Iqirvo (elafibranor) — Medica
Primary biliary cholangitis (PBC)
Initial criteria
- age ≥ 18 years
- Diagnosis of primary biliary cholangitis defined by TWO of the following: alkaline phosphatase elevated above the upper limit of normal OR positive anti-mitochondrial antibodies or other PBC-specific autoantibodies (sp100, gp210) if anti-mitochondrial antibodies are negative OR histologic evidence of PBC from a liver biopsy
- ONE of the following: has been receiving ursodiol therapy for ≥ 1 year with inadequate response according to the prescriber OR is unable to tolerate ursodiol therapy
- Patient does not currently have, or have a history of, hepatic decompensation (examples: ascites, gastroesophageal varices, variceal bleeding, hepatic encephalopathy, coagulopathy)
- Prescribed by or in consultation with a gastroenterologist, hepatologist, or liver transplant physician
Reauthorization criteria
- Patient does not currently have, or have a history of, hepatic decompensation (examples: ascites, gastroesophageal varices, variceal bleeding, hepatic encephalopathy, coagulopathy)
- Patient has demonstrated a response to therapy as determined by the prescriber (examples: improved biochemical markers such as ALP, bilirubin, GGT, AST, ALT)
Approval duration
Initial: 6 months; Reauthorization: 1 year