WHA

IQIRVO (elafibranor) 

Self-Administration-oral tablets

Diagnosis considered for coverage:

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

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

Coverage Criteria:

For diagnosis of PBC:

  • Diagnosis of primary biliary cholangitis (PBC) (also known as primary biliary cirrhosis); AND

  • ONE of the following: 

    • BOTH of the following: 

      • Patient has failed to achieve an alkaline phosphatase (ALP) level of less than 1.67 times the upper limit of normal (ULN) after at least 12 consecutive months of treatment with ursodeoxycholic acid (UDCA) (e.g., Urso, Urso Forte, ursodiol) 

      • Used in combination with ursodeoxycholic acid (UDCA) OR

    • History of contraindication or intolerance to ursodeoxycholic acid (UDCA); AND

  • Requested drug will not be used in combination with Ocaliva (obeticholic acid); AND

  • Prescribed by or in consultation with a hepatologist or gastroenterologist 

Reauthorization Criteria:

For diagnosis of PBC:

  • Patient demonstrates positive clinical response to therapy (e.g., ALP level less than 1.67 times ULN, total bilirubin less than or equal to ULN, ALP decrease greater than or equal to 15% from baseline); AND

  • Requested drug will not be used in combination with Ocaliva (obeticholic acid)

Coverage Duration:

  • Initial: 6 months

  • Reauthorization: 1 year

Dosing:

For diagnosis of PBC:

  • The recommended dosage is 80 mg orally once daily with or without food.

  • Before treatment, evaluate for muscle pain or myopathy, and/or verify that females of reproductive potential are not pregnant.

  • Interrupt treatment if liver tests worsen, or patients develop signs and symptoms consistent with clinical hepatitis.

Authorization is not covered for the following:

  • The use of this drug for indications not listed in this policy does not meet the coverage criteria established by the Western Health Advantage (WHA) Pharmacy and Therapeutics (P&T) Committee

Additional Information: 

  • UDCA was the only available FDA-approved drug for the treatment of PBC until the May 2016 approval of obeticholic acid (Ocaliva), a farnesoid X receptor (FXR) agonist for patients with PBC and an inadequate response or intolerance to UDCA.

  • The second agent to receive approval for the subsequent treatment of PBC was elafibranor (Iqirvo), a peroxisome proliferator-activated receptor (PPAR) agonist, in June 2024. 

  • UDCA 13 to 15 mg/kg/day is recommended for patients with PBC who have abnormal liver enzyme values for all histologic stages.

  • Biochemical response should be assessed after 1 year of treatment with UDCA.

  • Monitor patients with cirrhosis for evidence of decompensation. Consider discontinuation if patient progresses to moderate or severe hepatic impairment (Child-Pugh B or C).

Policy Updates:

  • 12/01/2024 – New policy for Iqirvo approved by WHA P&T Committee. (P&T, 11/20/2024)

References:

  1. Iqirvo Prescribing Information. Ipsen Biopharmaceuticals, Inc. Cambridge, MA. June 2024. 

  2. Lindor, Keith D.*,1; Bowlus, Christopher L.2; Boyer, James3; Levy, Cynthia4; Mayo, Marlyn5. Primary Biliary Cholangitis: 2018 Practice Guidance from the American Association for the Study of Liver Diseases. Hepatology 69(1):p 394-419, January 2019. | DOI: 10.1002/hep.30145

Last review date: December 1, 2024