Iqirvo (elafibranor tablets – Ipsen) — Cigna

Primary Biliary Cholangitis

Initial criteria

Patient is age ≥ 18 years; AND
According to the prescriber, the patient has a diagnosis of primary biliary cholangitis as defined by TWO of the following (a, b, or c): a) Alkaline phosphatase is elevated above the upper limit of normal as defined by normal laboratory reference values; OR b) Positive anti-mitochondrial antibodies or other primary biliary cholangitis-specific auto-antibodies, including sp100 or gp210, if anti-mitochondrial antibodies are negative; OR c) Histologic evidence of primary biliary cholangitis from a liver biopsy; AND
Patient meets ONE of the following (a or b): a) Patient has been receiving ursodiol therapy for ≥ 1 year and has had an inadequate response according to the prescriber; OR b) According to the prescriber the patient is unable to tolerate ursodiol therapy; AND
Patient does not currently have, or have a history of, a hepatic decompensation event (examples include ascites, gastroesophageal varices, variceal bleeding, hepatic encephalopathy, and coagulopathy); AND
The medication is prescribed by or in consultation with a gastroenterologist, hepatologist, or liver transplant physician.

Patient does not currently have, or have a history of, a hepatic decompensation event (examples include ascites, gastroesophageal varices, variceal bleeding, hepatic encephalopathy, and coagulopathy); AND
Patient has demonstrated a response to therapy as determined by the prescriber (examples include improved biochemical markers of primary biliary cholangitis such as alkaline phosphatase, bilirubin, gamma-glutamyl transpeptidase, aspartate aminotransferase, or alanine aminotransferase).

initial 6 months; renewal 1 year