| Effective Date:04/01/2013 |
Title:Synribo (Omacetaxine Mepesuccinate)
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| Revision Date:01/01/2017
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Document:BI405:00
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| CPT Code(s):J9262
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Public Statement
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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.
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Medical Statement
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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
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Limits
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Synribo is limited to two (2) doses per day.
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Reference
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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 This code is no longer valid effective 1/1/14.
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Application to Products
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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.
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Changes: QualChoice reserves the right to alter, amend, change or supplement benefit interpretations as needed.
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