Blinatumomab (Blincyto) (ARCHIVED)

Policy ID: I-127-012

Section: Injections

Effective Date: April 01, 2020

Revised Date: October 25, 2024

Revision Effective Date: December 08, 2024

Last Reviewed: November 19, 2024

Applies To: Commercial Only

**This policy has been Archived effective December 08, 2024. Click the Archive tab above for more information.**

Policy ID: I-127-012

Section: Injections

Effective Date: April 01, 2020

Revised Date: October 25, 2024

Revision Effective Date: December 08, 2024

Last Reviewed: November 19, 2024

Archived Date: December 08, 2024

Applies To: Commercial Only

Description

Blinatumomab (Blincyto™) is a bispecific CD19-directed CD3 T-cell engager (BiTE) antibody construct product. Blinatumomab (Blincyto) engages the T lymphocytes to destroy leukemia cells. The drug acts as a connector between CD19 protein, which is found on the surface of most B-cell lymphoblasts, and CD3 protein, which is found on T-cell lymphocytes. BiTE antibody constructs are modified antibodies that are designed to engage two (2) different targets simultaneously, thereby juxtaposing T cells to cancer cells.

Criteria

Coverage is subject to the specific terms of the member's benefit plan.

Federal Employee Program members (FEP) should check with their Retail Pharmacy Program to determine if prior approval is required by calling the Retail Pharmacy Program at 1-800-624-5060 (TTY: 1-800-624-5077). FEP members can also obtain the list through the www.fepblue.org website.

Blinatumomab (Blincyto) may be considered medically necessary as a single-agent therapy for ANY of the following indications:

Treatment of relapsed or refractory CD19-positive B-cell precursor acute lymphoblastic leukemia (ALL) in adults and children; or
Treatment of CD19-positive B-cell precursor ALL in adults and children in first or second complete remission with minimal residual disease (MRD) greater than or equal to 0.1%; or

Compendia Sources

Blinatumomab (Blincyto) may be considered medically necessary for treatment of any of the current category 1 or 2A NCCN recommendations.

The use of blinatumomab (Blincyto) for all other indications not listed in this policy is considered experimental/investigational and therefore non-covered because the safety and/or effectiveness cannot be established by the available published peer-reviewed literature.

Procedure Code

J9039

NOTE: In addition to the above criteria, product specific dosage and/or frequency limits may apply in accordance with the United States Food and Drug Administration (U.S. FDA)-approved product prescribing information, national compendia, Centers for Medicare and Medicaid Services (CMS) and other peer reviewed resources or evidence-based guidelines.

Diagnosis Codes

C83.50

C83.51

C83.52

C83.53

C83.54

C83.55

C83.56

C83.57

C83.58

C83.59

C91.00

C91.01

C91.02

Professional Statements and Societal Positions Guidelines

Not Applicable

ND Committee Review

Internal Medical Policy Committee 3-16-2020 Adopted policy

Internal Medical Policy Committee 3-17-2021 Annual review, no clinical content change

Internal Medical Policy Committee 9-21-2021

Added additional NCCN recommendations, and
Updated diagnosis codes

Internal Medical Policy Committee 9-28-2022 Annual review, no clinical content change

Internal Medical Policy Committee 11-29-2022

Removed NCCN recommendations; and
Added this statement 'Blinatumomab (Blincyto) may be considered medically necessary for treatment of any of the current category 1 or 2A NCCN recommendations.'; and
Updated experimental/investigational statement

Internal Medical Policy Committee 11-15-2023 Annual review, no clinical content change

Internal Medical Policy Committee 11-19-2024 Effective December 08, 2024

Archived policy

Links

References (PDF)

Disclaimer

Current medical policy is to be used in determining a Member's contract benefits on the date that services are rendered. Contract language, including definitions and specific inclusions/exclusions, as well as state and federal law, must be considered in determining eligibility for coverage. Members must consult their applicable benefit plans or contact a Member Services representative for specific coverage information. Likewise, medical policy, which addresses the issue(s) in any specific case, should be considered before utilizing medical opinion in adjudication. Medical technology is constantly evolving, and the Company reserves the right to review and update medical policy periodically.

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