Livdelzi (seladelpar capsules) — Cigna

Primary Biliary Cholangitis

Initial criteria

Patient age ≥ 18 years; AND
Diagnosis of primary biliary cholangitis defined by TWO of the following: (a) alkaline phosphatase elevated above upper limit of normal; OR (b) positive anti-mitochondrial antibodies or other primary biliary cholangitis-specific autoantibodies (sp100 or gp210) if anti-mitochondrial antibodies are negative; OR (c) histologic evidence of primary biliary cholangitis from liver biopsy; AND
Patient meets ONE of the following: (a) has received ursodiol therapy for ≥ 1 year with inadequate response according to the prescriber; OR (b) unable to tolerate ursodiol therapy; AND
Patient does not currently have, or have a history of, hepatic decompensation event (examples include ascites, gastroesophageal varices, variceal bleeding, hepatic encephalopathy, coagulopathy); AND
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, hepatic decompensation event; AND
Patient has demonstrated a response to therapy as determined by the prescriber (examples include improved biochemical markers such as alkaline phosphatase, bilirubin, gamma-glutamyl transpeptidase, aspartate aminotransferase, alanine aminotransferase)

initial: 6 months; reauth: 1 year