Iqirvo (elafibranor) — Highmark
primary biliary cholangitis (i.e., primary biliary cirrhosis)
Initial criteria
- age ≥ 18 years
- diagnosis of primary biliary cholangitis (ICD-10: K74.3)
- member has experienced therapeutic failure to ursodiol monotherapy defined by one (1) of the following: (a) Alkaline phosphatase (ALP) level ≥ 1.67 times the upper limit of normal (ULN) after at least 12 months of ursodiol therapy OR (b) Total bilirubin level > 1 to 2 times the ULN after at least 12 months of ursodiol therapy OR member has experienced contraindication or intolerance to ursodiol monotherapy
- drug will be used in combination with ursodiol unless ursodiol is contraindicated or not tolerated
Reauthorization criteria
- positive clinical response defined by one (1) of the following: (1) ALP level < 1.67 times the ULN OR (2) Total bilirubin level < ULN
- member requires additional therapy with Iqirvo, Livdelzi or Ocaliva
- drug will be used in combination with ursodiol unless ursodiol is contraindicated or not tolerated
Approval duration
12 months