Overview

This document addresses the use of Synribo (omacetaxine mepesuccinate). Synribo is a protein synthesis inhibitor used to treat chronic myelogenous leukemia (CML). It works by reducing levels of Bcr-Abl and Mcl-1, the proteins responsible for the initiation and progression of CML, and causing cell death. The FDA approved indication for Synribo include use in adults with chronic or accelerated chronic myeloid leukemia with resistance or intolerance to two or more tyrosine kinase inhibitors (TKI). FDA approved TKIs include Gleevec (imatinib), Tasigna (dasatinib), Sprycel (nilotinib), Bosulif (bosutinib), and Iclusig (ponatinib). The National Comprehensive Cancer Network® (NCCN) provides additional recommendations with a category 2A level of evidence for the use of Synribo when used as a single agent for patients with resistance and/or intolerance to two or more TKIs

• with chronic phase CML (CP-CML) (Philadelphia chromosome or BCR::ABL1 positive)
• as treatment of advanced phase CML for patients with disease progression to accelerated phase (useful in certain circumstances)
• as post-allogeneic hematopoietic stem cell transplant (HCT) follow-up therapy in patients with molecular relapse (BCR::ABL1 transcript positive) following complete cytogenetic response (CCyR)
• as post-allogeneic HCT follow-up therapy in patients with relapse or less than CCyR

Definitions and Measures

Disease Progression: Cancer that continues to grow or spread.

Hematopoietic stem cells: Primitive cells capable of replication and formation into mature blood cells in order to repopulate the bone marrow.

Kinase inhibitor: Type of drug which works by blocking several enzymes that promote cell growth, which has been found to be an effective approach to treat a variety of cancers.

Line of Therapy:

• First-line therapy: The first or primary treatment for the diagnosis, which may include surgery, chemotherapy, radiation therapy or a combination of these therapies.
• Second-line therapy: Treatment given when initial treatment (first-line therapy) is not effective or there is disease progression.
• Third-line therapy: Treatment given when both initial (first-line therapy) and subsequent treatment (second-line therapy) are not effective or there is disease progression.

Relapse or recurrence: After a period of improvement, during which time a disease (for example, cancer) could not be detected, the return of signs and symptoms of illness or disease. For cancer, it may come back to the same place as the original (primary) tumor or to another place in the body.

Clinical Criteria

1. Synribo (omacetaxine mepesuccinate) Requests for Synribo (omacetaxine mepesuccinate) may be approved if the following criteria are met:

1. Individual has a diagnosis of chronic or accelerated phase chronic myeloid leukemia (CML) (Label, NCCN 2A); AND
2. Individual has resistance and/or intolerance to two or more tyrosine kinase inhibitors (TKI)

Coding

The following codes for treatments and procedures applicable to this document are included below for informational purposes. Inclusion or exclusion of a procedure, diagnosis or device code(s) does not constitute or imply member coverage or provider reimbursement policy. Please refer to the member's contract benefits in effect at the time of service to determine coverage or non-coverage of these services as it applies to an individual member.

HCPCS

J9262

ICD-10 Diagnosis

• C92.10
  Chronic myeloid leukemia, BCR/ABL-positive, not having achieved remission
• C92.11
  Chronic myeloid leukemia, BCR/ABL-positive, in remission
• C92.12
  Chronic myeloid leukemia, BCR/ABL-positive, in relapse

Injection, omacetaxine mepesuccinate, 0.01 mg

Document History

Revised: 05/20/2022