Medical Policy

Effective Date:01/01/2016 Title:Cholbam (Cholic Acid)
Revision Date: Document:BI487:00
CPT Code(s):
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)    Cholbam (cholic acid) capsules require prior authorization.

2)    Cholbam is used to treat bile acid synthesis disorders and peroxisomal disorders including Zellweger spectrum disorders.

3)    Cholbam is a specialty drug covered under the pharmacy benefit.

Medical Statement

Cholbam (cholic acid) is considered medically necessary when the following criteria are met:

1)    Documented diagnosis of bile acid synthesis disorders due to single enzyme defects (SEDs)  OR

2)    As adjunctive therapy (not monotherapy) with documented diagnosis of peroxisomal disorders, including Zellweger spectrum disorders in patients who exhibit manifestations of liver disease, steatorrhea or complications from decreased fat soluble vitamin absorption.

Limits

As a specialty drug, Cholbam is limited to a maximum 30 day supply per fill.

Reference

1)    Cholbam Prescribing Information.  Asklepion Pharmaceuticals LLC. Baltimore, MD. March 2015

2)    Clinical Pharmacology.  Accessed online 9/10/2015

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.