CurrentmhnPolicy CP.PHAR.688

Elafibranor (Iqirvo) for primary biliary cholangitis

Defines medical necessity criteria, dosing, and prior authorization requirements for Iqirvo (elafibranor) for treatment of primary biliary cholangitis (PBC) for adult members under Centene-affiliated health plans.

Policy Summary

Payermhn

PolicyElafibranor (Iqirvo) for primary biliary cholangitis

Policy CodePolicy CP.PHAR.688

Change TypeMinor technical update / no material changes

Effective DateSep 1, 2024

Next Review DateN/A

Key ActionObtain prior authorization with documentation of PBC diagnosis, prescriber specialty, age ≥18, and a ≥12-month UDCA trial with sustained ALP ≥1.67×ULN (or document contraindication).

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

80 mg/daymaximum approved daily dose

6 monthsinitial approval duration

12 monthscontinued therapy approval duration

ALP ≥1.67×ULNUDCA treatment failure definition

≥18minimum patient age

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Coverage Criteria for Elafibranor (Iqirvo)

Initial Therapy

Covered when ALL of the following are met:

PBC Initial Therapy: 1. Diagnosis of primary biliary cholangitis (PBC). 2. Prescribed by or in consultation with a hepatologist or gastroenterologist. 3. Age ≥ 18 years. 4. Failure of a ≥ 12-month trial of ursodiol (UDCA) at a dose of ≥ 13 mg/kg/day, evidenced by sustained elevation in alkaline phosphatase (ALP) ≥ 1.67 times the upper limit of normal (ULN), unless UDCA is contraindicated or not tolerated. 5. Prescribed in combination with ursodiol (UDCA) unless UDCA is contraindicated or not tolerated. 6. Dose does not exceed 80 mg (1 tablet) per day.ALP ≥ 1.67 × ULN; Maximum dose 80 mg/day

Approval duration: 6 months

Continuation Therapy

Covered when ALL of the following are met:

PBC Continued Therapy: 1. Member meets one of the following: (a) currently receiving medication via Centene benefit or previously met initial approval criteria; OR (b) currently receiving medication and enrolled in a state/product with continuity of care regulations. 2. Member is responding positively to therapy as evidenced by: (a) for initial reauthorization: reduction in ALP from pretreatment level; (b) for subsequent reauthorization: continued reduction or maintenance of the initial ALP reduction. 3. If request is for a dose increase, the new dose does not exceed 80 mg (1 tablet) per day.Maximum dose 80 mg/day

Approval duration: 12 months

Other Indications / Label Changes

Other diagnoses/indications:

Other Indications: 1. If the drug underwent a label change within the last 6 months that is not yet reflected in this policy, follow the referenced formulary/non-formulary/no-coverage policies for the relevant line of business (see policy cross-references). 2. If the requested use (diagnosis, age, dosing regimen) is not specifically listed under the policy and criterion 1 does not apply, refer to the off-label use policy for the relevant line of business (e.g., CP.CPA.09 for commercial, HIM.PA.154 for marketplace, CP.PMN.53 for Medicaid).

Requests for non-FDA approved indications not addressed in this policy require sufficient documentation per off-label policies or evidence of coverage.

Non‑FDA approved indications that are not specifically addressed in this policy are not authorized for coverage unless the provider submits sufficient clinical documentation demonstrating efficacy and safety in accordance with the applicable off‑label use policy or evidence of coverage. Refer to the off‑label use policies (e.g., CP.CPA.09 for Commercial, HIM.PA.154 for Marketplace, CP.PMN.53 for Medicaid) for required supporting evidence and submission expectations.

Use of Iqirvo is not recommended in patients who have or develop decompensated cirrhosis (for example, clinical features such as ascites, variceal bleeding, or hepatic encephalopathy). Requests for therapy in members with decompensated liver disease should be carefully evaluated and generally will not meet coverage criteria.

Requests for non‑FDA approved indications that do not include sufficient supporting documentation per the referenced off‑label use policies will be considered not covered. Providers should follow the specific documentation requirements in the applicable off‑label policy when requesting coverage for an off‑label use.

Prior Authorization and Documentation Requirements

Prior Authorization

Prior Authorization Required

Prior authorization required. Provider must obtain prior authorization and submit documentation demonstrating diagnosis of primary biliary cholangitis (PBC), prescriber specialty (hepatologist or gastroenterologist), member age ≥ 18 years, prior ursodiol (UDCA) trial/failure as specified below, and proposed Iqirvo dosing not to exceed 80 mg/day.

Prior authorization required
Prescriber: hepatologist or gastroenterologist
Age ≥ 18 years
Dose limit: ≤ 80 mg (1 tablet) per day
Approval duration: 6 months

Step Therapy

UDCA Trial Required Prior to Iqirvo

Step requirement: Member must have failed a trial of ursodiol (UDCA) prior to initiation of Iqirvo unless UDCA is contraindicated or the member experienced clinically significant adverse effects. Failure is defined as a sustained elevation in alkaline phosphatase (ALP) ≥ 1.67 × ULN after a trial of UDCA at a dose ≥ 13 mg/kg/day for ≥ 12 months. Iqirvo should be prescribed in combination with ursodiol unless contraindicated or not tolerated.

UDCA dose: ≥ 13 mg/kg/day
UDCA duration: ≥ 12 months
Sustained ALP elevation: ≥ 1.67 × ULN
Iqirvo to be used withUDCA unless contraindicated

Documentation Required

Required Clinical Documentation

Provider must submit office chart notes, relevant laboratory results (including alkaline phosphatase and total bilirubin), and any other clinical information that supports the diagnosis of PBC and documents the UDCA trial, dosing, duration, and response (including sustained ALP values). Include documentation of prescriber specialty and rationale if UDCA was contraindicated or discontinued due to adverse effects.

Office chart notes
Laboratory results: ALP and total bilirubin
Documentation of UDCA dose and duration (≥ 13 mg/kg/day for ≥ 12 months)
Prescriber specialty (hepatology or gastroenterology)
If UDCA not used: documentation of contraindication or clinically significant adverse effects

Denial Risk

Documentation Absent or Criteria Unmet — Denial Risk

If documentation is absent or criteria are not met, the request will be denied. Lack of documentation of PBC diagnosis, absence of evidence of the required UDCA trial (dose, duration, and sustained ALP elevation ≥ 1.67 × ULN), missing prescriber specialty, age < 18 years, or proposed dose > 80 mg/day are common reasons for denial. Provide complete supporting records to avoid delay or denial.

Denial risks: missing PBC diagnosis, missing UDCA trial evidence, inadequate UDCA dose/duration, no sustained ALP documentation, prescriber not specialist, age < 18, proposed dose > 80 mg/day
If off-label indication is requested, provide evidence per off-label use policies (CP.CPA.09, HIM.PA.154, CP.PMN.53)

Definitions and Diagnostic Criteria

Primary biliary cholangitis (PBC) diagnostic criteria

Diagnostic ruleDiagnosis of PBC can be established when two of the following three criteria are met

Criterion 1Elevated alkaline phosphatase (ALP) above the laboratory upper limit of normal (per lab reference)

Criterion 2Positive anti-mitochondrial antibodies (AMA) or other PBC-specific autoantibodies (e.g., sp100, gp210) if AMA negative

Criterion 3Histologic evidence of PBC on liver biopsy

UDCA/ursodiol treatment failure

Definition of UDCA treatment failureSustained elevation in alkaline phosphatase (ALP) ≥ 1.67 times the upper limit of normal after ≥12 months of UDCA at ≥13 mg/kg/day

Required UDCA dose and durationUDCA (ursodiol) at ≥13 mg/kg/day for ≥12 months (eligibility in trials required ≥12 months of UDCA)

ExceptionUDCA not required if contraindicated or not tolerated; Iqirvo may be used as monotherapy in those unable to tolerate UDCA per indication

OpenPayer

Elafibranor (Iqirvo) for primary biliary cholangitis

Coverage Criteria for Elafibranor (Iqirvo)

Product Codes and Key Clinical Thresholds

Prior Authorization and Documentation Requirements

Clinical Background

Definitions and Diagnostic Criteria