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Omacetaxine mepesuccinate (Synribo)

Section: Injections
Effective Date: January 01, 2018
Revised Date: November 26, 2019

Description

Synribo (omacetaxine mepesuccinate) is an inhibitor of protein synthesis that is independent of BCR-ABL binding. It is indicated for adult patients with chronic myeloid leukemia (CML) in either the chronic or accelerated phase who are resistant and/or intolerant to at least two tyrosine kinase inhibitors.

Chronic myeloid leukemia is a form of cancer that causes abnormal (immature) white blood cells to proliferate. Many patients with CML develop a genetic translocation that results in a “Philadelphia Chromosome (BCR-ABL gene),” which in turn results in the production of tyrosine kinase, an enzyme that is involved in the excess production of white blood cells. This enzyme can be targeted by tyrosine kinase inhibitors (imatinib, nilotinib, bosutinib, dasatinib, etc.).

CML is differentiated into 3 phases based on the percentage of immature, or blast cells, in the bone marrow – chronic (<10%), accelerated (10-19%), and blast (≥20%).

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.

Synribo (omacetaxine mepesuccinate) will be approved when the following criteria are met:

  • Patient is an adult and has been diagnosed with chronic phase or accelerated phase CML and
  • Patient has documented resistance and/or intolerance to at least two tyrosine kinase inhibitors

Benefits may be allowed for the following indications and criteria recognized in the National Comprehensive Cancer Network Guidelines (NCCN Guidelines):

  • Chronic myeloid leukemia as post-allogenic hematopoietic stem cell transplant (HCT) follow-up therapy in patients with molecular relapse (BCR-ABL1 transcript positive) following complete cytogenic response (CCyR)
  • Chronic myeloid leukemia as post allogenic HCT follow-up therapy in patients with relapse or those who are not in CCyR
  • Chronic myeloid leukemia in patients with a T315l mutation or disease that is resistant and/or intolerant to 2 or more tyrosine kinase inhibitors

 

Omacetaxine mepesuccinate (Synribo) is considered experimental/investigational for all other indications. Scientific evidence does not support the use of Omacetaxine mepesuccinate (Synribo) for any other indications not listed above.

Procedure Codes

J9262

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

C92.10

C92.11

C92.12

C92.20

C92.21

C92.22

Professional Statements and Societal Positions Guidelines

NA

Links