Omacetaxine mepesuccinate (Synribo) (ARCHIVED)

Policy ID: I-9003-005

Section: Injections

Effective Date: July 01, 2020

Revised Date: October 25, 2024

Revision Effective Date: December 08, 2024

Last Reviewed: November 19, 2024

Applies To: Commercial Only

This policy has been Archived effective December 08, 2024. Click the Archive tab above for more information.

Policy ID: I-9003-005

Section: Injections

Effective Date: July 01, 2020

Revised Date: October 25, 2024

Revision Effective Date: December 08, 2024

Last Reviewed: November 19, 2024

Archived Date: December 08, 2024

Applies To: Commercial Only

Description

Omacetaxine mepesuccinate (Synribo) 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.

CML is differentiated into three (3) phases based on the percentage of immature, or blast cells, in the bone marrow - chronic (less than 10%), accelerated (10-19%), and blast (greater of equal to 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.

Omacetaxine mepesuccinate (Synribo) may be considered medically necessary for ANY ONE of the follow 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

Compendia Sources

Omacetaxine mepesuccinate (Synribo) may be considered medically necessary for treatment of any of the current category 1 or 2A NCCN recommendations

The use of omacetaxine mepesuccinate (Synribo) for all other indications not listed in this policy is considered experimental/investigational and therefore non-covered because the safety and/or effectiveness cannot be established by the available published peer-reviewed literature.

Procedure Code

J9262

NOTE: In addition to the above criteria, product specific dosage and/or frequency limits may apply in accordance with the United States Food and Drug Administration (U.S. FDA)-approved product prescribing information, national compendia, Centers for Medicare and Medicaid Services (CMS) and other peer reviewed resources or evidence-based guidelines.

Diagnosis Codes

C92.10

C92.11

C92.12

C92.20

C92.21

C92.22

Professional Statements and Societal Positions Guidelines

Not Applicable

ND Committee Review

Internal Medical Policy Committee 11-14-2019 Formatting and updated references.

Internal Medical Policy Committee 11-19-2020 Updated NCCN recommendations

Internal Medical Policy Committee 11-23-2021 Annual review, updated wording, no clinical content change

Internal Medical Policy Committee 11-29-2022

Removed NCCN recommendations; and
Added this statement 'Omacetaxine mepesuccinate (Synribo) may be considered medically necessary for treatment of any of the current category 1 or 2A NCCN recommendations.'; and
Updated experimental/investigational statement

Internal Medical Policy Committee 11-15-2023 Annual review, no clinical content change

Internal Medical Policy Committee 11-19-2024 Effective December 08, 2024

Archived policy

NOTE: Due to manufacturing issues, Synribo is being permanently discontinued upon exhaustion of the current inventory, expected in the fourth quarter of 2023.

Links

References (PDF)

Disclaimer

Current medical policy is to be used in determining a Member's contract benefits on the date that services are rendered. Contract language, including definitions and specific inclusions/exclusions, as well as state and federal law, must be considered in determining eligibility for coverage. Members must consult their applicable benefit plans or contact a Member Services representative for specific coverage information. Likewise, medical policy, which addresses the issue(s) in any specific case, should be considered before utilizing medical opinion in adjudication. Medical technology is constantly evolving, and the Company reserves the right to review and update medical policy periodically.

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