Pharmacy Prior Authorization Criteria

Chenodiol Products

Indications for Prior Authorization

Chenodal (chenodiol)

• For diagnosis of Radiolucent Gallstones
  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. Chenodiol will not dissolve calcified (radiopaque) or radiolucent bile pigment stones.

Ctexli (chenodiol)

• For diagnosis of Cerebrotendinous Xanthomatosis
  Indicated for treatment of cerebrotendinous xanthomatosis (CTX) in adults.

Criteria

Chenodal

If patient meets criteria above, please approve at NDC level.

Prior Authorization (Initial Authorization)

Length of Approval: 12 Month(s)

• Diagnosis of radiolucent gallstones
AND
• Patient has a well-opacifying gallbladder visualized by oral cholecystography
AND
• Trial and failure, contraindication or intolerance to ursodiol
AND
• Patient is not a candidate for surgery
AND
• Stones are not calcified (radiopaque) or radiolucent bile pigment stones
AND
• Prescribed by or in consultation with one of the following:
• Gastroenterologist
• A provider who has specialized expertise in the management of gallstones

Chenodal

If patient meets criteria above, please approve at NDC level.

Prior Authorization (Reauthorization)

Length of Approval: 12 Month(s)

• Patient’s disease status has been re-evaluated since the last authorization to confirm the patient’s condition warrants continued treatment as evidenced by oral cholecystograms or ultrasonograms
AND
• Prescribed by or in consultation with one of the following:
• Gastroenterologist
• A provider who has specialized expertise in the management of gallstones

Ctexli

If patient meets criteria above, please approve at NDC level.

Prior Authorization (Initial Authorization)

Length of Approval: 12 Month(s)

• Diagnosis of cerebrotendinous xanthomatosis (cholestanol storage disease)
AND
• Disease is confirmed by the presence of pathogenic variant(s) in the CYP27A1 gene, as detected by an FDA-approved test or a test performed at a facility approved by Clinical Laboratory Improvement Amendments (CLIA) [3, 4]
AND
• Prescribed by or in consultation with one of the following: [3]
• Neurologist
• Geneticist
• Metabolic disease specialist

Ctexli

If patient meets criteria above, please approve at NDC level.

Prior Authorization (Reauthorization)

Length of Approval: 12 Month(s)

• Patient demonstrates positive clinical response to therapy (e.g. stabilization or improvement in symptoms, reduction in biochemical markers [e.g., serum cholestanol, urine 23S-pentol]) [2-4]

P & T Revisions

2025-05-01, 2025-03-20, 2024-03-21, 2023-03-16, 2022-03-18, 2021-02-04, 2020-03-04

References

1. Chenodal Prescribing Information. Retrophin, Inc. San Diego, CA. December 2024.
2. Ctexli Prescribing Information. Mirum Pharmaceuticals, Inc. Foster City, CA 94404. February 2025.
3. Stelten BML, Dotti MT, Verrips A, Elibol B, Falik-Zaccai TC, Hanman K, Mignarri A, Sithole B, Steiner RD, Verma S, Yahalom G, Zubarioglu T, Mochel F, Federico A. Expert opinion on diagnosing, treating and managing patients with cerebrotendinous xanthomatosis (CTX): a modified Delphi study. Orphanet J Rare Dis. 2021;16(1):353. doi:10.1186/s13023-021-01980-5.
4. DeBarber A, Kisanuki Y, Nobrega P, Himes R, Jayadev S, Bernat J, Prakash V, Gibson J, Larson A, Sgobbi P, Murphy E, Fedor B, Wong Po Foo C, Dutta R, Imperiale M, Garner W, Vig P, Perez S, Ramdhani R, Saute J, Duell PB. Evaluation of Chenodeoxycholic Acid Treatment in Adult Patients with Cerebrotendinous Xanthomatosis: A Randomized, Placebo-Controlled Phase 3 Study [abstract].

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Revision History

• 2025-05-01: Added new product Ctexli. Renamed guideline to Chenodiol products.
• 2025-03-20: 2025 annual review - no criteria changes.
• 2024-03-21: 2024 annual review - no criteria changes.
• 2023-03-16: Annual review: no criteria changes.
• 2022-03-18: Annual review: updated diagnosis criterion to specify it's for "gallstones" and added specialist requirement for initial and reauthorization.
• 2021-02-04: Annual review
• 2020-03-04: New PA criteria

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