CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Iqirvo (elafibranor) and Livdelzi (seladelpar) for primary biliary cholangitis

Covers authorization and continuation criteria for Iqirvo and Livdelzi for treatment of primary biliary cholangitis (PBC) in adult Medicaid members of Neighborhood Health Plan of Rhode Island; applies when clinical criteria and exclusions in the policy are met.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyIqirvo (elafibranor) and Livdelzi (seladelpar) for primary biliary cholangitis

Policy CodePolicy N/A

Change TypeNo material change

Effective DateFeb 1, 2025

Next Review DateN/A

Key ActionObtain prior authorization; approvals granted for 6 months when all criteria (including ≥12 months UDCA unless intolerant and required ALP response for continuation) are met.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

6 monthsauthorization duration

>=12 monthsprior UDCA duration

>=15%ALP reduction threshold

<1.67x ULNALP absolute criterion

18+age requirement

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Coverage Criteria for Iqirvo and Livdelzi

inv-01: Initial Therapy

Covered for initial therapy when ALL of the following are met:

Initial Authorization Criteria: A. Member is 18 years of age or older; B. Diagnosis of PBC confirmed by at least two of: (1) biochemical evidence of cholestasis with elevation of alkaline phosphatase (ALP) level for at least 6 months; (2) presence of antimitochondrial antibodies (AMA) (titer >1:40) or PBC-specific antinuclear antibodies (e.g., anti-gp210, anti-sp100); (3) histologic evidence of PBC on liver biopsy (e.g., non-suppurative inflammation and destruction of interlobular and septal bile ducts); C. Documentation of an elevated serum ALP level prior to initiation of therapy; D. Prescribed by or in consultation with a hepatologist or gastroenterologist; E. Member does not have decompensated cirrhosis (e.g., ascites, variceal bleeding, hepatic encephalopathy); F. Either (1) inadequate response to >= 12 months of prior UDCA/ursodiol at 13-15 mg/kg/day with plan to continue concomitant UDCA/ursodiol, or (2) intolerance to UDCA/ursodiol; G. Member will not be using Iqirvo, Livdelzi and/or Ocaliva concomitantly.

Authorization granted for 6 months if met

inv-02: Continuation Therapy

Covered for continuation when ALL of the following are met:

Continuation Authorization Criteria: A. Documentation of clinical benefit with an ALP measurement within the last 6 months meeting any of: (1) at least a 15% reduction in serum ALP from baseline; (2) serum ALP < 1.67 x ULN; (3) normalization of ALP; B. Prescribed by or in consultation with a hepatologist or gastroenterologist; C. Member has not developed decompensated cirrhosis (e.g., ascites, variceal bleeding, hepatic encephalopathy); D. Member will not be using Iqirvo, Livdelzi and/or Ocaliva concomitantly.

Continuation approvals granted for 6 months

Use of Iqirvo (elafibranor) or Livdelzi (seladelpar) for indications other than primary biliary cholangitis (PBC) is considered experimental/investigational and not medically necessary.

Use of Iqirvo or Livdelzi in patients who have or develop decompensated cirrhosis (for example, ascites, variceal bleeding, or hepatic encephalopathy) is not recommended.

All other indications beyond primary biliary cholangitis (PBC) are considered not medically necessary (experimental/investigational).

Clinical Thresholds and Coding-related Thresholds

ALP reduction threshold

Threshold>= 15% reduction in serum alkaline phosphatase (ALP) from baseline

TimingALP measurement must be within the last 6 months

UseRequired for continuation authorization to demonstrate clinical benefit

ALP absolute threshold

ThresholdSerum ALP < 1.67 x upper limit of normal (ULN)

AlternativeNormalization of ALP is also acceptable for continuation

TimingALP level must be measured within the last 6 months for continuation review

Authorization, Documentation, and Denial Triggers

Prior Authorization

Prior Authorization Required

Prior authorization is required. Initial and continuation approvals may be granted for up to 6 months when all criteria are met.

Approval duration: 6 months for initial and continuation requests when criteria satisfied
Prescriber: Must be prescribed by or in consultation with a hepatologist or gastroenterologist

Documentation Required

UDCA (ursodeoxycholic acid) Requirement

Members must have trialed and had an inadequate response to UDCA/ursodiol for at least 12 months at recommended dosing, or have documented intolerance. If UDCA was effective, it must be continued concomitantly with Iqirvo or Livdelzi.

UDCA dosing: 13–15 mg/kg/day (recommended dose)
Required trial: ≥12 months of UDCA/ursodiol unless intolerant

Background on Therapies

Iqirvo (elafibranor) and Livdelzi (seladelpar) are indicated for the treatment of primary biliary cholangitis (PBC) in adults with an inadequate response to ursodeoxycholic acid (UDCA), or as monotherapy for those unable to tolerate UDCA. Both approvals were granted under accelerated approval based on reductions in alkaline phosphatase (ALP); improvement in survival or prevention of liver decompensation has not been demonstrated, and continued approval may depend on confirmatory trials. The policy grants prior authorization for initial and continuation therapy for 6 months when clinical criteria are met, and requires documentation of diagnosis, prior UDCA treatment (typically ≥12 months at 13–15 mg/kg/day unless intolerant), baseline and follow‑up ALP values, appropriate prescriber specialty, and absence of decompensated cirrhosis.

Definitions and Regulatory Notes

Accelerated approval

DefinitionRegulatory approval based on a surrogate endpoint (reduction in alkaline phosphatase [ALP]).

ImplicationImprovement in survival or prevention of liver decompensation has not been demonstrated; continued approval may depend on confirmatory trials.

ScopeApplies to Iqirvo and Livdelzi indications for PBC under accelerated approval pathway.

Decompensated cirrhosis

Clinical featuresAscites, variceal bleeding, or hepatic encephalopathy are examples of decompensated cirrhosis.

Coverage impactPresence of decompensated cirrhosis excludes use and is a criterion for denial or non‑recommendation of therapy.

Documentation Required

Required Documentation for Initial Authorization

For initial authorization, submit documentation confirming the diagnosis of primary biliary cholangitis (PBC), baseline laboratory evidence, prior UDCA therapy or intolerance, and prescriber specialty. Requests lacking required documentation may be denied.

Age: Member is ≥18 years
PBC diagnosis: Documentation meeting at least two of the following: (1) Biochemical cholestasis with elevated ALP for ≥6 months; (2) Positive antimitochondrial antibody (AMA) titer >1:40 or PBC-specific ANA (eg, anti-gp210, anti-sp100); (3) Histologic evidence on liver biopsy consistent with PBC
Baseline ALP: Elevated serum ALP prior to initiation
UDCA history: Documentation of ≥12 months of prior UDCA/ursodiol at 13–15 mg/kg/day with inadequate response, or documentation of UDCA intolerance
Prescriber: Prescribed by or in consultation with a hepatologist or gastroenterologist
No decompensated cirrhosis: Documentation that member does not have ascites, variceal bleeding, hepatic encephalopathy, or other signs of decompensation
Concomitant therapy: Plan to continue UDCA/ursodiol if previously effective
Concomitant drugs: Statement that Iqirvo/Livdelzi will not be used concurrently with Ocaliva