CurrentBlue Cross Blue Shield - IowaPolicy 05.05.56

Iqirvo (elafibranor) and Livdelzi (seladelpar) for Primary Biliary Cholangitis — Coverage Criteria

Defines prior authorization, medical necessity criteria, and coverage limitations for Iqirvo and Livdelzi in adults with primary biliary cholangitis (PBC) for Blue Cross Blue Shield - Iowa.

Policy Summary

PayerBlue Cross Blue Shield - Iowa

PolicyIqirvo (elafibranor) and Livdelzi (seladelpar) for PBC — Coverage Criteria

Policy CodePolicy 05.05.56

Change TypeNo material change

Effective DateDec 18, 2025

Next Review DateOct 1, 2025

Key ActionSubmit prior authorization with pretreatment ALP for initial requests and current ALP and/or total bilirubin for continuation requests.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 monthsauthorization duration

80 mgIqirvo dosing

10 mgLivdelzi dosing

30/30dIqirvo quantity limit

15% ALPclinical benefit metric

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Coverage criteria for Iqirvo and Livdelzi (PBC)

Initial and continuation coverage for PBC

Authorization of 12 months may be granted for treatment of PBC in adult patients when ALL of the following are met:

PBC diagnosis confirmation: Diagnosis of PBC is confirmed by at least two of the following: (A) biochemical evidence of cholestasis with elevation of alkaline phosphatase (ALP) level for at least 6 months; (B) presence of antimitochondrial antibodies (AMA) (titer >1:40) or PBC-specific antinuclear antibodies (e.g., antigp210, anti-sp100); (C) histologic evidence of PBC on liver biopsy (e.g., non-suppurative inflammation and destruction of interlobular and septal bile ducts).2 of 3 criteria

Refer to diagnostic criteria in policy

Baseline ALP: Patient has an elevated serum alkaline phosphatase (ALP) level prior to initiation of therapy with the requested drug.elevated ALP

Baseline ALP required

UDCA response or intolerance: Either: (A) inadequate response to at least 12 months of prior therapy with ursodeoxycholic acid (UDCA)/ursodiol and the member will continue concomitant UDCA/ursodiol, OR (B) intolerance to UDCA/ursodiol.12 months of UDCA unless intolerant

Continued UDCA recommended if applicable

Continuation of therapy

Authorization may be renewed for members who have achieved or maintained clinical benefit when ANY of the following are met:

Example clinical benefit metrics: At least a 15% reduction in alkaline phosphatase (ALP) level, OR ALP level less than 1.67 times the upper limit of normal (ULN), OR total bilirubin less than or equal to ULN.15% reduction or ALP <1.67x ULN or Tbili <= ULN

Examples of clinical benefit cited in policy

Use of Iqirvo (elafibranor) or Livdelzi (seladelpar) is not recommended and coverage will not be provided for members who have or develop decompensated cirrhosis. Examples of decompensated cirrhosis include ascites, variceal bleeding, and hepatic encephalopathy.

Iqirvo and Livdelzi are considered not medically necessary for members who do not meet the specified medical necessity criteria for treatment of primary biliary cholangitis (PBC) as outlined in this policy (including diagnostic confirmation, baseline ALP, and UDCA trial or documented intolerance).

Prior authorization, documentation, and prescribing requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required for the requested therapy for primary biliary cholangitis (PBC). Initial prior authorization requests must include a pretreatment serum alkaline phosphatase (ALP) level. Continuation/renewal requests must include current laboratory data showing response or ongoing need for therapy (see documentation requirements).

Authorization may be granted for up to 12 months for adults meeting criteria for PBC.
Agents (e.g., elafibranor, seladelpar) are not medically necessary for members who do not meet the criteria in this policy.

Documentation Required

UDCA (ursodiol) Requirement

Patient must have had an inadequate response to at least 12 months of ursodeoxycholic acid (UDCA)/ursodiol prior therapy unless the patient is intolerant to UDCA/ursodiol. When applicable, concomitant UDCA/ursodiol should be continued during treatment with the requested agent.

Documentation Required

Required Documentation

Submit the following documentation with the prior authorization request to initiate review and for renewals/continuation requests: for initial requests, provide a pretreatment serum alkaline phosphatase (ALP) level; for continuation requests, provide current serum ALP and/or current total bilirubin level demonstrating clinical response or continued need (examples of clinical benefit include ≥15% reduction in ALP, ALP <1.67×ULN, and total bilirubin ≤ULN).

Initial request: include pretreatment serum ALP.
Continuation/renewal: include current serum ALP and/or current total bilirubin; evidence of clinical benefit (e.g., ≥15% ALP reduction, ALP <1.67×ULN, total bilirubin ≤ULN) when available.

Denial Risk

Denial / Exclusion Triggers

Coverage will not be provided for members who have or develop decompensated cirrhosis (for example ascites, variceal bleeding, hepatic encephalopathy). Agents are considered not medically necessary if the member does not meet the diagnostic, laboratory, and prior-therapy requirements outlined in this policy.

Exclusion example conditions: ascites, variceal bleeding, hepatic encephalopathy.

Background and indications

Iqirvo (elafibranor) and Livdelzi (seladelpar) are indicated for the treatment of primary biliary cholangitis (PBC) in adults with inadequate response to ursodeoxycholic acid (UDCA) or as monotherapy if UDCA is not tolerated. Approval is based on surrogate endpoint reduction in alkaline phosphatase (ALP); improvements in survival or prevention of hepatic decompensation have not been demonstrated. Use is not recommended in patients with decompensated cirrhosis (for example, ascites, variceal bleeding, or hepatic encephalopathy).