR‑T cells; Day 10 (±2 days) = 400 x 10^6 CAR‑T cells. If bone marrow blasts ≤ 20%: Day 1 = 100 x 10^6 CAR‑T cells; Day 10 (±2 days) = 310 x 10^6 CAR‑T cells.split based on marrow blasts

Blast percentage measured within 7 days of starting lymphodepleting chemotherapy (per dosing guidance).

Continuation and Approval Duration

Continuation/Approval Duration

Approval duration and related operational notes:

Approval duration is 6 months to allow for preparation and administration of one therapeutic dose.6 months

Approval requires Aucatzyl to be prescribed by or in consultation with a physician who specializes in the condition being treated (oncologist).

Provider Actions & Documentation Requirements

Prior Authorization

Prior Authorization Required

Prior Authorization is required for medical benefit coverage of Aucatzyl. Approvals are recommended only for patients who meet the policy's clinical criteria and dosing. Because evaluation, diagnosis, monitoring for adverse events, and long‑term follow‑up require specialized skills, Aucatzyl must be prescribed by or in consultation with a physician who specializes in the condition being treated. Approval duration is 6 months to allow time to prepare and administer one dose of therapy.

Prior authorization required for medical benefit coverage of Aucatzyl; approval duration = 6 months
Prescriber requirement: prescribed by or in consultation with an oncologist/specialist in the treated condition
Claims submitted without covered diagnosis or procedure codes will be denied; services billed for non‑covered conditions will be denied

Step Therapy

Step therapy requirements: No step therapy is required beyond the specific criteria listed in the FDA‑approved indication. Do not approve if the patient has received prior CAR‑T therapy.

Coding and Billing

Considered Medically Necessary / Covered CodesCPT | HCPCSCovered

38225	Chimeric antigen receptor T-cell (CAR‑T) therapy; harvesting of blood‑derived T lymphocytes for development of genetically modified autologous CAR‑T cells, per day.
38226	Chimeric antigen receptor T-cell (CAR‑T) therapy; preparation of blood‑derived T lymphocytes for transportation (e.g., cryopreservation, storage).
38227	Chimeric antigen receptor T-cell (CAR‑T) therapy; receipt and preparation of CAR‑T cells for administration.
38228	Chimeric antigen receptor T-cell (CAR‑T) therapy; CAR‑T cell administration, autologous.
C9301	Obecabtagene autoleucel, up to 410 million cd19 car‑positive viable t cells, including leukapheresis and dose preparation procedures, per therapeutic dose (Effective until 6/30/2025).
Q2058	Obecabtagene autoleucel, up to 400 million cd19 car‑positive viable t cells, including leukapheresis and dose preparation procedures, per therapeutic dose (Effective Date 7/1/2025).

inv-06: Total dose — display total recommended CAR‑T cells per therapeutic dose

Total recommended therapeutic dose410 x 10^6 CD19 CAR‑positive viable T cells per therapeutic dose

Dose administration scheduleDose is split and administered on Days 1 and 10 (±2 days)

Split dosing by bone marrow blast %If bone marrow blasts >20%: Day 1 = 10 x 10^6; Day 10 = 400 x 10^6; If ≤20%: Day 1 = 100 x 10^6; Day 10 = 310 x 10^6

Quantity Limits

inv-16: Aucatzyl (obecabtagene autoleucel) — quantity limit (number of doses)

Quantity limit1 therapeutic dose per course

Therapeutic dose definitionOne therapeutic dose = up to 410 million CD19 CAR‑positive viable T cells (per C9301 description)

HCPCS transition noteHCPCS C9301 described the product per therapeutic dose (effective until 6/30/2025); Q2058 effective 7/1/2025

Site of Care and Administration

Note

Infusion center or hospital outpatient; specialized monitoring required

Administration should occur in a clinically appropriate site of care with specialized evaluation and monitoring available; because of required monitoring and specialized skills, Aucatzyl administration must be prescribed by or in consultation with an oncologist and is intended for infusion center or hospital outpatient settings.

Site of care: infusion center or hospital outpatient as clinically appropriate.
Requires specialized evaluation and monitoring for adverse events (e.g., cytokine release syndrome, neurologic toxicity).
Must be prescribed by or in consultation with a specialist (oncologist).

Definitions

inv-12: Aucatzyl — definition and short description of the product

Generic name (INN)Obecabtagene autoleucel

Proprietary nameAucatzyl

Product descriptionA CD19‑directed genetically modified autologous T‑cell immunotherapy indicated for relapsed or refractory B‑cell precursor acute lymphoblastic leukemia in adults

Safety highlightsBoxed warnings: cytokine release syndrome, neurologic toxicity including ICANS, and secondary hematologic malignancies

Step Therapy

Step	Requirement / Notes
1	No prior CAR‑T therapy: patient must not have been previously treated with CAR‑T therapy (examples listed in policy).
Ph‑positive patients	Prior tyrosine kinase inhibitor (TKI) therapy may be considered per NCCN guidance; policy does not specify a TKI step‑failure requirement — meeting the FDA‑approved criteria (including no prior CAR‑T) is required for approval.

Background

Aucatzyl is a CD19‑directed autologous CAR‑T cell therapy indicated for treatment of relapsed or refractory B‑cell precursor acute lymphoblastic leukemia in adults. It is administered as a single therapeutic dose of engineered autologous T cells and carries significant safety considerations that require specialist oversight and monitoring. Boxed warnings include risks such as cytokine release syndrome and neurologic toxicities (including ICANS), which inform the requirement that Aucatzyl be prescribed by or in consultation with an oncologist and administered in an appropriate clinical setting.