Cholbam — Medical Mutual

Initial criteria

• Diagnosis of bile acid synthesis disorder due to single enzyme defects (SEDs) [documentation required]; AND
• Diagnosis based on an abnormal urinary bile acid as confirmed by Fast Atom Bombardment ionization – Mass Spectrometry (FAB-MS) analysis; OR based on molecular genetic testing consistent with the diagnosis; 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 with an improvement in liver function tests (e.g., AST, ALT, GGT, ALP, bilirubin, INR); 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