Blinatumomab (Blincyto)

Policy ID: I-127-011

Section: Injections

Effective Date: April 01, 2020

Revised Date: November 07, 2022

Revision Effective Date: January 01, 2023

Last Reviewed: November 15, 2023

Applies To: Commercial and Medicaid Expansion

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 Codes

J9039

NOTE: In addition to the above criteria, product specific dosage and/or frequency limits may apply in accordance with the U.S. Food and Drug Administration (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

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.

Policy ID: I-127-009

Section: Injections

Effective Date: April 01, 2020

Revised Date: September 20, 2021

Revision Effective Date: November 01, 2021

Last Reviewed: September 28, 2022

Archived Date: December 31, 2022

Applies To: Commercial and Medicaid Expansion

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 betweenCD19 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 different targets simultaneously, thereby juxtaposing T cells to cancer cells.

Criteria

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

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

Food and Drug Administration (FDA) Indications

Treatment of relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL) in adults and children; or
Treatment of 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

National Comprehensive Cancer Network (NCCN) Recommendations

Pediatric Acute Lymphoblastic Leukemia
- Single-agent therapy for:
  - Ph-negative or Ph-like B-ALL that is minimal residual disease positive (MRD+) after consolidation therapy; or
  - Ph-positive B-ALL with less than complete response, MRD+ at end of consolidation, or high-risk genetics; or
  - Relapsed/refractory Ph-negative B-ALL; or
  - Relapsed/refractory Ph-positive TKI intolerant/refractory B-ALL; or

Acute Lymphoblastic Leukemia
- Single-agent therapy for:
  - Consolidation therapy for Philadelphia chromosome-negative B-ALL in adolescent and young adult individuals with minimal residual disease positive (MRD+) following a complete response to induction therapy; or
  - Consolidation therapy for Philadelphia chromosome-negative B-ALL in adult individuals with MRD+ following a complete response to induction therapy; or
  - Relapsed/refractory Philadelphia chromosome-negative B-ALL; or
- Consolidation therapy with or without TKI for Philadelphia chromosome-positive B-ALL in adolescent and young adult individuals with persistent/rising MRD following a complete response to induction therapy; or
- Relapsed/refractory Philadelphia chromosome-positive B-ALL with or without a TKI.

The use of blinatumomab (Blincyto) is considered experimental/investigational and, therefore, non-covered for all other indications. Scientific literature does not support the use of blinatumomab (Blincyto) for other indications.

Procedure Codes

J9039

Diagnosis Codes

Covered Diagnosis Codes for Procedure Code J9039

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

Links

References (PDF)

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