Aetna considers omacetaxine mepesuccinate (Synribo) medically necessary for members with chronic myelogenous leukemia (CML) (see appendix). Syribo is considered experimental and investigational for all other indications.

Synribo (omacetaxine) was approved by the U.S. Food and Drug Administration for the treatment of adult patients with chronic or accelerated phase CML with resistance and/or intolerance to two or more tyrosine kinase inhibitors. This labeling states that this indication is based upon response rate. The labeling notes that there are no trials verifying an improvement in disease-related symptoms or increased survival with omacetaxine.Current guidelines from the National Comprehensive Cancer Network (NCCN, 2013) recommend Synribo in chronic myeloid leukemia for patients with disease progression due to resistance and/or intolerance to two or more tyrosine kinase inhibitors for chronic phase, accelerated phase and posttransplant relapse.

Appendix

Synribo is considered medically necessary for members who meet the following criteria:

1. Patients diagnosed with chronic myeloid leukemia (CML) in chronic phase, accelerated phase, or posttransplant relapse, and
2. Patients have failed prior therapy with two or more tyrosine kinase inhibitors (See table for list of tyrosine kinase inhibitors) or documentation of T315I mutation

Table: Tyrosine Kinase Inhibitors (TKIs)

• chronic phase
• accelerated phase
• posttransplant relapse