Cholbam (cholic acid) recommended authorization criteria
Customize your policy alerts
Sign up for all medical mutual - ohio policy alerts
Know when medical mutual - ohio releases new policies or updates existing guidance.
Monitor payer policy activity
Guidance for recommended prior authorization and coverage criteria for Cholbam (cholic acid) under the pharmacy benefit, including indications, required documentation, prescriber specialty, and approval durations. Applies to providers seeking coverage for members under medical mutual - ohio.
No material clinical or coverage changes in this revision.
Coverage Criteria for Cholbam (cholic acid)
Bile Acid Synthesis Disorders Due to Single Enzyme Defects (SEDs), Initial Therapy
Covered when ALL of the following are met
Bile Acid Synthesis Disorders Due to Single Enzyme Defects (SEDs), Continuing Therapy
Covered when ALL of the following are met
Peroxisomal Disorders (PDs), Including Zellweger Spectrum Disorders, Initial Therapy
Covered when ALL of the following are met
Peroxisomal Disorders (PDs), Including Zellweger Spectrum Disorders, Continuing Therapy
Covered when ALL of the following are met
Combination therapy of Cholbam (cholic acid) with chenodeoxycholic acid products such as Chenodal or Ctexli is not recommended because there are no efficacy data to support combined use. In addition, coverage is not recommended for circumstances that are not specifically listed in the Recommended Authorization Criteria; the criteria will be updated if new published data become available.
Uses of Cholbam that are not listed in the Recommended Authorization Criteria should not be approved routinely. Such requests require case‑by‑case review with supporting clinical evidence and documentation; the Company may deny reimbursement when the service is determined to be not medically necessary, investigational, experimental, or outside the member’s benefits. Providers should be prepared to submit relevant records, test results, and provider credentials when requested to support medical necessity.
Testing and Laboratory Documentation Requirements
Actions Required from Prescribers and Documentation to Support Prior Authorization
Prior authorization and specialist prescriber requirement
Prior authorization is recommended for pharmacy benefit coverage of Cholbam. Initial approval requires the drug 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; reauthorization requires demonstration of response to therapy unless otherwise noted.
Do not combine Cholbam with Chenodal or Ctexli
Combination therapy with chenodeoxycholic acid (Chenodal) or Ctexli is not recommended because there are no efficacy data available to support use of combination therapy with Cholbam.
- Coverage for combination use is listed under Conditions Not Recommended for Approval.
Required documentation and test recency
Include diagnostic confirmation and recent liver testing in the request: abnormal urinary bile acid confirmed by FAB‑MS or molecular genetic testing, and liver function tests within the past 6 months (AST, ALT, GGT, ALP, bilirubin, INR). The Company may request additional records to support medical necessity.
- Diagnostic confirmation: abnormal urinary bile acid by Fast Atom Bombardment‑Mass Spectrometry (FAB‑MS) OR molecular genetic testing consistent with diagnosis.
- Liver function testing documented within the past 6 months: AST, ALT, GGT, ALP, bilirubin, and INR.
- Be prepared to provide patient records, test results, and provider credentials if requested.
Denial risk: insufficient medical necessity or documentation
The Company may deny reimbursement when the drug or services are not medically necessary, investigational or experimental, not within the scope of member benefits, or when documentation is inappropriate, excessive, or unavailable upon request.
- Failure to provide additional requested documentation (e.g., patient records, test results, provider credentials) may result in denial.
- Requests for uses not listed in the Recommended Authorization Criteria may be denied as investigational or not medically necessary.
Background and Indications
Cholbam (cholic acid) is indicated for treatment of bile acid synthesis disorders due to single enzyme defects (SEDs) and may be used as adjunctive therapy for peroxisomal disorders (PDs), including Zellweger spectrum disorders, when patients have liver disease, steatorrhea, or complications from decreased fat‑soluble vitamin absorption. Diagnosis for SEDs and PDs should be confirmed by abnormal urinary bile acid analysis (FAB‑MS) or molecular genetic testing. Prior authorization requests should include recent liver function testing within the past 6 months (AST, ALT, GGT, ALP, bilirubin, INR), and Cholbam should be prescribed by or in consultation with a hepatologist, metabolic specialist, or gastroenterologist. The drug’s effects on extrahepatic manifestations (for example, neurologic features) of SEDs are not established.
Definitions of Disorders
OpenPayer is powered by Trek Health's payer performance platform. Trek continuously ingests, validates, and normalizes Transparency in Coverage data alongside payer policies and other commercial payer data to create a structured payer intelligence foundation. OpenPayer uses this foundation to deliver personalized search results, dynamically generated policy pages, and tailored policy monitoring based on each user's payers, specialties, billing codes, and areas of interest. The same intelligence powers broader payer performance workflows, including reimbursement benchmarking, contract evaluation, payer negotiations, and financial decision-making.