CurrentCignaPolicy IP0710

Iqirvo

Defines Cigna's prior authorization and medical necessity criteria for coverage of Iqirvo for adults with primary biliary cholangitis (PBC), including initial and continuation therapy requirements and excluded indications.

Policy Summary

PayerCigna

PolicyIqirvo

Policy CodePolicy IP0710

Change TypeNew policymaterial changes

Effective DateAug 15, 2025

Next Review Date

Key ActionObtain prior authorization and document PBC diagnosis, prior UDCA trial or intolerance, absence of hepatic decompensation, and specialist involvement.

SourceLink

POLICY UPDATE CHANGES

New policy for Iqirvo with criteria for use in primary biliary cholangitis.

Limitation that Iqirvo is not recommended in patients who have or develop decompensated cirrhosis.

6 monthsinitial approval duration

1 yearrenewal/continuation approval duration

IP0710Policy Number

AcceleratedRegulatory status

Coverage Criteria for Iqirvo (elafibranor)

FDA-Approved Indication

Iqirvo is considered medically necessary when the following are met for Primary Biliary Cholangitis (approve when ONE of A or B is met):

FDA-Approved Indication: Approve Iqirvo for PBC if the patient meets ONE of A (Initial Therapy) or B (Currently Receiving Therapy).

A) Initial Therapy: Approve for 6 months if patient meets ALL of the following (i–v).

Initial Therapy details

i: Patient is ≥ 18 years of age.
ii:

Policy Summary

PayerCigna

PolicyIqirvo

Policy CodePolicy IP0710

Change TypeNew policymaterial changes

Effective DateAug 15, 2025

Next Review Date

Key ActionObtain prior authorization and document PBC diagnosis, prior UDCA trial or intolerance, absence of hepatic decompensation, and specialist involvement.

SourceLink

On This Page

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According to the prescriber, diagnosis of primary biliary cholangitis as defined by TWO of the following: (a) alkaline phosphatase elevated above the laboratory upper limit of normal; OR (b) positive anti-mitochondrial antibodies or other PBC-specific auto-antibodies (including sp100 or gp210) if anti-mitochondrial antibodies are negative; OR (c) histologic evidence of PBC from liver biopsy.

iii: Patient meets ONE of the following: (a) has been receiving ursodiol therapy for ≥ 1 year with inadequate response according to the prescriber; OR (b) is unable to tolerate ursodiol therapy.

Examples of ursodiol products include ursodiol generic tablets and capsules, Urso 250, Urso Forte, and Actigall.

iv: Patient does not currently have, or have a history of, a hepatic decompensation event (examples: ascites, gastroesophageal varices, variceal bleeding, hepatic encephalopathy, coagulopathy).

v: Medication is prescribed by or in consultation with a gastroenterologist, hepatologist, or liver transplant physician.

B) Currently Receiving Therapy: Approve for 1 year if both i and ii are met.

Continuation Therapy details

i: Patient does not currently have, or have a history of, a hepatic decompensation event (examples: ascites, gastroesophageal varices, variceal bleeding, hepatic encephalopathy, coagulopathy).
ii: Patient has demonstrated a response to therapy as determined by the prescriber (examples: improved biochemical markers such as alkaline phosphatase, bilirubin, GGT, AST, ALT).

Use of Iqirvo for any purpose other than treatment of primary biliary cholangitis (PBC) is considered not medically necessary. Explicit examples listed in the policy include treatment of Alcoholic Liver Disease and MASLD/NAFLD (including MASH/NASH).

Iqirvo (elafibranor) is not medically necessary for indications other than PBC. The policy specifically names Alcoholic Liver Disease and Metabolic Dysfunction‑Associated Steatotic Liver Disease/Nonalcoholic Fatty Liver Disease (MASLD/NAFLD), including MASH/NASH as non‑covered because clinical trials (for example RESOLVE‑IT in MASH) did not demonstrate clinically meaningful benefit.

Coding and Age Eligibility

Covered CPT Codesmixed

No codes listed

Age

Age requirementPatient is ≥ 18 years of age.

Approval duration (initial)Initial approval is for 6 months when criteria met.

ContextApplies to Iqirvo (elafibranor) use for Primary Biliary Cholangitis (PBC).

Provider Actions, Prior Authorization, and Documentation

Prior Authorization

Prior Authorization Required

Prior Authorization Required. Approvals are time-limited: initial approvals are for 6 months; continuation (patients currently receiving therapy) approvals are for 1 year. Iqirvo must be prescribed by or in consultation with a gastroenterologist, hepatologist, or liver transplant physician.

Initial approval: 6 months (1 month = 30 days)
Continuation approval: 1 year
Prescriber requirement: gastroenterologist, hepatologist, or liver transplant physician

Step Therapy

UDCA (ursodiol) Trial Requirement

Ursodiol (UDCA) trial requirement. Prior to approval for initial therapy, the prescriber must document a trial of ursodiol (e.g., ursodiol generic tablets/capsules, Urso 250, Urso Forte, Actigall) for ≥ 1 year with inadequate response, or document that the patient is unable to tolerate ursodiol.

Required UDCA trial: ≥ 1 year with inadequate response (unless intolerant)
Examples of ursodiol products: ursodiol generic tablets/capsules, Urso 250, Urso Forte, Actigall

Documentation Required

Documentation Requirements

Required documentation. Prescriber must document the diagnosis of primary biliary cholangitis meeting diagnostic criteria, prior UDCA use or intolerance, and absence of hepatic decompensation. For initial therapy, diagnosis must be supported by TWO of: elevated alkaline phosphatase, positive antimitochondrial or other PBC-specific autoantibodies (e.g., sp100, gp210), or histologic evidence on liver biopsy. Do not approve if there is current or prior hepatic decompensation (examples: ascites, gastroesophageal varices/bleeding, hepatic encephalopathy, coagulopathy).

Diagnosis: documentation of TWO of the following – elevated alkaline phosphatase; positive anti-mitochondrial or other PBC-specific autoantibodies (sp100, gp210) if AMA negative; or liver biopsy showing PBC
Document UDCA therapy duration and response, or intolerance
Document absence of hepatic decompensation (e.g., ascites, varices/bleeding, encephalopathy, coagulopathy)

Denial Risk

Denial Triggers

Claims without a covered diagnosis or procedure code consistent with this policy, or submitted without prior authorization when required, will be denied.

Submit appropriate covered diagnosis/procedure codes per policy
Prior authorization must be obtained before billing/claim submission

Background on Iqirvo

Iqirvo (elafibranor) is a peroxisome proliferator‑activated receptor (PPAR) agonist approved for the treatment of primary biliary cholangitis (PBC) in adults who have an inadequate response to ursodeoxycholic acid (UDCA) or as monotherapy if UDCA is not tolerated. Approval was granted under an accelerated pathway based on reduction in alkaline phosphatase; improvement in survival or prevention of liver decompensation has not been established. The medication is not recommended for patients with decompensated cirrhosis and should be discontinued if a patient progresses to moderate or severe hepatic impairment (Child‑Pugh B or C).

Definitions and Diagnostic Criteria

Primary biliary cholangitis (PBC) diagnosis

Diagnostic ruleDiagnosis confirmed when TWO of the following are met: (a) alkaline phosphatase elevated above the lab upper limit of normal; (b) positive antimitochondrial antibodies or other PBC-specific autoantibodies (e.g., sp100 or gp210) if AMA negative; (c) histologic evidence of PBC on liver biopsy.

Source guideline noteAASLD guidance states diagnosis can be confirmed when patients meet two of the listed criteria; biopsy not required if other criteria met when AMA negative.

Clinical implicationUse these criteria to document PBC for Iqirvo prior authorization and to determine eligibility for initial therapy.

Alternate namePrimary Biliary Cholangitis is also known as Primary Biliary Cirrhosis.