ModifiedUnitedHealthcarePolicy 2025 P 3162-4

Clinical Pharmacy Programs

UnitedHealthcare step therapy program requiring trial of ursodiol before coverage of Chenodal for radiolucent gallstones; allows continuation for members currently on Chenodal and sets authorization duration and additional clinical/billing rules.

Policy Summary

PayerUnitedHealthcare

PolicyClinical Pharmacy Programs

Policy CodePolicy 2025 P 3162-4

Change TypeClarified; Added effective date

Effective DateApr 1, 2025

Next Review Date

Key ActionProviders must obtain authorization for Chenodal; approval requires documented history of ursodiol failure/contraindication/intolerance OR documentation that the patient is currently on Chenodal and was not established via manufacturer samples or assistance programs.

POLICY UPDATE CHANGES

Annual review with no change to coverage criteria for 1/2023, 1/2024, and 1/2025 noted in change control.

Program effective date added as 4/1/2025.

12 monthsAuthorization Duration

Step therapy requiredCoverage Condition

1/2022-1/2025P&T Approval Dates

What changed / at-a-glance

Summary: UnitedHealthcare implemented a step therapy program (Program Number 2025 P 3162-4) that requires a trial of ursodiol before authorizing Chenodal (chenodiol) for treatment of radiolucent cholesterol gallstones. The program effective date is 2025-04-01. P&T review/approval dates listed include 1/2022, 1/2023, 1/2024, and 1/2025 (annual reviews with no change to coverage criteria noted).

What providers must do

Prior Authorization

Step therapy prior authorization

Providers must obtain authorization for Chenodal; approval requires documented history of ursodiol failure/contraindication/intolerance OR documentation that the patient is currently on Chenodal and was not established via manufacturer samples or assistance programs.

Documentation Required

Documentation of ursodiol trial

Document date of ursodiol trial and specific reason for therapeutic failure, contraindication, or intolerance when claiming ursodiol trial exception.

Billing Rule

Authorization duration

Authorizations for Chenodal will be issued for 12 months.

Denial Risk

Manufacturer sample exclusion for current-user status

Patients established on therapy only via manufacturer-supplied samples or Retrophin-sponsored assistance will not be considered current users and must meet initial authorization criteria; claims may be denied if this is not documented.

Documentation Required

Automated approvals

UnitedHealthcare may approve initial and re-authorization based solely on previous claim/medication history, diagnosis codes (ICD-10) and/or claim logic; use of automated processes varies by program.

Clinical background and definitions

Background/Rationale: This step therapy program encourages use of the lower-cost alternative ursodiol before prescribing Chenodal for radiolucent gallstones because ursodiol dissolves cholesterol gallstones and is preferred when appropriate. Chenodal is indicated for patients with radiolucent stones in well-opacifying gallbladders when selective surgery would be indicated except that surgery is high risk due to systemic disease or age. Members who are currently on Chenodal as documented in claims history may continue their therapy.

Definition: Current user established by sample — Patients who received a manufacturer-supplied sample at no cost in the prescriber’s office or any form of assistance from a Retrophin, Inc. sponsored program (for example, sample cards redeemable at a pharmacy) are NOT considered current users for authorization purposes and must meet initial authorization criteria as if new to therapy.

Evidence: Chenodal [package Insert]. Retrophin, Inc.; June 2015.

Policy changes and effective dates

2022-01-01P&T Approval

P&T approval recorded; new step therapy program for Chenodal (chenodiol) initiated.

2023-01-01P&T Approval

Annual P&T review with no change to coverage criteria.

2024-01-01P&T Approval

Annual P&T review with no change to coverage criteria.

2025-01-01P&T Approval

Annual P&T review with no change to coverage criteria.

2025-04-01Program Effective DateLatest

Program effective date added as 4/1/2025.

Policy Summary

PayerUnitedHealthcare

PolicyClinical Pharmacy Programs

Policy CodePolicy 2025 P 3162-4

Change TypeClarified; Added effective date

Effective DateApr 1, 2025

Next Review Date

On This Page

Chenodal (chenodiol)	Covered via step therapy program when criteria met
Ursodiol	Required step-therapy agent prior to Chenodal except when contraindicated/failed/intolerant

OpenPayer

Clinical Pharmacy Programs

What changed / at-a-glance

Coverage criteria for Chenodal

Drug codes and status

What providers must do

Clinical background and definitions

Policy changes and effective dates