Aucatzyl (obecabtagene autoleucel) — Medical Prior Authorization / Coverage Criteria
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This document governs prior authorization and step-edit requests for Aucatzyl (obecabtagene autoleucel) for AvMed members, specifying required documentation, clinical eligibility, dosing, and site-of-care information for providers requesting coverage.
No material clinical or coverage changes in this revision.
Coverage Criteria for Aucatzyl (obecabtagene autoleucel)
Initial therapy/Eligibility
Covered when ALL of the following are met:
Anti-CD19 therapy and re-biopsy
- Anti-CD19 history: Either no prior anti-CD19 therapy OR prior anti-CD19 with confirmed CD19-positive disease on re-biopsy
Documentation required
Either Ph+ with prior TKI or Ph- acceptable
Laboratory documentation required
Coverage will be provided for one treatment course and may NOT be renewed. This policy allows a single lifetime treatment (one dose per lifetime) of Aucatzyl (obecabtagene autoleucel) and does not permit additional treatment courses beyond that single authorized course.
A member is not eligible for coverage if they have received prior CAR-T therapy. Coverage also requires meeting all clinical criteria documented on the authorization form (for example: age ≥18, appropriate provider and facility training, diagnosis of relapsed or refractory B‑cell precursor ALL, infection screening and absence of clinically significant active systemic infection, adherence to infection prophylaxis, no live vaccines within 6 weeks prior to lymphodepleting chemotherapy, and documented bone marrow blast assessment to determine dosing). Failure to meet these requirements will render the request not medically necessary.
Coding and Billing
| Q2058 | Aucatzyl (obecabtagene autoleucel) |
Provider Submission & Authorization Requirements
Samples and Prior Therapy Verification
Samples do not satisfy preauthorization/step-edit requirements. If therapy was started with a sample, the request still requires full prior authorization documentation. Prior therapies will be verified by AvMed via pharmacy paid claims review or submitted chart notes — include documentation of prior treatments.
- Samples do not meet preauthorization criteria
- Previous therapies will be verified through pharmacy paid claims or chart notes
Required Submission Information
Complete submission must include prescriber signature (hand-signed; preprinted stamps not valid), member name, AvMed ID number, date of birth, prescriber name, office contact, phone and fax numbers, prescriber NPI, drug name/form/strength, dosing schedule, length of therapy, diagnosis and ICD code (if applicable), weight and date obtained (if applicable), and clear documentation of dosing and bone marrow blast assessment to support selected dose.
- Prescriber signature (hand-signed; stamps not valid)
- Member AvMed # and DOB
- Prescriber NPI and contact phone/fax
- Drug name/form/strength, dosing schedule, length of therapy
- Diagnosis and ICD code (if applicable)
- Weight and date weight obtained (if applicable)
- Bone marrow blast percentage documentation to support dose selection
Incomplete or Illegible Submission — Denial Risk
Incomplete, incorrect, or illegible information — including missing labs, diagnostic reports, bone marrow blast percentage, or unclear signatures — can delay review or result in denial. For urgent reviews, contact AvMed Pre-Authorization Department per instructions if lack of treatment would seriously jeopardize life or health.
- Missing labs or diagnostics may lead to delayed authorization or denial
- Illegible or missing prescriber signature will invalidate request
- Contact AvMed Pre-Authorization Department for urgent review requests
Key Definitions
Dosing and Quantity Limits (Initial Therapy)
Dosing and quantity limits
Initial dosing and quantity limits:
Coverage will be provided for one treatment course only
Dose allocation depends on blast percentage
Laboratory documentation of bone marrow blast percentage required to support selected dosing
Step Therapy Rules
| Step | Requirement |
|---|---|
| 1 | Use of samples to initiate therapy does not meet preauthorization/step edit criteria; previous therapies will be verified through pharmacy paid claims or submitted chart notes. |
Quantity Limits and Treatment Course
Site-of-Care Requirements
Infusion center/site must be trained and documented
Administer Aucatzyl at a facility with staff trained in management of cytokine release syndrome (CRS) and neurologic toxicities, and document the administering location and its NPI or DEA (or indicate specialty pharmacy if applicable).
Background — Drug Overview
Aucatzyl (obecabtagene autoleucel) is a CD19-directed CAR T‑cell therapy provided as a single treatment course for adults with relapsed or refractory B‑cell precursor acute lymphoblastic leukemia (ALL). The total recommended dose is 410 × 10^6 CD19 CAR‑positive viable T cells supplied in 3 to 5 infusion bags and administered as a split‑dose infusion on Day 1 and Day 10 (±2 days). The specific Day 1 and Day 10 doses are determined by documented bone marrow blast percentage: if bone marrow blast >20%, Day 1 = 10 × 10^6 and Day 10 = 100 × 10^6 and 300 × 10^6; if ≤20%, Day 1 = 100 × 10^6 and Day 10 = 10 × 10^6 and 300 × 10^6.
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