Currentmedical mutual - ohioPolicy N/A

Chenodiol Products Prior Authorization Policy

Defines prior authorization requirements and coverage criteria for Chenodiol products (Chenodal and Ctexli) for pharmacy benefit coverage, including initial and extended approval durations and conditions not recommended for approval. Affects prescribers and payers administering pharmacy benefits to members.

Policy Summary

Payermedical mutual - ohio

PolicyChenodiol Products Prior Authorization Policy

Policy CodePolicy N/A

Change TypeAnnual review — no material changes

Effective DateN/A

Next Review DateMar 19, 2026

Key ActionSubmit prior authorization showing ursodiol trial or current ursodiol use for Chenodal and specialty prescribing/diagnostic confirmation for Ctexli.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

2products covered

1initial approval (yrs)

1extended approval (yrs)

2FDA indications listed

1combination therapy not recommended

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.

Coverage Criteria

Initial Therapy Criteria

Covered when the following criteria are met for each product and indication

Chenodal - Gallstones (FDA-Approved Indication)

A: Patient has tried an ursodiol product
B: Patient is currently receiving an ursodiol product

Ctexli - Cerebrotendinous Xanthomatosis (FDA-Approved Indication)

A - Diagnostic confirmation
- i: Molecular genetic test demonstrating a pathogenic variant in CYP27A1
- ii: Laboratory test demonstrating elevated serum cholestanol levels
B - Prescriber specialty: Medication prescribed by or in consultation with a geneticist, neurologist, ophthalmologist, metabolic specialist who treats CTX, or a specialist who focuses in the treatment of CTX

Combination therapy with Cholbam (cholic acid capsules) is not recommended. The policy states there are no efficacy data available to support concomitant use of Chenodiol products with Cholbam, and such combinations are listed among conditions not recommended for approval.

Coverage is not recommended for uses that are not explicitly listed in the Recommended Authorization Criteria. Requests for off-label or unlisted indications will be reviewed on a case-by-case basis for evidence of efficacy and medical necessity, and criteria will be updated if new published data become available.

Use of Chenodiol products in combination with Cholbam (cholic acid) is considered not recommended due to the absence of supporting efficacy data for concomitant administration.

Initial Therapy

Initial therapy — Initial approval criteria by indication

Initial approval criteria by indication

Chenodal initial: Approve for 1 year if patient has tried an ursodiol product OR is currently receiving an ursodiol product1 year

Must be prescribed by or in consultation with a specialist due to required skills for evaluation and monitoring

Ctexli initial

A - Diagnostic confirmation
- i: Molecular genetic test demonstrating a pathogenic variant in CYP27A1
- ii: Laboratory test demonstrating elevated serum cholestanol levels
B - Prescriber specialty: Medication prescribed by or in consultation with a geneticist, neurologist, ophthalmologist, metabolic specialist who treats CTX, or a specialist who focuses in the treatment of CTX

Continuation / Extended Therapy

Extended Therapy

Continued authorization requires response to therapy and prescribing by or in consultation with a specialist as noted.

Extended approval is for 1 year; reauthorization requires demonstration of response to therapy unless otherwise noted1 year

Prescriber specialty requirement applies for initial therapy

Step	Requirement	Applies to
1	Trial of an ursodiol product (prior trial) OR current use of an ursodiol product	Chenodal (for gallstones) — required for approval for 1 year

Provider Actions and Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is recommended for pharmacy benefit coverage of Chenodiol products. Approval is recommended only for patients who meet the criteria in the policy and the specified initial/extension approval duration. Initial prescriptions should be written by, or in consultation with, a physician who specializes in the condition being treated.

Prior authorization recommended for Chenodiol products
Initial therapy requires specialist prescribing or consultation

Prior Authorization

Ursodiol Trial Requirement

For gallstones treated with Chenodiol (Chenodal/Ctexli), approval requires that the patient has tried an ursodiol product previously or is currently receiving an ursodiol product.

Patient has tried an ursodiol product; OR
Patient is currently receiving an ursodiol product

Documentation Required

Documentation Upon Request

The Company may request additional documentation as part of its coverage determination. Providers must make available, upon request, documentation supporting medical necessity. Requested materials may include patient medical records, relevant test results, and provider credentials. Initial approvals may require specialist consultation documentation.

Documentation may include patient records, test results, and provider credentials
Provide additional documentation upon request to support medical necessity

Denial Risk

Grounds for Denial

The Company may deny reimbursement if it determines the drug or services were not medically necessary, are investigational/experimental, fall outside the member's benefit scope, or if there is a pattern of inappropriate or excessive billing or practice. Requests that do not meet the policy criteria or are for uses not listed will be reviewed and may be denied.

Denial grounds: not medically necessary, investigational/experimental, outside benefit limits, inappropriate or excessive billing practices
Uses not listed in policy reviewed case-by-case and may be denied

Product Definitions

inv-10: Chenodal (chenodiol) — Indication summary and key points

ProductChenodal (chenodiol)

Drug classBile acid (chenodeoxycholic acid) product

FDA‑approved indicationRadiolucent gallstones in well-opacifying gallbladders when surgery is precluded by increased surgical risk due to systemic disease or age.

Typical authorization durationInitial and extended approval: 1 year (per policy)

Prior authorization notePrior authorization required for pharmacy benefit coverage; approval recommended only for patients meeting specific criteria.

inv-11: Ctexli (chenodiol) — Indication summary and key points

ProductCtexli (chenodiol)