Cholbam (cholic acid) — United Healthcare

Initial criteria

• Diagnosis of a bile acid synthesis disorder AND bile acid synthesis disorder is due to single enzyme defects (SEDs)
• OR
• Diagnosis of a peroxisomal disorder including Zellweger spectrum disorders AND patient exhibits manifestations of liver disease, steatorrhea or complications from decreased fat-soluble vitamin absorption AND Cholbam is being used as adjunctive treatment

Reauthorization criteria

• Documentation of positive clinical response to Cholbam therapy as evidenced by BOTH of the following:
• Improvement in liver function (e.g., aspartate aminotransferase [AST], alanine aminotransferase [ALT])
• AND
• Absence of complete biliary obstruction

Approval duration

Initial: 3 months; Reauthorization: 12 months