Currentmedical mutual - ohioPolicy N/A

Cholbam (cholic acid) coverage

Defines medical necessity and prior authorization criteria for Cholbam (cholic acid) for treatment of bile acid synthesis disorders due to single enzyme defects and adjunctive treatment of peroxisomal disorders (including Zellweger spectrum disorders) for Medical Mutual - Ohio members.

Policy Summary

Payermedical mutual - ohio

PolicyCholbam (cholic acid) coverage

Policy CodePolicy N/A

Change TypeAnnual review — no material changes

Effective DateN/A

Next Review DateMay 22, 2025

Key ActionObtain prior authorization and ensure Cholbam is prescribed by or in consultation with a hepatologist, metabolic specialist, or gastroenterologist.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

90 daysInitial approval duration

365 daysExtended approval duration

FAB-MS or molecularDiagnostic confirmation

LFTs ≤6moDocumentation required

SpecialistPrescribed by specialist

Coverage Criteria for Cholbam (cholic acid)

Policy Summary

Payermedical mutual - ohio

PolicyCholbam (cholic acid) coverage

Policy CodePolicy N/A

Change TypeAnnual review — no material changes

Effective DateN/A

Next Review DateMay 22, 2025

Key ActionObtain prior authorization and ensure Cholbam is prescribed by or in consultation with a hepatologist, metabolic specialist, or gastroenterologist.

SourceLink

On This Page

Trek Health ingests and normalizes Transparency in Coverage data and payer policy updates to give provider organizations a clear view of how commercial reimbursement behaves across markets, payers, and services. Our platform transforms raw payer disclosures into structured intelligence that supports contract evaluation, payer negotiations, and service line strategy. By combining market benchmarks with ongoing policy visibility, Trek helps teams identify variability, risk, and opportunity in commercial reimbursement. The result is faster insight, stronger negotiating positions, and more informed financial decisions.

Bile Acid Synthesis Disorders Due to Single Enzyme Defects (Initial)

Covered when ALL of the following are met for initial therapy for SEDs

SEDs Initial Therapy: A. Diagnosis of bile acid synthesis disorder due to single enzyme defects (SEDs) [documentation required]; AND B. The patient has a diagnosis of SED 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 C. The patient has documentation of liver function testing in the past 6 months (e.g., AST, ALT, GGT, ALP, bilirubin, and INR); AND D. Cholbam is prescribed by or in consultation with a hepatologist, metabolic specialist, or a gastroenterologist.

Initial approval duration 90 days; extended approval 365 days

Bile Acid Synthesis Disorders Due to Single Enzyme Defects (Continuation)

Covered when ALL of the following are met for patients currently receiving Cholbam for SEDs

SEDs Ongoing Therapy: A. The patient has responded to initial Cholbam therapy with an improvement in liver function tests (e.g., AST, ALT, GGT, ALP, bilirubin, and INR levels); AND B. The patient does not have complete biliary obstruction; AND C. Cholbam is prescribed by or in consultation with a hepatologist, metabolic specialist, or a gastroenterologist.

Extended approval 365 days when criteria met

Peroxisomal Disorders (Initial)

Covered when ALL of the following are met for initial therapy for peroxisomal disorders (including Zellweger spectrum)

Peroxisomal Disorders Initial Therapy: A. Diagnosis of peroxisomal disorder, including Zellweger Spectrum Disorder [documentation required]; AND B. The patient has peroxisomal disorders with an abnormal urinary bile acid analysis by Fast Atom Bombardment ionization - Mass Spectrometry (FAB-MS); OR based on molecular genetic testing consistent with the diagnosis; AND C. The patient has liver disease, steatorrhea, or complications from decreased fat‑soluble vitamin absorption (e.g., rickets); AND D. The patient has documentation of liver function testing in the past 6 months (e.g., AST, ALT, GGT, ALP, bilirubin, and INR levels); AND E. Cholbam is prescribed by or in consultation with a hepatologist, metabolic specialist, or a gastroenterologist.

Initial approval duration 90 days; extended approval 365 days

Peroxisomal Disorders (Continuation)

Covered when ALL of the following are met for patients currently receiving Cholbam for peroxisomal disorders

Peroxisomal Disorders Ongoing Therapy: A. The patient has responded to initial Cholbam therapy as per the prescribing physician (e.g., improvements in liver enzymes, improvement in steatorrhea); AND B. Patient does not have complete biliary obstruction; AND C. Cholbam is prescribed by or in consultation with a hepatologist, metabolic specialist, or a gastroenterologist.

Extended approval 365 days when criteria met

Combination therapy of Cholbam (cholic acid) with Chenodal is not recommended. The policy specifies that there are no efficacy data to support combined use of Cholbam and Chenodal, and therefore combination therapy should not be used as a basis for coverage.

Uses of Cholbam that are not specifically listed in the policy's Recommended Authorization Criteria are not recommended for approval in the absence of supporting published data. The criteria will be updated if new peer‑reviewed evidence becomes available, but requests for indications outside the listed criteria should include supportive published data to be considered.

Provider Requirements, Prior Authorization, and Documentation

Prior Authorization

Prior Authorization Required

Prior authorization is required for coverage. Initial approval requires Cholbam be prescribed by or in consultation with a hepatologist, metabolic specialist, or gastroenterologist. All approvals for initial therapy are provided for the initial approval duration noted in the policy; if reauthorization is allowed, a documented response to therapy is required for continuation unless otherwise noted.

Initial prescribing or consultation by a hepatologist, metabolic specialist, or gastroenterologist is required
Prior authorization recommended for pharmacy benefit coverage of Cholbam

Step Therapy

Step/Combination Therapy Restrictions

Combination therapy with Chenodal is not recommended due to lack of efficacy data supporting combined use with Cholbam.

Do not initiate Cholbam in combination with Chenodal; requests for such combinations are not recommended for approval

Documentation Required

Required Documentation

Require documentation of diagnosis and diagnostic confirmation. Acceptable diagnostic confirmation includes FAB-MS urinary bile acid analysis or molecular genetic testing. Also require recent liver function testing and other supporting clinical records as specified in the criteria.

Documentation of diagnosis (SED or peroxisomal disorder) is required
Diagnostic confirmation via Fast Atom Bombardment ionization - Mass Spectrometry (FAB-MS) urinary bile acid analysis or molecular genetic testing
Liver function testing results within the past 6 months (AST, ALT, GGT, ALP, bilirubin, INR)
Additional records as requested (patient records, test results, provider credentials)

Denial Risk

Denial Risk Summary

The Company may deny reimbursement when the drug or services are not medically necessary, are investigational/experimental, are not within the member's benefit scope, or when documentation is insufficient. The Company reserves the right to request additional documentation and to modify or interpret this policy at its discretion.

Denial may occur if treatment is not medically necessary or is investigational/experimental
Denial may occur if the request is outside the scope of the member's benefits
Denial may occur for insufficient or missing documentation supporting diagnosis, diagnostic confirmation, liver testing, or provider specialty involvement
The Company may request patient records, test results, and provider credentials; failure to supply requested documentation may result in denial

Definitions

inv-13: Bile acid synthesis disorders due to single enzyme defects (SEDs)

DefinitionInherited disorders of bile acid synthesis due to single enzyme defects (SEDs) leading to abnormal bile acid profiles

Diagnostic methodsAbnormal urinary bile acid analysis confirmed by Fast Atom Bombardment ionization - Mass Spectrometry (FAB-MS) OR molecular genetic testing consistent with the diagnosis

Treatment contextIndication for Cholbam (cholic acid) as replacement therapy for SEDs; coverage requires documentation of diagnosis and specialist prescription or consultation

LimitationsEffects on extrahepatic manifestations (e.g., neurologic symptoms) have not been established

inv-14: Peroxisomal disorders (PDs), including Zellweger Spectrum Disorders

DefinitionGenetic peroxisomal biogenesis or enzyme defects, including Zellweger Spectrum Disorders

When adjunctive cholic acid may be usedWhen patients exhibit manifestations of liver disease, steatorrhea, or complications from decreased fat‑soluble vitamin absorption (e.g., rickets)

Diagnostic methodsAbnormal urinary bile acid analysis by FAB-MS OR molecular genetic testing consistent with the diagnosis

Treatment contextCholbam is indicated as adjunctive therapy for PDs when the above clinical features are present and prescribed by or in consultation with a hepatologist, metabolic specialist, or gastroenterologist

OpenPayer

Cholbam (cholic acid) coverage

Coverage Criteria for Cholbam (cholic acid)

Testing and Laboratory Documentation

Provider Requirements, Prior Authorization, and Documentation

Background on Cholbam and Indications

Definitions