Medical Policy

Effective Date:03/01/2015 Title:Xofigo (Radium-223 Dichloride)
Revision Date: Document:BI474:00
CPT Code(s):A9606
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)    Xofigo (Radium-223 Dichlroide) requires prior authorization.

2)    Xofigo is used to treat resistant prostate cancer.

3)    Xofigo is considered a specialty drug.

Medical Statement

Xofigo (Radium-223 dichloride) is considered medically necessary for members meeting the following criteria:

1)    Member is over 18 years of age  AND

2)    Member has a diagnosis of castration-resistant prostate cancer  AND

3)    Member has symptomatic bone metastases AND

4)    Member has no known visceral metastatic disease (i.e. liver, lungs, brain) AND

5)    Member has tried/failed multiple other agents including Jevtana, Zytiga, and Xtandi.

Limits

Approval is limited to 6 injections (one per month).  Safety and efficacy beyond 6 injections with Xofigo have not been studied.

Reference

1)    Xofigo Package Insert.  Bayer HealthCare Pharmaceuticals.  Wayne, NJ. May 2013.

2)    Clinical Pharmacology. Accessed online 12/23/2014.

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.