Cholbam (cholic acid) prior authorization
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Defines UnitedHealthcare prior authorization and reauthorization criteria for Cholbam (cholic acid) for treatment of bile acid synthesis disorders due to single enzyme defects and as adjunctive therapy for peroxisomal disorders including Zellweger spectrum disorders.
No material clinical or coverage changes in this revision.
Coverage Criteria
inv-01: Initial Therapy
Cholbam will be approved based on one of the following criteria:
inv-02: Continuation/Reauthorization
Cholbam will be approved for reauthorization when the following are documented:
Authorization issued for 12 months if criteria met.
The policy notes a specific limitation: the safety and effectiveness of Cholbam for extrahepatic manifestations of bile acid synthesis disorders — whether due to single enzyme defects (SEDs) or peroxisomal disorders (PDs) including Zellweger spectrum disorders — has not been established. This limitation should inform coverage determinations and clinical expectations; treatment with Cholbam may be supported for hepatic manifestations and related malabsorption but not for unproven benefits on extrahepatic disease manifestations.
Initial Therapy Criteria
inv-13: Initial Therapy — initial authorization criteria and duration
Initial authorization criteria and duration
Initial authorization will be issued for 3 months when criteria are met.
Continuation / Reauthorization Criteria
inv-14: Reauthorization — reauthorization requirements for continued coverage
Reauthorization requirements for continued coverage
Authorize continued therapy for 12 months if reauthorization criteria documented.
Coding and Timing
Provider Actions and Documentation Requirements
Prior authorization required; initial 3‑month approval, reauthorization 12 months
Prior authorization is required for Cholbam. Initial authorizations are issued for 3 months when criteria are met; reauthorization may be granted for 12 months when reauthorization criteria are satisfied.
Program automation and potential supply limits
UnitedHealthcare may use automated approval or determine approval based on prior claim/medication history, diagnosis codes, or claim logic; supply limitations may also apply.
- Automated approval and re-approval processes vary by program.
- Approvals may be based solely on previous claims/medication history, diagnosis codes (ICD‑10), and/or claim logic.
- Supply limitations may be applied.
Document positive clinical response for reauthorization
For reauthorization, document a positive clinical response to Cholbam therapy, including improvement in liver function tests (e.g., AST, ALT) and absence of complete biliary obstruction.
- Reauthorization criterion requires both: (1) improvement in liver function (e.g., AST, ALT) and (2) absence of complete biliary obstruction.
- When these are documented, authorization may be issued for a longer interval (per policy thresholds).
Discontinue if no clinical improvement or complete biliary obstruction
If liver function does not improve within 3 months, or if complete biliary obstruction or persistent/worsening liver dysfunction or cholestasis occurs, therapy should be discontinued and continued authorization may be denied.
- Discontinue Cholbam if no liver function improvement within 3 months of starting therapy.
- Discontinue if complete biliary obstruction develops or if persistent clinical or laboratory indicators of worsening liver function or cholestasis are present.
- Lack of documented improvement may trigger denial of continued authorization.
Definitions
Background
Cholbam (cholic acid) is a prescription bile acid replacement therapy indicated for patients with bile acid synthesis disorders due to single enzyme defects (SEDs) and as adjunctive therapy for certain peroxisomal disorders (PDs), including Zellweger spectrum disorders, when patients exhibit hepatic manifestations, steatorrhea, or complications from impaired fat‑soluble vitamin absorption. Clinical use focuses on correcting deficient bile acid production to improve liver function and fat absorption; providers should monitor response and discontinue therapy if liver function does not improve within 3 months or if contraindications such as complete biliary obstruction develop.
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