Ocaliva (obeticholic acid tablets) — Cigna

Primary Biliary Cholangitis

Initial criteria

Patient age ≥ 18 years; AND
According to the prescriber, the patient has a diagnosis of primary biliary cholangitis as defined by TWO of the following (TWO of a, b, or c): a) Alkaline phosphatase elevated above the upper limit of normal; 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) According to the prescriber, the patient has been receiving ursodiol therapy for ≥ 1 year and has had an inadequate response; OR b) According to the prescriber, the patient is unable to tolerate ursodiol therapy; AND
Patient meets ONE of the following (a or b): a) Patient does not have cirrhosis; OR b) Patient has compensated cirrhosis without evidence of portal hypertension (e.g., ascites, gastroesophageal varices, persistent thrombocytopenia); AND
Medication is prescribed by or in consultation with a gastroenterologist, hepatologist, or liver transplant physician.

Patient meets ONE of the following (a or b): a) Patient does not have cirrhosis; OR b) Patient has compensated cirrhosis without evidence of portal hypertension (e.g., ascites, gastroesophageal varices, persistent thrombocytopenia); AND
Patient has responded to Ocaliva as determined by the prescriber (e.g., improved biochemical markers of primary biliary cholangitis such as ALP, bilirubin, GGT, AST, ALT).

initial: 6 months; reauth: 1 year