Medical Policy

Effective Date:10/01/2014 Title:Zykadia (Ceritinib)
Revision Date: Document:BI460:00
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)    Zykadia (Ceritinib) requires prior authorization.

2)    Zykadia is used to treat a type of lung cancer.

3)    Zykadia is an oral specialty medication and must be obtained through the contracted specialty pharmacy.

Medical Statement

:

Zykadia is considered medically necessary for members who meet the following criteria:

1)    Diagnosis of metastatic non-small cell lung cancer  AND

2)    Member has anaplastic lymphoma kinase (ALK)-positive disease as detected with an FDA-approved test  ANDj

3)    Member has had an inadequate response, progressed on, or had an intolerance or contraindication to Xalkori (Crozotinib)

 

Reauthorization is granted if the member has not experienced any of the following while on therapy:

1)    ALT or AST elevation greater than 3 times the upper limit of normal with total bilirubin elevation greater than 2 times the ULN.

2)    Treatment-related interstitial lung disease/pneumonitis

3)    QTc interval prolongation in combination with Torsade de Pointes or polymorphic ventricular tachycardia or signs/symptoms of serious arrhythmia

4)    Life-threatening bradycardia and not taking a concomitant medication also known to cause bradycardia or hypotension

Limits

 

As a specialty medication, Zykadia is limited to no more than a 30-day supply per fill.

Reference

 

1)    Zykadia Prescribing Information.  Novartis Pharmaceuticals.  April 2014.

2)    Clinical Pharmacology. Accessed online September 2014.

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.