Subject: Chenodal SGM 4350-A P2026

Drug

CHENODAL  (chenodiol)

Policy:

Indications

The indications below including FDA-approved indications and compendial uses are considered a covered benefit provided that all the approval criteria are met and the member has no exclusions to the prescribed therapy.

FDA-approved Indications¹

Chenodal is indicated for patients with radiolucent stones in well-opacifying gallbladders, in whom selective surgery would be undertaken except for the presence of increased surgical risk due to systemic disease or age. The likelihood of successful dissolution is far greater if the stones are floatable or small. For patients with nonfloatable stones, dissolution is less likely and added weight should be given to the risk that more emergent surgery might result from a delay due to unsuccessful treatment. Safety of use beyond 24 months is not established. Chenodal will not dissolve calcified (radiopaque) or radiolucent bile pigment stones.

All other indications are considered experimental/investigational and not medically necessary.

Documentation

Submission of the following information is necessary to initiate the prior authorization review: Chart notes or medical record documentation supporting an inadequate treatment response or an intolerance to ursodiol.

Coverage Criteria

Radiolucent Stones in Well-Opacifying Gallbladders^1-3

[Note: Chenodal will not dissolve calcified (radiopaque) or radiolucent bile pigment stones.]

Authorization of 12 months may be granted for treatment of members with radiolucent stones in well-opacifying gallbladders when all of the following criteria are met:

·        Member has an increased surgical risk due to systemic disease or age.

·        Member experienced an inadequate treatment response or intolerance to ursodiol.

·        Member will not exceed a dose of 16 mg/kg/day. Member’s current weight must be provided.

Continuation of Therapy

Radiolucent Stones in Well-Opacifying Gallbladders¹

Authorization of 12 months may be granted for continued treatment in members requesting reauthorization when all of the following criteria are met:

·        Member has experienced partial (or complete) dissolution of stones, or member has not experienced a partial dissolution and provider will discontinue therapy with the requested drug if response is not seen by 18 months of treatment.

·        Member has not experienced signs and symptoms of hepatotoxicity (e.g., abdominal pain, bruising, dark-colored urine, jaundice).

·        Member will not exceed a dose of 16 mg/kg/day. Member’s current weight must be provided.

·        Cumulative use with Chenodal will not exceed 24 months.

Place of Service:

Outpatient

The above policy is based on the following references:

1.      Chenodal [package insert]. San Diego, CA: Travere Therapeutics; December 2025.

2.     Micromedex (electronic version). Merative; 2025. Accessed March 7, 2026.  https://www.micromedexsolutions.com

3.     Abraham S, Rivero HG, Erlikh IV, Griffith LF, Kondamudi VK. Surgical and nonsurgical management of gallstones. Am Fam Physician. 2014;89(10):795-802.

Copyright Aetna Inc. All rights reserved. Pharmacy Clinical Policy Bulletins are developed by Aetna to assist in administering plan benefits and constitute neither offers of coverage nor medical advice. This Clinical Policy Bulletin contains only a partial, general description of plan or program benefits and does not constitute a contract. Aetna does not provide health care services and, therefore, cannot guarantee any results or outcomes. Participating providers are independent contractors in private practice and are neither employees nor agents of Aetna or its affiliates. Treating providers are solely responsible for medical advice and treatment of members. This Clinical Policy Bulletin may be updated and therefore is subject to change.

August 16, 2026