Medical Policy

Effective Date:01/01/2016 Title:Unituxin (Dinutuximab)
Revision Date: Document:BI493:00
CPT Code(s):None
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)    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.

Medical Statement

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


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).


1)    Unituxin Prescribing Information.  United Therapeutics Corp.  Silver Spring, MD.  March 2015.

2)    Clinical Pharmacology.  Accessed online November 13, 2015.

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.