CurrentMass General Brigham Health PlanPolicy N/A

PPAR agonists (Iqirvo, Livdelzi) for primary biliary cholangitis

Prior authorization policy for the pharmacy benefit coverage of PPAR agonists Iqirvo (elafibranor) and Livdelzi (seladelpar) for treatment of primary biliary cholangitis (PBC) in commercially insured members.

Policy Summary

PayerMass General Brigham Health Plan

PolicyPPAR agonists (Iqirvo, Livdelzi) for primary biliary cholangitis

Policy CodePolicy N/A

Change TypeAdded product (Livdelzi) and title update

Effective DateApr 1, 2025

Next Review DateN/A

Key ActionSubmit prior authorization through the pharmacy benefit with documentation of PBC diagnosis, ≥12 months UDCA trial or intolerance, specialist involvement, and baseline/follow-up labs.

SourceLink

POLICY UPDATE CHANGES

Added Livdelzi (seladelpar) to the policy and updated the policy title to 'PPAR Agonists.'

2drugs covered by policy

12 monthsinitial and reauthorization approval duration

1/dayquantity limit per drug

12 monthsminimum UDCA trial

Commercial/Exchange

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Coverage Criteria for PPAR Agonists (Iqirvo, Livdelzi)

Initial Therapy

Authorization may be granted when ALL of the following are met:

Initial approval criteria: 1. Diagnosis of primary biliary cholangitis (PBC) confirmed by at least two of: (a) biochemical evidence of cholestasis with elevated alkaline phosphatase (ALP); (b) presence of antimitochondrial antibodies (AMA) or PBC-specific antinuclear antibodies (ANA) (e.g., anti-gp210, anti-sp100); (c) histologic evidence of PBC on liver biopsy (e.g., non-suppurative inflammation and destruction of interlobular and septal bile ducts).two of the three diagnostic criteria

UDCA treatment requirement: 2. Inadequate response to ursodeoxycholic acid (UDCA) after at least 12 months of therapy (recommended dose 13–15 mg/kg/day), OR documented intolerance or contraindication to UDCA.>= 12 months or intolerance

Cirrhosis exclusion: 3. Member does not have decompensated cirrhosis (e.g., ascites, variceal bleeding, hepatic encephalopathy).absence of decompensation

Prescriber specialty: 4. Medication prescribed by or in consultation with a gastroenterologist or hepatologist.specialist involvement

Drug-specific combination prohibitions: 5a. For Iqirvo (elafibranor): will not be used in combination with obeticholic acid or seladelpar. 5b. For Livdelzi (seladelpar): will not be used in combination with obeticholic acid or elafibranor.no concurrent listed agents

drug-specific

Continuation Therapy

Requests for reauthorization will be approved when ALL of the following criteria are met:

Demonstrated response: 1. Member has demonstrated a positive response to therapy as indicated by at least one of the following: (a) ALP < 1.67 x ULN; (b) total bilirubin <= ULN; (c) ALP decrease >= 15% from baseline.one of three labs criteria

response at reauthorization

Ongoing combination prohibitions: 2. Ongoing avoidance of prohibited combinations: Iqirvo not used with obeticholic acid or seladelpar; Livdelzi not used with obeticholic acid or elafibranor.no concurrent listed agents

These agents are not recommended for use in patients who have or develop decompensated cirrhosis. Examples of decompensating complications include ascites, variceal bleeding, and hepatic encephalopathy. Presence of any of these findings should contraindicate initiation or continuation of Iqirvo (elafibranor) or Livdelzi (seladelpar) per the policy.

Clinical Thresholds and Coding-related Values

ALP and bilirubin response thresholds for continuation

ALP thresholdALP < 1.67 x ULN

Total bilirubin thresholdTotal bilirubin ≤ ULN

Relative ALP improvementALP decrease ≥ 15% from baseline

UDCA trial duration

Minimum UDCA trial duration>= 12 months

Recommended UDCA dose13-15 mg/kg/day

Alternative to trialDocumented intolerance or contraindication to UDCA

Provider Actions, Prior Authorization and Documentation

Prior Authorization

Prior Authorization Required

Prior authorization is required through the pharmacy benefit for Commercial/Exchange members. Authorization may be granted for members new to the plan within the last 90 days who are currently receiving treatment with the requested medication (excluding product obtained as samples or via manufacturer patient assistance programs). Specialty designation applies — medication must be filled at a contracted specialty pharmacy.

Commercial/Exchange: Prior authorization through pharmacy benefit required
Members new to plan within 90 days may be eligible if currently receiving treatment (excluding samples or manufacturer assistance)
Medication is specialty — must be dispensed by a contracted specialty pharmacy
Pharmacy Benefit Contact: Phone 800-711-4555, Fax 844-403-1029

Step Therapy

Step Therapy Status

No step therapy program is designated for these agents in this policy.

Key Definitions

Inadequate response to UDCA

Required UDCA exposureAt least 12 months of UDCA therapy (recommended 13-15 mg/kg/day) prior to deeming response inadequate

Insufficient biochemical responseFailure to achieve therapeutic biochemical endpoints (per policy) after the UDCA trial

ExceptionDocumented intolerance or contraindication to UDCA can substitute for trial requirement

Decompensated cirrhosis

DefinitionDecompensated cirrhosis: presence of complications such as ascites, variceal bleeding, or hepatic encephalopathy

Coverage implicationAgents are not recommended in patients who have or develop decompensated cirrhosis

Background

Iqirvo (elafibranor) and Livdelzi (seladelpar) are peroxisome proliferator-activated receptor (PPAR) agonists indicated for the treatment of primary biliary cholangitis (PBC) in adults who have an inadequate response to ursodeoxycholic acid (UDCA) when used in combination with UDCA, or as monotherapy for patients who cannot tolerate UDCA. Both agents carry the same recommendation against use in patients with decompensated cirrhosis (for example, those with ascites, variceal bleeding, or hepatic encephalopathy).

Policy Summary

PayerMass General Brigham Health Plan

PolicyPPAR agonists (Iqirvo, Livdelzi) for primary biliary cholangitis

Policy CodePolicy N/A

Change TypeAdded product (Livdelzi) and title update

Effective DateApr 1, 2025

Next Review DateN/A

Key ActionSubmit prior authorization through the pharmacy benefit with documentation of PBC diagnosis, ≥12 months UDCA trial or intolerance, specialist involvement, and baseline/follow-up labs.

SourceLink

On This Page

Documentation Required

Required Documentation

Documentation should include evidence supporting the diagnosis of primary biliary cholangitis (PBC), prior ursodeoxycholic acid (UDCA) treatment, and specialist involvement.

Evidence of PBC: at least two of the following — (a) ALP elevation indicating cholestasis; (b) presence of antimitochondrial antibodies (AMA) or PBC-specific ANA (e.g., anti-gp210, anti-sp100); (c) histologic liver biopsy consistent with PBC
Prior UDCA therapy: documentation of at least 12 months of UDCA (recommended 13–15 mg/kg/day) with inadequate response, or documentation of UDCA intolerance/contraindication
Prescriber documentation: prescribed by or in consultation with a gastroenterologist or hepatologist
Specialty dispensing documentation if applicable

Denial Risk

Triggers for Denial

Denial may be triggered when the coverage criteria are not met or required documentation is absent.

Diagnosis of PBC not supported by at least two diagnostic criteria (ALP elevation, AMA/PBC-specific ANA, or liver biopsy)
No documentation of at least 12 months of UDCA therapy without inadequate response, and no evidence of UDCA intolerance/contraindication
Requested agent prescribed by a non-specialist without documented consultation with a gastroenterologist or hepatologist
Use in the setting of decompensated cirrhosis
Concurrent use of contraindicated combination therapies (Iqirvo with obeticholic acid or seladelpar; Livdelzi with obeticholic acid or elafibranor)
Requests for non-specialty dispensing when medication is designated specialty

AssessmentDocument absence of these complications before approval and on an ongoing basis