CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Iqirvo (elafibranor) and Livdelzi (seladelpar) for Primary Biliary Cholangitis

Covers authorization criteria for use of Iqirvo and Livdelzi to treat adults with primary biliary cholangitis (PBC) under Medicaid when approval criteria are met and no exclusions exist.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyIqirvo (elafibranor) and Livdelzi (seladelpar) for Primary Biliary Cholangitis

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateFeb 1, 2025

Next Review DateNov 1, 2024

Key ActionObtain prior authorization for a 6-month initial approval and document PBC diagnosis, baseline ALP, specialist involvement, and prior UDCA treatment or intolerance.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

6 monthsauthorization duration

>=18minimum age

>=12 monthsrequired prior UDCA

15% / <1.67x ULNALP response for continuation

Coverage Criteria for Iqirvo (elafibranor) and Livdelzi (seladelpar)

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Initial therapy for PBC

Authorization of 6 months may be granted when ALL of the following are met:

Initial authorization criteria

Age requirement: Member is 18 years of age or older
Diagnostic confirmation (any 2 of 3): Diagnosis of PBC confirmed by at least two of: 1) Biochemical evidence of cholestasis with elevation of alkaline phosphatase (ALP) 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.
Baseline ALP: Documentation of an elevated serum ALP level prior to initiation of therapy
Specialist involvement: Medication prescribed by or in consultation with a hepatologist or gastroenterologist
No decompensated cirrhosis: Member does not have decompensated cirrhosis (e.g., ascites, variceal bleeding, hepatic encephalopathy)
UDCA treatment history: Either inadequate response to at least 12 months of prior UDCA/ursodiol at 13–15 mg/kg/day with continued concomitant UDCA, or intolerance to UDCA/ursodiol13-15 mg/kg/day for ≥12 months
If inadequate response, UDCA should be continued concomitantly
No concomitant use with Ocaliva: Member will not be using Iqirvo, Livdelzi and/or Ocaliva concomitantly

Operational note: Initial approvals granted for 6 months when all listed diagnostic, specialist, and prior therapy criteria are met.

Continuation of therapy

Authorization of 6 months may be granted when ALL of the following are met:

Continuation criteria

Demonstrated clinical benefit (ALP): Evidence of benefit demonstrated by any of: at least a 15% reduction in serum ALP; serum ALP < 1.67 × ULN; or normalization of ALP (with ALP measurement within the last 6 months).ALP measured within last 6 months
Specialist involvement: Medication prescribed by or in consultation with a hepatologist or gastroenterologist
No decompensated cirrhosis: Member has not developed decompensated cirrhosis (e.g., ascites, variceal bleeding, hepatic encephalopathy)

All indications for Iqirvo (elafibranor) and Livdelzi (seladelpar) other than treatment of primary biliary cholangitis (PBC) are considered experimental/investigational and not medically necessary. Requests for use outside of the approved PBC indication will be denied unless supported by specific coverage language elsewhere in policy or by an approved exception process.

Use of Iqirvo or Livdelzi in patients who have or develop decompensated cirrhosis (for example, ascites, variceal bleeding, or hepatic encephalopathy) is not recommended / considered not appropriate and will be treated as not medically necessary. Other non‑PBC indications are likewise not medically necessary.

Clinical Thresholds and Dosing Requirements

ALP response thresholds for continuation

ALP response — percent reductionAt least a 15% reduction in serum ALP (measured within the last 6 months)

ALP response — multiple of ULNSerum ALP level less than 1.67 × ULN (measured within the last 6 months)

ALP response — normalizationNormalization of ALP (with ALP measurement within the last 6 months)

UDCA dosing requirement

UDCA dosing range13–15 mg/kg/day

Minimum duration of UDCA therapyAt least 12 months

UDCA contextRequired as prior therapy for inadequate response evaluation; when inadequate response, UDCA should be continued concomitantly

Prior Authorization, Documentation, and Denial Risk

Prior Authorization

Prior authorization required

Prior authorization is required for Iqirvo (combination therapy) and Livdelzi for treatment of primary biliary cholangitis (PBC). Initial approvals are granted for 6 months when all listed diagnostic, specialist, and prior therapy criteria are met. Prescriptions must be by or in consultation with a hepatologist or gastroenterologist.

Initial authorization duration: 6 months
Prescriber requirement: hepatologist or gastroenterologist
Concomitant use restriction: member must not be using Iqirvo, Livdelzi, and/or Ocaliva concurrently

Prior Authorization

Required trial of UDCA (ursodiol)

Members must have had at least 12 months of prior therapy with ursodeoxycholic acid (UDCA/ursodiol) at the recommended dose of 13–15 mg/kg/day unless the member is intolerant to UDCA. If UDCA response is inadequate after this trial, documentation of ongoing or planned concomitant UDCA use with the requested agent is required.

Required UDCA trial: >= 12 months at 13–15 mg/kg/day unless intolerant
If inadequate response, member should continue concomitant UDCA/ursodiol when starting Iqirvo or Livdelzi

Documentation Required

Documentation requirements

Provide documentation confirming the diagnosis of PBC, baseline laboratory values, prior UDCA therapy, and other supporting records before initiating therapy.

Diagnosis of PBC must be confirmed by at least two of: (1) biochemical cholestasis with elevated ALP for ≥6 months, (2) presence of antimitochondrial antibodies (AMA) or PBC-specific ANAs (e.g., anti-gp210, anti-sp100), (3) histologic evidence on liver biopsy
Document baseline elevated serum alkaline phosphatase (ALP) level prior to initiation
Document prior UDCA/ursodiol therapy (duration and dose) or intolerance to UDCA
Provide recent ALP level (within 6 months) for continuation requests demonstrating clinical benefit (e.g., ≥15% ALP reduction, ALP <1.67× ULN, or normalization)

Denial Risk

Provider documentation and denial risk

Requests may be denied if required diagnostic criteria or documentation are missing, if the member has decompensated cirrhosis, or if exclusion criteria are met. Ensure all required lab values, specialist consultation notes, and prior therapy records are included to avoid denials.

Denial may occur if diagnosis of PBC is not documented by ≥2 diagnostic criteria
Denial may occur if baseline elevated ALP prior to initiation is not provided
Denial if member has decompensated cirrhosis (e.g., ascites, variceal bleeding, hepatic encephalopathy)
Denial if member will be using Iqirvo, Livdelzi, and/or Ocaliva concomitantly

Key Definitions

Inadequate response to UDCA

DefinitionLack of sufficient biochemical response after at least 12 months of UDCA therapy at 13–15 mg/kg/day (documented elevated ALP prior to initiation)

Documentation requiredElevated serum ALP level documented prior to initiation of the requested drug

Therapy implicationIf inadequate response, member must continue concomitant UDCA when initiating Iqirvo or Livdelzi

Decompensated cirrhosis

Key clinical featuresClinical features include ascites, variceal bleeding, or hepatic encephalopathy

Treatment recommendationUse of Iqirvo or Livdelzi is not recommended in patients who have or develop decompensated cirrhosis

Authorization impactRequests may be denied if member has decompensated cirrhosis

Background and Indications

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 patients intolerant to UDCA. These approvals are under accelerated approval based on reductions in alkaline phosphatase (ALP); improvement in survival or prevention of liver decompensation has not been demonstrated. Authorization under this policy is available when the documented diagnostic, prior‑therapy, and monitoring criteria are met, and prior authorization is required for initial and continuation therapy (authorizations may be granted for 6 months when criteria are satisfied).