| Effective Date:01/01/2016 |
Title:Unituxin (Dinutuximab)
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| Revision Date:
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Document:BI493:00
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| CPT Code(s):None
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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)
Unituxin (Dinutuximab)
requires prior authorization.
2)
Unituxin is
used to treat high-risk Neuroblastoma in pediatric patients.
3)
Unituxin is a
specialty drug covered under the medical benefit.
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Medical Statement
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Unituxin (Dinutuximab)
is considered medically necessary for members meeting the following criteria:
1)
Pediatric
patient with diagnosis of high-risk Neuroblastoma who have achieved partial
response to prior first-line multi-agent, multi-modality therapy (i.e.
induction combination chemotherapy, myeloblative consolidation chemotherapy
followed by autologous stem cell transplant, and radiation therapy) AND
2)
Being used in
combination with GM-CSF, interleukin-2, and 13-cis-retinoic acid
3)
Unituxin is
considered experimental and investigational for all other uses
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Limits
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Coverage is
provided for up to 24 weeks to accommodate a maximum of 5 cycles (cycles 1, 3,
and 5 are 24 days in duration; cycles 2 and 4 are 32 days in duration).
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Reference
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1)
Unituxin
Prescribing Information. United Therapeutics Corp. Silver Spring, MD. March
2015.
2)
Clinical
Pharmacology. Accessed online November 13, 2015.
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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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