Cholbam — Cigna
Bile Acid Synthesis Disorders Due to Peroxisomal Disorders (PDs), including Zellweger Spectrum Disorders
Initial criteria
- Patient has peroxisomal disorders with at least ONE of the following (a or b): a) An abnormal urinary bile acid analysis by Fast Atom Bombardment ionization – Mass Spectrometry (FAB-MS); OR b) 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
- The medication is prescribed by or in consultation with a hepatologist, metabolic specialist, or gastroenterologist
Reauthorization criteria
- According to the prescriber, patient has responded to initial Cholbam therapy (e.g., improvements in liver enzymes or improvement in steatorrhea); 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, reauth 1 year