Omacetaxine mepesuccinate (Synribo)

Policy ID: I-9003-004

Section: Injections

Effective Date: July 01, 2020

Revised Date: November 23, 2022

Revision Effective Date: January 01, 2023

Last Reviewed: November 15, 2023

Applies To: Commercial and Medicaid Expansion

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

- 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.

Policy ID: I-9003-003

Section: Injections

Effective Date: January 01, 2020

Revised Date: November 18, 2021

Revision Effective Date: January 01, 2022

Last Reviewed: November 23, 2021

Archived Date: December 31, 2022

Applies To: Commercial and Medicaid Expansion

Description

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 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.

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

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.

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

Links

References (PDF)

Disclaimer

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