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.
Omacetaxine mepesuccinate (Synribo) may be considered medically necessary when used for ANY of the following:
Food and Drug Administration (FDA) Indications
Chronic Myeloid Leukemia (CML)
- Individual is an adult and has been diagnosed with chronic phase or accelerated phase CML; and
- Individual has documented resistance and/or intolerance to at least two tyrosine kinase inhibitors; or
National Comprehensive Cancer Network (NCCN) Recommendations
Chronic Myeloid Leukemia (CML)
- Used as a single agent for individuals with disease that is resistant and/or intolerant to two or more tyrosine kinase inhibitors; and
- One of the follow:
- As a primary treatment of advanced phase CML for individuals with disease progression to accelerated phase; or
- As post-allogenic hematopoietic stem cell transplant (HCT) follow-up therapy in individuals with molecular relapse (BCR-ABL1 transcript positive) following complete cytogenic response (CCyR); or
- As post allogenic HCT follow-up therapy in individuals with relapse or less than CCyR.
The use of omacetaxine mepesuccinate (Synribo) is considered experimental/investigational, and therefore, non-covered for any other indication. Scientific evidence does not support the use for any other indication.
Procedure Codes