Blincyto (blinatumomab) — Coverage Criteria
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Clinical criteria governing prior authorization and medical necessity for Blincyto (blinatumomab) for treatment of CD19+ B-cell acute lymphoblastic leukemia (ALL) under the medical benefit; applies to Anthem members and providers requesting coverage.
Updated NCCN 2A recommendation for use with a TKI to clarify use in Philadelphia chromosome positive disease.
Wording and formatting criteria updates across the document.
Coverage Criteria for Blincyto (blinatumomab)
Requests for Blincyto (blinatumomab) for the treatment of diffuse large B‑cell lymphoma (DLBCL) are not approved under these criteria.
Use of Blincyto (blinatumomab) for any indication that does not meet the specified coverage criteria (including any other unspecified indications) is not approved.
Coding and Diagnostic Codes
| J9039 | Injection, blinatumomab, 1 microgram [Blincyto] |
| C91.00-C91.02 | Acute lymphoblastic leukemia [ALL] |
Provider Actions, Documentation, and Prior Authorization
Prior Authorization Required
Prior Authorization Required: Prior authorization is required for Blincyto (blinatumomab). Approval is contingent on meeting the policy clinical criteria (patient under 19 years of age OR diagnosis of CD19+ B‑cell precursor ALL with one of the listed indications).
- Prior authorization required before initiation of therapy
- Approval contingent on meeting criteria: age <19 OR CD19+ B‑cell precursor ALL with specified indications
Step Therapy
Step therapy: There is no required step‑therapy sequence of prior systemic agents in this policy. Coverage is determined by the clinical criteria described in the policy and alignment with FDA‑approved indications and NCCN recommendations (including NCCN 1 and NCCN 2A listed uses).
- No mandatory prior therapies or step‑up sequence required by this policy
- Coverage contingent on meeting listed clinical criteria and NCCN/FDA indicated uses
Required Documentation
Required documentation: Submit documentation that verifies the diagnosis, supporting clinical details, and relevant ICD‑10 code(s). Include treatment intent and specific indication justification (relapsed/refractory disease, Ph+ disease with TKI combination, MRD ≥ 0.1% after first/second complete response, consolidation, maintenance alternating with POMP, or use with Interfant regimens for infant ALL with KMT2A rearrangement).
- Include member age and proof of CD19+ B‑cell precursor ALL when applicable
- Provide documentation of the specific indication being treated (one of the policy‑listed indications)
- Include relevant ICD‑10 diagnosis code(s) (e.g., C91.00‑C91.02)
Denial Triggers
Denial triggers: Requests will be denied if the clinical criteria are not met. Common denial reasons include use for non‑CD19+ B‑cell ALL diagnoses (for example DLBCL), indications not listed in the policy, lack of documentation confirming CD19 positivity or the specific policy indication, or failure to provide required supporting records.
- Not CD19+ B‑cell precursor ALL when required by criteria
- Indication is diffuse large B‑cell lymphoma (DLBCL) or other non‑covered diagnoses
- Insufficient documentation of diagnosis, CD19 status, MRD level, prior response status, or use with required combination regimens
Background on Blinatumomab
Blincyto (blinatumomab) is a bispecific T‑cell engager that links CD3 on T cells with CD19 on B cells to facilitate immune‑mediated lysis of malignant B cells. It is used clinically for CD19+ B‑cell precursor acute lymphoblastic leukemia (ALL) in specific situations such as relapsed/refractory disease, as consolidation or maintenance (including maintenance alternating with POMP), for minimal residual disease (MRD) ≥ 0.1% after first or second complete response, and in combination with TKIs for Ph+ disease or with interfant regimens for infants with KMT2A rearrangement per NCCN guidance.
Definitions
Line of Therapy
Line of Therapy Classification
Requests for Blincyto (blinatumomab) may be approved when the following criteria are met:
Pediatric approval allowed as standalone criterion
Adult/pediatric CD19+ disease indications
- Indications: A: Relapsed or refractory disease; OR B: Blinatumomab used in combination with a tyrosine kinase inhibitor (bosutinib, dasatinib, imatinib, nilotinib, or ponatinib) for Philadelphia chromosome positive (Ph+) disease; OR C: Minimal residual disease (MRD) >= 0.1% following a first or second complete response to induction therapy; OR D: As consolidation therapy; OR E: Used as maintenance therapy as a single agent alternating with POMP (prednisone, vincristine, methotrexate, and mercaptopurine); OR F: Used in combination with interfant regimens for infant ALL with KMT2A (11q23) rearranged
NCCN label references: 1, 2A depending on indication
Biomarker and Genetic Requirements
Covered Regimens and Combinations
| Regimen | Indication / Notes | Coverage |
|---|---|---|
| Blinatumomab + bosutinib | Use in combination with a tyrosine kinase inhibitor (TKI) for Philadelphia chromosome–positive (Ph+) B‑ALL per NCCN 2A. | Covered |
| Blinatumomab + dasatinib | Use in combination with a tyrosine kinase inhibitor (TKI) for Philadelphia chromosome–positive (Ph+) B‑ALL per NCCN 2A. | Covered |
| Blinatumomab + imatinib | Use in combination with a tyrosine kinase inhibitor (TKI) for Philadelphia chromosome–positive (Ph+) B‑ALL per NCCN 2A. | Covered |
| Blinatumomab + nilotinib | Use in combination with a tyrosine kinase inhibitor (TKI) for Philadelphia chromosome–positive (Ph+) B‑ALL per NCCN 2A. | Covered |
| Blinatumomab + ponatinib | Use in combination with a tyrosine kinase inhibitor (TKI) for Philadelphia chromosome–positive (Ph+) B‑ALL per NCCN 2A. | Covered |
| Regimen | Indication / Notes | Coverage |
|---|---|---|
| Blinatumomab as single agent alternating with POMP (prednisone, vincristine, methotrexate, mercaptopurine) | Used as maintenance therapy alternating with POMP per NCCN guidance; applicable for CD19+ B‑cell precursor ALL. | Covered |
| Regimen | Indication / Notes | Coverage |
|---|---|---|
| Blinatumomab in combination with Interfant regimens | Recommended by NCCN (2A) for infant ALL with KMT2A (11q23) rearrangement; Interfant denotes infant‑specific chemotherapy protocols described in guidelines. | Covered |
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