CurrentCignaPolicy N/A

Hepatology - Peroxisome Proliferator-Activated Receptor Agonists Preferred Specialty Management Policy

Defines Cigna's preferred specialty management and prior authorization exception criteria for peroxisome proliferator-activated receptor (PPAR) agonists (Iqirvo and Livdelzi) for adults with primary biliary cholangitis; applies to benefit plans administered by Cigna companies.

Policy Summary

PayerCigna

PolicyHepatology - Peroxisome Proliferator-Activated Receptor Agonists Preferred Specialty Management Policy

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateFeb 4, 2026

Key ActionSubmit prior authorization with documentation and, for Livdelzi, document trial of the preferred product Iqirvo or meet exception criteria.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

2products listed (Preferred and Non-Preferred)

1preferred product (Iqirvo)

1non-preferred product (Livdelzi)

acceleratedapproval basis

requireddocumentation

Coverage Criteria for Non-Preferred Product

Non-Preferred Product Exception Criteria (Livdelzi)

Non-preferred product (Livdelzi) is covered as medically necessary when the following exception criteria are met:

Livdelzi exception criteria

A: Patient meets the standard Hepatology - Livdelzi Prior Authorization Policy criteria.
B: Patient has tried Iqirvo (Preferred Product).
Documentation required: may include chart notes, prescription claims records, prescription receipts, and other patient-specific information identifying the patient.

Offer if only A met: If the patient has met criterion 1A (standard Hepatology - Livdelzi Prior Authorization Policy criteria) but has NOT met criterion 1B (trial of Iqirvo): Offer to review for the Preferred Product using the respective standard Prior Authorization Policy criteria.

Policy Summary

PayerCigna

PolicyHepatology - Peroxisome Proliferator-Activated Receptor Agonists Preferred Specialty Management Policy

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateFeb 4, 2026

Key ActionSubmit prior authorization with documentation and, for Livdelzi, document trial of the preferred product Iqirvo or meet exception criteria.

SourceLink

On This Page

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Provider Actions, Prior Authorization, and Documentation

Prior Authorization

Prior Authorization Required

Prior authorization is required for all products (Preferred and Non-Preferred). Patients must meet the respective standard Prior Authorization Policy criteria found in the applicable Hepatology prior authorization policy. All approvals are provided for the duration noted in the respective standard Prior Authorization Policy. Requests for Non-Preferred products are reviewed under the Non-Preferred Product Exception Criteria; if the patient meets the standard Livdelzi prior authorization criteria but has not tried the Preferred Product, the reviewer will offer a review for the Preferred Product(s) under the applicable standard prior authorization criteria.

All products require review under the standard Prior Authorization Policy for the named product.
Non-Preferred requests are evaluated using the Non-Preferred Product Exception Criteria.
Approvals follow the duration specified in the corresponding standard Prior Authorization Policy.

Step Therapy

Step Therapy: Try Preferred Product First

The Preferred Specialty Management program requires patients to try the Preferred Product (Iqirvo) before a Non-Preferred Product (Livdelzi) will be approved, except when an exception is documented and meets the exception criteria below. Specifically, approval of Livdelzi requires that the patient meet the standard Hepatology - Livdelzi prior authorization criteria AND have tried Iqirvo (documentation required). If the patient meets the Livdelzi prior authorization criteria but has not tried Iqirvo, a review for the Preferred Product will be offered.

Preferred product: Iqirvo
Non-preferred product: Livdelzi
Livdelzi approval requires documented trial of Iqirvo per exception criteria.

Documentation Required

Documentation is required for requests and exceptions as indicated in the criteria. Acceptable documentation may include chart notes, prescription claims records, prescription receipts, and other supporting information. All documentation must include patient-specific identifying information and be sufficient to demonstrate that required criteria (including trials of the Preferred Product) have been met.

Examples of acceptable documentation: chart notes, prescription claims records, prescription receipts, and similar records.
All documentation must include patient identifiers and be sufficient to verify trials and criteria.
Documentation is required to support exception requests and approvals.

Denial Risk

Coding / Claims Omission Denial Risk

Claims submitted without covered diagnosis and/or procedure codes that correspond to the applicable coverage policy may be denied as not covered. When billing, providers must use the most appropriate codes effective on the date of service. Reimbursement is not allowed for services billed for conditions or diagnoses that are not covered under this coverage policy.

Use the most appropriate diagnosis/procedure codes as of the date of service.
Claims lacking covered code(s) under the applicable coverage policy will be denied as not covered.
Ensure submitted codes align with the coverage criteria to avoid omission denials.

Indication and Use Definitions

Primary biliary cholangitis (PBC) — indication and therapy context

Indication summaryTreatment of primary biliary cholangitis (PBC) in adults: use Iqirvo or Livdelzi in combination with ursodeoxycholic acid (UDCA) for patients with inadequate response to UDCA, or as monotherapy for adults unable to tolerate UDCA.

Therapy classPeroxisome proliferator-activated receptor (PPAR) agonists (Iqirvo, Livdelzi).

Approval basisBoth products approved under accelerated approval based on reduction in alkaline phosphatase.

Clinical effects observedDemonstrated sustained biochemical responses and improvement in pruritus in clinical studies.

Unestablished benefitImprovement in survival or prevention of liver decompensation has not been established; continued approval may depend on confirmatory trials.

OpenPayer

Hepatology - Peroxisome Proliferator-Activated Receptor Agonists Preferred Specialty Management Policy

Coverage Criteria for Non-Preferred Product

Provider Actions, Prior Authorization, and Documentation

Background on PPAR Agonists

Indication and Use Definitions