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:
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