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Clinical Policy Bulletin:
Omacetaxine (Synribo)
Number: 0872


Policy

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.



Background

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)

Gleevec® (imatinib)

Tasigna® (nilotinib)

Sprycel® (dasatinib)

Bosulif® (bosutinib)

  • chronic phase
  • accelerated phase
  • posttransplant relapse
 
CPT Codes / HCPCS Codes / ICD-9 Codes
Other CPT codes related to the CPB:
96372
96401
HCPCS Codes covered if selection criteria are met:
J9262 Injection, omacetaxine mepesuccinate, 0.01 mg
ICD-9 codes covered if selection criteria are met:
205.10 - 205.12 Myeloid leukemia, chronic


The above policy is based on the following references:
  1. National Comprehensive Cancer Network. Practice Guidelines in Oncology – 2013.
  2. Synribo [package insert]. North Wales, PA: Teva U.S.; October 2012.
  3. Cortes J, Lipton J, Delphine R, et al., Phase 2 study of subcutaneous omacetaxine mepesuccinate after TKI failure in patients with chronic-phase CML with T315I mutation. Blood 2012;120(13):2573-80.


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Copyright Aetna Inc. All rights reserved. Clinical Policy Bulletins are developed by Aetna to assist in administering plan benefits and constitute neither offers of coverage nor medical advice. This Clinical Policy Bulletin contains only a partial, general description of plan or program benefits and does not constitute a contract. Aetna does not provide health care services and, therefore, cannot guarantee any results or outcomes. Participating providers are independent contractors in private practice and are neither employees nor agents of Aetna or its affiliates. Treating providers are solely responsible for medical advice and treatment of members. This Clinical Policy Bulletin may be updated and therefore is subject to change.
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