CurrentCentenePolicy CP PHAR.688

Elafibranor (Iqirvo) for Primary Biliary Cholangitis

Defines medical necessity criteria, prior authorization requirements, dosing limits, and continuation criteria for Iqirvo (elafibranor) for treatment of primary biliary cholangitis (PBC) for Centene lines of business (Commercial, HIM, Medicaid).

Policy Summary

PayerCentene

PolicyElafibranor (Iqirvo) for Primary Biliary Cholangitis

Policy CodePolicy CP PHAR.688

Change TypeAnnual review — no significant changes

Effective DateSep 1, 2024

Next Review DateSep 30, 2025

Key ActionProvider must submit office chart notes and lab results (baseline and on-treatment ALP) and documentation of prior ursodiol use/failure and specialist prescribing/consultation to support approval.

POLICY UPDATE CHANGES

Policy created 06.02.24; P&T Approval Date 08.24; 3Q 2025 annual review: no significant changes; clarified UDCA is ursodiol; references reviewed and updated (05.06.25); P&T Approval Date 08.25.

1Covered Indication (PBC)

80 mg/dayMaximum Dose

12 monthsRequired ursodiol trial

1.67 x ULNALP failure threshold

Coverage Summary

Iqirvo (elafibranor) is a PPAR agonist approved under accelerated approval for the treatment of primary biliary cholangitis (PBC) in adults: in combination with ursodeoxycholic acid (UDCA/ursodiol) for those with inadequate response to UDCA, or as monotherapy for UDCA‑intolerant patients. Continued approval may be contingent on confirmatory trial(s) to verify clinical benefit; improvement in survival or prevention of liver decompensation has not been demonstrated. The policy defines medical necessity, prior authorization and specialist prescriber requirements, dosing limits, and continuation criteria for Centene lines of business (Commercial, HIM, Medicaid).

Initial Approval Criteria

Iqirvo is medically necessary when ALL of the following are met:

ALL of the following

Diagnosis of primary biliary cholangitis (PBC)
Prescribed by or in consultation with a hepatologist or gastroenterologist
Age is >= 18 years
Failure of a >= 12 month trial of ursodiol (ursodeoxycholic acid) at a dose >= 13 mg/kg/day, evidenced by sustained elevation in alkaline phosphatase (ALP) >= 1.67 times the upper limit of normal (ULN), unless ursodiol is contraindicated or clinically significant adverse effects are experiencedALP >= 1.67 x ULN; ursodiol >= 12 months at >= 13 mg/kg/day
Prescribed in combination with ursodiol, unless ursodiol is contraindicated or clinically significant adverse effects are experienced
Dose does not exceed 80 mg (1 tablet) per day<= 80 mg/day

Approval Duration (Initial)

Approval duration for initial authorization: 6 months6 months

Continuation Therapy Criteria

Continuation (Reauthorization) Criteria

Member must meet one of the following (A or B) and show response:

ANY of the following

A
- A.1: Member is currently receiving medication via Centene benefit OR member has previously met initial approval criteria
- A.2: Member is responding positively to therapy as evidenced by reduction in ALP level from pretreatment baseline (initial reauthorization)reduction in ALP from pretreatment baseline
B
- B.1: Member is currently receiving medication and is enrolled in a state and product with continuity of care regulations (refer to state specific addendums CCPHARM.03A and CCPHARM.03B)
- B.2: For subsequent reauthorization: continued reduction or maintenance of the initial reduction in ALP levelmaintenance of initial ALP reduction

If request is for a dose increase, new dose does not exceed 80 mg (1 tablet) per day<= 80 mg/day

Approval Duration (Continuation)

Approval duration for reauthorization: 12 months12 months

Other / Exclusions

Other/Off-Label Uses

Coverage for other diagnoses or indications:

For uses not listed or newly approved indications not yet reflected in this policy, refer to formulary/no coverage/off-label policies for the relevant line of business as specified (CP.CPA.190, HIM.PA.103, CP.PMN.16, HIM.PA.33, CP.PMN.255, CP.CPA.09, HIM.PA.154, CP.PMN.53).

Diagnoses/Indications Not Authorized

Non-FDA approved indications not addressed in this policy are not authorized unless sufficient documentation for off-label use is provided per referenced off-label use policies

Provider Actions & Authorization Requirements

Prior Authorization

Submit documentation to support approval criteria

Submit office chart notes, baseline and on-treatment alkaline phosphatase (ALP) lab results, and other clinical information demonstrating the diagnosis of primary biliary cholangitis (PBC). Include documentation of prior ursodiol (UDCA) use and evidence of ursodiol failure or intolerance (e.g., sustained ALP elevation ≥ 1.67 × ULN after ≥ 12 months of ursodiol at ≥ 13 mg/kg/day). Provide evidence that the prescription is by a specialist or was issued in consultation with a hepatologist or gastroenterologist (e.g., consultation note, co-signature, or referral documentation).

Office chart notes
Baseline and on-treatment ALP lab results
Documentation of prior ursodiol (UDCA) use and failure/intolerance (≥ 12 months at ≥ 13 mg/kg/day; ALP ≥ 1.67 × ULN)
Specialist prescribing or consultation evidence (hepatologist/gastroenterologist notes)

Documentation Required

Specialist involvement requirement

Prescriptions must be written by a hepatologist or gastroenterologist or written in consultation with one. Provide documentation of the specialist involvement with the request (for example, a consultation note, specialist prescription, or documented discussion/co-signature).

Specialist prescription or consultation note
Documentation of consultation (co-signature, referral, or clinical note)

Billing Rule

Dose limit enforcement

Dose increases or dosing requests that exceed 80 mg per day (more than one 80 mg tablet) are not authorized. Ensure submitted dosing and claim information do not exceed the maximum allowed daily dose of 80 mg.

Maximum authorized dose: 80 mg/day (1 tablet)

Prior Authorization

Reauthorization lab documentation

For reauthorization, provide ALP lab results demonstrating response: for initial reauthorization, a reduction in ALP from the pretreatment baseline; for subsequent reauthorizations, continued reduction or maintenance of the initial ALP reduction. Include the pretreatment baseline ALP and on-treatment values to show the change.

Pretreatment baseline ALP
On-treatment ALP demonstrating reduction (initial reauthorization) or maintenance of reduction (subsequent reauthorization)

Clinical Evidence & Definitions

Accelerated approval was granted based on reduction of alkaline phosphatase (ALP); improvement in survival or prevention of liver decompensation events has not been demonstrated and continued approval may depend on confirmatory trials.

In the pivotal PBC clinical trial the composite response was defined as: ALP < 1.67 x ULN, total bilirubin ≤ ULN, and an ALP decrease ≥ 15%.

Glossary:

ALP — alkaline phosphatase.

UDCA (ursodiol) — ursodeoxycholic acid (ursodiol).

ULN — upper limit of normal.

PBC — primary biliary cholangitis.

Policy Revision History

2024-06-02policy_created

Policy created (Policy created, Date = 06.02.24).

2024-08-24pt_approval

P&T Approval Date (P&T Approval Date = 08.24).

2025-05-06annual_review_references_updated

3Q 2025 annual review: references reviewed and updated; clarified UDCA is ursodiol; no significant clinical policy statement changes (references reviewed and updated, Date = 05.06.25).

2025-08-25pt_approvalLatest

P&T Approval Date for 3Q 2025 annual review (P&T Approval Date = 08.25).