CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Aucatzyl (obecabtagene autoleucel)

Defines accepted indications, contraindications/warnings, exclusion criteria, coding, and applicable lines of business for Aucatzyl (obecabtagene autoleucel) use in cancer treatment, including FDA-approved and off-label uses supported by recognized compendia or peer-reviewed literature. Applies to medication requests processed by Evolent for Neighborhood Health Plan of Rhode Island lines of business (Commercial, Exchange/Marketplace, Medicaid).

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyAucatzyl (obecabtagene autoleucel)

Policy CodePolicy N/A

Change TypeTemplate conversion; reference updates

Effective Date

Next Review Date

Key ActionAll medication requests for Aucatzyl must be processed and authorized by Evolent; ensure use is supported by FDA labeling, CMS-recognized compendia, NCCN/ASCO guidelines, or peer-reviewed literature meeting CMS Chapter 15 requirements.

SourceLink

POLICY UPDATE CHANGES

December 2025 entry: Converted to new Evolent guideline template and replaced prior UM ONC_1513 Aucatzyl policy; updated references.

December 2024: New policy created.

1Covered Indications (adult B-cell precursor ALL)

1HCPCS code listed

410e6Dose cap (CD19 CAR-positive viable T cells)

Coverage Summary

Scope: Defines accepted indications, contraindications/warnings, exclusion criteria, coding, and applicable lines of business for Aucatzyl (obecabtagene autoleucel) use in cancer treatment. The policy accepts use for adult members with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL) and applies to Neighborhood Health Plan of Rhode Island lines of business including Commercial, Exchange/Marketplace, and Medicaid.

Coverage stance is mixed; the policy requires that all medication requests for Aucatzyl be processed and authorized by Evolent. Medications not authorized by Evolent may be deemed not approvable and not reimbursable.

Policy thresholds & stats

Total dose maximum≤ 410 × 10^6 CD19 CAR-positive viable T cells

Continuation authorization lapse≤ 30 days (continuation requires no lapse > 30 days and used within last year)

Covered indication count1 adult B-cell precursor ALL indication

HCPCS codes listedQ2058

Dose cap stat410e6

Initial Therapy / Medical Necessity

Indications / Medically Necessary

Aucatzyl may be used when ALL of the following are met:

ALL of the following

Patient is an adult member
Diagnosis of relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL)
Use is consistent with FDA approved product labeling, or supported by CMS-approved compendia, NCCN, ASCO clinical guidelines, or peer-reviewed literature meeting CMS Medicare Benefit Policy Manual Chapter 15 requirements

Continuation Therapy / Exemption

Continuation Therapy Exemption (for otherwise not-approvable medication)

Continuation requests for a not-approvable medication shall be exempt provided ALL of the following are met:

ALL of the following

Member has not experienced disease progression on the requested medication
Requested medication was used within the last year without a lapse of more than 30 days of having an active authorization<= 30 days lapse
Continuation authorization lapse threshold
Additional medication(s) are not being added to the continuation request

Exclusions / Not Medically Necessary

Exclusion Criteria / Not Medically Necessary or Not Covered

Aucatzyl is excluded if ANY of the following apply:

ANY of the following

Disease progression while taking Aucatzyl (obecabtagene autoleucel)
Concurrent use with other anticancer therapies
Dose threshold is an absolute exclusion: Dosing exceeds total dose of 410 × 10^6 CD19 chimeric antigen receptor (CAR) positive viable T cells> 410 × 10^6 CD19 CAR-positive viable T cells (absolute exclusion)
Dose threshold is an absolute exclusion
ANY of the following
- Evidence insufficiency considerations include
  - Whether the clinical characteristics of the patient and the cancer are adequately represented in the published evidence
  - Whether the administered therapy regimen is adequately represented in the published evidence
  - Whether reported study outcomes represent clinically meaningful outcomes (ASCO definitions e.g., HR < 0.80; recommended OS/PFS benefit ≥ 3 months)HR < 0.80; OS/PFS benefit ≥ 3 months
    ASCO-recommended metrics
  - Whether experimental design is appropriate (recognizes non-randomized trials may be supportive in some contexts)
  - Case reports and abstracts without full peer-reviewed articles lack adequate supportive evidence

Contraindications & Warnings (Safety Requirements)

Contraindications / Warnings (administrative safety requirements)

Do not administer or use caution when ANY of the following apply; monitor and ensure readiness:

ANY of the following

Active infection or inflammatory disorders (do not administer)
Risk of cytokine release syndrome (CRS); ensure immediate access to medications and resuscitative equipment to manage CRS
Risk of immune effector cell-associated neurotoxicity syndrome (ICANS); monitor neurologic signs and ensure immediate access to medications/resuscitative equipment; provide supportive care and/or corticosteroids as needed
Risk of T cell malignancies following treatment with BCMA- and CD19-directed genetically modified autologous T cell immunotherapies

Provider Actions & Authorization Requirements

Prior Authorization

Authorization required and processed by Evolent

All medication requests for Aucatzyl (obecabtagene autoleucel) must be processed and authorized by Evolent. Medications not authorized by Evolent may be deemed not approvable and not reimbursable.

Q2058

Documentation Required

Support with recognized evidence

Use must be supported by FDA approved product labeling, CMS‑approved compendia, National Comprehensive Cancer Network (NCCN) or American Society of Clinical Oncology (ASCO) clinical guidelines, or peer‑reviewed literature that meets the requirements of the CMS Medicare Benefit Policy Manual Chapter 15. Documentation must demonstrate the adequacy of evidence for any off‑label uses.

Denial Risk

Denial if exclusion criteria met

Requests will be excluded or denied if any exclusion criteria are met, including disease progression while taking Aucatzyl, concurrent use with other anticancer therapies, a total dosing that exceeds 410 × 10^6 CD19 CAR‑positive viable T cells, or investigational/off‑label use that lacks sufficient evidence or general acceptance.

Q2058

Documentation Required

Safety preparedness at administration

Prior to administering Aucatzyl, ensure immediate access to medications and resuscitative equipment and the capability to monitor for and manage cytokine release syndrome (CRS) and immune effector cell‑associated neurotoxicity syndrome (ICANS). Document the member’s infection and inflammatory status; do not administer Aucatzyl to patients with active infection or inflammatory disorders.

Clinical Evidence & References

Evidence cited: Key trial/publication is Roddie C, et al., "Obecabtagene Autoleucel in Adults with B-Cell Acute Lymphoblastic Leukemia," N Engl J Med. 2024. The policy also references the product Prescribing Information: "Aucatzyl prescribing information," Autolus Inc., 2025.

Policy references FDA labeling and recognizes CMS-approved compendia, NCCN and ASCO clinical guidelines, and peer-reviewed literature meeting CMS Medicare Benefit Policy Manual Chapter 15 requirements as acceptable sources of support for use.

Definitions

Clinically meaningful outcomesASCO-recommended metrics (e.g., Hazard Ratio < 0.80 and OS/PFS benefit ≥ 3 months)

Background

Background: The policy outlines use of Aucatzyl (obecabtagene autoleucel) for relapsed or refractory B-cell precursor ALL in adults and references FDA labeling and recognized compendia/guidelines (e.g., CMS‑recognized compendia, NCCN, ASCO).

Evolent is responsible for processing and authorizing all medication requests for Aucatzyl; requests not authorized by Evolent may be deemed not approvable and not reimbursable. For off-label indications, the policy requires documentation demonstrating adequacy of evidence consistent with CMS Medicare Benefit Policy Manual Chapter 15 standards.