Cholbam — Medical Mutual

Initial criteria

• Diagnosis of peroxisomal disorder, including Zellweger Spectrum Disorder [documentation required]; AND
• Diagnosis based on abnormal urinary bile acid analysis by Fast Atom Bombardment ionization – Mass Spectrometry (FAB-MS); OR molecular genetic testing consistent with the diagnosis; AND
• Patient has liver disease, steatorrhea, or complications from decreased fat soluble vitamin absorption (e.g., rickets); AND
• Documentation of liver function testing in the past 6 months (e.g., AST, ALT, GGT, ALP, bilirubin, INR); AND
• Prescribed by or in consultation with a hepatologist, metabolic specialist, or a gastroenterologist

Reauthorization criteria

• Patient has responded to initial Cholbam therapy as per the prescribing physician (e.g., improvements in liver enzymes, improvement in steatorrhea); AND
• Patient does not have complete biliary obstruction; AND
• Prescribed by or in consultation with a hepatologist, metabolic specialist, or a gastroenterologist

Approval duration

initial 90 days, reauth 365 days