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Cholbam (cholic acid)Highmark

Bile acid synthesis disorders due to single enzyme defect

Initial criteria

  • age ≥ 3 weeks
  • Diagnosis of bile acid synthesis disorder (ICD-10: E78.7, excluding E78.71) due to a single enzyme defect confirmed by one of the following: abnormal urinary bile acid detected by mass spectrometry (e.g., FAB-MS) OR other biochemical or genetic testing

Reauthorization criteria

  • Prescriber attests that the member has experienced positive clinical response to therapy

Approval duration

Initial: up to 3 months; Reauthorization: up to 12 months