Cholbam (cholic acid) — Medica

Initial criteria

• Patient has at least ONE of the following (a or b): a) An abnormal urinary bile acid as confirmed by Fast Atom Bombardment ionization – Mass Spectrometry (FAB-MS) analysis; OR b) Molecular genetic testing consistent with the diagnosis; AND
• The medication is prescribed by or in consultation with a hepatologist, metabolic specialist, or gastroenterologist

Reauthorization criteria

• Patient has responded to initial Cholbam therapy with an improvement in liver function tests (e.g., aspartate aminotransferase [AST], alanine aminotransferase [ALT], bilirubin levels); AND
• Patient does not have complete biliary obstruction; AND
• The medication is prescribed by or in consultation with a hepatologist, metabolic specialist, or gastroenterologist

Approval duration

initial: 3 months; reauthorization: 1 year