Livdelzi (seladelpar) — Medica

Initial criteria

• age ≥ 18 years
• Diagnosis of primary biliary cholangitis defined by TWO of the following: alkaline phosphatase elevated above upper limit of normal; positive anti‑mitochondrial antibodies or other PBC‑specific autoantibodies including sp100 or gp210 if anti‑mitochondrial antibodies are negative; or histologic evidence of primary biliary cholangitis from liver biopsy
• Patient has been receiving ursodiol therapy for ≥ 1 year and has had an inadequate response according to the prescriber OR patient is unable to tolerate ursodiol therapy
• Patient does not currently have, or have a history of, a hepatic decompensation event (e.g., ascites, gastroesophageal varices, variceal bleeding, hepatic encephalopathy, coagulopathy)
• Medication is 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, a hepatic decompensation event (e.g., ascites, gastroesophageal varices, variceal bleeding, hepatic encephalopathy, coagulopathy)
• Patient has demonstrated a response to therapy as determined by the prescriber (e.g., improved biochemical markers such as alkaline phosphatase, bilirubin, gamma‑glutamyl transpeptidase, aspartate aminotransferase, alanine aminotransferase)

Approval duration

Initial: 6 months; Reauthorization: 1 year