Coverage Policies

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INDEX:



Effective Date: 04/01/2013	Title: Synribo (Omacetaxine Mepesuccinate)
Revision Date: 01/01/2017	Document: BI405:00
CPT Code(s): J9262
Public Statement
*Effective Date:* a) This policy will apply to all services performed on or after the above revision date which will become the new effective date. b) For all services referred to in this policy that were performed before the revision date, contact customer service for the rules that would apply. 1) Synribo is used to treat adults with chronic myeloid leukemia (CML). 2) Synribo is considered an injectable specialty drug covered under the medical benefit. 3) Synribo (Omacetaxine Mepesuccinate) requires pre-authorization.
Medical Statement
Synribo (Omacetaxine Mepesuccinate) is considered medically necessary for members who meet the following criteria: 1) Diagnosis of chronic or accelerated phase chronic myeloid leukemia (CML) (C92.10, C92.12, C92.20, C92.22), 2) Resistance or intolerant to prior tyrosine kinase inhibitor (TKI) therapy as evidenced by trial of at least 3 other TKI’s (e.g. Gleevec, Tasigna, Sprycel, and Bosulif). Codes Used In This BI: J9262 Omacetaxine Mepesuccinate Injection, 0.01 mg
Limits
Synribo is limited to two (2) doses per day.
Reference
1) Synribo prescribing information. Teva Pharmaceuticals USA, Inc. North Wales, PA. October 2012. 2) Clinical Pharmacology. Synribo. Accessed online March 26, 2013. 3) NCCN Clinical Practice Guidelines in Oncology. Chronic Myelogenous Leukemia. v4.2013. http://www.nccn.org/professionals/physician_gls/pdf/cml.pdf Accessed March 26, 2013. Addendum: 1) Effective 01/01/2017: Removed HCPCS code C9297 from Claim Statement & Codes Used in This BI section. This code is no longer valid effective 1/1/14.
Application to Products
This policy applies to all health plans administered by QualChoice, both those insured by QualChoice and those that are self-funded by the sponsoring employer, unless there is indication in this policy otherwise or a stated exclusion in your medical plan booklet. Consult the individual plan sponsor Summary Plan Description (SPD) for self-insured plans or the specific Evidence of Coverage (EOC) for those plans insured by QualChoice. In the event of a discrepancy between this policy and a self-insured customer’s SPD or the specific QualChoice EOC, the SPD or EOC, as applicable, will prevail. State and federal mandates will be followed as they apply.
Changes: QualChoice reserves the right to alter, amend, change or supplement benefit interpretations as needed.

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