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.

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 forANYof 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 less than 65 years of age without substantial comorbidities with MRD+ following a complete response to induction therapy; or
    • Relapsed/refractory Philadelphia chromosome-positive TKI intolerant/refractory B-ALL; or
    • Relapsed/refractory Philadelphia chromosome-negative B-ALL.

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

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. Blue Cross Blue Shield of North Dakota may deny, in full or in part, reimbursement for utilization that does not fall within the applicable dosage and/or frequency limits.

Diagnosis Codes

Covered Diagnosis Codes for Procedure Code J9039

Professional Statements and Societal Positions Guidelines

NA