Subject: Iqirvo SGM 6531-A P2026

Drug

IQIRVO  (elafibranor)

Policy:

Indications

The indications below including FDA-approved indications and compendial uses are considered a covered benefit provided that all the approval criteria are met and the member has no exclusions to the prescribed therapy.

FDA-approved Indications¹

Iqirvo is indicated for the treatment of primary biliary cholangitis (PBC) in combination with ursodeoxycholic acid (UDCA) in adults who have an inadequate response to UDCA, or as monotherapy in patients unable to tolerate UDCA.

This indication is approved under accelerated approval based on a reduction in alkaline phosphatase (ALP). Improvement in survival or prevention of liver decompensation events have not been demonstrated. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s).

Limitations of Use

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

All other indications are considered experimental/investigational and not medically necessary.

Documentation

Submission of the following information is necessary to initiate the prior authorization review:

·        Initial requests:

§  Pretreatment serum alkaline phosphatase (ALP) level.

§  Chart notes, medical record documentation, or claims history supporting previous medications tried (if applicable), including response to therapy. If therapy is not advisable, documentation of clinical reason to avoid therapy.

·        Continuation requests: Current serum alkaline phosphatase (ALP) and/or current total bilirubin level.

Exclusions

Coverage will not be provided for members who have or develop decompensated cirrhosis (e.g., ascites, variceal bleeding, hepatic encephalopathy).

Prescriber Specialties

This medication must be prescribed by or in consultation with a hepatologist or gastroenterologist.

Coverage Criteria

Primary Biliary Cholangitis (PBC)^1-3

Authorization of 12 months may be granted for treatment of PBC in adult members when all of the following criteria are met:

·        Diagnosis of PBC is confirmed by at least two of the following criteria:

§  Biochemical evidence of cholestasis with elevation of alkaline phosphatase (ALP) level for at least 6 months duration.

§  Presence of antimitochondrial antibodies (AMA) (titer >1:40 by immunofluorescence or immunoenzymatic reactivity) or PBC-specific antinuclear antibodies (ANA) (e.g., anti-gp210, anti-sp100).

§  Histologic evidence of PBC on liver biopsy (e.g., non-suppurative inflammation and destruction of interlobular and septal bile ducts).

·        Member has an elevated pretreatment serum ALP level.

·        Member meets either of the following criteria:

§  Member has had an inadequate response to at least 12 months of prior therapy with ursodeoxycholic acid (UDCA)/ursodiol and the member will continue concomitant therapy with UDCA/ursodiol.

§  Member has an intolerance to UDCA/ursodiol.

Continuation of Therapy¹

Authorization of 12 months may be granted for adult members who have achieved or maintained a clinical benefit from therapy with the requested drug (e.g., at least a 15% reduction in ALP level, ALP level less than 1.67 times upper limit of normal [ULN], total bilirubin less than or equal to ULN).

Place of Service:

Outpatient

The above policy is based on the following references:

1.      Iqirvo [package insert]. Cambridge, MA: Ipsen Biopharmaceuticals, Inc.; June 2024.

2.     Lindor KD, Bowlus CL, Boyer J, Levy C, Mayo M. Primary biliary cholangitis: 2018 Practice guidance from the American Association for the Study of Liver Diseases. Hepatology. 2019;69(1):394-419. doi: 10.1002/hep.30145.

3.     European Association for the Study of the Liver (EASL). EASL clinical practice guidelines: The diagnosis and management of patients with primary biliary cholangitis. J Hepatol. 2017;67(1):145-172. doi: 10.1016/j.jhep.2017.03.022.

Copyright Aetna Inc. All rights reserved. Pharmacy Clinical Policy Bulletins are developed by Aetna to assist in administering plan benefits and constitute neither offers of coverage nor medical advice. This Clinical Policy Bulletin contains only a partial, general description of plan or program benefits and does not constitute a contract. Aetna does not provide health care services and, therefore, cannot guarantee any results or outcomes. Participating providers are independent contractors in private practice and are neither employees nor agents of Aetna or its affiliates. Treating providers are solely responsible for medical advice and treatment of members. This Clinical Policy Bulletin may be updated and therefore is subject to change.

October 03, 2026