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Prior Authorization Protocol
CHOLBAM (cholic acid)
NATL
Coverage of drugs is first determined by the member’s pharmacy or medical benefit. Please consult with or refer to the Evidence of Coverage document.
  1. FDA Approved Indications:
    • Treatment of bile acid synthesis disorders due to single enzyme defects (SEDs).
    • Adjunctive treatment of peroxisomal disorders (PDs) including Zellweger spectrum disorders in patients who exhibit manifestations of liver disease, steatorrhea or complications from decreased fat soluble vitamin absorption.
  2. Health Net Approved Indications and Usage Guidelines:
    • Diagnosis of bile acid synthesis disorders due to single enzyme defects
    OR
    • Diagnosis of peroxisomal disorders including Zellweger spectrum disorders
  3. Coverage is Not Authorized For:
    • Non-FDA approved indications, which are not listed in the Health Net Approved Indications and Usage Guidelines section, unless there is sufficient documentation of efficacy and safety in the published literature.
  4. General Information:
    • Treatment should be initiated and monitored by a hepatologist or pediatric gastroenterologist.
    • Discontinue Cholbam if liver function does not improve within 3 months of starting treatment or complete biliary obstruction develops.
    • Discontinue treatment with Cholbam at any time if there are persistent clinical or laboratory indicators of worsening liver function or cholestasis.
    • The safety and effectiveness of Cholbam on extrahepatic manifestations of bile acid synthesis disorders due to SEDs or PDs including Zellweger spectrum disorders have not been established.
  5. Therapeutic Alternatives:
    Drug Dosing Regimen Dose Limit/ Maximum Dose
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    * Requires Prior Authorization
  6. Recommended Dosing Regimen and Authorization Limit:
    Drug Dosing Regimen Authorization Limit

    Cholbam

    Bile Acid Synthesis Disorder due to Single Enzyme Defects and Peroxisomal Disorders including Zellweger Spectrum Disorders
    10 to 15 mg/kg administered orally once daily or in two divided doses, in pediatric patients and in adults.
    Bile Acid Synthesis Disorder due to Single Enzyme Defects and Peroxisomal Disorders including Zellweger Spectrum Disorders with concomitant familial hypertriglyceridemia
    11 to 17 mg/kg administered orally once daily, or in two divided doses

    Length of Benefit

  7. Product Availability:
    Cholbam capsules: 50 mg, 250 mg
  8. References:
    1. Cholbam [Prescribing Information]. Baltimore, MD: Asklepion Pharmaceuticals LLC; March 2015.
The material provided to you are guidelines used by this plan to authorize, modify or determine coverage for persons with similar illnesses or conditions. Specific care and treatment may vary depending on individual need and the benefits covered under your contract.