CurrentMass General Brigham Health PlanPolicy 088

Aucatzyl (Obecabtagene Autoleucel)

Defines clinical coverage criteria, required documentation, exclusions, dosing overview, payer-specific variations, and related billing codes for Aucatzyl (obecabtagene autoleucel) for adults with relapsed/refractory B-cell precursor acute lymphoblastic leukemia (B-ALL). Applies to Commercial, MassHealth, and Medicare Advantage members of Mass General Brigham Health Plan with noted program variations.

Policy Summary

PayerMass General Brigham Health Plan

PolicyAucatzyl (Obecabtagene Autoleucel)

Policy CodePolicy 088

Change TypeAdded - initial coverage criteria and requirements

Effective DateMay 12, 2025

Next Review Date

Key ActionPrior authorization is required for Aucatzyl for Commercial, MassHealth, and Medicare Advantage members; submit MassHealth prior authorizations to the MassHealth Drug Utilization Review Program per Table 75.

POLICY UPDATE CHANGES

Policy establishes coverage criteria and requirements for Aucatzyl (obecabtagene autoleucel) for adult R/R B-ALL.

1FDA-approved indication

>=18Minimum age

5%Min bone marrow blasts

38225-38228,C9301Informational codes listed

Background: Aucatzyl (obecabtagene autoleucel, also referred to as obe-cel) is a CD19-directed CAR‑T therapy approved for the treatment of adults with relapsed or refractory B‑cell precursor acute lymphoblastic leukemia (R/R B‑ALL). It is intended for patients aged ≥ 18 years meeting clinical eligibility criteria and is subject to prior authorization for Commercial, MassHealth, and Medicare Advantage members.

Scope summary: This policy defines coverage criteria, required documentation, exclusions, a dosing overview (a split‑dose infusion schedule), and informational billing codes for Aucatzyl for adults with R/R B‑ALL. Prior authorization is required for Commercial, MassHealth (submitted to the MassHealth Drug Utilization Review Program for Mass General Brigham ACO members), and Medicare Advantage plans; Medicare determinations follow applicable CMS NCD/LCD guidance. The FELIX trial context: the pivotal FELIX cohort showed an overall remission rate of 77%, median event‑free survival of 11.9 months, 12‑month overall survival of 61.1%, and low rates of severe CRS and ICANS (Grade ≥3 CRS 2.4%, Grade ≥3 ICANS 7.1%), providing the primary evidence metrics referenced in the policy.

Surface thresholds

Age>= 18 years

Bone marrow blasts>= 5% blasts in bone marrow

ECOG Performance Status0 or 1

Creatinine clearance (Cockcroft-Gault)>= 50 cc/minute

ALT/AST<= 2.5x ULN

Total bilirubin<= 1.5x ULN (normal direct bilirubin if Gilbert's syndrome)

LVEF>= 45% (or institution lower limit of normal when applicable)

Baseline oxygen saturation> 92% on room air

FELIX trial metrics

Overall remission rate (FELIX pivotal cohort)77%

Median event-free survival (FELIX)11.9 months

12-month overall survival (FELIX)61.1%

Grade >=3 cytokine release syndrome (FELIX)2.4%

Grade >=3 ICANS (FELIX)7.1%

Initial Approval Criteria

Initial Approval

Covered when ALL of the following are met:

ALL of the following

Age at least 18 years
Diagnosis: Relapsed or refractory CD19-positive B-cell precursor acute lymphoblastic leukemia (B-ALL)
CD19 expression must be demonstrated (see Required Documentation)
Disease status (ONE of)
- Primary refractory disease (not achieving complete remission after two cycles of induction chemotherapy)
- First relapse if first remission duration was up to 12 months
- Relapsed or refractory disease after two or more lines of systemic therapy
- Relapsed or refractory disease after allogeneic transplant provided obe-cel infusion occurs at least 3 months after stem cell transplant
ECOG Performance Status 0 or 1
Ph+ (Philadelphia chromosome-positive) disease condition (ONE of)
- If CD19-positive Ph+ ALL, intolerant to or has failed two lines of tyrosine kinase inhibitor (TKI) therapy
- If CD19-positive Ph+ ALL, failed one line of second-generation TKI therapy
- If CD19-positive Ph+ ALL, TKI therapy is contraindicated
Adequate organ function (ALL of)
- Presence of at least 5% blasts in bone marrow
- Serum alanine aminotransferase (ALT) and aspartate aminotransferase (AST) up to 2.5x upper limit of normal (ULN)<= 2.5x ULN
- Creatinine clearance (Cockcroft-Gault) at least 50 cc/minute>= 50 cc/minute
- Total bilirubin up to 1.5x ULN, except patients with Gilbert's syndrome who must have normal direct bilirubin<= 1.5x ULN
- Left ventricular ejection fraction (LVEF) at least 45% (or at least institution's lower limit of normal) confirmed by ECHO or MUGA in patients with history of coronary artery disease or cardiovascular disease or prior low LVEF
Baseline oxygen saturation > 92% on room air>92%

Required Documentation

ALL of the following

CD19 expression on leukemic blasts in bone marrow, peripheral blood, or cerebrospinal fluid by flow cytometry within 1 month of screeningwithin 1 month of screening
For patients treated with blinatumomab, testing should be undertaken after blinatumomab therapy has been stopped

Documentation Required

Document CD19 expression

Provide flow cytometry demonstrating CD19 expression on leukemic blasts (bone marrow, peripheral blood, or cerebrospinal fluid) by flow cytometry within 1 month of screening. If the patient received prior blinatumomab, testing should be performed after blinatumomab therapy has been stopped.

Documentation Required

Document organ function and performance status

Submit laboratory and assessment results as part of the authorization request to document adequate organ function and performance status: serum ALT/AST, total bilirubin, creatinine clearance (Cockcroft‑Gault), left ventricular ejection fraction (ECHO or MUGA when indicated), baseline oxygen saturation on room air, and ECOG performance status (0 or 1).

Exclusions / Not Eligible

Not covered when ANY of the following apply:

ANY of the following

B-ALL with isolated extramedullary disease
Diagnosis of Burkitt's leukemia/lymphoma according to WHO classification or chronic myelogenous leukemia lymphoid in blast crisis
History or presence of clinically relevant CNS pathology (epilepsy, paresis, aphasia, stroke within 3 months prior to consent, severe brain injuries, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome, uncontrolled mental illness, or psychosis)
CNS disease severity (ONE of)
- Presence of CNS 3 disease
- Presence of CNS 2 disease with neurological changes
Active or uncontrolled infection requiring systemic antimicrobials
Active or latent hepatitis B virus or active hepatitis C virus
Positive test for HIV, HTLV-1, HTLV-2, or syphilis
Received a prior stem cell transplant less than 3 months prior to obe-cel infusion< 3 months
Active significant (overall grade ≥2, Seattle criteria) acute Graft vs Host Disease (GVHD) or moderate/severe chronic GVHD (NIH consensus criteria) requiring systemic steroids or other immunosuppressants within 4 weekswithin 4 weeks
Received prior anti-CD19 targeted therapy other than blinatumomab
Patients who experienced Grade ≥3 neurotoxicity following blinatumomabGrade ≥3
Therapeutic doses of corticosteroids (>10 mg daily prednisone equivalent) within 7 days of leukapheresis or 72 hours prior to obe-cel administration (physiological replacement, topical, and inhaled steroids are permitted)>10 mg prednisone equivalent
Immunosuppressive medication not stopped at least 2 weeks prior to leukapheresis and obe-cel infusionnot stopped ≥2 weeks
Any donor lymphocyte infusions completed ≤2 weeks prior to leukapheresis or planned to be repeated thereafter≤2 weeks
GVHD therapies not stopped >2 weeks prior to leukapheresis or planned to be reinitiated thereafternot stopped >2 weeks
Chemotherapy (including TKI therapy for Ph+ ALL) not stopped 1 week prior to leukapheresis or starting preconditioning chemotherapynot stopped 1 week
Treatment with any T-cell lytic or toxic antibody (e.g., alemtuzumab) within 6 months prior to leukapheresis, or clofarabine or cladribine within 3 months prior to leukapheresis6 months or 3 months as specified
Live vaccine within 4 weeks prior to leukapheresiswithin 4 weeks
Intrathecal therapy within 2 weeks prior to starting preconditioning chemotherapywithin 2 weeks
Use of blinatumomab after leukapheresis

Documentation Required

Timing restrictions for prior therapies and vaccinations

Ensure prior therapies and vaccinations meet required cessation intervals before leukapheresis and/or obe-cel infusion. Stop or document timing for corticosteroids, immunosuppressants, donor lymphocyte infusions, GVHD therapies, certain T‑cell–lytic antibodies or specified chemotherapies, live vaccines, intrathecal therapy, and avoid blinatumomab after leukapheresis.

Therapeutic corticosteroids >10 mg prednisone eq.: not within 7 days of leukapheresis or 72 hours prior to infusion
Immunosuppressive medications: stopped ≥2 weeks prior to leukapheresis and infusion
Donor lymphocyte infusions: completed >2 weeks before leukapheresis and not repeated
GVHD therapies: stopped >2 weeks before leukapheresis and not reinitiated
Chemotherapy (including TKIs): stopped 1 week before leukapheresis or before preconditioning
T‑cell lytic/toxic antibodies (e.g., alemtuzumab): not within 6 months prior to leukapheresis
Clofarabine or cladribine: not within 3 months prior to leukapheresis
Live vaccines: not within 4 weeks prior to leukapheresis
Intrathecal therapy: not within 2 weeks prior to starting preconditioning chemotherapy
Do not use blinatumomab after leukapheresis

Coding (informational)

CAR-T related procedure codes (informational)CPT

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 (eg, 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

Aucatzyl specific HCPCS (informational)HCPCS

C9301

Obecabtagene autoleucel, up to 410 million CD19 CAR-positive viable T cells, including leukapheresis and dose preparation procedures, per therapeutic dose

Billing Rule

Use informational CAR-T procedure and HCPCS codes

The following CAR‑T procedure CPT codes and HCPCS code are listed for informational purposes only; inclusion does not by itself imply coverage or reimbursement.

38225
38226
38227
38228
C9301

Provider Actions & Authorization

Prior Authorization

Authorization required

Prior authorization is required for Aucatzyl for Commercial, MassHealth, and Medicare Advantage members. For MassHealth members, prior authorization requests should be submitted to the MassHealth Drug Utilization Review Program per the MassHealth variation.

Commercial and Medicare Advantage: prior authorization required
MassHealth: prior authorization required; submit requests to the MassHealth Drug Utilization Review Program (see Table 75: T‑Cell Immunotherapies)

Documentation Required

Timing restrictions (prior therapies & vaccines)

Document key timing rules affecting leukapheresis and infusion, including required cessation intervals for steroids, immunosuppressants, donor lymphocyte infusions, GVHD therapies, chemotherapy/TKIs, certain antibodies or nucleoside analogs, live vaccines, intrathecal therapy, and the prohibition on blinatumomab use after leukapheresis.

Steroids: therapeutic corticosteroids >10 mg prednisone eq. avoided within 7 days of leukapheresis and 72 hours before infusion
Immunosuppressants/GVHD therapies: stopped ≥2 weeks before leukapheresis and not reinitiated
Donor lymphocyte infusions: completed >2 weeks prior to leukapheresis and not repeated
Chemotherapy/TKIs: stopped 1 week prior to leukapheresis or before preconditioning
T‑cell lytic/toxic antibodies (e.g., alemtuzumab): avoid within 6 months prior to leukapheresis
Clofarabine/cladribine: avoid within 3 months prior to leukapheresis
Live vaccines: avoid within 4 weeks prior to leukapheresis
Intrathecal therapy: avoid within 2 weeks prior to starting preconditioning chemotherapy
Do not use blinatumomab after leukapheresis

Background & Evidence

Aucatzyl (obe‑cel) is a chimeric antigen receptor T‑cell (CAR‑T) therapy that genetically modifies a patient’s T cells to target CD19-expressing malignant B cells. It is FDA‑approved for the treatment of adults with relapsed or refractory B‑cell precursor acute lymphoblastic leukemia (ALL).

Dosing and schedule: obe‑cel is administered as a split‑dose infusion delivered on Day 1 and Day 10 (±2 days), with a therapeutic dose of up to 410 × 10^6 CD19 CAR‑positive viable T cells; the actual dose administered is determined by the patient’s bone marrow blast assessment.

Evidence context (FELIX): the combined phase 1b‑2 FELIX study served as the pivotal evidence base, with the pivotal cohort demonstrating a 77% overall remission rate, median event‑free survival of 11.9 months, 12‑month overall survival of 61.1%, and relatively low rates of severe toxicity (Grade ≥3 CRS 2.4%, Grade ≥3 ICANS 7.1%), supporting the approval and favorable safety/efficacy profile.

Additional evidence / definitions

Definition: ICANSImmune effector cell-associated neurotoxicity syndrome

Split-dose regimenInfusions on Day 1 and Day 10 (±2 days), dose up to 410 x10^6 CD19 CAR-positive viable T cells

Patient group with better outcomesLow (<5%) or intermediate (5-75%) bone marrow blasts saw better outcomes (FELIX)

ECOG: Eastern Cooperative Oncology Group (ECOG) Performance Status – a scale measuring a patient’s functional status; this policy requires ECOG Performance Status of 0 or 1 for coverage.

ICANS: Immune effector cell‑associated neurotoxicity syndrome (ICANS) – neurotoxic adverse events associated with immune effector cell therapies; Grade ≥3 ICANS rates from the FELIX pivotal cohort were 7.1%.

GVHD: Graft versus Host Disease (GVHD) – immune‑mediated complication after allogeneic transplant; the policy references acute and chronic GVHD severity and timing in exclusions (e.g., active significant acute GVHD overall grade ≥2 or moderate/severe chronic GVHD requiring systemic immunosuppression).

OpenPayer

Aucatzyl (Obecabtagene Autoleucel)

Coverage Summary

Initial Approval Criteria

Required Documentation

Dosage and Administration

Exclusions / Not Eligible

Coding (informational)

Provider Actions & Authorization

Background & Evidence

Medicare Determinations

Revision History