CurrentEmblemHealthPolicy N/A

Drug Policy: Blincyto TM (blinatumomab)

Defines accepted indications, continuation/extension rules, exclusions, coding, and approval authority for blinatumomab (Blincyto) use in members; includes FDA-approved and supported off-label indications per CMS compendia/NCCN/peer-reviewed literature.

Policy Summary

PayerEmblemHealth

PolicyDrug Policy: Blincyto TM (blinatumomab)

Policy CodePolicy N/A

Change TypeNo material change

Effective DateJan 31, 2025

Next Review Date

Key ActionAll medication requests for blinatumomab must be processed/authorized by Evolent; medications not authorized may be deemed not reimbursable.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes were made in this update.

3Covered Indications Listed

4Exclusion Criteria Items

1HCPCS Codes

Coverage Summary

This policy: Blincyto (blinatumomab) is covered with criteria for specified indications in acute lymphoblastic leukemia (ALL) and has continuation rules. Accepted uses include consolidation for MRD-positive disease at end of induction for both BCR-ABL (Philadelphia) negative and positive B-cell ALL; consolidation for MRD-negative disease at end of induction for BCR-ABL negative B-cell ALL after standard induction chemotherapy; and single-agent therapy for relapsed/refractory CD19-positive B-cell ALL. Continuation exemption allows ongoing use when the medication was used within the last year, the member has not experienced disease progression or intolerance, and no additional medications are being added. Effective date: 2025-01-31. Last review/committee approval date: 2025-01-08.

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Initial Therapy Criteria (Approved Indications)

Approved Indications - Acute Lymphoblastic Leukemia (ALL)

Blincyto (blinatumomab) is acceptable for the following ALL indications:

One of

Consolidation therapy for MRD-positive disease (at the end of induction therapy) for both BCR-ABL negative and BCR-ABL positive B-cell ALL
Consolidation therapy for MRD-negative disease (at the end of induction therapy) for BCR-ABL negative B-cell ALL after standard induction chemotherapy
Single-agent therapy for relapsed/refractory CD19-positive B-cell ALL

Continuation Therapy Criteria

Continuation exemption for not-approvable medication

Continuation requests for a not-approvable medication shall be exempt provided:

ALL of the following

The requested medication was used within the last year
The member has not experienced disease progression and/or no intolerance to the requested medication
Additional medication(s) are not being added to the continuation request

Provider Actions & Authorization

Prior Authorization

Medication requests processed by Evolent

All medication requests for blinatumomab must be processed/authorized by Evolent; medications not authorized may be deemed not reimbursable.

J9039

Documentation Required

Supportive evidence requirement for off-label use

Off-label use must be supported by FDA labeling, CMS-recognized compendia, NCCN/ASCO guidelines, or peer-reviewed literature meeting CMS Medicare Benefit Policy Manual Chapter 15 standards. Documentation should address whether the patient population and administered regimen are represented in the published evidence, and whether reported study outcomes represent clinically meaningful outcomes (per ASCO definitions).

Denial Risk

Denial for exceeded dose or duration

Claims may be denied if dosing or duration limits are exceeded for blinatumomab.

Single dose limit: 28 mcg
Maximum duration (induction/consolidation): 4 cycles
Affected code: J9039

Note

Final approval

Initial review is performed by the Utilization Management Department; final approval decisions are made by the Utilization Management Committee.

Clinical Evidence & References

Key evidence and supporting citations referenced by the policy include: E1910 (ECOG-ACRIN randomized Phase III trial reported in Blood 2022), the NEJM 2017 trial (Blinatumomab versus chemotherapy for advanced ALL), the ALCANTARA Phase 2 single-arm multicenter study (relapsed/refractory Philadelphia-positive ALL), Blood 2018 (blinatumomab for MRD in adults with B-cell precursor ALL), the Blincyto prescribing information (2024), and NCCN guidance (2025). These sources are cited as the basis for the accepted indications and evidence requirements for off-label use.

Background

Scope: The policy defines accepted indications for blinatumomab in cancer treatment including FDA-approved and off-label uses supported by FDA labeling, CMS-recognized compendia, NCCN/ASCO guidelines, or peer-reviewed literature that meet CMS Medicare Benefit Policy Manual Chapter 15 standards. All medication requests for blinatumomab (HCPCS code J9039) must be processed/authorized by Evolent, and medications not authorized may be deemed not reimbursable. Continuation requests for a not-approvable medication may be exempt if the drug was used within the last year, the member has not experienced disease progression or intolerance, and no additional medications are added. Final approval authority rests with the Utilization Management Committee; reviewers should refer to the FDA prescribing information for medication management details.

Definitions

MRDMeasurable Residual Disease

BCR-ABLBreakpoint cluster region - Abelson (Philadelphia chromosome) fusion gene